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The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hip: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.

Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".

The Suture Anchors - GM Reis is composed of two different groups of anchors:

• HTA – Headless Titanium Anchor.
  • Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
• -ZIP Anchor.
  • Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.

The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.

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The Arthrex FiberTak Suture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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

The Arthrex FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair. The device is provided sterile intended for single use. The anchor is constructed from a hollow braid of polyester. A blue and white striped suture comprised of UHMWPE (white) and Polyester (blue) is assembled through the hollow braid. The striped suture component is designated as TigerWire CL. The device comes preloaded on a disposable inserter. The inserter is made from surgical grade nitinol and ABS plastic. The FiberTak Suture may be sold separately or in a kit with implantation instrumentation.

The provided text describes the Arthrex FiberTak Suture Anchor, a medical device intended for soft tissue fixation. It does not contain information about acceptance criteria for a study that proves the device meets specific performance metrics in the context of an AI/ML or diagnostic device. Instead, the document is a 510(k) premarket notification approval letter for a physical medical device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML study, nor any of the other requested information pertaining to studies for AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies.

The document primarily focuses on establishing substantial equivalence to a predicate device based on mechanical testing and similar indications for use.

Here's what can be extracted related to this device approval, but it doesn't align with your request for AI/ML study details:

Device: Arthrex FiberTak Suture Anchor
Purpose of Submission: To obtain clearance for the Arthrex FiberTak Suture Anchor by demonstrating substantial equivalence to a predicate device.
Predicate Device: K112237: Arthrex MicroSuture Anchor

Substantial Equivalence Summary (equivalent to showing device meets certain criteria):
The submission states:

• "The indications for use of the proposed Arthrex FiberTak Suture Anchor are identical to the predicate device."
• "The submitted mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices."

This indicates that the key acceptance criteria for this specific device clearance were:

1. Identical Indications for Use as the predicate device.
2. Equivalent or superior mechanical performance (specifically "pull-out strength") compared to the predicate device.

The document does not provide:

• A table of specific quantitative acceptance criteria or detailed mechanical test results.
• Sample sizes for mechanical testing.
• Information on "experts" or "ground truth" in the context of diagnostic/AI performance.
• Any details about AI/ML studies (MRMC, standalone, training sets, etc.).

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