(174 days)
The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.
The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement. The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.
This submission is a 510(k) for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical or performance trials. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be directly extracted from the provided text.
The core of the document is a 510(k) Summary of Safety and Effectiveness, which declares the device's characteristics and its equivalence to a legally marketed predicate device.
Here's a breakdown of what can be inferred or directly stated, and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. 510(k) submissions typically do not include detailed performance acceptance criteria in the same way a clinical trial might for a novel device. The "performance" being demonstrated here is primarily the technological equivalence to a predicate device.
2. Sample size 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. This is not a study that involved a "test set" in the sense of patient data or clinical samples. The basis for substantial equivalence is "material, design and indications."
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. There was no "ground truth" to establish for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. There was 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:
This is not applicable. The device is a "CEMSTOP Cement Restrictor," a physical diaphyseal plug, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. The submission relies on demonstrating substantial equivalence to a predicate device based on its design, material, and indications, rather than establishing a new "ground truth" through clinical or laboratory data.
8. The sample size for the training set:
This information is not applicable. There is no "training set" for this type of device submission.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" or "ground truth" establishment in the context of this 510(k) submission.
Summary derived from the document:
The provided document describes a 510(k) submission for the CEMSTOP Cement Restrictor. The submission aims to demonstrate substantial equivalence to a previously marketed predicate device, the BIOSTOP G Cement Restrictor (Landos, Inc.).
The basis for claiming substantial equivalence is that the CEMSTOP Cement Restrictor shares the same technological characteristics (design and material) and indications for use as the predicate device.
Its intended use is as a diaphyseal plug to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty, preventing cement flow and facilitating pressurization. The device is biocompatible and resorbable.
The FDA reviewed the submission and determined that the device is substantially equivalent, allowing it to be marketed. This determination is based on the comparison to the predicate device, not on specific performance criteria met through a detailed study on a "test set."
§ 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.