(82 days)
The FASTak Suture Anchor is intended for fixation of suture to bone. The 11.7mm FASTak is intended for the following uses:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female unnary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency
The 7.5mm FASTak is intended for the same uses except Rotator Cuff Repair, Bankart Repair, and SLAP Lesion Repair
The FASTak is a threaded anchor with an eyelet for holding suture. The largest suture size used with the 11.7mm FASTak is a single strand of #2. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of #2 suture (~ 15 lbs.). The pull-out strength of the FASTak in cortical bone, as well as cancellous, is at least 90 Ibs. and thus provides an acceptable factor of safety.
The largest suture size used with the 7.5mm FASTak is a single strand of size 0. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of size 0 suture (~ 10 lbs.). The pull-out strength of the FASTak in cortical bone as well as cancellous is at least 60 lbs. and thus provides an acceptable factor of safety.
In addition to fulfilling the requirements of a suture anchor, the FASTak eliminates the need for predilling. In a single motion, the tissue is grasped, shifted and the FASTak inserted. The result is a technique which is both easier and more reproducible.
The FASTak is made of Titanium 6Al-4V alloy (ASTM F136-92). The biocompatibility of this alloy has been well documented.
Here's an analysis of the provided 510(k) summary regarding the Arthrex FASTak Suture Anchor, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance (FASTak 11.7mm) | Reported Device Performance (FASTak 7.5mm) |
|---|---|---|---|
| Pull-out Strength (Cortical Bone) | > 15 lbs (tensile strength of #2 suture) | 91 lbs | 68 lbs |
| Pull-out Strength (Cancellous Bone) | > 15 lbs (tensile strength of #2 suture) | 95 lbs | 71 lbs |
| Factor of Safety | Acceptable (pull-out strength > suture tensile strength) | At least 90 lbs (vs ~15 lbs suture strength) | At least 60 lbs (vs ~10 lbs suture strength) |
| Elimination of Predrilling | Device eliminates need for predrilling | Eliminates need for predrilling | Eliminates need for predrilling |
| Biocompatibility | Made of biocompatible material | Titanium 6Al-4V alloy (ASTM F136-92) - well documented biocompatibility | Titanium 6Al-4V alloy (ASTM F136-92) - well documented biocompatibility |
Study Proving Device Meets Acceptance Criteria:
The document describes material and mechanical testing performed on the FASTak Suture Anchor. The study's objective was to demonstrate that the pull-out strength of the FASTak anchor in both cortical and cancellous bone exceeds the tensile strength of the suture it is designed to hold, thus providing an "acceptable factor of safety."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size (e.g., number of anchors tested) for the pull-out strength tests. It provides average or minimum "at least" pull-out strength values.
- Data Provenance: The document implies laboratory testing (mechanical and material characterization). There is no information provided about the country of origin of the data or whether it was retrospective or prospective. It is assumed to be prospective, specifically designed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is objective physical properties (pull-out strength, material composition) determined through mechanical and material science testing, not through expert interpretation of biological data.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the assessment is based on objective physical measurements, not on expert consensus or adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The device is a physical surgical implant (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating compliance with acceptance criteria is:
- Mechanical Testing Results: Direct measurements of pull-out strength using laboratory-controlled tests.
- Material Characterization: Verification of the device's material composition against established standards (Titanium 6Al-4V alloy, ASTM F136-92).
- Suture Tensile Strength: Known industry standards for the tensile strength of specific suture sizes.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, there is no ground truth for it to be established.
§ 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.