(57 days)
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal 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, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws are a family of screws that are offered in a 3.5 mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The Arthrex Low Profile Screws are manufactured from Stainless Steel materials conforming to ASTM F138. The screws are sold sterile or non-sterile and single-use.
This document is a 510(k) summary for the Arthrex Low Profile Screws. It describes mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating device performance against pre-defined acceptance criteria for a diagnostic algorithm. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity and performance statistically equivalent to predicate devices for insertion torque/failure torque | Insertion torque/failure torque demonstrated to be statistically equivalent to the predicate. |
| Design modifications to previously cleared 3.5 mm Arthrex Low Profile Screws do not affect safety or performance (evaluated via pull-out testing and insertion torque/failure torque testing) | Pull-out testing and insertion torque/failure torque testing conducted on previously cleared 3.5 mm screws demonstrated that design modifications do not affect safety or performance. |
| MR compatibility per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact) | MR compatibility testing successfully conducted per specified ASTM standards. |
2. Sample sized used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "mechanical testing data" but does not quantify the number of screws or tests performed.
- Data provenance: Not explicitly stated, however, as mechanical testing, it would be laboratory-generated data, not from human subjects or clinical settings, thus neither retrospective nor prospective in the typical sense for clinical data. It would be considered prospective for the testing itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes mechanical testing of a physical device, not the evaluation of a diagnostic tool against a ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for clinical studies involving reader interpretations, not for 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:
- Not Applicable. This is a 510(k) for a medical screw, not an AI or diagnostic imaging device.
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 Applicable. For mechanical testing, the "ground truth" would be the measured physical properties and performance metrics of the previous devices as a benchmark for comparison.
8. The sample size for the training set:
- Not Applicable. This document describes mechanical testing, not a machine learning model or algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.