(86 days)
The Stryker AlphaVent™ Knotless SP Biocomposite Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use 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/Tendon Repair
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
- Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair
The AlphaVent Knotless SP Biocomposite Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and a biocomposite (Poly-L-lactic Acid (PLLA)/beta-tricalcium phosphate (β-TCP)) anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone either via a self-punching mechanism or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).
This FDA 510(k) clearance letter is for a medical device (Stryker AlphaVent™ Knotless SP Biocomposite Anchor), not an AI/ML medical device. Therefore, a significant portion of the requested information (items 2-5, 7-9) is not applicable as these relate specifically to studies conducted for AI/ML performance evaluation.
However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this physical medical device.
Acceptance Criteria and Study for Stryker AlphaVent™ Knotless SP Biocomposite Anchor
Based on the provided FDA 510(k) summary, the device is a physical implant, and its performance is evaluated through non-clinical benchtop testing. The acceptance criteria are implicitly defined by demonstrating equivalence or superiority to predicate devices in key performance areas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Ultimate Tensile Strength (UTS) | Statistically equivalent or higher UTS compared to predicate devices immediately after insertion, after cyclic loading, and after accelerated degradation at multiple time points through the anticipated duration of healing. | This demonstrates the device's mechanical strength and durability over time, comparable to or better than existing approved devices. |
| Insertion Performance | Successful insertion confirmed under worst-case conditions. | This indicates the device can be reliably implanted in challenging scenarios. |
| Bacterial Endotoxin Levels | Passing results below the required limits. | This confirms the device meets sterility and biocompatibility requirements. |
| Design, Intended Use, Indications for Use, Implantation Technique (in comparison to Primary Predicate K233893) | Identical | This establishes direct equivalence in fundamental aspects to the primary predicate. |
| Intended Use, Indications for Use, Raw Material for Implantation, General Anchor System Design Features (in comparison to Secondary Predicate K203495) | Identical (for intended use, indications for use, raw material for implantation); Equivalent (for general anchor system design features) | This establishes equivalence to the secondary predicate in key areas, despite some differences. |
| Overall Safety and Effectiveness | Raises no new questions of safety or effectiveness and is substantially equivalent to the predicate devices. | This is the overarching conclusion required for 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the non-clinical benchtop testing (e.g., number of anchors tested for UTS or insertion). The testing is described as "non-clinical benchtop testing," which implies laboratory-based experiments rather than human or animal studies. Therefore, provenance such as country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical implant, and its performance is assessed through objective, quantitative, non-clinical benchtop tests, not through expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective physical measurements and comparisons, not through adjudication by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not an AI/ML device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective physical measurements and laboratory standards. For example:
- Ultimate Tensile Strength (UTS): Measured in a lab using force-testing equipment against established engineering standards and comparison with predicate device performance.
- Insertion Performance: Evaluated against defined mechanical parameters and successful deployment in simulated "worst-case" conditions.
- Bacterial Endotoxin Testing: Measured against predefined regulatory limits for endotoxin levels (e.g., ISO or USP standards).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" for an AI/ML algorithm.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.