(210 days)
The Arthrex Compression Plates are intended to be used for internal bone fixation for bonc fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
The Arthrex Compression Plates are a family of low profile plates available in various design configurations. The plates are made of stainless steel and are available in lengths of 20mm, 25mm and 30mm (interaxis lengths).
The prompt requests information for an AI/ML device, but the provided text describes a traditional medical device (Arthrex Compression Plates), which is a physical implant, not an AI or software device. Therefore, the questions related to AI/ML device performance metrics, such as sample size for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to this submission.
The document describes the Arthrex Compression Plates, a family of low-profile plates made of stainless steel, intended for internal bone fixation in the ankle, foot, hand, and wrist.
Here's the relevant information based on the provided text, adapted to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: The bending and compression distraction properties of the proposed devices must be substantially equivalent to predicate devices. | Mechanical testing data demonstrated that the bending and compression distraction of the proposed devices (Arthrex Compression Plates) is substantially equivalent to that of the predicate devices (Arthrex Low Profile Plates and Arthrex Compression Staple). |
| Material Equivalence: The material of the proposed device must be equivalent to predicate devices. | The Arthrex Compression Plates are made of stainless steel, similar to predicate devices. (Implied from the "material, technological characteristics and performance of the devices are similar" statement and the general nature of orthopedic implants). |
| Technological Characteristics Equivalence: The technological characteristics of the proposed device must be similar to predicate devices. | The device is a family of low-profile plates available in various design configurations and lengths (20mm, 25mm, 30mm interaxis lengths), similar to the predicate devices. |
| Intended Use Equivalence: The intended use of the proposed device must be the same as predicate devices. | The Arthrex Compression Plates are intended for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist. This is stated to be the same as the predicate devices (Arthrex Low Profile Plate and Screw System). |
| Safety and Effectiveness: Differences between the proposed device and predicates must be minor and not raise new questions concerning safety and effectiveness. | Any differences were considered minor and did not raise questions concerning safety and effectiveness, based on the mechanical testing and comparison of intended use, technological characteristics, and material. The device was deemed substantially equivalent. |
2. Sample size used for the test set and the data provenance:
Not applicable for this type of device (physical implant evaluated via mechanical testing for substantial equivalence, not a data-driven AI/ML device). The study involved mechanical testing, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) 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:
Not applicable. This is a physical orthopedic implant, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" is based on established engineering principles and measurements of material properties, strength, and performance under simulated loads/conditions, compared against the known performance of predicate devices.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for this type of device as it does not involve AI/ML.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.