(37 days)
The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.
The Responsive Arthroscopy (RA) Knotless Push-In Suture Anchor System is an updated version of the RA Knotless Push-In Suture Anchor System previously cleared under K180951. The RA Knotless Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone. The system includes a variety of anchors made of polyetheretherketone per ASTM F2026 (PEEK) along with repair suture tape, inserters, drills, broaches, and guides.
The only differences in the subject device are regarding suture geometry, anchor body geometry, and internal screw geometry. The RA Knotless Push-In Suture Anchor System anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Knotless Push-In Suture Anchor System anchors range in diameter from 3.5mm to 4.75mm and are either pre-loaded with or accept #2 suture or 2.5mm suture tape.
The RA Knotless Push-In Suture Anchor System anchors are pre-loaded on inserters and provided sterilized with ethylene oxide. The RA Knotless Push-In Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user.
The provided text describes a 510(k) premarket notification for a medical device, the "Responsive Arthroscopy Knotless Push-In Suture Anchor System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in a clinical study. Therefore, several of your requested points related to clinical study design, ground truth establishment, expert involvement, and reader studies are not applicable to this type of regulatory submission.
The FDA 510(k) process for Class II medical devices like this one typically relies on bench testing and comparison to predicate devices, not extensive clinical trials with human subjects to prove performance metrics in the way you've outlined for diagnostic AI.
Here's a breakdown of the information that is available and a note on what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The submission demonstrates substantial equivalence through various performance tests, but it does not specify explicit "acceptance criteria" in a numerical sense as one would expect for a diagnostic AI study (e.g., AUC > 0.9, sensitivity > 90%). Instead, the "acceptance criteria" for a 510(k) are generally that the new device performs as well as or better than the predicate device, or at least does not introduce new safety or effectiveness concerns, for its intended use. The performance reported aims to support this substantial equivalence.
| Performance Characteristic | Reported Device Performance (Responsive Arthroscopy Knotless Push-In Suture Anchor System) | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate K180951) |
|---|---|---|
| Insertion Force | Tested. (Details not provided in summary) | Comparable to or safer than predicate, demonstrating appropriate ease of use and placement. |
| Static & Cyclic Pullout Force | Tested. (Details not provided in summary) | Comparable to or better than predicate, demonstrating sufficient strength for soft tissue to bone fixation under various loading conditions, without introducing new risks. |
| Suture Locking Force | Tested. (Details not provided in summary) | Comparable to or better than predicate, ensuring secure fixation of suture. |
| Suture Characterization | Tested (reference to previously cleared devices K100006, K153307) | Sutures meet established standards for strength, biocompatibility, etc. |
| Biocompatibility | Risk Assessment performed. (Details not provided in summary) | Device components (PEEK anchors, sutures) are biocompatible per relevant standards, posing no new biological risk. |
| Bacterial Endotoxin | Risk Assessment performed. (Details not provided in summary) | Endotoxin levels are controlled to be safe for implantation. |
| Sterilization, Cleaning, and Shelf-Life | Adoptions performed. (Details not provided in summary) | Sterilization method is effective and validated, cleaning instructions are adequate for reusable components, and shelf-life is established. |
Study Proving Substantial Equivalence:
The provided document describes a 510(k) Pre-Market Notification submission, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the collection of bench testing and risk assessments performed to support this claim.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically for each test. Bench testing involves a certain number of samples, but these are material/device samples, not patient data.
- Data Provenance: The "data" comes from bench testing (laboratory mechanical tests) of the device components and system. It is not clinical data from patients, so concepts like "country of origin" or "retrospective/prospective" patient data do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not a diagnostic AI study involving expert radiologists/pathologists. The "ground truth" for bench testing is derived from established engineering and materials science principles, industry standards (e.g., ASTM F2026 for PEEK), and comparison to the predicate device's known performance.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation of data in the sense of a diagnostic study that would require adjudication. Bench test results are quantitative measurements.
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
Not applicable. This is not a study of AI assistance or human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this regulatory submission is based on:
- Performance standards and literature: Established engineering principles, material properties (e.g., ASTM F2026 for PEEK), and industry standards for surgical implants.
- Predicate device performance: The performance of the Responsive Arthroscopy Suture Anchor System (K180951) serves as the primary benchmark.
- Risk assessment: Evaluation against known biological and mechanical risks associated with similar devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device and Regulatory Context:
The "Responsive Arthroscopy Knotless Push-In Suture Anchors" are intended for surgical fixation of soft tissue to bone in various joints (shoulder, foot/ankle, hip, knee, hand/wrist, elbow). Key features mentioned are:
- Made of PEEK (polyetheretherketone) per ASTM F2026.
- Available in 3.5mm to 4.75mm diameters.
- Pre-loaded with or accept #2 suture or 2.5mm suture tape (ultra-high molecular weight polyethylene).
- Introduces changes in "suture geometry, anchor body geometry, and internal screw geometry" compared to its predicate.
- Sterilized with ethylene oxide (anchors). Reusable instruments are non-sterile and sterilized by the end-user.
The FDA's determination of substantial equivalence for this Class II device means that, based on the submitted information (primarily bench testing and comparison to the predicate), the new device is as safe and effective as a legally marketed predicate device. This pathway does not typically require clinical trials in the sense of demonstrating new clinical efficacy or diagnostic accuracy with human subjects.
§ 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.