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• MectaLock All-Suture Anchor
  The MectaLock All-Suture anchor is intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:
• Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; cuff rotator repair
• SnugFit All-Suture Anchor
  The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:
• Hip: acetabular labral repair
• Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

The subject devices are implantable devices indicated for the treatment of hip and shoulder instability. The subject SnugFit All-Suture Anchor size 1 is entirely composed of sutures, made up of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET), which are specifically arranged and braided to create an anchoring point within the bone, after their deployment. The sutures themselves, are also used to secure soft tissues to a supporting structure, i.e. bone.
The sterile, individually packaged, subject device is composed of two parts: an all-suture anchor and a driver made of a stainless-steel shaft with an over-moulded plastic handle. The all-suture anchor is provided pre-loaded on the specifically designed disposable driver.
The new SnugFit All-Suture Anchor size 1 is available in two (2) different configurations depending on the driver length (long and short).

This document is a 510(k) premarket notification from the FDA, which assesses the substantial equivalence of modifications to existing medical devices (SnugFit All-Suture Anchor and MectaLock All-Suture Anchor). It does not contain information about software performance, AI algorithm acceptance criteria, or related study details.

Therefore, I cannot provide the requested information regarding acceptance criteria and study data for an AI/software device, as the provided text pertains to a physical medical device (all-suture anchor).

If you can provide a text that describes a medical device with an artificial intelligence/machine learning component, I would be happy to extract the requested information.

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