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K Number
K180101
Device Name
HEALIX ADVANCE KNOTLESS BR Anchor
Manufacturer
Medos International SARL
Date Cleared
2018-05-10

(114 days)

Product Code
MAI
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K171114,K130917,K131974,K130539,K131683,K101679,K082810,K071177,K061863,K051219
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

Foot/Ankle: Achilles Tendon Repair

Device Description

The HEALIX ADVANCE KNOTLESS BR Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE KNOTLESS BR Anchors are molded from Biocryl Rapide® (BR) material. The HEALIX ADVANCE KNOTLESS BR Anchor is provided sterile and is for single use only.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the HEALIX ADVANCE™ KNOTLESS BR Anchor. It is a clearance letter and a summary of the device, not a study report or clinical trial. Therefore, it does not contain the specific information required to answer the prompt regarding acceptance criteria and performance data for an AI/ML medical device.

The prompt is asking for details typically found in a clinical study report for an AI/ML-driven device, such as:

  1. A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
  2. Sample size, data provenance, and retro/prospective nature of the test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for golden standard.
  5. MRMC study details and effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, clinical outcome).
  8. Training set sample size.
  9. Method for establishing training set ground truth.

This 510(k) summary focuses on the substantial equivalence of a physical medical device (suture anchor) to predicate devices, based on material, design, and mechanical performance (fixation strength, insertion torque). It does not involve any AI/ML components or related performance metrics that would require the establishment of ground truth by multiple experts, MRMC studies, or analysis of sensitivity/specificity for diagnostic tasks.

Therefore, I cannot fulfill the request using the provided document. The document describes a physical medical device and its premarket clearance, not an AI/ML device with associated performance studies.

§ 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.