(76 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 Mini MaxLock Extreme® Plating System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured small bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy.
The provided text describes the "Mini MaxLock Extreme® Plating System," a medical device, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to existing devices through mechanical testing. This type of regulatory submission for a physical implantable device (bone fixation system) does not involve AI or machine learning. Therefore, most of the requested information regarding AI study design (like ground truth, expert consensus, MRMC studies, training/test sets, etc.) is not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the type of study used to prove it.
Here's the information based on the provided text:
Device: Mini MaxLock Extreme® Plating System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices | "The Mini MaxLock Extreme® Plating System is substantially equivalent to the Synthes Modular Mini Fragment LCP System (K063049), the Small Bone Innovations Hand Fracture System (K050462), the DePuy Orthopedic Small Bone Locking Plate System (K083364), and the OrthoHelix Modular Foot System (K073624)." |
| "Static mechanical testing and calculations comparing the bending and torsional strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, materials, and superior static testing performance, fatigue testing was not required." |
2. Sample size used for the test set and the data provenance:
- Not Applicable: This is a physical device, not an AI/ML product. The "test set" in this context refers to the samples used in mechanical testing. The text does not specify the exact number of plates and screws tested, but it refers to "various size plates and screws." The provenance is internal testing by OrthoHelix Surgical Designs, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: There is no "ground truth" in the AI/ML sense for a mechanical device. The "ground truth" for mechanical properties would be established by validated engineering standards and testing protocols. No human experts are mentioned as establishing a ground truth for mechanical performance, as it's a quantitative measurement.
4. Adjudication method for the test set:
- Not Applicable: As there are no human interpretations or classifications involved, no adjudication method like 2+1 or 3+1 is relevant. Mechanical tests are typically governed by standardized protocols.
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 is a physical medical device (bone fixation system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This is a physical implantable device, not an algorithm.
7. The type of ground truth used:
- Mechanical Engineering Standards and Measurements: For the mechanical testing, the "ground truth" would be the direct measurements of bending and torsional strength, compared against established engineering standards and the performance of predicate devices.
8. The sample size for the training set:
- Not Applicable: There is no "training set" in the context of an AI/ML model for this physical device.
9. How the ground truth for the training set was established:
- Not Applicable: There is no "training set" or corresponding "ground truth" in the AI/ML sense for this physical 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.