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Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The ATTUNE Medial Stabilized FB Insert is an asymmetrical fixed bearing tibial insert that will form part of the ATTUNE Knee system. It is designed to work with the ATTUNE CR femur and any of the ATTUNE Fixed Bearing Tibial Base options. The insert can be used with or without the posterior cruciate ligament.

Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device (a knee implant insert), not typically a submission for an AI/ML powered device. Therefore, many of the requested AI/ML specific details (like sample size for test set, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of submission.

Device Name: ATTUNE Medial Stabilized Fixed Bearing (MS FB) Insert

Device Type: Knee implant insert (part of a total knee replacement system)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a knee implant and not an AI/ML device, the "acceptance criteria" are related to mechanical and physical performance, demonstrating substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

2. 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 is a physical medical device. The "tests" refer to non-clinical laboratory and mechanical testing of the physical implant components, not data analysis on a "test set" of patient data for an AI/ML algorithm.

3. 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 diagnostic devices is typically established by medical experts reviewing cases. For this physical knee implant, "ground truth" relates to engineering specifications and performance standards established through mechanical and material testing, not expert interpretation of patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication is a process for resolving discrepancies among expert readers in AI/ML studies. This is a non-clinical, mechanical performance study.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers. This submission is for a physical knee implant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering Specifications and Performance Standards. The "ground truth" for this device's performance would be the established engineering specifications for material properties, mechanical integrity, and kinematic behavior, as well as the performance of the legally marketed predicate device to which it claims substantial equivalence. These are assessed through physical and mechanical tests.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

• Not Applicable. (See #8)

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