(87 days)
The MectaLock PEEK Suture anchors (size 4.5, 5.5 & 6.5 mm) are intended for use in arthroscopic or open surgical approaches:
· soft tissue refixation within the shoulder joint (i.e .: rotator cuff repair)
The MectaLock Suture Anchor Extension includes implantable devices used for soft tissue re-fixation (e.g. muscles, tendons, ligaments) composed of a PEEK anchoring component and an Ultra High Molecular Weight PolyEthylene (UHMWPE) non-absorbable braided suture.
Specifically, the devices subject of this submission are MectaLock PEEK Suture Anchors Ø4.5, Ø5.5 and 06.5 mm with short driver; a range extension of the already cleared MectaLock PEEK Suture Anchor (K190474).
Identically to the reference device cleared within K190474, the MectaLock Suture Anchor Extension implants are knotless devices provided mounted on the tip of a dedicated disposable driver which allows the surgeon to insert the anchor into a pilot hole, previously drilled in the desired position into the patient's bone. The surgeon must combine the anchor with the provided non-absorbable suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed.
The provided text describes a 510(k) premarket notification for a medical device called the "MectaLock Suture Anchor Extension." This document, issued by the FDA, determines the device's substantial equivalence to legally marketed predicate devices.
However, the information you're asking for, which pertains to the acceptance criteria and the study proving a device meets those criteria (specifically for AI/Software-as-a-Medical-Device performance), is not present in this regulatory document.
This FDA letter is for a physical medical device (suture anchors) and focuses on non-clinical performance and biocompatibility. It explicitly states: "No clinical studies were conducted." The performance data section lists:
- Design Validation: MectaLock Suture Anchor Extension Design Validation Report.
- Performance Testing: MR Safety evaluation, Cyclic and load-to-failure properties of suture anchors.
- Pyrogenicity: Bacterial endotoxin test, Pyrogen test.
- Biocompatibility: Assessment as per ISO 10993 series and FDA Biocompatibility Guidance Document.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and reported device performance related to AI/software.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone (algorithm-only) performance results.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/software.
- Sample size for the training set for AI/software.
- How ground truth for the training set was established for AI/software.
The document is about a different type of medical device and does not involve AI or software performance evaluation.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.