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These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.
   The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions.
   The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.

The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone.

The provided text describes a 510(k) premarket notification for the "Balanced Knee Revision System Trabecular Tibial Cone Augments." This is a medical device (knee joint prosthesis component) and not an AI/ML-driven device or an imaging device.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document discusses the substantial equivalence of the device to existing predicate devices based on technological characteristics and non-clinical performance testing.

Here's an assessment of the provided information relative to the device type described:

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

The document lists the following non-clinical tests that were conducted and "successfully met the predetermined acceptance criteria." However, the specific numerical acceptance criteria and reported performance values are not detailed in this 510(k) summary. It only states that the tests met the criteria.

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

This information is not applicable as this is a physical medical device, not an AI/ML imaging device. The "test set" here refers to physical specimens subjected to biomechanical and material tests, not a dataset for AI model evaluation. No data provenance in terms of country of origin or retrospective/prospective collection is relevant in this context.

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 establishment by experts in the context of radiology or clinical interpretation is not relevant for this physical device's mechanical and material testing. The "ground truth" for these tests are the established ASTM and ANSI/AAMI standards.

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

This is not applicable. Adjudication methods are relevant for ambiguous or challenging cases in AI/ML performance evaluation, usually involving human experts. For mechanical testing, the results are objectively measured against predefined standards.

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:

This is not applicable. MRMC studies are specific to imaging devices and AI/ML aids that influence human reader performance. This device is a prosthetic component.

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

This is not applicable. Standalone performance refers to an algorithm's output without human intervention, which is not relevant for a physical implant.

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

The ground truth for this device's performance evaluation lies in the established industry standards (ASTM, ANSI/AAMI) for mechanical, material, and biocompatibility testing. There is no "pathology" or "outcomes data" specifically mentioned for establishing ground truth for the premarket clearance of this component.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. The requested information pertains to an AI/ML or imaging device, which is a different category of medical product. Therefore, most of the specific questions are not applicable to the content of this document. The device's acceptance criteria are based on meeting established national and international standards for mechanical properties and biocompatibility.

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