(52 days)
The MectaLock All-Suture Anchor is 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
The MectaLock All-Suture Anchors are implantable, knotted, devices composed entirely of ultrahigh molecular weight polyethylene (UHMWPE) specifically arranged and braided to create an anchoring point within the bone after deployment. The sutures that compose the anchor are also used to secure soft tissues to a supporting structure (i.e., bone).
The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is pre-loaded on the disposable driver.
MectaLock All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded floating sutures (standard or tape sutures).
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "MectaLock All-Suture Anchors" and outlines the device's characteristics, indications for use, comparison to a predicate device, and summarily lists non-clinical studies conducted (design validation, MR compatibility, characterization testing, pyrogenicity, biocompatibility, sterilization, shelf-life). It explicitly states that "No clinical studies were conducted."
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth details for training sets.
§ 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.