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The Arthrex Bio-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in:

• Carpal, metacarpal, and small hand bone
• tarsal and metatarsals
• phalanges
• Intra-articular fractures
• ankle
• proximal and distal humerus
• proximal and distal radius
• proximal and distal ulna
• osteochondral fixation and fractures
• Osteochondritis Dissecans
• Fixation of fractures and osteotomies about the knee
• Oblique fractures of the fibula
• Reconstructive surgeries of the foot:
• malleolar fixation
  where size of offered implant is patient appropriate.

The Arthrex Bio-Compression Family is currently comprised of enhanced Poly(I-Lactide) or PLLA implants in various lengths and diameters. They are offered sterile.

This 510(k) summary (K060478) describes the Arthrex Bio-Compression Family of implants, which are enhanced Poly(L-Lactide) or PLLA implants used for the fixation of fractures, osteotomies, and arthrodesis in various anatomical locations.

Based on the provided text, the submission does not contain information regarding an AI/ML powered device or a study involving acceptance criteria and device performance in the context of an AI/ML solution.

This document is a traditional 510(k) submission for a physical medical device (bone fixation screw) and, as such, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, and ground truth for training are not applicable to this type of submission.

The "studies" mentioned relate to "in house test data" and "articles cited" to support the use of the device in the same manner as a competitor, indicating traditional engineering and biomechanical testing for device safety and effectiveness.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as these concepts, as framed in the request, are not present in the provided 510(k) for this specific type of physical medical implant.

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The Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically; Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal Osteochondral Fragments: Talar Vault, femoral condyle Cancellous Fragments: Talus

The Arthrex Bio-Compression Screw is manufactured using poly(L-lactide). These are offered sterile, in distinct sizes.

The provided text is a 510(k) summary for the Arthrex Bio-Compression Screw, a medical device for bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable or cannot be extracted from this type of document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This 510(k) summary does not define specific performance-based acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility metrics) or report the device's performance against such criteria. The submission aims to prove substantial equivalence, implying that the device performs similarly to already approved predicate devices, not that it meets a new set of defined performance goals with quantified results.

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

• Not Applicable. No specific test set or clinical study data is provided in this 510(k) summary. The submission relies on a comparison to predicate devices and the known properties of the material used.

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

• Not Applicable. As no specific clinical or performance test set is described, there's no mention of experts establishing ground truth for such a set.

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

• Not Applicable. No test set or related adjudication method is mentioned.

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 bioabsorbable screw, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

• Not Applicable. This device is a physical implant, not an algorithm.

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

• Not Applicable. Since no specific performance study is detailed, no ground truth types are mentioned. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness profile of the predicate devices and the well-characterized nature of the PLLA material.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not Applicable. See point 8.

Summary of Device Acceptance (as per 510(k) process):

The device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, as stated in the 510(k) summary:

"By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Compression Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices."

The FDA's letter explicitly confirms this: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..."

In essence, the "study" proving the device meets "acceptance criteria" is the 510(k) submission itself, which primarily relied on a comparative analysis of the device's and predicate devices' intended use, technological characteristics, and material properties, rather than new, extensive performance testing data explicitly documented in this summary.

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