(103 days)
The 2.5mm Arthrex Mini Bio-PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The 2.9mm BioComposite PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair.Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
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, Ulnar or Radial Collateral Ligament Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair
The Arthrex PushLock is a two piece "push-in" suture anchor device comprising a biodegradable anchor body manufactured from either PLLA or PLDLA/betaTCP with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body ranges in diameter from 2.5mm to 2.9mm and 8mm to 15.5mm in length.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Degradation (Shelf-life expansion) | Inherent viscosity and minimum peak load testing was performed after four years on the shelf. The results supported the shelf-life expansion from 2 years to 4 years. (Implies meeting established acceptance limits for these properties). |
| Biocompatibility/Pyrogenicity | Bacterial endotoxin per EP 2.6.14/USP was conducted and demonstrated that the device meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" in the context of validating a device for its intended use or performance against a specific clinical outcome. The testing mentioned (inherent viscosity, peak load, bacterial endotoxin) is related to material properties and safety rather than a clinical performance test.
- Sample Size: Not explicitly stated for a "test set" in the traditional sense of clinical or performance validation. It refers to the number of units tested for material properties and shelf-life.
- Data Provenance: The testing was performed after four years on the shelf, indicating a controlled laboratory environment. No country of origin for the data is specified, but the submission is from Arthrex Inc. in Naples, Florida, USA, implying U.S. based testing or standards. The testing is retrospective in the sense that it evaluates the effects of storage over time.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a surgical implant (suture anchor), and the submitted data pertains to material properties, shelf-life, and biocompatibility, not a diagnostic or AI-driven device requiring expert-established ground truth from images or clinical assessments.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the context of diagnostic performance requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a surgical implant, not a diagnostic device that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a surgical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed relates to:
- Material Specifications: Established limits for inherent viscosity and minimum peak load for the biodegradable materials (PLLA, PLDLA/βTCP) to ensure structural integrity and proper degradation over time.
- Regulatory Standards: Pyrogen limit specifications as defined by EP 2.6.14/USP for bacterial endotoxin.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of 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.