(244 days)
The Tahoe Unicompartmental Knee System (TUKS) is designed as a system and is not intended for substitution of components from other systems. The indications for use are as follows:
Primary medial or lateral compartmental intervention of (1) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis, or osteonecrosis; (2) posttraumatic degenerative disease; (3) varus or valgus deformities; and (4) damage due to previous surgical intervention when the opposite compartment is preserved and when the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments are present and functional.
All TUKS implants are single use only, and are intended for implantation only with bone cement.
The Tahoe Uni Knee System (TUKS) is a primary fixed-bearing, round-on-flat unicompartmental knee system offering flexibility to restore function in the affected medial or lateral tibial compartments. The femoral and tibial components are intended use only. The femoral component is made from cast CoCr alloy (ASTM F75), whereas the tibial baseplate is made from wrought CoCr alloy (ASTM F1537). The tibial insert is made from UHMWPE (ASTM F648) or Vitamin-E polyethylene (VitalitE, ASTM F2695). The tibial insert is designed to snap into the baseplate via an anterior-posterior locking mechanism.
I am sorry, but the provided text is a document from the FDA related to a 510(k) premarket notification for a medical device (Tahoe Uni Knee System). It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.
The document discusses:
- The product name, classification, and indications for use.
- The device description and its components.
- Substantial equivalence to predicate devices.
- Non-clinical performance data, which includes bench testing, FEA simulations, and engineering justifications for the physical knee implant components, such as fatigue testing and contact characteristics. It mentions "Wear testing was deemed unnecessary due to meeting the minimum requirement for poly thickness in the load bearing region (6mm) per ISO 21536. Pyrogenicity testing was completed and was deemed to be within 20 Endotoxin Units per surgical construct per the FDA Guidance Document Pyrogen and Endotoxins Testing."
This information pertains to the physical characteristics and safety of the knee implant itself, not to the performance or validation of an AI/ML device. Therefore, I cannot extract the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device from this text.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.