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The RoG™ 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction. . scapholunate ligament reconstruction.
• . Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Scapholunate ligament reconstruction. .
• Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral . ligament reconstruction.
• . Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. Iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The RoG 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• Shoulder indications:- Bankart repair. rotator cuff repair. SLAP lesion repair. . capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• . Wrist/Hand indications:- Ulnar/Radial collateral ligament reconstruction. scapholunate ligament reconstruction.
• Foot/Ankle indications:- Achilles tendon repair/reconstruction, hallax valgus . reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• Elbow indications :- Biceps tendon reconstruction, ulnar or radial collateral ● ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament . repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in both standard ("knotted") and "knotless" configurations. It is also available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is provided sterile and supplied with non-absorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.

This document is a 510(k) Summary for the RoG Sports Medicine Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed performance studies or specific acceptance criteria for a new AI/software device. Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text.

The document states: "Performance characteristics of the anchors have not changes from those described in K110229 and L110230. The only changes to the device are supplying the device with non-absorbable suture and pre-sterilized."

This indicates that the current submission (K111590) is for a modified version of an already cleared device, and thus, extensive new performance studies (especially those involving AI or software as typically implied by your request) are not part of this particular submission. The focus is on demonstrating that the modifications (suture type and sterilization method) do not alter the substantial equivalence to the predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This is not present as the device itself hasn't undergone new performance testing for this submission. The "performance characteristics" are stated to be unchanged from predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable for a non-AI/software device submission of this nature.
3. Number of experts used to establish the ground truth...: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as there is no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Safety Characteristics" section mentions compliance with ISO 10993 (biocompatibility) and ISO 11135-1 (sterilization), but these are standards for material safety and manufacturing processes, not specific performance criteria for the device's functional use in the way described in your request for AI/software.

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