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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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The PFC® Sigma Total Knee Prosthesis is intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.

The DePuy Sigma Femoral Adapters are a modification to the previously cleared DePuy PFC Sigma Femoral Adapters included in K040281. The devices consist of a selection of adapters and bolts that attach to Sigma TC3 and C/S femoral components' intracondylar boxes. When assembled to a femoral component, they provide a construct for the attachment of additional fixation extensions such as metaphyseal sleeves or cemented and fluted stem extensions. The Sigma Femoral Adapters are available in five and neveous degree valgus angle options and +2 mm, 0 mm, and -- 2 mm anterior/posterior offset options.

This document describes a 510(k) premarket notification for a medical device called the "DePuy Sigma Knee Prosthesis Femoral Adapter." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics (like those for AI/standalone algorithms) is not applicable to this type of regulatory submission.

Here's why and what information is provided:

• 510(k) Premarket Notification: This regulatory pathway focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.
• Basis for Substantial Equivalence (as described in the document):
  • Design Similarity: The design of the PFC Sigma Knee Prosthesis Femoral Adapter is stated to be "substantially equivalent" to two predicate devices: the LPS Metaphyseal Sleeve (K040281) and the Darwin Knee System (TC3) (K952830).
  • Material Identity: The materials used for the subject device components are identical to those of the predicate devices.
  • Attachment Mechanism: The attachment mechanism incorporates similar adapter, retaining ring, and bolt components.
  • Offset Options: The available offset options (+2mm anterior, neutral, -2mm posterior) are the same as the predicate devices.
  • Valgus Angle Options: While both the PFC Sigma and Darwin Knee systems offer 5 and 7-degree valgus angle components, the LPS system offers only a 5-degree component. This difference is deemed acceptable within the substantial equivalence framework.
  • Mechanical Testing: The document mentions "results from the mechanical testing of the PFC Sigma Femoral Adapter" as a basis for substantial equivalence. However, no specific performance metrics or acceptance criteria for this testing are provided in the excerpt. It's implied that these tests demonstrated the new device performed equivalently or acceptably compared to the predicate, likely according to industry standards for mechanical properties of knee implants.

In summary, the provided document does not contain the information requested in points 1-9 because it is a 510(k) submission focused on substantial equivalence rather than a study designed to meet specific performance acceptance criteria for a novel device or AI algorithm.

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