(88 days)
The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
The Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium.
The provided document is a 510(k) summary for the Synthes MatrixMANDIBLE Plate and Screw System. It is a regulatory submission for a medical device and therefore describes the device's technical specifications and intended use, but not a detailed study proving its performance against acceptance criteria in the way a clinical trial or algorithm validation study would.
This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, rather than providing raw performance data from a specific study. Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be gathered, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not describe specific acceptance criteria or performance metrics for a study demonstrating the device's efficacy or safety directly. It establishes substantial equivalence to existing devices. In general, for devices like these, performance is demonstrated through mechanical testing (e.g., fatigue, pull-out strength), biocompatibility testing, and often comparison to predicate device performance specifications, but these details are not included here.
- Device Description: The device is a plate and screw system made of titanium, designed in various shapes and thicknesses, accepting self-tapping and self-drilling screws.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This is not a study report with test sets or data provenance in that sense. Substantial equivalence is often based on design comparisons, material specifications, and performance data from internal engineering tests rather than patient-based test sets.
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)
- Not applicable. This question pertains to studies involving expert review for tasks like image interpretation, which is not relevant for this type of medical device submission. Ground truth, in this context, would relate to engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Similar to point 3, this refers to expert adjudication in studies, which is not part of this 510(k) submission.
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 question describes an AI-related study design. The Synthes MatrixMANDIBLE Plate and Screw System is a physical surgical implant, not an AI or imaging device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As above, this is for AI/algorithm-based devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be directly stated from the document. For a device like this, ground truth would typically relate to established biomechanical properties, material standards (e.g., ASTM, ISO for titanium implants), and successful long-term use of similar predicate devices in clinical practice. The "ground truth" for this submission is that it is substantially equivalent to legally marketed predicate devices.
8. The sample size for the training set
- Applicable only if considering the "training" of the design process based on predicate devices. This document does not detail a "training set" in a data science context. The design of the device is likely informed by the specifications and successful history of the predicate devices.
9. How the ground truth for the training set was established
- Not applicable in the data science sense. The "ground truth" for the predicate devices would be their long-standing clinical use and compliance with regulatory standards.
Summary of what can be extracted from the document:
- Device Name: Synthes MatrixMANDIBLE Plate and Screw System
- Intended Use: Oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
- Classification: Class II per 21 CFR §872.4880: Screw, Fixation, Intraosseous; and also 872.4760: Bone Plate.
- Predicate Devices: Synthes MatrixMANDIBLE Plate and Screw System (implies an updated version of an existing device or a new product line within the same family), Synthes SMF Self-Drilling Screws.
- Basis for Acceptance: The FDA determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and safety/effectiveness profiles to devices already on the market.
§ 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.