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The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only.

The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.

Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.

The general indications associated with the use of the Recon Ring in total hip arthroplasty include:

• Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Fracture or avascular necrosis of the femoral head,
• Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

The Prevision Hip System is a modular system which consists of a proximal body, distal stem and a tension nut. The three individual components utilize a modular junction. The individual components may be assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem. All proximal components are able to mate with all distal components providing a comprehensive range of combinations offering optimal flexibility. It is designed for use with currently available Aesculap Implant Systems femoral heads, acetabular components and Bipolar cups.

The Prevision Hip System is manufactured from Titanium Alloy and intended for cementless use. The proximal body is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®).

The Recon Ring will be offered in three sizes with left and right configurations. The Recon Ring is manufactured from Titanium. It is designed to be used with the PE acetabular cup cleared in BiContact (K040191).

The provided text describes a medical device submission (K102424) for the "Prevision Hip System with Recon Ring." However, it does not contain the detailed information requested regarding clinical study findings, acceptance criteria, or performance metrics in a format that would allow for a direct numerical comparison of acceptance criteria vs. device performance.

Instead, the document states:

"Testing of the Aesculap Implant Systems Prevision Hip System was performed in accordance with ISO 7206 and ASTM F 2068 and the results were found to be similar to other legally marketed predicate devices."

This indicates that the device's performance was evaluated against established industry standards for hip implants and compared to predicate devices, but no specific numerical acceptance criteria or performance data for the device itself are provided. The FDA's letter of clearance confirms substantial equivalence based on this information but does not elaborate on specific performance metrics.

Therefore, an exhaustive answer to your request is not possible with the provided document. I can, however, extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in numerical terms within the document. The general acceptance criterion appears to be "similarity to other legally marketed predicate devices" and compliance with ISO 7206 and ASTM F 2068 standards.
• Reported Device Performance: "the results [of testing per ISO 7206 and ASTM F 2068] were found to be similar to other legally marketed predicate devices." No specific numerical performance values are given.

2. Sample Size Used for the Test Set and Data Provenance:

• The document implies that the testing was pre-clinical/bench testing rather than a clinical study with human subjects. Thus, terms like "test set" in the context of clinical data provenance are not directly applicable.
• Sample Size for Test Set: Not specified.
• Data Provenance: Not applicable in the context of human data. The testing was conducted in accordance with referenced ISO and ASTM standards, which are international/US standards for medical device testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

• This information is not applicable. The testing described is mechanical and material testing, not a study involving expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable, as it's not a clinical study involving human assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, a MRMC comparative effectiveness study was not done. The document describes pre-clinical testing, not a clinical study.

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

• Not applicable. This is a physical medical device (hip implant), not a software algorithm.

7. The Type of Ground Truth Used:

• For the pre-clinical performance testing, the "ground truth" would be established by the specified test methods and acceptance limits defined in ISO 7206 and ASTM F 2068 standards. These standards typically define how performance (e.g., fatigue strength, wear resistance) is measured and what constitutes acceptable results.

8. The Sample Size for the Training Set:

• Not applicable. As this is a physical medical device and the described testing is pre-clinical, there is no "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set was Established:

• Not applicable for the same reasons as above.

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