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510(k) Data Aggregation
(84 days)
The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.
The OSTEOMED ExtremiLOCK Ankle Plating System is a comprehensive ankle fracture system intended to provide solutions for various bony fractures, including simple to complex fractures of the distal tibia and fibula. The plates are provided in a variety of shapes and sizes, offering surgeons compression, non-locking and locking hole designs. The ExtremiLOCK Ankle Plating System includes angulated locking screws and standard non-locking screws as well as K-wires. Surgical instrumentation is provided to facilitate insertion, modification and/or removal of implants.
The implants of the OsteoMed ExtremiLOCK Ankle Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided text describes a medical device, the OsteoMed ExtremiLOCK Ankle Plating System, and its performance evaluation for substantial equivalence, not a study involving AI or human readers. Therefore, many of the requested points related to AI/human reader studies, ground truth establishment for training sets, and expert consensus for test sets are not applicable.
Here's an analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: Meet required mechanical strength for intended use. | Verification Evaluations: Underwent pull-out, torque, and bending tests. |
| Biocompatibility: Materials are biocompatible. | Material Composition: Implants made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), same as predicate devices; these materials are biocompatible. |
| Functional Equivalence: Similar intended use, function, design, technology, and operational principles to predicate devices. | Performance Equivalence: Shown through verification and comparison to predicate devices. Substantial equivalence based on similarities in intended use, function, performance, design, technology, and operational principles to listed predicate devices. |
| Safety and Effectiveness: No new safety or effectiveness issues. | No New Issues: Similar extended use, design, technology, and operational principles to predicate devices imply no new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The performance evaluation involved verification evaluations (pull-out, torque, bending tests) on the device components themselves. The provenance of the data for these engineering tests (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study described is a mechanical performance evaluation of hardware, not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, this was a mechanical performance evaluation, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a medical device (bone plating system) focusing on its mechanical properties and substantial equivalence to predicate devices, not an AI-assisted diagnostic or prognostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not a study of an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context would be the established mechanical standards and performance of the predicate devices. The new device's mechanical performance (pull-out, torque, bending) was compared against these established benchmarks to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI or machine learning study.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
Summary of the Study:
The study conducted was a mechanical performance evaluation of the OsteoMed ExtremiLOCK Ankle Plating System. This involved:
- Verification evaluations including pull-out, torque, and bending tests on the device's implants.
- Comparison of these results to the performance of legally marketed predicate devices (Synthes Dynamic Compression Locking Plating System, OsteoMed Foot Plating System, OsteoMed Super Screw 3.5mm, and Merete Locking Bone Plate System III).
- The primary goal was to demonstrate substantial equivalence in terms of intended use, function, performance, design, technology, operational principles, and material composition to existing devices, without raising new safety or effectiveness issues.
- The document explicitly states that clinical testing was not required to support substantial equivalence for this device.
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