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The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.

Candidates for total knee replacement include patients with and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System 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 porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.

The provided text is a 510(k) summary for a medical device (ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology) and does not describe acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" in this context are related to meeting established performance standards for orthopaedic implants and demonstrating similar characteristics to the predicate devices.

Here's a breakdown of what is provided, framed as closely as possible to your request for acceptance criteria and study information, considering that the primary goal here is substantial equivalence, not a standalone performance study with accuracy metrics.

1. A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria in the format typically used for AI/diagnostic device performance (e.g., sensitivity >X%, specificity >Y%). Instead, the "acceptance criteria" are implied by the performance standards for orthopaedic implants to demonstrate substantial equivalence, and "reported device performance" refers to the successful completion of these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists various non-clinical tests. For these tests (fatigue, fixation, biocompatibility, coating characterization, etc.), the sample sizes are not explicitly stated in this summary. It is typical for these types of engineering tests to involve controlled laboratory specimens rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable here as these are laboratory tests, not clinical studies.

3. 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)

This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI performance studies rather than the engineering and material performance tests described for this knee implant. The "ground truth" for these tests is established by the specifications and acceptance criteria of the ASTM and ANSI/AAMI standards themselves.

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

Not applicable, as this refers to a method used to resolve discrepancies in expert interpretation, which is not relevant for the non-clinical, objective engineering tests described.

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 is a knee implant, not an AI diagnostic device. No human-in-the-loop performance or MRMC studies were conducted for this type of device.

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

Not applicable, as this is related to AI/diagnostic algorithms, not a knee implant.

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

For the non-clinical tests, the "ground truth" is defined by the established industry standards (e.g., ASTM F1800, ASTM F1044, ANSI/AAMI ST 72:2019). The tests measure physical properties against defined limits or performance benchmarks within these standards.

8. The sample size for the training set

Not applicable. This is a physical device, and the evaluation is based on non-clinical engineering and material tests, not on machine learning or AI models which would require training sets.

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

Not applicable, for the same reason as point 8.

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The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system.

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

The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components

The provided text does not describe an AI medical device or a study involving AI. It is a 510(k) submission for a Total Knee System and specifically concerns an extension of the product's shelf life (from 5 years to 8 years) for certain components made from AOX Polyethylene that are gamma irradiated.

Therefore, I cannot extract information related to:

• Acceptance criteria for an AI device.
• Sample size for a test set or data provenance for an AI study.
• Number of experts for ground truth establishment for an AI study.
• Adjudication method for an AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI.
• Standalone performance for an AI algorithm.
• Type of ground truth for an AI study.
• Sample size for a training set for AI.
• How ground truth for a training set was established for AI.

The document discusses non-clinical testing to support the shelf-life extension, specifically:

• Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003)
• Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05)

It explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella components and the predicate devices."

In summary, the provided text does not contain the information requested as it pertains to a mechanical medical device (knee implant) and a shelf-life extension, not an AI device or an AI study.

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

The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components, and existing ATTUNE patella components (K103756).

The document provided is a 510(k) premarket notification for a medical device, the ATTUNE All Polyethylene Tibia, and does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data.

Here's why the requested information cannot be extracted from this document:

• Device Type: The device is a "Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis," which is a physical implant for total knee replacement, not a software or AI/ML-driven device.
• Study Type: The studies mentioned are "non-clinical tests" related to mechanical properties and material performance of the physical implant (e.g., Contact Area/Pressure, Wear, Constraint on tibiofemoral interface, Spine Fatigue, C2 Fixation Testing, Range of Motion, and bacterial endotoxin testing). These are not studies to evaluate AI/ML performance.
• Lack of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any form of software performance evaluation.
• Clinical Testing: The document explicitly states: "No clinical testing was conducted to demonstrate substantial equivalence." This further indicates that the type of clinical performance study typically associated with AI/ML device validation (e.g., impact on human readers, standalone performance) was not performed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) submission for a knee implant.

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