(251 days)
a) The Bone Plates are indicated for orofacial (maxilla or mandible) fracture or damage.
b) The Bone Screws are indicated for the fixation of the Bone Plate.
Bone Plate; Bone Screw
This document is a 510(k) clearance letter from the FDA for a bone plate and bone screw. It primarily focuses on regulatory approval rather than a detailed study description of how the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details is not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics for the bone plate and bone screw. The letter is a clearance for market entry based on substantial equivalence to predicate devices, not a detailed performance study report.
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 in the document.
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 in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 in the document. The device in question (bone plate and screw) is a physical medical device, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. As noted, 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 provided in the document. The clearance is based on substantial equivalence, implying that the device's design and materials are comparable to existing, legally marketed predicate devices, rather than being validated against specific clinical ground truth data presented in this letter.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.