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The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The BioBuck™ Cement Restrictor is a bioabsorbable version and modification of the Buck™ Cement Restrictor that was cleared for marketing by FDA on 27 June 1979 (K791125). The material for the BioBuck device is PolyActive®, a biocompatible copolyether. PolyActive is currently used to manufacture other cement restrictor devices (Shuttle Stop , K000587; SynPlug™ , K010840).

This document is a 510(k) summary for the BioBuck™ Cement Restrictor and primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data. Therefore, many of the requested elements for a study evaluating device performance cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not explicitly state acceptance criteria or report specific performance data for the BioBuck™ Cement Restrictor. It focuses on the device's design, materials, and intended use being "identical" or "very similar" to predicate devices, implying that their established performance is sufficient for proving substantial equivalence.

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

This information is not provided because no specific performance study on a test set is described.

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 information is not provided because no specific performance study on a test set is described.

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

This information is not provided because no specific performance study on a test set is 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

This information is not provided. The device is a physical medical device (cement restrictor), not an AI or imaging diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI is not applicable.

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

This information is not provided. The device is a physical medical device (cement restrictor), not an algorithm.

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

This information is not provided because no specific performance study to establish ground truth is described. For this type of device, ground truth would likely relate to mechanical properties, biocompatibility, and clinical outcomes, but no such studies are detailed.

8. The sample size for the training set

This information is not provided because no training set is relevant for this type of physical device (cement restrictor).

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

This information is not provided because no training set is relevant for this type of physical device (cement restrictor).

Summary of what can be extracted related to "acceptance criteria" and "proof":

The "acceptance criteria" for the BioBuck™ Cement Restrictor, as presented in this 510(k) summary, are implicitly tied to demonstrating substantial equivalence to existing predicate devices.

The study that proves the device meets the acceptance criteria (i.e., substantial equivalence) is the comparison to predicate devices.

• Key points of this "proof" (comparison study):
  • Intended Use: "The intended use of the BioBuck Cement Restrictor is identical to the predicate devices."
  • Technological Characteristics/Principles of Operation: "The principles of operation for the BioBuck Cement Restrictor are identical to the Buck Cement Restrictor... The design and material of the BioBuck device has the same technological characteristics as one or more of the predicate devices."
  • Design and Material: "The BioBuck device shape and design are very similar to the Buck predicate device, and the BioBuck device is manufactured from the identical material as the Shuttle Stop and SynPlug predicate devices."
  • Predicate Devices Used: Buck™ Cement Restrictor (K791125), Shuttle Stop® Cement Restrictor (K000587), SynPlug™ Cement Restrictor (K010840).

In essence, the "acceptance criteria" here are that the BioBuck™ Cement Restrictor is functionally and materially similar enough to established predicate devices that it presents no new questions of safety or effectiveness. The "study" is the detailed comparison of its characteristics against those of the legally marketed predicates. The FDA's letter acts as the "proof" by affirming that based on this comparison, the device is deemed "substantially equivalent."

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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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