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The Cadence PEEK Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The Cadence™ PEEK Cement Restrictor is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The device is crafted of PEEK (ASTM F136). The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.

The provided text is related to a 510(k) premarket notification for a medical device called the Cadence™ PEEK Cement Restrictor. It primarily discusses the device description, intended use, and the FDA's determination of substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The 510(k) process for this type of device (a cement restrictor) relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined performance acceptance criteria and associated studies for the new device itself.

Therefore, many of the requested categories of information cannot be extracted from the provided text.

Here is a summary of what can be inferred or stated based on the document:

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

• Not applicable / Not provided. The document does not define specific performance acceptance criteria for the Cadence™ PEEK Cement Restrictor, nor does it present data from a study against such criteria. The FDA's 510(k) clearance in this case is based on substantial equivalence to a predicate device.

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

• Not applicable / Not provided. No specific test set or associated data are mentioned for the Cadence™ PEEK Cement Restrictor.

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)

• Not applicable / Not provided. As no test set data is discussed, there's no mention of experts establishing ground truth.

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

• Not applicable / Not provided.

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 / Not provided. This device is a cement restrictor, not an AI-powered diagnostic tool. MRMC studies would not be relevant in this context.

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

• Not applicable / Not provided. This is not an algorithm-based device.

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

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided.

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

• Not applicable / Not provided.

Summary of what the document DOES state regarding substantial equivalence:

• Predicate Device: The Spinal Concepts, Inc. Cadence™ PEEK Cement Restrictor was demonstrated to be substantially equivalent to the Spinal Concepts Cadence™ Titanium Cement Restrictor (K022218).
• Regulatory Classification: The device is classified under 21 CFR 878.3300, a "Prosthesis, Hip, Cement Restrictor" (Product Code: JDK). The FDA also noted "Surgical mesh" as a regulation name, which appears to be a broader classification under which this type of device might fall, but "Cement Restrictor" is more specific.
• Intended Use: The Cadence™ PEEK Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
• Warning/Limitation: The FDA required a specific warning to be added: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates that while the device was found substantially equivalent for specified orthopedic uses, its safety and effectiveness for spinal applications were not established.

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