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The 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.

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

This document is a 510(k) summary for the Cadence™ Cement Restrictor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria with numerical performance metrics.

Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance, sample sizes, ground truth establishment methods, MRMC studies, standalone performance) cannot be filled with information from the provided text.

Based on the information provided, here's what can be inferred or stated:

Acceptance Criteria and Device Performance Study Information

The provided document is a 510(k) submission, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. In this context, "acceptance criteria" are generally met by demonstrating substantial equivalence, often through a comparison of technological characteristics, materials, and intended use, rather than a clinical trial with performance metrics.

Therefore, there is no table of acceptance criteria and reported device performance as would be found in a clinical study report proving performance against specific numerical benchmarks. The "acceptance" for this submission is FDA's determination of substantial equivalence.

1. A table of acceptance criteria and the reported device performance
Not applicable. The provided document is a 510(k) summary demonstrating substantial equivalence to predicate devices, not a study reporting performance against specific numerical acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or clinical data is described in this 510(k) summary. The submission relies on a comparison to predicate devices, not independent testing for performance.

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. There is no test set, and therefore no ground truth established by experts, described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.

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. No MRMC study is mentioned. This device is a cement restrictor, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical cement restrictor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth described as this is not a study assessing diagnostic or predictive performance.

8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/ML device or a study involving data training.

9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth described.

Summary of the 510(k) submission and "Study" (Demonstration of Substantial Equivalence):

The "study" in this context is the design review provided to demonstrate substantial equivalence to previously cleared devices.

• Predicate Devices: Medtronic Sofamor Danek Cement Restrictor (K010528) and its predicates (K003718 and K010529).
• Method of Equivalence: Comparison of intended use, materials of construction (titanium alloy - ASTM F136), and technological characteristics (hollow device with teeth on two opposing flat sides, tapered style).
• Outcome for "Acceptance Criteria": FDA's determination of "Substantial Equivalence," allowing the device to be marketed. The primary "acceptance criterion" was that the device must be as safe and effective as the predicate devices, which was argued through design review and direct comparison.
• Limitation: FDA required a specific warning label stating: "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 it met the criteria for non-spinal use, its safety and effectiveness for spinal indications were not established and therefore not substantially equivalent for that specific use.

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