(56 days)
The GMK knee cemented prosthesis is designed for cemented application in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components.
The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications.
The GMK 3D Metal Tibial Baseplate is indicated for cemented application if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Collagen disorders, and avascular necrosis of the femoral condyle
- Post traumatic loss of joint configuration
- Primary implantation failure
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semiconstrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.
It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal Tibial Baseplate.
Limitations for use for GMK Sphere/GMK SpheriKA used with kinematic alignment
GMK Sphere and GMK SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Collagen disorders, and/or avascular necrosis of the femoral condyle
- Moderate valgus, varus, or flexion deformities.
The GMK Sphere & GMK SpheriKA Cementless is a line extension to the GMK Total Knee System and includes the following devices:
- GMK Sphere Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
- GMK SpheriKA Cementless Femoral Components. Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
- GMK SpheriKA ST Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes).
The subject devices are marketed as individually packaged femoral components, designed for cementless use in total knee arthroplasty procedures where the surgeon considers the bone quality to be sufficient for cementless applications.
The GMK Sphere & GMK SpheriKA Cementless implants are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with double-layer coating composed of Titanium plasma spray according to ISO 13179-1 Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants -- Part 1: General requirements and Hydroxyapatite according to ISO 13779-2 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite on the internal surface pockets.
This document refers to the review of a 510(k) premarket notification for the "GMK Sphere & GMK SpheriKA Cementless" knee prosthesis. Based on the provided text, there is no acceptance criteria and study that proves the device meets the acceptance criteria in the traditional sense of evaluating an algorithm's performance against predefined metrics (e.g., sensitivity, specificity for diagnostic devices).
This submission is for a medical device (knee prosthesis), not an AI/ML powered device, and the "performance data" provided refers to engineering and biocompatibility testing, not clinical performance metrics or studies involving human readers or ground truth as would be relevant for AI.
Here's a breakdown of why the requested information cannot be provided from the given text:
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A table of acceptance criteria and the reported device performance: Not applicable. The document describes a comparison to predicate devices, not the setting of specific performance targets (like accuracy, precision, etc.) for an AI/ML algorithm. The "performance data" listed are non-clinical engineering tests (mechanical properties, microscopy, pyrogenicity, biocompatibility, shelf-life) which are not presented with acceptance criteria and results in the format requested.
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Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's performance evaluation. The "tests" performed are on the physical device components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to an independently verified correct answer for a given input. This concept is not relevant to the described premarket notification for a knee prosthesis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no adjudication process described as it pertains to medical image interpretation or similar tasks for an algorithm.
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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 document explicitly states: "No clinical studies were conducted." The device is a physical knee implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" as an expert-derived annotation or definitive diagnosis is not relevant to the evaluation of a physical knee implant.
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The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable, as there is no AI/ML algorithm or training set.
In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review for a physical orthopedic implant (a knee prosthesis), not an AI/ML-powered medical device. Therefore, the questions related to acceptance criteria and study design for AI/ML performance evaluation are not applicable to this document. The "Performance Data" section details non-clinical laboratory testing for material properties, sterility, and biocompatibility to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation from AI/ML performance studies.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.