(63 days)
The Arthrex Fracture Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Fracture Plates are a family of flat and contoured plates and screws. The plates are comprised of stainless steel and come in a variety of configurations. The Arthrex Fracture Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed Low Profile Screws, in this submission, are comprised of Stainless Steel and are 2.7mm in diameter and range from 32mm to 60mm in length.
The provided text is a 510(k) premarket notification for the Arthrex Fracture Plates and accompanying screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested categories for AI/ML study description (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a mechanical performance study to demonstrate substantial equivalence.
Here's the information that can be extracted relevant to acceptance criteria and the "study" conducted for this type of device:
1. A table of acceptance criteria and the reported device performance:
The document describes material and mechanical testing to demonstrate substantial equivalence. It implies that the acceptance criteria for these tests were met by being comparable to the predicate devices. The specific raw data or numerical acceptance limits are not provided in this summary, but the conclusion of meeting them is stated.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| 4-point bend | Performance comparable to predicate devices | Performance is substantially equivalent to predicate devices |
| Section modulus comparison | Performance comparable to predicate devices | Performance is substantially equivalent to predicate devices |
| Torque | Performance comparable to predicate devices | Performance is substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated for the mechanical tests in this summary. Mechanical tests typically involve a small number of samples of the device and predicate.
- Data provenance: The tests were "in-vitro testing" conducted by the manufacturer, Arthrex, Inc., in the USA (Naples, FL).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to mechanical testing, not expert-based evaluation of medical images.
4. Adjudication method for the test set:
- Not applicable. This pertains to mechanical testing.
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 not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- Mechanical properties comparison to predicate devices. The "ground truth" here is the established mechanical performance of legally marketed predicate devices, against which the new device's performance is compared.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what the document does say about the "study":
The study conducted was in-vitro mechanical testing (4-point bend, section modulus comparison, torque) to compare the performance of the Arthrex Fracture Plates and screws to their predicate devices. The conclusion was that the "performance of the proposed devices is substantially equivalent to that of the predicate devices" and that "The mechanical data indicate that the Arthrex Fracture Plates are adequate for their intended use." The document explicitly states: "Clinical data and conclusions are not needed for this 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.