W81K0224Q0030 SOW Excelsius GPS.pdf

W81K0224Q0030 Statement of Work For

Excelsius GPS

I. INTRODUCTION

This action is for the procurement of two minimally invasive surgical robot systems for performing delicate spinal surgery within Defense Health Agency (DHA) medical Treatment Facilities (MTF). The contractor shall supply two

(2) spinal robotic systems to support DHA mission requirements. One system to be delivered to Madigan Army Medical Center in Fort Lewis, Washington and one system to be delivered to Mike O’Callaghan Military Medical Center at Nellis Air Force Base, Nevada.

The Excelsius GPS Robotic Navigation System will be utilized in the Sterile Processing Department at the Mike O’Callaghan Federal Hospital (MOFH) at Nellis Air Force Base, NV, and Madigan Army Medical Center (MAMC) at Joint Base Lewis-McChord, WA.

II. BACKGROUND

MOFH and MAMC provides preventative, emergency, and acute care services for approximately 78,000 beneficiaries to include active duty, Guard, Reserve, NATO, retirees, VA, and all eligible dependents. This equipment is needed in the Ortho Spine Program to improve patient care capabilities.

The Excelsius GPS System is a robotic guided spine system with Excelsius surgical instruments that is used to treat multiple spine pathologies. It is used pre-operatively and intra-operatively to plan spinal procedures of both acute and chronic spinal morphology. It is used for both diagnostic and intervention applications, including identification vertebral anatomy and deformities. It can read CT imagery and allows the surgeon to accurately measure disc space to execute surgery in a precise manner avoiding future revisions. This system will be used to assist in the safe and accurate placement of pedicle screws during spine fusion surgeries. It will assist in the placement of minimally invasive (MIS) percutaneous pedicle screws without the use of excessive radiation or the extra cost and steps of using K-Wires, Jamshidis, or cannulated pedicle screws. This system will allow for 100% accuracy of implant placement of spinal cases. This system will facilitate the wider adoption of Minimally Invasive Spine Surgery (MIS) which we believe to be safest and best form of care for our patients.

III. SCOPE

The overall purpose of this requirement is to provide the government delivery of two Excelsius GPS Spine Robot Systems to MAMC and MOFH. The Excelsius GPS Spine Robot will be in the operating room at each facility. The software for this device is included with the procurement of spine robot system.

IV. WORK REQUIREMENTS

The contractor shall deliver, install, and provide training for the Excelsius GPS system to ensure the systems function as designed.

a. The contractor shall provide all equipment, software, and complete the install. Installation will not be marked complete until the contractor submits letter of readiness to inspect, and the COR ensures the system functions as designed.

b. The contractor shall provide Excelsius GPS 101 Surgeon Training, a one-day Excelsius certification training, which includes didactic and cadaveric training. The training shall provide an in-depth cadaver lab experience for the Surgeon to gain experience and knowledge on the system, instruments, and workflows. The training should teach the start-to-finish operations of the Excelsius GPS to include