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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.
• t 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 subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding sizes.

The provided document is a 510(k) summary for the RoG Suture Anchor, a medical device. It describes the device's technical specifications, intended use, and its equivalence to predicate devices, but it does not contain information about a study involving AI, human readers, or image analysis.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on design considerations, materials, performance characteristics (mechanical testing), and indications for use. It typically does not involve the kind of clinical or comparative effectiveness studies with human readers or AI that your request outlines.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human readers, or ground truth establishment in the way you described, because the provided document does not pertain to such a device or study.

The "Performance Characteristics" section explicitly states: "Both sizes of subject were evaluated in accordance with FDA's Guidance Document for Testing Bone Anchor Devices (4/20/96). Testing consisted of tapping and pull testing with comparison to the corresponding size of predicate devices. The subject device was found to be equivalent to the corresponding sizes of the predicate devices in such testing." This indicates the evaluation was purely mechanical and comparative to existing similar devices.

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