(30 days)
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:
- Trauma
- Reconstructive surgery
- Orthognathic surgery (surgical correction of dentofacial deformities)
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw System.
These devices are offered non-sterile and must be sterilized prior to use. MatrixMANDIBLE screws are intended for single use.
Here's an analysis of the provided text regarding the Synthes MatrixMANDIBLE Plate and Screw System, focusing on acceptance criteria and the supporting study:
The provided document describes a 510(k) premarket notification for a medical device. This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "acceptance criteria" and "study" described will primarily revolve around mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the mechanical tests. Instead, it states that the performance of the proposed devices is "equivalent to or better than" the predicate devices. The reported device performance is presented as the results of the mechanical tests, which are implicitly compared against the predicate's performance.
| Test Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Strip-out resistance (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Pull-out strength (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Yield Torque (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Insertion Torque (N·m) | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
| Insertion Factor of Safety | Equivalent to or better than predicate devices | Demonstrated equivalence or superiority to predicate devices (specific values not provided in summary) |
Note: The summary document only states that the device's performance was "equivalent to or better" than the predicate. Specific numerical values for the predicate or the proposed device's performance are not provided in this 510(k) summary. For a full understanding of the acceptance criteria (e.g., specific thresholds or statistical equivalence margins) and the detailed results, one would typically need access to the full test report submitted to the FDA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each mechanical test (e.g., how many screws were tested for pull-out strength).
- Data Provenance: The testing was "Non-Clinical Testing" performed by the submitter, Synthes (USA), which is based in West Chester, PA, United States of America. The data is retrospective in the sense that it's generated for the submission, but it's new data specific to the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the study described is non-clinical mechanical testing, not a clinical study involving expert judgment of medical images or patient outcomes. The "ground truth" here is objective physical force measurements.
4. Adjudication Method for the Test Set
This section is not applicable for non-clinical mechanical testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in clinical or image-based studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed to support this submission."
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
This section is not applicable. This device is a bone plate and screw system, a physical medical device, not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts here.
7. Type of Ground Truth Used
The ground truth used for the non-clinical testing was objective physical measurements of mechanical properties (e.g., force, torque) under controlled laboratory conditions, as defined by engineering standards. The "truth" is established by the direct measurement of these physical properties rather than by expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
§ 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.