(29 days)
The Arthrex MicroSuture Anchors 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 MicroSuture Anchors consist of four anchors which are line extensions to existing anchors. The new anchors are comprised of titanium or PLA/ βTCP and are provided preloaded on a driver with suture. The anchors range from 2.2-2.7mm in diameter and 4-7mm in length.
The provided document is a 510(k) summary for the Arthrex MicroSuture Anchors. This document describes a medical device rather than an AI/ML device, and therefore does not contain information typically found in an AI/ML device submission, such as acceptance criteria based on performance metrics like sensitivity/specificity, sample sizes for training/test sets, expert qualifications for ground truth establishment, or details about comparative effectiveness studies (MRMC).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing.
Here's a breakdown of the information that is relevant to the device's acceptance, based on the provided text, and an explanation of why other requested information (common for AI/ML devices) is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Mechanical Testing) |
|---|---|
| Mechanical properties (specifically pull-out strength) meet or exceed predicate devices. | "The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices." |
| Basic features are the same as predicate devices. | (Claimed as part of substantial equivalence) |
| Intended uses are the same as predicate devices. | (Claimed as part of substantial equivalence) |
| Differences between the MicroSuture Anchors and predicates are minor and do not raise questions concerning safety and effectiveness. | (Claimed as part of substantial equivalence after mechanical testing) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not explicitly stated in the document. For a physical medical device, "test set" typically refers to the samples used in mechanical or biocompatibility testing rather than a patient dataset. The document mentions "mechanical testing" but does not specify the number of anchors or the materials tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a physical medical device, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a physical medical device's mechanical testing. Adjudication methods are typically associated with human interpretation of medical images or data.
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
No. This is not an AI/ML device, so an MRMC study comparing human readers with AI assistance would not be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for its performance evaluation comes from mechanical testing results, specifically pull-out strength measurements. This is compared against the performance of legally marketed predicate devices.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical medical device.
Summary of the Study Proving Acceptance:
The acceptance of the Arthrex MicroSuture Anchors is based on demonstrating substantial equivalence to three predicate devices: Arthrex Corkscrew Suture Anchor (K061863), Arthrex Mini PushLock (K063479), and Arthrex Micro BioComposite Suture Tak (K091844).
The primary study proving this equivalence, as stated in the document, is:
- Mechanical Testing: This testing focused on comparing the pull-out strength of the proposed MicroSuture Anchors to that of the predicate devices. The study concluded that "the mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices."
The document implicitly states that other factors like basic features, intended uses, and technological characteristics were also compared and determined to be equivalent, with any differences considered minor and not raising new questions of safety or effectiveness.
§ 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.