(294 days)
The GMK(R) UNI knee prosthesis is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The GMK® UNI is a unicompartmental knee prosthesis. The GMK® UNI is comprised of individually packaged femur and tibial components designed for cemented use in partial knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components. The femoral component is made of cobalt-chromium-molybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal-backed tray component (Co-Cr-Mo per ISO 5832-4). The GMK® UNI system implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.
The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs. Available in six (6) sizes (0 - 5), the femoral component is offered in both Right Medial/Left Lateral (RM-LL) and Left Medial/Right Lateral (LM-RL) options for each size.
The Fixed Tibial Insert has a fixed design and is available in five (5) sizes (1 – 5). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).
The Fixed Plus Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability, and an UHMWPE plug. Available in five (5) sizes (1 – 5), the Fixed Plus Tibial Trays are offered in both Right Medial/Left Lateral (RM-LL) and Left Medial/Right Lateral (LM-RL) options for each size.
This document primarily concerns the 510(k) premarket notification for a medical device, the GMK® UNI knee prosthesis. The core purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to present a study proving the device meets acceptance criteria based on rigorous clinical performance benchmarks for an AI/ML device.
Therefore, I cannot extract the information you requested regarding acceptance criteria and study details in the context of an AI/ML device. The provided text describes the regulatory approval process for a medical implant (knee prosthesis) and focuses on its design, materials, and mechanical performance testing, which is very different from the evaluation of an AI/ML diagnostic tool.
The "Performance Testing" section lists:
- Fatigue under dynamic physiological loads according to ASTM F1800
- Excessive wear according to ASTM F2083
- Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006, . ANSI/AAMI/ISO 11137-2:2006 and ISO 11135-1:2007
- Accelerated and real time aging
- Packaging validation
These are engineering and manufacturing quality tests for a physical implant, not performance metrics for an AI system. There is no mention of "human in the loop," "ground truth establishment," "expert consensus," "sample size for training/test sets," or "MRMC studies" because these concepts are not relevant to the approval of a joint prosthesis.
In summary, the provided document does not contain the type of AI/ML device performance study details you are asking for.
§ 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.