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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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These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

Screws are generally intended for alignment and fixation of bone fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace). The Inion OTPS™ Screws are offered in several dimensions and lengths typical for this application. The Inion OTPS™ Screws are made of resorbable polylactic acid / trimethylenecarbonate [poly(L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Inion OTPS™ 2.5/2.8/3.1 Biodegradable Screws:

The provided 510(k) summary (K043142) does not contain specific numerical acceptance criteria or detailed study data to prove the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on two general aspects: mechanical characteristics and biocompatibility.

Therefore, many of the requested sections below cannot be populated with specific data from the provided text.

Acceptance Criteria and Reported Device Performance

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance:

   • The document states "Based on the performance data presented in section I of this premarket notification..." However, Section I is not provided in the given text. Therefore, specific sample sizes for test sets or data provenance (country, retrospective/prospective) are not available here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not available/not mentioned. The document discusses the device's characteristics and equivalence to predicates, not a study involving expert-established ground truth on a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/not mentioned. This type of adjudication method typically applies to studies where human readers are interpreting images or data, which is not described here.

4. 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 a medical device (biodegradable screws), not an AI/imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation would be relevant or conducted for this type of product.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a physical medical implant, not an algorithm or software. Standalone performance for an algorithm is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the demonstration of mechanical characteristics, the "ground truth" would likely be engineering specifications, material testing standards (e.g., ISO, ASTM), and comparison to the known performance of predicate devices.
   • For biocompatibility, the "ground truth" would be established through a series of standardized biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation tests, hemocompatibility) performed according to ISO 10993 standards. These tests have defined pass/fail criteria.
   • No "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical diagnostic study is described as the ground truth. The substantial equivalence argument relies on meeting established engineering and biological safety profiles.

7. The sample size for the training set:

   • Not applicable/not mentioned. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an algorithm is involved.

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