(76 days)
The Bio-Fastak Suture Anchor is intended for fixation of soft tissue to bone. This product is intended for the following indications:
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, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
The Bio-Fastak Suture Anchor is manufactured using poly (L, DL-lactide). It is a threaded design with an evelet of braided polyester suture insert molded down the length of the device. The anchor has a hex head, which is seated in a disposable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a tap. Once in place, additional suture may be passed through the eyelet and used to reattach soft tissue to the bone.
This document describes a 510(k) premarket notification for a medical device called the "Arthrex Bio-Fastak Suture Anchor." A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that does not require premarket approval.
Based on the provided text, there is no information present regarding acceptance criteria or a study proving the device meets acceptance criteria related to software performance, AI/ML algorithms, or diagnostic accuracy. This document is for a physical surgical implant (suture anchor), and the FDA's review focuses on its substantial equivalence to predicate devices, material safety, and intended use.
Therefore, I cannot provide the requested information. The document is concerned with:
- Device Description: What the Bio-Fastak Suture Anchor is made of (poly L, DL-lactide), its design (threaded, eyelet with polyester suture, hex head), and how it's used to reattach soft tissue to bone.
- Intended Use/Indications: The specific surgical procedures and body parts where the anchor is intended to be used (e.g., Rotator Cuff Repair, Bankart Repair, Achilles Tendon Repair, Bladder Neck Suspension).
- Substantial Equivalence: The primary basis for FDA clearance, stating that the device has the same intended use and similar technological characteristics (or proven equivalent safety and effectiveness with different characteristics) as legally marketed predicate devices, and raises no new safety or effectiveness questions.
- Regulatory Classification: The device is classified as Class II, under Product Codes MAI and HWC.
- FDA Clearance Letter: Official communication from the FDA stating that the device has been reviewed and determined to be substantially equivalent, allowing it to be marketed.
The concept of "acceptance criteria" and "device performance" in this context refers to the physical and biological performance of the implant (e.g., strength, biodegradability, biocompatibility), which would have been assessed through bench testing and potentially animal or clinical studies that are NOT detailed in this summary. The document explicitly states that the "material is well characterized, and has been used in a predicate device with a similar indication," implying that the testing on the material properties and the device's mechanical functions were deemed sufficient based on the established equivalence.
No mention is made of:
- Any software, AI, or diagnostic components.
- Test sets for performance evaluation.
- Experts establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Training set information.
Conclusion: The provided text is a 510(k) summary for a physical medical implant, not a software or AI-driven diagnostic device. Therefore, the questions related to acceptance criteria, study design, and performance metrics for AI/ML or diagnostic accuracy are not applicable to the information contained in this document.
§ 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.