(90 days)
Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.
Satyrne InterFlex Mandibular Fixation System is a new bone plate system for use in oral and maxillofacial surgery. The design includes plates of different thicknesses that are secured to the mandibular bony tissue using bone screws of varying lengths and designs. The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136.
This document is a 510(k) summary for the Satyrne InterFlex Mandibular Fixation System, which is a bone plate system. The device is being submitted for substantial equivalence to existing predicate devices, not requiring extensive new clinical studies to prove effectiveness. Therefore, many of the requested elements regarding acceptance criteria and performance studies are not directly applicable in the typical sense for a brand new AI or software device.
However, based on the provided text, here's an analysis of what information can be extracted regarding the device's "acceptance criteria" and "study":
1. A table of acceptance criteria and the reported device performance
For this type of device (bone plates), acceptance criteria are typically met through mechanical testing demonstrating equivalent or superior performance to predicate devices. The document states:
| Criterion | Acceptance Metric (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Mechanical) | Similar or equivalent mechanical properties to predicate devices. | "Based on mechanical test results, the Satyrne InterFlex Mandibular Fixation System is substantially equivalent to the legally marketed Stryker Leibinger Universal CMF System K022185 and the Synthes Mandibular Modular Fixation System K954385." |
| Material Composition | Use of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136. | "The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136." "The plates and screws are made of the same material as predicate devices." |
| Design/Shapes | Contains various shapes of plates and screws similar to predicate devices. | "The system contains various shapes of plates and screws similar to predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "mechanical test results." For mechanical testing of medical devices, the "test set" typically refers to the number of physical samples of the device tested, not necessarily a patient-based dataset.
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but generally, mechanical testing is conducted in a lab environment. The document is a 510(k) submission from the US (Albuquerque, NM, with FDA in Rockville, MD), so the testing would likely be performed in the US or by a contracted lab. It's a "retrospective" comparison in the sense that its performance is being compared to already marketed (predicate) devices.
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 is not applicable to a submission based on substantial equivalence through mechanical testing. "Ground truth" in this context would be defined by engineering specifications and material standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Mechanical test results are objective measurements against established standards, not subjective interpretations requiring adjudication.
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 device is a physical implant, not an AI or imaging diagnostic tool. An MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance, as implied by the substantial equivalence argument, is:
- Mechanical Performance Standards: Demonstrated equivalence to the mechanical performance of legally marketed predicate devices through engineering tests.
- Material Standards: Compliance with ASTM F67 (CP titanium) and ASTM F136 (Ti6Al4V alloy).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "mechanical test results." These tests demonstrated that the Satyrne InterFlex Mandibular Fixation System is substantially equivalent in its mechanical properties to the predicate devices: the Stryker Leibinger Universal CMF System (K022185) and the Synthes Mandibular Modular Fixation System (K954385). Furthermore, the device's materials (CP titanium or Ti6Al4V alloy) comply with established ASTM standards (F67 and F136), and its design (various plate and screw shapes) is similar to those of the predicate devices. The 510(k) process accepts this comparison as sufficient evidence for market clearance for devices of this type, as it indicates that the new device performs as safely and effectively as legally marketed devices.
§ 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.