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The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the site of be either arthroscopically or in an open technique.

The Pre-Loaded UltraFix® RC is supplied sterile and consists of an suture anchor with USP#2 non-absorbable polyester suture with cartidge and needles preloaded onto a single from disposable inserter. The Pre-Loaded UltraFix® RC is made from 316(L) stainless steel per ASTM F138-92 or ASTM F138-92 and conforms to ISO 5832-1.

The provided text is a 510(k) summary for the "Pre-Loaded UltraFix® RC" suture anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria for a new device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets those criteria are not present in the provided document. The document primarily attests to a comparative analysis against a legally marketed predicate device rather than independent performance validation against predefined criteria.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document. The document describes the device and its intended use but does not provide a table of performance metrics with acceptance criteria and corresponding reported values from a study.

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

• Sample size for test set: Not specified.
• Data provenance: Not specified. The document states "Performance testing has been conducted to demonstrate safety and effectiveness" but does not detail the nature, size, or origin of this testing data. Given the context of a 510(k) summary focused on substantial equivalence, it's highly probable the "testing" involved verification and validation activities rather than a large-scale clinical test set for new performance criteria.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: 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

This is not applicable as the device is a physical suture anchor, not an AI or imaging diagnostic tool.

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

This is not applicable as the device is a physical suture anchor, not an algorithm.

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

• Type of ground truth: Not explicitly stated. For a physical medical device like this, "ground truth" would typically relate to mechanical performance (e.g., tensile strength, pull-out force) or biocompatibility, evaluated against established standards or predicate device performance. The document mentions "Performance testing has been conducted to demonstrate safety and effectiveness" and that the device is "substantially equivalent in design, materials, manufacturing, works of technology and intended use to Linvatec's existing UltraFix® RC Suture Anchor System." This implies performance was compared against the predicate's known characteristics, which would serve as a de facto "ground truth" for equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical suture anchor, not an AI model requiring a training set.

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

This is not applicable for the same reason as above.

Summary of what is present:

• Device Name: Pre-Loaded UltraFix® RC
• Intended Use: Used for rotator cuff repairs and the site of tendon or ligament to bone reattachment, either arthroscopically or in an open technique.
• Predicate Device: K963812 UltraFix® RC from Linvatec.
• Substantial Equivalence Claim: The Pre-Loaded UltraFix® RC is substantially equivalent in design, materials, manufacturing, works of technology, and intended use to Linvatec's existing UltraFix® RC Suture Anchor System.
• Performance Testing: "Performance testing has been conducted to demonstrate safety and effectiveness." (No details provided on the specific tests, criteria, or results.)

In conclusion, this 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a previously cleared device. It does not provide the kind of detailed study design, acceptance criteria, and performance metrics typically associated with establishing new performance claims or with AI/diagnostic device validation.

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