(310 days)
The Overture Resurfacing Uni Knee Resurfacing System is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.
The Uni Knee Resurfacing System is comprised of femoral implants, and a set of ancillary instruments. The femoral implants are titanium and feature a spherical polished articulating surface with a titanium nitride (TIN) coating. The tibial implants are comprised of a titanium tibial tray with an integrated ultra-high molecular weight polyethylene (UHMWPE) tibial insert. The femoral implants and tibial trays utilize cemented pegs and porous titanium bone-contacting surfaces to allow for fixation. The femoral implant articulates against the tibial insert in a non-constrained manner.
The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. Femoral implants are offered in oblong and round configurations. The oblong femoral implants are offered in lengths ranging 25-40mm and diameters ranging 17.5-27.5mm, and the round femoral implants are offered in diameters ranging 17.5-27.5mm. The tibial implants are offered in diameters ranging 17.5-22.5mm.
The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.
This document is a 510(k) summary for the Uni Knee Resurfacing System. It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and performance testing, rather than an AI/ML-based device requiring extensive clinical study for performance metrics like accuracy, sensitivity, or specificity.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of AI/ML performance (e.g., sample size, data provenance, expert ground truth, MRMC studies) is not applicable to this submission.
The "Performance Testing" section (page 4) details bench testing conducted for the Uni Knee Resurfacing System, which typically involves mechanical and material evaluations, not clinical performance metrics for an AI algorithm.
To specifically address the prompts:
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A table of acceptance criteria and the reported device performance: Not applicable. The document describes engineering and material-based performance tests, not AI-related performance metrics. The conclusion states that these tests "indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." Specific numerical acceptance criteria for each bench test are not provided in this summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document refers to bench testing of physical implants, not an AI algorithm's performance on clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on medical images) is not relevant to this device's testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for the performance testing would be established by objective measurements and scientific standards for material properties, mechanical strength, wear, etc., as per the listed ASTM and other relevant engineering standards.
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The sample size for the training set: Not applicable. There is no AI algorithm being trained.
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How the ground truth for the training set was established: Not applicable.
§ 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.