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510(k) Data Aggregation
(234 days)
The Evolis®/GMK® knee prosthesis is designed for cemented use in total knee arthroplasty, 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.
- · Avascular necrosis of 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 semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
The GMK Revision extension is comprised of tibial trays and tibial augments that can be used in either a Primary or Revision surgery. The only difference between the tibial trays and the tibial trays of the predicate device (K090988) is the addition of four threaded screw holes in the bottom surface to allow the connection with the tibial augments. The tibial trays are equivalent to the predicate device (K090988) in terms of material, sizes, general design features and manufacturing process. The tibial trays are offered in six sizes (1 thru 6) in left and right configuration and are made of Cobalt-Chromium-Molybdenum alloy according to ISO 5832-4:1996. The tibial augments are offered in the same seven different sizes (0 thru 6), and 5mm or 10mm thicknesses as the predicate device (K102437) and have a similar shape. They are made of High Nitrogen Stainless Steel M30NW ISO 5832-9. The tibial augments are secured to the tibial trays with either 5mm or 10mm screws made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:1996.
The provided document describes the 510(k) premarket notification for the "GMK Revision extension" Total Knee Prosthesis. It discusses the device's design, indications for use, and comparison to predicate devices, focusing on the changes and how its safety and effectiveness are supported.
However, this document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of device performance as typically understood for AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy).
Instead, the "Performance Testing" section describes mechanical testing conducted for substantial equivalence. It refers to:
- Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| "pre-defined acceptance criteria" based on standards, FDA guidance, and comparison to the predicate device system for mechanical performance. Implicitly, these criteria would ensure the device can "withstand expected in vivo loading without failure" and be "equivalent to devices currently cleared for use." | The GMK Revision extension was subjected to testing according to ASTM F1800 - 07 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements. This analysis determined that the GMK Revision extension is not worst case compared to the predicate devices. A review of the mechanical data indicates that the GMK Revision extension is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure. |
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Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing of physical components, not a clinical study on human data. The "test set" would be the specific physical components (worst-case configuration) tested.
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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 for mechanical testing is based on engineered design specifications, material properties, and relevant ASTM standards, not expert clinical consensus.
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Adjudication method for the test set: Not applicable. Mechanical testing follows established protocols and measurements.
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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 device is a knee prosthesis, not an AI/ML-enabled diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a knee prosthesis.
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The type of ground truth used: For mechanical testing, the "ground truth" is defined by the ASTM F1800-07 standard, engineering design specifications, and performance of predicate devices.
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The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical fatigue testing of a physical device. Design and engineering principles guide the device's creation.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided text details a regulatory submission for a knee prosthesis focused on mechanical performance and substantial equivalence to existing predicate devices, rather than a study involving human data or AI/ML algorithm performance. The "acceptance criteria" and "study" described are confined to the physical, mechanical properties of the implant component.
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