(164 days)
The MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.
The provided text describes the 510(k) premarket notification for the MatrixWAVE MMF System. However, it explicitly states that clinical testing was not necessary for the determination of substantial equivalence and therefore does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
The document focuses on demonstrating substantial equivalence to a predicate device (Stryker Universal SMARTLock Hybrid MMF System) through technological similarities, differences, and non-clinical performance data.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided text.
Here's a breakdown of what is and is not available based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not Available. No specific acceptance criteria for clinical performance are mentioned, nor are device performance results from a clinical study. The document lists several non-clinical tests (Mechanical Construct Testing, Screw Testing, Corrosion Testing, Hook Testing, and Biocompatibility Testing according to ISO 10993-18:2005) and states that "The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixWAVE MMF System is comparable to that of the predicate."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. As no clinical testing was performed, there is no test set or data provenance from a human study.
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 Available. No clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available. No clinical study was conducted.
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 Available. This device is a mechanical MMF system, not an AI software, and no clinical comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Available. This device is a mechanical MMF system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Available. No clinical study was conducted.
8. The sample size for the training set:
- Not Available. No clinical study data or machine learning model for which a training set would be relevant is discussed.
9. How the ground truth for the training set was established:
- Not Available. No clinical study data or machine learning model for which a training set would be relevant is discussed.
§ 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.