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The Biotrak™ resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.

The ARC Surgical Biotrak™ Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the variable pitch of the threads. The screws are provided sterile.

This document is a 510(k) summary for the ARC Surgical Biotrak™ Screw System. It describes a medical device, specifically a resorbable compression screw for bone fixation. The provided text is a regulatory submission to the FDA, asserting substantial equivalence to previously marketed devices.

Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

Here's why and what information is available:

• Type of Submission: This is a 510(k) Pre-market Notification. For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove performance against specific acceptance criteria in the way a clinical study for a new technology might.
• Performance Data Mention: The document explicitly states: "Performance data is included in Section 10. A discussion of clinical and non-clinical tests is not applicable." This means the details of any performance data are in a separate, unprovided section of the 510(k) submission, and the current document does not include a discussion of studies with acceptance criteria, sample sizes, or expert ground truth.
• Focus on Substantial Equivalence: The document repeatedly emphasizes that the device's safety and effectiveness are based on "similarities" and "substantial equivalence" to predicate devices. This approach relies on the existing track record of the predicate devices rather than new performance studies with specific statistical targets.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: What the device is made of (PLLA, injection molded), its dimensions, and how it works (headless screw, variable pitch threads).
• Intended Use: Specific types of bone fractures and fusions in upper and lower extremities for which the screw is intended.
• Technological Characteristics: The materials and manufacturing process (PLLA pellets, ring-opening polymerization, stannous octoate catalyst).
• Predicate Devices: A list of existing devices to which the Biotrak™ system is compared for substantial equivalence.

Without "Section 10" or further documentation detailing specific performance tests and their results, none of the points (1-9) in your request can be answered.

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