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Rotium® is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Rotium® is composed of two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Rotium® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. Rotium® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 20mm to 70mm x 25mm. Rotium® is designed for stand-alone use. At the discretion of the surgeon, Rotium® may be hydrated with sterile isotonic solution.

The provided text is a 510(k) premarket notification for a medical device called Rotium®, a surgical mesh for tendon injuries. It does not contain information about an AI/ML-driven medical device, nor does it detail a study proving such a device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence of the Rotium® surgical mesh to a predicate device based on its material composition, physical and mechanical properties, biocompatibility, and animal testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a different type of medical device (surgical mesh) and its traditional regulatory submission.

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The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed over the tendon and is designed to facilitate tendon-bone reattachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.

The provided document is a 510(k) premarket notification for a medical device called the "Rotium™ Bioresorbable Wick." This submission is for updating the labeling of an already cleared device, K183236 and K201414, to allow for its placement on top of the rotator cuff tendon.

Therefore, the document explicitly states that "No new performance data is required because the labeling changes made to the device will have no impact on the Biocompatibility, Bench Testing, or Animal Testing results of the predicate (K183236, K201414)."

This means there is no new study described in this document to prove that the device meets acceptance criteria for the current labeling changes. The device's performance data and its ability to meet acceptance criteria were established during the clearance of the predicate devices (K183236, K201414).

Given this, it is not possible to provide detailed information on acceptance criteria and a study from this specific document, as no new study was conducted for this 510(k) submission.

To answer your request, I would typically need information about the original studies for the predicate devices (K183236, K201414), which are not included in this document.

However, based on the information provided in this document, here's what can be inferred or stated about the lack of a new study:

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

• Not applicable to this submission. This document states no new performance data was required. The original acceptance criteria and performance data would have been part of the K183236 and K201414 submissions.

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

• Not applicable to this submission. No new test set was used as no new performance data was generated.

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 to this submission. No new ground truth was established for the purpose of this submission.

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

• Not applicable to this submission. No new test set required adjudication for this submission.

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. The device is a bioresorbable wick, not an AI diagnostic tool.

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

• Not applicable. The device is a bioresorbable wick, not an algorithm.

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

• Not applicable to this submission. No new ground truth was established. For medical devices like this, ground truth for performance would typically come from bench testing standards, animal studies, and potentially human clinical outcomes from previous studies.

8. The sample size for the training set:

• Not applicable. This submission doesn't involve training data as it's not an AI/machine learning device.

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

• Not applicable. This submission doesn't involve training data.

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