(108 days)
The Knotless SutureTak Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure Hip: Capsular Repair, Acetabular Labral repair
The Knotless SutureTak Anchors are "tap-in" suture anchors with a ribbed profile and a proximally placed external suture eyelet. The anchors are preloaded with Arthrex Suture and are offered preassembled on a driver/inserter, for single use. The Knotless SutureTak Anchors are manufactured from either PEEK or bioabsorbable materials. The PEEK anchor was originally cleared under K120155 for indications in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. The indication for the PEEK anchor was expanded to include Joint Capsule Closure under K171020. The bioabsorbable version of the cleared Arthrex Knotless SutureTak Anchor is made of the same material as the Arthrex PushLock cleared under K101679.
This document is a 510(k) Pre-market Notification for a medical device, not a study report for an AI/ML device. Therefore, it does not contain the information required to answer your prompt. The questions you posed—regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device—are not applicable to this submission, which is for physical surgical anchors.
Specifically, the document pertains to:
- Device Name: Knotless SutureTak Anchors
- Device Type: Surgical anchors for suture or tissue fixation in orthopedic applications.
- Purpose of Submission: To obtain additional indications for use (Lateral Epicondylitis Repair) and introduce a bioabsorbable version of an already cleared device, demonstrating substantial equivalence to predicate devices.
There is no mention of any AI or machine learning component, diagnostic capabilities, or a study involving human readers or algorithm-only performance. The "Performance Data" section explicitly states that "Pull-out and degradation testing was conducted to demonstrate that the Knotless SutureTak Anchors perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This confirms that the performance evaluation was mechanical and material-based, not AI/ML model validation.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, study design, sample sizes for AI/ML validation, expert adjudication, or MRMC studies based on the provided text.
§ 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.