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The MectaLock TI Triple Loaded Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:

• Shoulder: rotator cuff repair and biceps tenodesis.

The MectaLock TI Triple Loaded Suture Anchor is a line extension to the MectaLock TI Suture Anchor cleared within K191300.

The MectaLock TI Triple Loaded Suture Anchors are implantable devices used for soft tissue refixation within the shoulder joint (rotator cuff repair, biceps tenodesis). They are composed of an anchoring component (Titanium alloy anchor) and preloaded with UHMWPE non-absorbable braided sutures.

This implantable assembly, is provided sterile and individually packaged, mounted on a dedicated disposable stainless steel driver with a plastic handle, allowing the surgeon to insert and place the MectaLock TI Triple Loaded Suture Anchor into the patient.

The MectaLock TI Triple Loaded Suture Anchor are available in 4 different configurations depending on anchor size (Ø5.0 or Ø6.5 mm) and typology of preloaded sutures.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving a device meets those criteria in the context of an AI-powered medical device.

The document is a 510(k) summary for a physical medical device called "MectaLock TI Triple Loaded Suture Anchor," which is a suture anchor used for orthopedic procedures.

The information requested in your prompt, such as:

• Acceptance criteria for an AI device (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets (relevant to AI model validation)
• Data provenance (retrospective/prospective, country of origin) for an AI study
• Number of experts for ground truth establishment
• Adjudication methods (2+1, 3+1)
• MRMC comparative effectiveness studies (AI vs. human readers)
• Stand-alone AI performance
• Type of ground truth (pathology, outcomes data, etc.) for AI
• Training set details (sample size, ground truth establishment)

These are all specific to the validation of an AI/Software as a Medical Device (SaMD).

The provided document details non-clinical performance testing for a mechanical implant, including:

• Design validation (cadaver lab)
• Substantial equivalence assessment
• MR safety evaluation
• Pyrogenicity testing
• Biocompatibility evaluation
• Shelf-life evaluation

It explicitly states: "No clinical studies were conducted." This further confirms there is no AI component being evaluated here.

Therefore, I cannot fulfill your request using the provided input.

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