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The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.

The provided text is a 510(k) summary for a medical device called the "Arthrex TightRope Soft Button, RT". This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

The summary does not contain information about acceptance criteria or a detailed study report with the specific metrics requested. Instead, it states that the device is "equivalent to the primary Arthrex ACL Tightrope RC predicate device" based on "cyclic pull-out testing".

Therefore, I cannot provide the detailed tables and information requested, as it is not present in the provided text.

Based on the information available:

1. Table of acceptance criteria and reported device performance:
This information is not explicitly provided in the document. The document states: "Based on cyclic pull-out testing, the proposed Arthrex TightRope Soft Button, RT device is equivalent to the primary Arthrex ACL Tightrope RC predicate device." This implies that the performance of the new device met the performance of the predicate device in cyclic pull-out testing, but the specific acceptance criteria and the numerical results are not given.

2. Sample size used for the test set and the data provenance:
Not specified in the document. The document only mentions "cyclic pull-out testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is a mechanical test, not an evaluation by human experts using a test set with ground truth.

4. Adjudication method for the test set:
Not applicable for a mechanical test.

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 is a medical device for bone/soft tissue fixation, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device, not an algorithm. The "equivalence" is based on mechanical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here would be the validated performance of the predicate device in cyclic pull-out testing, which serves as the benchmark for equivalence. The specific details of that ground truth are not provided.

8. The sample size for the training set:
Not applicable. This is a mechanical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary of available details regarding the study:

• Study type: Cyclic pull-out testing (a type of mechanical bench testing).
• Purpose: To demonstrate substantial equivalence to a predicate device (Arthrex ACL TightRope RC, K112990).
• Outcome: The proposed device was found to be "equivalent" to the predicate.

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