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The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

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® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.

The design features of the CONSERVE® Plus Revision Shell are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum .
• Porous coated with CoCrMo sintered beads
• The articulating surface of the implants will be superfinished .
• Offered in inner diameters ranging from 36mm-56mm .
• Increased eccentricity and offset and screw holes .
• Fins for enhanced fixation .

The design features of the CONSERVE® Plus Thick Shell are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum .
• Porous coated with CoCrMo sintered beads .
• The articulating surface of the implants will be superfinished .
• Offered in inner diameters ranging from 36mm-56mm .
• Minimum wall thickness: 5.5mm .

The provided document is a 510(k) summary for a medical device (CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a new study with explicit acceptance criteria and performance data in the typical AI/software sense. Therefore, many of the requested data points (like sample sizes for training/test sets, ground truth establishment, MRMC studies, etc.) are not applicable to this type of submission.

However, I can extract the information that is present concerning the device's characteristics and the basis for its safety and effectiveness.

Here's the breakdown based on the provided text, with clarifications where the information is not present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" and "reported device performance" are typically framed around substantial equivalence to a predicate device based on design features, intended use, and materials. Explicit performance metrics like sensitivity, specificity, or AUC are not usually presented in this context unless the device has an active diagnostic function that would typically be evaluated this way.

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 in the 510(k) summary. Given the nature of a 510(k) for an orthopedic implant, "test sets" typically refer to mechanical and material testing, not human subject data in the way an AI/diagnostic device would. The document refers to "materials data, and testing results" but does not detail the nature or sample size of these tests.

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 to this 510(k) submission. "Ground truth" in this context (an orthopedic implant) would relate to clinical outcomes or mechanical performance, which are not established by expert consensus in the same way as an image-based diagnostic AI.

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

This is not applicable to this 510(k) submission. Adjudication methods are typically used for expert consensus on ground truth in studies involving subjective interpretation, which is not the primary focus here.

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 to this 510(k) submission. MRMC studies are used for evaluating diagnostic performance of systems that produce outputs interpreted by human readers, typically in imaging diagnostics. This device is an orthopedic implant, not a diagnostic tool that assists human readers.

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

This is not applicable to this 510(k) submission. This device is an orthopedic implant, not a standalone algorithm.

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

For this type of device, "ground truth" would implicitly refer to established biomechanical properties, material standards, and potentially clinical outcomes of the predicate device. However, the document does not explicitly define or provide details on the "ground truth" for its "testing results." It primarily relies on the concept of substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

This is not applicable to this 510(k) submission. Machine learning "training sets" are not part of the evaluation for this type of medical implant.

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

This is not applicable to this 510(k) submission. As above, training sets and ground truth for them are not relevant to this traditional medical device submission.

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