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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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