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SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following:

• Adoption of a cylindrical shape for the proposed SynPlug
• Elimination of sidewall slots and addition of five flanges
• Increase in the rigidity of the proposed device
• Expansion of the number of available sizes for the proposed device to 13, designed to fit intramedullary canal diameters of 9 to 21 mm
  This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions. The document is a 510(k) summary for a medical device called SynPlug™, which is a cement restrictor. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, it explicitly states:

• "The differences between the proposed and parent devices are minor and do not raise new issues of safety or effectiveness."
• "These design modifications were validated according to IsoTis' Design Control Procedures, in compliance with the design control procedure requirements of the Quality Systems Regulations as specified in 21 CFR 820.30."

This indicates that the submission relies on design control validation and substantial equivalence claims rather than reporting on a specific study that tested the device against explicit acceptance criteria with performance metrics, ground truth, or expert involvement as described in your prompt.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics for the SynPlug™ are listed.
2. Sample size used for the test set and the data provenance: No test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned.
4. Adjudication method: Not applicable as no test set or ground truth is described.
5. MRMC comparative effectiveness study results: No such study is mentioned.
6. Standalone performance results: No standalone performance metrics are provided.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: No training set is mentioned for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

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