(85 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.