Search Results

The TissueTak is intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization

The Arthrex TissueTak is manufactured using Poly (L, DL-lactide). It is cannulated with an oblong head and seven raised ridges along the circumference of the central shaft. There are two spikes on the head of the device to aid in soft tissue fixation.

The provided text is a 510(k) summary for the Arthrex TissueTak device, a medical implant. The document establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating that the new device has "the same intended use and the same technological characteristics as the predicate device" or is "as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device." This is achieved by:

• Showing the material (Poly (L, DL-lactide)) is already used in an FDA-cleared device (Synthes Polypin) and has undergone testing.
• Stating that the TissueTak has the same intended use as other predicate devices (Acufex Suretac and Bionx Bankart Tack).
• Asserting that technological differences do not raise new safety or efficacy concerns.

Therefore, I cannot provide the requested information in the table or the additional details about a study, as they are not present in the given text.

Summary of missing information:

• Table of Acceptance Criteria and Reported Device Performance: Not provided.
• Sample size used for the test set and data provenance: Not provided.
• Number of experts used to establish the ground truth and qualifications: Not provided.
• Adjudication method for the test set: Not provided.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable for this type of medical implant.
• Type of ground truth used: Not applicable for demonstrating substantial equivalence based on material and intended use.
• The sample size for the training set: Not applicable (no algorithm training mentioned).
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device