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The CONSERVE® BioFoam® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed

The CONSERVE® BioFoam® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• . Monoblock acetabular cup
• . Available in 11 sizes
• . Manufactured from CoCr alloy with a cpTi coating

The CONSERVE® BioFoam® Shells were evaluated via mechanical testing; including frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing. A review of these results indicates that the CONSERVE® BioFoam® Shells are equivalent to predicate devices.

Here's the analysis of the acceptance criteria and study information for the CONSERVE® BioFoam® Shell, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a distinct "test set" in the traditional sense of a clinical or image-based diagnostic study. The evaluation appears to be based on mechanical testing of the device itself, comparing its performance to predicate devices. Therefore, the "sample size" would refer to the number of devices or components tested. This information is not provided in the summary.
   • Data Provenance: Not applicable in the context of this device's evaluation (it's a physical device, not an AI/diagnostic system using human data).

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

   • This is not applicable as the evaluation described is for a physical medical device (an acetabular cup) through mechanical testing, not a diagnostic system requiring expert interpretation or ground truth establishment in a clinical setting.

3. Adjudication method for the test set:

   • Not applicable for the type of evaluation described. Mechanical testing results are typically objective measurements, not subjective interpretations requiring adjudication.

4. 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:

   • No. This is a 510(k) submission for a physical orthopedic implant (acetabular cup), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

   • No. This is not an algorithm or AI device.

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

   • For the mechanical testing, the "ground truth" would be the objective, measured physical properties and performance characteristics (e.g., specific thresholds for frictional torque, bending fatigue limits, tensile strength, corrosion resistance, wear rates) that demonstrate the device's equivalence to the predicate devices. These are engineering specifications and material science standards rather than biological or clinical ground truth.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/machine learning device.

Summary of the Study and Findings:

The study described for the CONSERVE® BioFoam® Shell is a mechanical testing and substantial equivalence assessment (K110029). The purpose was to demonstrate that the new device is as safe and effective as existing legally marketed predicate devices.

The study primarily involved:

• Mechanical Testing: Frictional torque, bending fatigue, shear fatigue, tensile, corrosion, and wear testing were performed on the CONSERVE® BioFoam® Shells.
• Comparison to Predicate Devices: The results from these mechanical tests were reviewed and used to demonstrate that the CONSERVE® BioFoam® Shells are equivalent to the identified predicate devices (Metal TRANSCEND® Articulation System, CONSERVE® Plus Spiked Shells, and DYNASTY® Acetabular System).
• Substantial Equivalence Argument: The submission asserts that the new device's indications for use are identical, and its design features, materials, and fundamental scientific technology are substantially equivalent to the predicate devices.

The "study" in this context is an engineering and regulatory comparison, not a clinical trial or an AI performance evaluation. The "proof" that the device meets acceptance criteria lies in the successful demonstration of this equivalence through the aforementioned tests and comparisons.

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