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The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

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 using other techniques; and

5. Revision procedures where other treatment or devices have failed.

The Renovis Porous Acetabular Cup System ("Porous shell") are titanium, hemispherical cups consisting of varying sizes (outer diameter of 44 - 66 mm) and screw hole options (no hole shell and cluster hole shells) to accommodate patient anatomy and/or surgical technique. Instrumentation is provided with the system.

The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.

The provided text is a 510(k) summary for the Renovis Surgical Porous Acetabular Cup System, a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device through design comparison, materials, and performance testing against recognized standards. It does not typically involve clinical studies with acceptance criteria in the same way a diagnostic AI device would.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. The document describes performance testing bench studies to ensure the device meets certain engineering and material standards, rather than clinical studies establishing diagnostic accuracy or efficacy in patients.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information is absent because it's not a clinical study for an AI device:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a way that would typically be seen for a diagnostic AI device. Instead, it states that "Performance testing was successfully completed" and lists various standards the device complies with. Compliance with these standards implies meeting their embedded acceptance criteria.

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. The document describes bench testing rather than testing on a "test set" of patient data. The "samples" would refer to the physical devices or materials tested according to engineering standards. No information on data provenance (country, retrospective/prospective) is relevant or mentioned for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for material and mechanical performance testing is established by engineering specifications and objective measurements, not by human expert consensus on clinical cases.

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

This information is not applicable and not provided. Adjudication methods are relevant for human interpretation in clinical studies, not for bench testing of medical devices.

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 information is not applicable and not provided. An MRMC study is designed for evaluating diagnostic devices, especially those involving human interpretation, and often with AI assistance. This document describes a physical hip implant, not a diagnostic AI device.

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

This information is not applicable and not provided. This question pertains to AI algorithm performance.

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

For the performance testing bench studies, the "ground truth" implicitly used is adherence to established engineering and material standards (e.g., tensile strength, shear strength, porosity characteristics, sterilization efficacy, packaging integrity). This is determined by standardized measurement techniques guided by the listed ASTM and ISO standards, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

This information is not applicable and not provided. This question pertains to AI algorithm training, which is not relevant to this device submission.

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

This information is not applicable and not provided. This question pertains to AI algorithm training, which is not relevant to this device submission.

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