(83 days)
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The submission is a modification to the Mini MaxLock Extreme® Plating System to add Mini MTP Plates. This submission also includes the ISO plate that was previously cleared through internal documentation. No modifications were made to the existing plates or screws. The OrthoHelix Mini MTP Plates are designed for 18 MTP joint fusions.
This document describes a 510(k) submission for a medical device called the Mini MaxLock Extreme® Plating System. The submission is for a modification to an existing system, specifically the addition of Mini MTP Plates for MTP joint fusions.
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for a diagnostic AI/ML device.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. For mechanical devices like bone plates, this usually involves showing that the new device has similar:
- Indications for use
- Design
- Materials
- Performance (often through mechanical testing and/or finite element analysis)
Therefore, the requested information elements related to AI/ML device performance (like accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable or available in this specific regulatory filing.
Based on the provided text, here’s an analysis of what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength and performance comparable to predicate devices | Calculations, mechanical testing, and finite element analysis comparing the strength of the subject and predicate devices were performed. The results support substantial equivalence. |
| Similar indications for use to predicate devices | The Mini MaxLock Extreme® Plating System's intended use is to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments, which is consistent with the predicate devices. |
| Similar design and materials to predicate devices | The device uses Titanium Alloy and PEEK, consistent with existing systems. The design modification (Mini MTP Plates) is evaluated for substantial equivalence. |
| No new issues of safety and effectiveness | Stated that "No new issues of safety and effectiveness have been raised." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device, not an AI/ML diagnostic. The "test set" would refer to mechanical test samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device.
4. Adjudication method for the test set
Not applicable. This is a mechanical device.
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 is a mechanical device, not an AI/ML system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used
Not applicable in the context of diagnostic performance. For a mechanical device, "ground truth" would relate to material properties, mechanical limits, and biomechanical performance data, which are typically established through engineering standards, material science, and physical testing.
8. The sample size for the training set
Not applicable. This is a mechanical device. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth establishment" in the AI/ML sense for this mechanical device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.