(118 days)
INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint.
The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without a porous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are available without a porous coating. The all-polyethylene unicompartmental tibial component manufactured from polyethylene.
The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
The provided text describes a 510(k) premarket notification for a medical device, the SIGMA High Performance (HP) Partial Knee System. While the document outlines information about the device itself and its equivalence to predicate devices, it does not contain the acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML-driven device's performance.
The document states:
- "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE": This lists a number of engineering and material tests (Biocompatibility, UHMWPE Material Property Characterization, Range of Motion/Constraint, Contact Area/Stress, Wear Testing, Pull-Off, Bacterial Endotoxin testing).
- "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION - Clinical testing was not necessary to demonstrate substantial equivalence."
This indicates that the submission is focused on demonstrating substantial equivalence based on material properties, design, and manufacturing processes, rather than the performance of an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not present in the provided text, as these are typically associated with the evaluation of AI/ML software performance.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.