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The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

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

· patient conditions of non-inflammatory degenerative joint disease (NIDJ), 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.

· post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

The ATTUNE Revision LPS Inserts are designed to replace the tibio-femoral articular surface of the knee joint when used in conjunction with a femoral, tibial, patellar, and other associated prostheses as required. The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a forged cobalt chrome molybdenum hinge post.

This document describes the FDA's clearance of the ATTUNE® Revision LPSTM Inserts, a medical device. It does not contain information about an AI/ML-driven device or study results related to AI performance. Therefore, I cannot extract the requested information to describe acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-driven device.

The provided text pertains to a knee joint prosthesis and its 510(k) premarket notification to the FDA. The "acceptance criteria" and "study" discussed in this document relate to the mechanical performance, materials, and manufacturing processes of this physical medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

Specifically:

• Acceptance Criteria and Device Performance: These are detailed under "Non-Clinical Testing" on page 4. The device performance is deemed acceptable if it meets the requirements of the listed functional verification tests (e.g., A/P Shear Fatigue, Insert Subluxation, Hinge Post Fatigue) and ANSI AAMI ST-72:2011 for bacterial endotoxin testing. The document states that the testing "verified that the implant performance is substantially equivalent to predicate devices for anticipated in-vivo loading."
• Sample size for test set and data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the prototypes of the physical device or materials used for mechanical and material testing. The document doesn't specify the exact number of physical units tested but refers to standard engineering tests.
• Number of experts and qualifications, adjudication method, MRMC study, standalone performance: These concepts are relevant to the evaluation of AI/ML models, not physical medical devices like a knee implant. Therefore, this information is not present.
• Type of ground truth: For this physical device, the "ground truth" is defined by established engineering and biomechanical principles, industry standards (e.g., FDA Guidance, ANSI AAMI ST-72:2011), and comparison to the performance of predicate devices.
• Training set sample size and ground truth establishment for training set: Not applicable to a physical device. There's no "training set" in the AI/ML sense. The "training" for such a device would involve its design, manufacturing processes, and quality control, ensuring it meets established specifications.

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