(91 days)
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
The Stryker Universal SMARTLock Hybrid MMF System is a maxillomandibular fixation system that consists of a pure titanium fixation Plate, 2 self-drilling locking Screws made out of titanium alloy (6mm and 8mm), a bending instrument and a spacing instrument. These devices are stored in a dedicated module and in a dedicated generic instrument tray, respectively. Both the tray and the module are stored in a generic storage container.
The Plate has in-plane bendable attachment loops for screw fixation on either the maxilla or mandible. The fixation loops can be bent with the Bender. The locking screw fixation together with use of the Spacer is designed to prevent pressure on the gingiva from the fixated Plate.
The provided text describes a medical device, the "Stryker Universal SMARTLock Hybrid MMF System," and its submission for FDA 510(k) clearance. However, it explicitly states that no clinical testing was performed to support this submission. Therefore, it is based on non-clinical testing and substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through clinical performance.
Due to the lack of clinical testing, the requested information regarding acceptance criteria derived from a clinical study, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies cannot be provided from this document.
Here's what can be extracted based on the "Non-Clinical Testing" section:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility | Successful |
| Cleaning | Successful |
| Screw Insertion | Successful |
| Corrosion Resistance | Successful |
| Mechanical Stability of Construct | Successful |
| Locking Test | Successful |
| System Handling Test | Successful |
| End-User (Cadaver) Test | Successful |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified (since clinical testing was not performed). For non-clinical tests, specific sample sizes (e.g., number of cadavers, number of screws tested) are not detailed.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, it would originate from in vitro laboratory tests or cadaveric testing conducted by Stryker Craniomaxillofacial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set for ground truth establishment was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set with human assessments requiring adjudication was used.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a physical fixation system, not an AI-assisted diagnostic tool involving "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be established by engineering and material science standards (e.g., material specifications for biocompatibility, force thresholds for mechanical stability, established protocols for cleaning validation, successful insertion without damage).
8. The sample size for the training set:
- Not applicable, as no algorithm or AI required a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no algorithm or AI required a training set.
Summary based on the provided text:
The Stryker Universal SMARTLock Hybrid MMF System gained 510(k) clearance based on non-clinical testing that demonstrated success in various physical and mechanical properties, and its substantial equivalence to existing predicate devices (Stryker MMF Screw – K050535 and KLS Martin Erich Arch Bar – K061271). No clinical studies or any form of human-in-the-loop or standalone AI performance evaluation were conducted or documented in this submission.
§ 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.