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The RC Loop Anchor with Dual Orthocord Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Rotator cuff repair

RC Loop with Dual Suture is a preloaded, absorbable disposable suture anchor/ inserter assembly for rotator cuff repair. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok RC Loop Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The information provided describes a 510(k) premarket notification for a medical device and not a study assessing device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and reader studies is not present in the provided text.

However, I can extract the relevant information regarding the type of assessment performed for this medical device:

Device: RC Loop Anchor with Dual Orthocord Suture

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not applicable. The "test set" in this context refers to physical bench testing, not a dataset of medical images or patient records. This was a bench test, and not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. Ground truth for bench testing is established by technical specifications and validated testing methodologies, not expert consensus in a clinical diagnostic sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Bench testing results are typically evaluated against predefined engineering and material standards.

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:

• MRMC Study: No. This is a physical medical device (suture anchor), not an AI/ML diagnostic tool.

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

• Standalone Performance: Not applicable. This is a physical medical device.

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

• Type of Ground Truth: Engineering specifications, material standards (e.g., USP monograph), and predefined technical criteria for suture compatibility and deployment.

8. The sample size for the training set:

• Sample Size: Not applicable. This refers to a physical medical device, not an AI/ML algorithm.

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

• How Ground Truth Was Established: Not applicable.

Summary of the Study:

The provided text describes a 510(k) Premarket Notification for a medical device. The "study" mentioned is a series of bench tests conducted to demonstrate that the RC Loop Anchor with Dual Orthocord Suture is "substantially equivalent" to a predicate device.

• Study Type: Bench testing (not a clinical trial, diagnostic accuracy study, or AI/ML performance study).
• Purpose: To demonstrate conformance to consensus and voluntary standards, and that the device performs as intended in terms of material properties (suture conformance to USP monograph) and functional aspects (suture compatibility and deployment).
• Conclusion: Based on the bench testing, device description, and comparison to predicate devices, the manufacturer concluded that the device is substantially equivalent to predicate devices.

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