(18 days)
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."
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.