(73 days)
The FASTak Suture Anchor is intended for fixation of suture to bone. This product is intended for use in repairing rotator cuff tears and Bankart lesions.
The FASTak is a self tapping, threaded anchor with an eyelet for holding suture. The largest suture size used with this device 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 38 lbs. and thus provides an acceptable factor of safety. In addition to fulfilling the requirements of a suture anchor, the FASTak also offers the advantage of a self tapping design which eliminates the need for predrilling. 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.
This document describes a 510(k) summary for the Arthrex FASTak Suture Anchor. Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out strength greater than the tensile strength of #2 suture (~15 lbs.) | Pull-out strength: at least 38 lbs. in cortical bone and cancellous |
| Biocompatibility of Titanium 6Al-4V alloy (ASTM F136-92) must be well documented. | Biocompatibility "has been well documented". |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (e.g., number of anchors tested for pull-out strength). It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a suture anchor is typically objective mechanical performance (pull-out strength) and material biocompatibility, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" involves objective mechanical testing, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not applicable to this type of device. MRMC studies are typically used in imaging diagnostics where human readers interpret medical images, and the aim is to evaluate how AI assistance impacts their performance. This document concerns a physical implantable device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This concept is not applicable to a physical suture anchor. "Standalone performance" usually refers to the accuracy of an AI algorithm operating independently, without human intervention, which is not relevant here.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's primary function (fixation) is objective mechanical testing data (pull-out strength) against a predefined benchmark (tensile strength of #2 suture). For biocompatibility, it relies on documented material properties (ASTM F136-92).
8. Sample Size for the Training Set
This document does not mention a training set. This is because the development and validation of a physical medical device like a suture anchor typically involve engineering design, material selection, mechanical testing, and biocompatibility studies, rather than machine learning models that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for a machine learning algorithm.
§ 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.