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The DePuy LPS System is intended for use in replacement of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, ciant cell tumors, bone tumors) requiring extensive resection and replacement;

· patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and

inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;

· revision cases for a failed previous prosthesis requiring extensive resection and replacement;

· severe trauma requiring extensive resection and replacement.

The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The porous-coated metaphyseal sleeves are intended for either cementless applications.

The ATTUNE® Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.

This document is a 510(k) summary for the ATTUNE® Revision Sleeve LPS™ Femoral Adaptors. It is a premarket notification for a medical device, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for new acceptance criteria.

Based on the provided text, the device itself is a component of a knee replacement prosthesis, specifically an adaptor. The "performance data" section focuses on non-clinical tests to demonstrate substantial equivalence, not a study to prove acceptance criteria for a diagnostic AI device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI performance, sample sizes, ground truth establishment, and MRMC studies are not applicable to this document as it describes a mechanical orthopedic implant, not an AI/ML-driven diagnostic device.

Here's a breakdown of the information that can be extracted or inferred:

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

Since this is a mechanical device, the "acceptance criteria" are related to mechanical strengths, biocompatibility, and MRI safety, not a diagnostic performance metric like sensitivity or specificity.

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

This information is not provided as the tests are non-clinical (mechanical, material, safety) rather than clinical studies with patient data. The "test set" would refer to the number of physical devices or components tested.

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 typically for diagnostic interpretation. For mechanical devices, material science and engineering standards define performance.

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

This is not applicable as it refers to expert adjudication for diagnostic ground truth.

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

A MRMC comparative effectiveness study is not applicable as this is not an AI/ML diagnostic or assistive device.

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

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

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

For mechanical aspects: Engineering standards and test methodologies serve as the "ground truth" for performance.
For biocompatibility: ISO standards for biological evaluation of medical devices.
For MRI safety: ASTM standards for testing medical devices in MRI environments.
For endotoxin testing: ANSI/AAMI ST 72:2019 standard.

8. The sample size for the training set

This is not applicable as there is no AI/ML model involved.

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

This is not applicable as there is no AI/ML model involved and therefore no "training set."

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