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The Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for:

• Total Knee Replacement in severely disabled joints as a result of degenerative a) arthritis;
• Secondary revision of a previously unsuccessful tibial component; b)
• Other knee problems where clinical experience has shown that alternative c) modes of treatment are less likely to achieve satisfactory results;
• d) Trauma, or other fractures in which adequate bony fixation cannot be obtained;
• Non-union of the proximal tibia; and e)
• f) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.

Components are machined from forged titanium, which provides excellent fatigue strength, load transfer and biocompatibility. For use where severe degeneration, trauma, or other Intended Use: pathology of the knee joint indicates cemented total knee arthroplasty. This device is intended for cemented use only.

The provided text describes a 510(k) submission for the Implex CK Porous Tibial Component, Cemented. It details the device's intended use and the basis for its substantial equivalence to predicate devices, but it does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, or improvement with AI.

Instead, the performance data section states: "The CK Porous Tibial Tray has demonstrated acceptable Performance data: performance in mechanical tests that were conducted in accordance with CDRH recognized standards and Design Verification requirements of 21 CFR § 820.30."

This indicates that the device's "performance" was assessed based on engineering and materials testing to ensure it meets mechanical and design verification standards, not clinical performance metrics in the way one might evaluate an AI-powered diagnostic device.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary, as it pertains to a mechanical orthopedic implant rather than a software or AI medical device.

Here's a breakdown of the requested information based only on the provided text, with explanations where information is missing or not applicable:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. (The text refers to mechanical tests, not a clinical test set with patient data).
• Data Provenance: Not applicable. (The tests are mechanical in nature, likely conducted in a lab).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on a diagnosis) is not relevant for mechanical performance testing of an implant. The "ground truth" would be the engineering specifications and test methodologies themselves.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data where consensus is needed to establish ground truth, which is not relevant here.

5. 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 physical knee implant, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical knee implant, not an algorithm.

7. The type of ground truth used

• Engineering specifications and validated mechanical test methodologies (e.g., fatigue strength, load transfer properties).

8. The sample size for the training set

• Not applicable. This device is a physical knee implant, not an AI software that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This device is a physical knee implant, not an AI software.

Summary based on the provided text:

The Implex CK Porous Tibial Component, Cemented, demonstrated "acceptable performance in mechanical tests that were conducted in accordance with CDRH recognized standards and Design Verification requirements of 21 CFR § 820.30." The study supporting this is described as "mechanical tests," implying laboratory-based testing of the physical properties and durability of the implant. No details about sample sizes for these mechanical tests, specific ground truth establishment methodologies by experts, or any human-reader involvement are provided, as these concepts are generally not relevant for the regulatory approval of a mechanical orthopedic implant based on substantial equivalence and engineering performance.

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