(5 days)
The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
The Arthrex Low Profile Plate and Screw System consists of plates and screws. The plate is an L-shaped plate with four holes for insertion of screws for fixation. The plate is available in opening and closing wedge design, in various lengths, in both left and right configurations. The Arthrex screw is a cortical, headed, self-tapping screw available in one diameter, in numerous length options.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) summary for a medical device (Arthrex Low Profile Plate and Screw System) seeking FDA clearance based on substantial equivalence to a predicate device.
Here's a breakdown of what is and is not in the document, in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not define specific performance metrics or acceptance criteria for the device, nor does it report detailed performance results against such criteria. The clearance is based on substantial equivalence, implying similarity in fundamental features and intended use to an already cleared device, not necessarily on meeting new, explicit performance targets.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. There is no mention of a "test set" or any data used for performance evaluation in the context of a study. The 510(k) summary focuses on comparing the new device to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not present. This information would be relevant for clinical studies, which are not described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. Again, this pertains to clinical study design, which is not detailed here.
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 document is for a physical medical device (bone plates and screws), not an AI/software device. Therefore, MRMC studies or AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No ground truth is mentioned as no performance study is detailed.
8. The sample size for the training set
- Not present. This would be relevant for an AI/machine learning device, not a bone plate and screw system.
9. How the ground truth for the training set was established
- Not present. As above, not relevant for this type of device and no training set is mentioned.
Summary of Device and Approval Process:
The Arthrex Low Profile Plate and Screw System is a physical medical device intended for internal bone fixation in the ankle, foot, hand, and wrist. The approval granted in this 510(k) is based on the device being "substantially equivalent" to an already legally marketed predicate device (Arthrex Small Fragment Plates and Screws K040907). This means that the FDA determined that the new device has "basic features and intended uses [that] are the same" as the predicate, and any differences are "considered minor and do not raise questions concerning safety and effectiveness." The 510(k) process typically relies on comparisons to existing devices rather than extensive new clinical performance studies for demonstrating safety and effectiveness, especially for well-understood device types like bone fixation hardware.
§ 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.