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1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include an Active Articulation polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

This document is a 510(k) premarket notification from the FDA regarding a hip joint prosthesis (G7 Dual Mobility System, Active Articulation System). It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria and a study proving an AI/ML device's performance is not available in this document.

The document discusses the substantial equivalence of the hip prosthesis to already marketed predicate devices based on:

• Identical Intended Use and Indications for Use: (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, etc.)
• Identical Materials: The materials of the new components are the same as predicates.
• Identical Design Features: No design changes from originally cleared predicate devices.
• Identical Sterilization Methods and Processes.
• Performance Data: This refers to mechanical and physical performance tests for the hip implant itself, not an AI algorithm.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The device described is a physical medical implant (hip prosthesis). There is no mention of any artificial intelligence or machine learning component.
• No Diagnostic/Predictive Function: The device's function is mechanical replacement of a hip joint, not diagnostic imaging analysis, risk prediction, or any other function typically associated with AI/ML medical devices.
• Performance Data is for Physical Attributes: The "Summary of Performance Data" explicitly lists engineering analyses and physical tests such as "Wear Justification Reports ISO 7206-2: 2011," "Interference Fit Analyses," "Push-in, Pull-out, Lever-out Analysis - ASTM F1820-13," and "Range of Motion Analyses – ISO 21535:2007." These are all standard tests for a physical implant.

In summary, this document does not contain the information needed to answer your questions about acceptance criteria and a study proving an AI/ML device meets those criteria because the device in question is a mechanical implant, not an AI/ML product.

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• 1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 5. Revision of previously failed total hip arthroplasty.
• 6. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

The G7 Dual Mobility system consists of two articulating surfaces in the same joint space. The proposed system includes an UHMWPE Active Articulation Bearing and Cobalt-Chromium Alloy (CoCr) Liner. A femoral head articulates on the inner, concave surface of the Active Articulation Bearing. Once the femoral stem contacts the Active Articulation Bearing, a secondary motion occurs between the Active Articulation Bearing and the CoCr Liner. The G7 Dual Mobility system is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

The proposed CoCr Liners are manufactured from cast Cobalt-Chromium-Molybdenum per ASTM F75. The proposed G7 Active Articulation Bearings are manufactured from E1® (aka E-Poly) or ArComXL highly cross-linked polyethylene per ASTM F648. The proposed Active Articulation Bearings are available in sizes 32 and 36mm with a 22.2mm inner diameter. The proposed CoCr Liners are available in sizes A-J (sizes 32-60mm).

This document, a 510(k) Premarket Notification for the Biomet G7 Dual Mobility System, describes the device and claims substantial equivalence to existing predicate devices. However, it does not include acceptance criteria or a study with performance data against those criteria in the way typically expected for an AI/CADe device.

This document is for a medical device (hip implant components), not a software algorithm or AI device. Therefore, the concept of "acceptance criteria" and "device performance" relating to metrics like sensitivity, specificity, or AUC based on a test set and ground truth is not applicable in this context. The "performance data" referred to in this document relates to mechanical and material properties of the implant.

Here's a breakdown of the requested information based on the provided document, highlighting why many aspects are not present for this type of device:

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device (hip implant components), the "acceptance criteria" and "reported device performance" are based on mechanical testing and material compatibility, not diagnostic-style metrics.

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 provided in the document, as it pertains to mechanical testing rather than a clinical or AI performance study. The "test set" would refer to the physical device components tested, but specific sample sizes for each test are not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for in-vitro mechanical testing.

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 for a physical medical device. "Ground truth" in this context would be objective physical and chemical properties measured during mechanical and material testing, performed by laboratory technicians and engineers according to established (ASTM/ISO) standards. Expert consensus for AI model ground truth is not relevant here.

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

This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI or diagnostic performance studies. For mechanical testing, adherence to established test methods and measurement protocols are the "adjudication."

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. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a hip implant, which does not involve "human readers" in a diagnostic capacity or AI assistance for interpretation.

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

This is not applicable. This describes a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance is based on objective measurements from standardized mechanical and material testing (e.g., precise force measurements for push-out/lever-out, visual inspection for fretting/corrosion, precise angular measurements for range of motion). It is not based on expert consensus, pathology, or clinical outcomes data in this 510(k) submission summary. The demonstration of substantial equivalence relies on these physical measurements compared to predicate devices or established standards.

8. The sample size for the training set

This is not applicable. This document does not describe an AI/ML algorithm that requires a training set.

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

This is not applicable. This document does not describe an AI/ML algorithm that requires a training set and associated ground truth.

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