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The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

The RABEAT™ Cement Restrictor is a hollow, PEEK rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The provided text describes a 510(k) submission for the RABEA™ Cement Restrictor Device. It outlines the device's functional and safety testing, concluding that it is substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in a quantitative manner as requested by the prompt.

Therefore, many of the requested sections regarding the study and acceptance criteria cannot be extracted from this document.

Here's a breakdown of what can be inferred/stated based on the provided text, and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds or quantitative targets.
• Reported Device Performance: The document only states: "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device." No specific performance metrics (e.g., strength, durability, failure rates) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.
• Retrospective/Prospective: Not mentioned.

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 as the study described is for a cement restrictor device, not an AI/diagnostic algorithm where expert ground truth is typically established.

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

• Not applicable for this type of device testing.

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

• Not applicable as this is a physical medical device, not an AI-assisted diagnostic tool.

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

• Not applicable as this is a physical medical device.

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

• For this type of device, "ground truth" would likely be based on engineering specifications and physical testing standards rather than expert consensus on diagnostic images or pathology. However, the specific type of ground truth is not detailed in the provided text, other than it involved "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications."

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI algorithm that requires training data.

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

• Not applicable for the same reason as above.

Summary Table of Available Information based on the provided text:

Conclusion from the document:

The study involved "Functional and Safety Testing" consisting of "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." The conclusion was that "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device," leading to the determination of substantial equivalence to predicate devices. The document does not provide the specific quantitative acceptance criteria or the detailed results of these tests.

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