(228 days)
The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
The Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
The provided text is a 510(k) summary for the Synthes MatrixMANDIBLE Subcondylar Plates. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or specific studies that prove the device meets performance criteria.
The 510(k) process for medical devices typically focuses on demonstrating substantial equivalence to a predicate device already on the market. This often involves comparing design features, materials, and intended use, and sometimes includes mechanical testing to show similar performance characteristics. However, detailed clinical studies with acceptance criteria, sample sizes, and ground truth establishment, as described in your request, are more commonly associated with PMA (Premarket Approval) applications for novel, high-risk devices, or specific performance studies for new technologies like AI algorithms.
Therefore, for your request, I can only state that the document does not provide the requested information:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence based on design and intended use, not on specific performance metrics against pre-defined acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not provided. No test sets or data provenance are mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. No test set adjudication 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: Not applicable. This is a traditional medical device (bone plate), not an AI-powered diagnostic or assistive tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a traditional medical device (bone plate).
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No ground truth is established as there are no diagnostic claims requiring such validation.
- 8. The sample size for the training set: Not applicable. This is a manufactured device; there is no "training set" in the context of an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
The document states that "Information presented supports substantial equivalence" regarding the Synthes MatrixMANDIBLE Subcondylar Plates to the Synthes MatrixMANDIBLE Plate and Screw System and the MODUS® Titanium Osteosynthesis System. This implies that the device is considered safe and effective because it is similar to devices already legally marketed, rather than through meeting specific, novel performance acceptance criteria via extensive new studies.
§ 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.