Search Results

The Arthrex TRIMit implant is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments. Specific indications include metatarsal and metacarpal fractures.

The Arthrex TRIMit™ Screw is manufactured using poly(L-lactide). It is a fully threaded small diameter screw.

This 510(k) premarket notification describes the "Arthrex TRIMit™ Screw," a bioabsorbable polylactide (PLLA) screw intended for fixation of small bone fragments. However, the provided document does not contain acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary and the FDA's letter of "substantial equivalence" to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, rather than requiring extensive new performance studies with specific acceptance criteria that would typically be detailed in a PMA (Premarket Approval) application.

Therefore, I cannot populate the requested table and information based on the provided text, as the detailed performance study data is not present. The submission focuses on demonstrating substantial equivalence primarily through comparison of materials, intended use, and existing predicate device characteristics.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Device Performance: These are not specified because the submission is for substantial equivalence. The "performance" is implicitly deemed equivalent to the predicate device.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (for a new study), Training Set: These are all aspects of a new clinical or detailed performance study. Since the 510(k) does not present such a study for the Arthrex TRIMit™ Screw, this information is not available in the provided text. The "study" mentioned here is the 510(k) submission itself, demonstrating equivalence, not a new performance trial.

The document states: "The difference between the Arthrex TRIMit 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." This is the core of the "proof" for a 510(k) submission – demonstrating analogous characteristics to existing devices.

Ask a specific question about this device