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The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

The ThRevo™ Suture Anchor with Disposable Driver consists of a titanium suture anchor with a self-tapping cutting tip. The design requires no predrilling and can be inserted by hand into the bone with the accompanying disposable driver. The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in design, performance specifications, function and intended use to the Super Revo® Suture Anchor. The design of the implant has not been modified.

The only modification to the currently marketed device is the ThRevo™ Suture Anchor with Disposable Driver is preloaded with three (3) nonabsorbable USP size # 2 braided polyester sutures (green, white and green/white striped) instead of two (2) nonabsorbable, USP size # 2 braided polyester sutures (green and white). The surgical technique has been slightly modified to for account for the addition of the third suture.

The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor (510(k) # K003984). Both are provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. Also, both the ThRevoTM Suture Anchor with Disposable Driver and Super Revo® Suture Anchor are supplied sterile and single use.

This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

This is a 510(k) premarket notification for a medical device called the ThRevo™ Suture Anchor with Disposable Driver. It is primarily a declaration of substantial equivalence to a previously marketed device, the Super Revo® Suture Anchor, rather than a study proving the device meets acceptance criteria.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of submission. However, I can extract the relevant information provided:

Here's a breakdown of the available information:

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

The document does not provide specific numerical acceptance criteria or performance metrics in a table format. The core of this 510(k) is to demonstrate substantial equivalence. It states:

• Acceptance Criteria Implied: The new device (ThRevo™ Suture Anchor with Disposable Driver) must be substantially equivalent to the predicate device (Super Revo® Suture Anchor) in design, performance specifications, function, and intended use, and not raise new issues regarding safety and effectiveness.
• Reported Device Performance: The document explicitly states: "The design of the implant has not been modified." and "The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor". The only modification is the addition of a third suture.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document refers to "Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness." However, the details of this testing (sample size, methodology) are not provided in this summary.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. This is not a study involving expert assessment of a test set for ground truth establishment.

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

• Not applicable/Not specified.

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

• No. This is a submission for a physical medical device (suture anchor), not an AI-assisted diagnostic tool.

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

• No. Not applicable, as this is not an algorithm.

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

• Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning model.

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

• Not applicable.

Summary of the Study (or justification for substantial equivalence):

The "study" presented here is a Special 510(k) Summary aiming to demonstrate "substantial equivalence" of the ThRevo™ Suture Anchor with Disposable Driver to a legally marketed predicate device, the Super Revo® Suture Anchor (510(k) # K003984).

Key "Proof" points:

• Device Description (E): The titanium suture anchor implant itself has not been modified from the predicate device.
• Modification: The only change is the addition of a third non-absorbable USP size #2 braided polyester suture.
• Intended Use (F): The intended use (rotator cuff repairs in the shoulder) remains the same.
• Substantial Equivalence (G): "The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in intended use, scientific technology and design to the Super Revo® Suture Anchor. Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness."
• Suture Safety: The additional suture material (Polydek) is from TeleFlex Medical, which is approved for commercial distribution under 510(k) number K021019. The other two sutures are from Surgical Specialties and approved under NDA 80-950.

In essence, the "study" for this 510(k) filing relies on the established safety and effectiveness of the predicate device and the materials used, asserting that the minor modification (addition of a suture) does not alter the fundamental safety or performance profile. No detailed clinical or performance study data is provided in this summary.

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