(82 days)
The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or Repair.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.
The AlphaVent PEEK Suture Anchor (herein referred to as the proposed device(s)) are bone anchors with a screw-in design. Each anchor is vented and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a poly-ether-ether-keytone (PEEK) material with the integrated suture eyelet offered in non-absorbable USP braided ultra-high molecular weight polyethylene (UHMWPE) high strength suture. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.
Here's an analysis of the provided FDA 510(k) summary regarding the AlphaVent PEEK Suture Anchor, focusing on "acceptance criteria" and the "study that proves the device meets the acceptance criteria."
Based on the provided document, the device described is a medical implant (suture anchor), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the typical questions related to AI device evaluation (e.g., sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth for AI) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical benchtop testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for each test in a formal table, but rather describes the types of tests performed and the outcome in relation to the predicate.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Ultimate Tensile Strength (UTS) / Pull-out Strength | Comparable to or greater than the predicate device to ensure equivalent or superior mechanical fixation. (The standard approach for demonstrating substantial equivalence for mechanical properties.) | "The proposed devices demonstrated similar or increased pull-out strength to the predicate devices." |
| Insertion Testing | Successful and reliable insertion without device failure or significant issues, comparable to the predicate device. | Performed; specific quantitative results not detailed, but the overall conclusion is that "no new issues of safety and effectiveness were identified." |
| Biocompatibility | Conformance to ISO 10993-1 for patient contact nature and duration. | "Device conforms to ISO 10993-1 for patient contact nature and duration." |
| Sterilization | Achieves a Sterility Assurance Level (SAL) of 10^-6. | "SAL: 10^-6" (Ethylene Oxide sterilization method). |
| Bacterial Endotoxin | Meets specified endotoxin limits to ensure safety. | "results of testing met the acceptance criteria." |
| Shelf Life | Maintains performance characteristics for the stated shelf life. | "The shelf life of the device is 2 years." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of anchors) used for each non-clinical benchtop test (UTS, insertion testing, bacterial endotoxin, etc.). This information is typically detailed in the full test reports referenced in the 510(k) submission but not fully included in the summary.
- Data Provenance: The data is generated from non-clinical benchtop testing conducted by the manufacturer, Stryker Endoscopy. It's not human patient data (retrospective or prospective) from a particular country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable. The "ground truth" for non-clinical benchtop performance testing of a suture anchor is based on engineering specifications, standardized test methods (e.g., ASTM or ISO standards for material properties, pull-out strength), and comparison to a legally marketed predicate device. It does not involve human expert consensus in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
This question is not applicable. As this is non-clinical benchtop testing, there is no need for adjudication by multiple experts in the sense of reviewing clinical cases or interpreting images. The results are quantitative measurements against predefined engineering benchmarks or predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this was not done. MRMC studies are typically conducted for diagnostic or AI-assisted devices where human readers interpret medical images or data. This submission is for a physical medical implant (suture anchor).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The AlphaVent PEEK Suture Anchor is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on:
- Engineering specifications and measurements: Quantitative physical properties like ultimate tensile strength, insertion force, and sterilization efficacy.
- Predicate device performance: The performance of the AlphaVent PEEK Suture Anchor is compared to a legally marketed predicate device (Arthrex SwiveLock Anchors, K191226) to demonstrate substantial equivalence, particularly regarding mechanical characteristics like pull-out strength.
- Biocompatibility standards: Conformance to recognized international standards like ISO 10993-1.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device, not an AI/ML system that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no training set for a physical medical device.
§ 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.