(143 days)
The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy
Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only)
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair
Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 – 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).
The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with an anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.
The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor, which seeks to obtain pediatric indications and an extended shelf life for an existing device. It largely focuses on mechanical testing, a review of clinical literature, and real-world data to demonstrate substantial equivalence to predicate devices, rather than an AI-powered device's performance study.
Therefore, many of the requested details regarding acceptance criteria for an AI device, specific study methodologies (like MRMC, standalone AI performance), ground truth establishment for AI training/testing, expert qualifications, and adjudication methods are not present in the provided document. The document details testing for a physical medical device (suture anchor).
However, I can extract information related to the performance data and the "study" (testing) that was done to support the submission for the physical device.
Acceptance Criteria and Device Performance (Based on Provided Text)
The "acceptance criteria" here refer to the standards the physical device needed to meet to demonstrate substantial equivalence, particularly concerning the proposed modifications (pediatric indication, extended shelf life).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Ultimate Load & Cyclic Displacement) | Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device. The results demonstrated that the modifications do not negatively impact mechanical strength. |
| Pyrogenicity (Bacterial Endotoxin) | Bacterial endotoxin testing per EP 2.6.14/USP was conducted, demonstrating that the device meets pyrogen limit specifications. |
| Effectiveness in Proposed Patient Population (Pediatric) | Clinical literature review showed the device is effective when used in the proposed patient population with skeletally mature bone. |
| Equivalence in Outcomes for Different Age Groups (Skeletally Mature Pediatric vs. Adult) | Real World Data/Evidence from the Surgical Outcomes System registry showed no statistical differences in patient outcomes for those less than 22 years of age versus those greater than 22 years of age. |
Study Details (Based on Provided Text)
1. Sample sized used for the test set and the data provenance:
- Mechanical Testing: Not explicitly stated (e.g., number of anchors tested), but it was performed on the "subject device" and "predicate device." No geographical provenance is specified.
- Clinical Literature: The text states "Clinical literature was provided on the subject devices involving the proposed patient population of skeletally mature pediatric patients." The number of studies or patients is not specified. It's a retrospective review of existing data.
- Real World Data/Evidence: "Real World Data/Evidence is provided from the Surgical Outcomes System registry." The sample size (number of patients) is not specified, but it compares "patients less than 22 years of age versus patients greater than 22 years of age." The provenance of this registry data (e.g., country of origin) is not specified. This is retrospective data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable here as the "ground truth" for a physical medical device's performance primarily comes from engineering and clinical outcome data, not expert consensus on image interpretation. For the clinical literature review and RWD, the "truth" is established by the clinical outcomes themselves, as documented in studies and registries.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept applies to interpreting complex data, typically images or clinical scenarios, often for AI or diagnostic devices. It is not relevant to the mechanical/biological testing or the clinical literature/RWD review described for this physical medical device.
4. 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 study type is for evaluating reader performance with and without AI assistance for diagnostic or prognostic devices. It is not relevant for a physical medical device like a suture anchor.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This applies to AI algorithms. Not relevant for this physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Testing: Ground truth established through direct physical measurement and engineering standards (e.g., force applied, displacement measured).
- Pyrogenicity Testing: Ground truth established by laboratory assay results meeting specified pyrogen limits.
- Clinical Literature/Real World Data: Ground truth is clinical outcomes data (e.g., success of repair, complications, patient outcomes), as documented in published literature and registries.
7. The sample size for the training set:
- Not applicable in the context of this device. This pertains to machine learning models. This submission is for a physical medical device.
8. How the ground truth for the training set was established:
- Not applicable. This pertains to machine learning models. This submission is for a physical medical device.
§ 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.