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The Sulzer Spine-Tech RPX™ Cement Restrictor 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 RPX™ Cement Restrictor is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The RPX™ Cement Restrictor Device is a hollow, tapered block that is titanium. This device is intended to be used in conjunction with PMMA cement.

The provided text describes a 510(k) premarket notification for a medical device, the Sulzer Spine-Tech RPX™ Titanium Cement Restrictor. This submission is for regulatory clearance based on substantial equivalence to predicate devices, not for demonstrating clinical efficacy or performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, expert consensus, ground truth, and sample sizes is not applicable to this type of regulatory submission as presented in the provided document.

Here's a breakdown of what can be extracted and what is not available:

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

• Not applicable. This document is a 510(k) summary, which focuses on substantial equivalence based on intended use, design, and physical characteristics comparison to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical study. Performance data, if any, for mechanical or functional aspects would typically be presented in the full 510(k) submission, not in this summary, and would usually relate to bench testing rather than clinical performance against acceptance criteria.

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. No test set or clinical study data is mentioned in this 510(k) summary. This submission relies on a comparison to predicate devices.

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. No test set requiring expert-established ground truth is mentioned.

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

• Not applicable. No test set requiring adjudication is mentioned.

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. This device is a cement restrictor, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

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

• Not applicable. No ground truth data is established or used for this 510(k) submission.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set and therefore no ground truth for it.

In summary: The provided document is a 510(k) submission for substantial equivalence. It does not contain information about clinical studies with acceptance criteria, test sets, training sets, ground truth establishment, or expert reviews, as these are typically part of a different type of regulatory submission (e.g., PMA for novel devices or specific clinical studies for efficacy claims). The basis for clearance here is the similarity to existing, legally marketed predicate devices.

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