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Intended Use: The PopLok™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

Indications for Use: The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The 2.8 mm/3.3 mm PopLok™ Suture Anchors are sterile, single use devices. The 2.8 mm/3.3 mm PopLokTM Suture Anchors are manufactured from PEEK Optima LT1 (polyetheretherketone) material. The anchors are available in two (2) sizes (2.8 mm and 3.3 mm diameters). The anchors are supplied with one (1) #2 Hi-Fi® suture or two (2) #0 Hi-Fi® sutures, packaged separately. The anchors are provided sterile, single use and preloaded on a disposable driver with a threader.

The provided text describes a 510(k) premarket notification for a medical device, the 2.8 mm/3.3 mm PopLok Suture Anchors. This documentation focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria and reported device performance in the way a clinical trial for a new drug or diagnostic device would.

Therefore, many of the requested elements for a detailed study of diagnostic or AI-assisted devices (like sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, training set details, etc.) are not applicable or available from this type of regulatory document.

However, I can extract information related to the performance testing conducted to support substantial equivalence.

Here's the information based on the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test or detailed quantitative performance results in a table format. It lists the types of verification and validation testing performed and states that the device "met the endotoxin limits" and "perform as intended." The purpose of these tests in a 510(k) submission is to demonstrate that the new device performs comparably to or better than predicate devices and does not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the document. The tests performed ("Ultimate Fixation Strength", "Cyclic", etc.) typically involve a number of samples to achieve statistical significance but the exact count is not disclosed here.
• Data Provenance: Not specified. These are laboratory/bench tests, not clinical studies. The data would be generated in a controlled testing environment, likely at the manufacturer's facilities or a contracted testing lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. This document describes performance testing for a physical medical device (suture anchors), not a diagnostic or AI algorithm relying on expert interpretation of data or images. Ground truth as typically defined in diagnostic studies (e.g., expert consensus on medical images or pathology results) is not relevant for this type of device submission.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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. This is a physical medical device (suture anchors), not an AI-assisted diagnostic or imaging device.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable. For mechanical performance tests, the "ground truth" would be the objective measurements of physical properties (e.g., force, displacement, material composition) against engineering specifications, rather than expert consensus or pathology.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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