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510(k) Data Aggregation
(140 days)
The OsteoMed ICON IMF Screw System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices.
The OsteoMed ICON IMF (Intermaxillary Fixation) Screw System is offered in 2.4mm and 2.0mm standard IMF screws in lengths from 10mm (thread lengths from 5mm to 15mm) and 2.0mm ICON AutoDrive IMF Screws in lengths from 12mm to 18mm (thread lengths of 8mm).
The implants of the OsteoMed ICON IMF Screw System are made from Titanium alloy (ASTM F-136) and the ligature wire is made from Stainless Steel.
The system instruments include drill bits, wire cutters, pliers, drill guides and screwdrivers to facilitate the placement of screws and ligature wires. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided document describes the mechanical testing required for OsteoMed ICON IMF Screw System to demonstrate substantial equivalence to predicate devices, not acceptance criteria for an AI/ML device study. Therefore, most of the requested information (MRMC study, number of experts, ground truth, training set size, etc.) is not applicable to this document.
However, I can extract the acceptance criteria and performance data for the mechanical tests that were conducted:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | OsteoMed ICON IMF Screw System Performance |
|---|---|---|
| Failure Torque Testing | Met minimum requirement based on screw diameter (according to ASTM F543) | Met minimum failure torque requirement (according to ASTM F543) |
| Insertion Torque Testing | FT/IT (Failure Torque/Insertion Torque) ratio > 1.0 (according to ASTM F543) | Met FT/IT ratio of > 1.0 (according to ASTM F543) |
| Pull-Out Force Testing | Equivalent to predicate device results | Equivalent to predicate device results (as shown in K962774) |
| Bending Force Testing | Equivalent to predicate device results | Equivalent to predicate device results (as shown in K962774) |
| Simulated Use | Equivalent to predicate device | Found to be equivalent to the predicate device |
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 does not specify the exact sample sizes used for each mechanical test. It mentions "all devices" for failure torque and insertion torque, and implicitly a sample of the new devices for pull-out and bending tests. The data provenance is laboratory testing for mechanical properties, not clinical data, so country of origin or retrospective/prospective is not applicable.
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 applicable. This is a mechanical device, not an AI/ML device relying on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is mechanical testing against engineering standards and predicate device performance, not clinical data 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 document is for a medical device (IMF Screw System), not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering standards (ASTM F543) and comparison to the established performance of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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