(212 days)
The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulmar styloid, capitellum, radial head and radial styloid.
The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.
The provided text is a 510(k) Premarket Notification summary for the AREX SCRU 2 Headless Compression Screw. This document is for a medical device (a screw for bone fixation), not a software or AI-driven diagnostic device.
Therefore, the specific questions related to acceptance criteria for a study proving device performance, sample sizes for test and training sets, expert review, MRMC studies, standalone performance, and ground truth establishment are not applicable to this type of submission.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving novel performance through extensive clinical studies with specified acceptance criteria as would be required for a new diagnostic technology or a high-risk device.
Here's how the provided information relates to the request, focusing on the concept of "acceptance" in the context of this 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (for 510(k) submission): The primary "acceptance criteria" here is demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by comparing the device's design, materials, and intended use to those of the predicates.
- Reported Device Performance: The document states that the "design, materials and indications for use demonstrate that the AREX SCRU 2 headless compression screws are substantially equivalent to the predicate devices, and safe and effective for use, when used in accordance with the supplied instructions for use."
- No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) are provided, as these are typically not required for substantial equivalence claims for this type of device.
2. Sample size used for the test set and the data provenance: Not applicable. There was no "test set" in the context of clinical performance data in this 510(k) submission. The evaluation is based on a comparison to predicate devices, not on a new clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is not relevant for a substantial equivalence claim for a bone screw.
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 device is a passive implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. There is no "training set" for an AI model, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a medical device (a bone screw) demonstrating substantial equivalence to already approved devices. It does not involve performance studies in the way one would analyze a diagnostic tool or an AI-driven device, and therefore most of the requested information regarding study design and performance metrics is not present. The "study" in this context is the comparison of the device's characteristics to those of predicate devices.
§ 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.