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The DePuy LPS Diaphyseal and Metaphyseal Sleeves are intended for use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty.

The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements.

The DePuy LPS is intended for use in replacement of the mid-shaft portion 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, chondrosarcomas, giant 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 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 diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.

The DePuy LPS Diaphyseal Sleeve is a modular, porous-coated, cone-shaped component designed to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral and proximal tibial replacements. The existing LPS Metaphyseal Sleeve (K040281) is a modular, porous-coated, flared component designed for enhanced fit and fill of the metaphyseal region of the distal femur with femoral replacements. Both are manufactured from titanium alloy.

This 510(k) Pre-Market Notification provides information about a medical device rather than a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes is not available in the provided document.

A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical trials or detailed performance studies.

Here's a breakdown of what can be extracted and what cannot:

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

Not applicable. The document does not describe acceptance criteria and performance data in the way a clinical study or validation report would. The basis of substantial equivalence relies on similarity to predicate devices in intended use, indications for use, materials, and design, not on meeting specific quantitative performance metrics defined by acceptance criteria in a study.

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

Not applicable. No test set or associated data provenance is mentioned.

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)

Not applicable. No ground truth establishment is described for a test set.

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

Not applicable. No adjudication method is 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 device is a physical orthopedic implant (sleeves for knee replacement), not an AI-assisted diagnostic tool.

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

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

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

Not applicable. No ground truth is described.

8. The sample size for the training set

Not applicable. This device is a physical orthopedic implant, and as such, there is no "training set" in the context of an AI or software algorithm.

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

Not applicable. There is no training set mentioned.

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