(126 days)
The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).
The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metallic archbars with sliding locking plates that attach to the dental arches with self-drilling locking screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67:2013), are available in either a 7-hole or 9-hole sliding plate configuration with two different lengths, and are 0.5 mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm or 2.0 x 8 mm self-drilling locking screws manufactured from Ti-6Al-4V (ASTM F136:2013). Implants are available both sterile and non-sterile. The system also includes the necessary instruments to facilitate placement of the implants.
The provided text describes the KLS Martin L1 MMF System, a medical device for temporary stabilization of mandibular and maxillary fractures. It includes information about its indications for use, technological characteristics, and comparison to predicate devices, but it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the particular information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established).
The document primarily focuses on establishing substantial equivalence for regulatory approval, which often relies on comparison to existing legally marketed devices rather than extensive new clinical trials with detailed statistical endpoints.
Based on the provided text, here's what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties: | |
| Tensile Strength: Equal or greater than the predicate device (Synthes MatrixWAVE MMF System K141165). | The subject device system demonstrated an equal or greater tensile force than the predicate device. |
| Torsional Properties of Screws: Successfully withstands testing without device failure. | All screw test articles successfully completed testing without any signs of device failure. |
| Driving Torque of Screws: Successfully withstands testing without device failure. | All screw test articles successfully completed testing without any signs of device failure. |
| Axial Pullout Strength of Screws: Successfully withstands testing without device failure. | All screw test articles successfully completed testing without any signs of device failure. |
| Pyrogenicity (Endotoxin Levels): Below USP allowed limit for medical devices and meets pyrogen limit specifications. | Endotoxin levels in subject device plates and screws are below the USP allowed limit for medical devices and meet pyrogen limit specifications. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for mechanical or pyrogenicity testing.
- Data Provenance: Not specified (e.g., country of origin). The testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this was non-clinical mechanical and pyrogenicity testing, not an expert-based clinical review or ground truth labeling study.
4. Adjudication method for the test set
- Not applicable.
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. This device is a physical bone fixation system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable for this type of medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For mechanical properties: Engineering specifications, stress/strain measurements, and comparison to predicate device performance.
- For pyrogenicity: LAL endotoxin testing against predefined regulatory limits (USP allowed limit).
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.