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The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.

The provided text describes the 510(k) premarket notification for the Innovasive Bio-Interference Screw. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided information:

1. A table of acceptance criteria and the reported device performance

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

The document does not explicitly state the sample size used for the bone model testing or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Bone Model Testing."

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

This information is not provided in the document. The study involves mechanical testing on a bone model, not expert assessment of images or data that would require "ground truth" established by experts in the typical sense for medical imaging algorithms.

4. Adjudication method for the test set

This information is not applicable and not provided. The study involves mechanical testing, not a process that would typically require adjudication.

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

An MRMC comparative effectiveness study was not done. This document describes a medical device (an interference screw) and its mechanical performance, not an AI algorithm for diagnosis or interpretation that would typically involve human readers.

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

This is not applicable. The device is a physical medical implant, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" in this context is the mechanical performance of the predicate device (Arthrex Bio-Interference Screw). The Innovasive Bio-Interference Screw's performance was compared directly to this established device. This is a form of functional equivalence based on established device performance.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI algorithm that would have a "training set."

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

This information is not applicable and not provided, as there is no "training set" for this type of medical device.

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To provide interference fixation of bone-tendon-bone and soft tissue-grafts in ACL reconstruction through arthroscopy or arthrotorry.

The Arthrex Bio-Interference Screw is a bioabsorbable interference screw used to fix a graft to a bone in ACL reconstruction. It is inserted between the tunnel wall and graft to hold the graft in place. It is implanted with accessories such as a screw sheath, driver, guide wire, dilator, notcher, tap, and remover.

This 510(k) summary (K971358) for the Arthrex Bio-Interference Screw does not contain any information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document details the device's functionality, technological characteristics, and intended use, comparing it to a previously cleared Bio-Interference Screw from Arthrex and Linvatec's BioScrew, to argue that it raises no new issues of safety or effectiveness. There is no mention of clinical studies, performance metrics, sample sizes, expert involvement, or ground truth establishment.

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