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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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Indications for the 2.8 and 3.5mm LactoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/tendon repair.

The 2.8 and 3.5mm LactoScrew® Suture Anchors, which are comprised of LactoSorb® resorbable copolymer (85% PLLA/15% PGA), are molded suture anchors used to reattach soft tissue to bone. All 2.8 and 3.5mm LactoScrew® Suture Anchors are pre-loaded with either one or two sutures.

The provided text is a 510(k) summary for the 2.8 and 3.5mm LactoScrew® Suture Anchors. This documentation is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for this specific device is not present in the provided document. The document explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."

It instead relies on "Non-Clinical Testing" which "indicated that the devices were functional within their intended use" and a comparison of technological characteristics to predicate devices.

Summary of available information based on the prompt's request:

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

• Not provided. The document does not specify quantitative acceptance criteria or performance metrics derived from clinical testing for this device. It only states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use."

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

• Not applicable. No clinical test set or data provenance is mentioned.

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. No clinical test set requiring expert ground truth is mentioned.

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

• Not applicable. No clinical test set requiring adjudication is mentioned.

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 device is a physical medical device (suture anchor), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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 (expert consensus, pathology, outcomes data, etc)

• Not applicable. No clinical ground truth is mentioned. The basis for substantial equivalence was "Non-Clinical Testing" for functionality and comparison to predicate devices.

8. The sample size for the training set

• Not applicable. No training set data is mentioned for this type of device submission.

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

• Not applicable. No training set data or ground truth establishment process is mentioned.

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