(70 days)
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow 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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The following indications are for the S and SL type anchors only:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Hip: Capsular repair, Acetabular Labral repair
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver.
B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair.
Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type.
SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas.
S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist
The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone.
Devices are provided sterile. Single use only.
The provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) submission to the FDA. This submission aims to demonstrate substantial equivalence to previously cleared devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document discusses:
- Device Description: What the Fixone Biocomposite Anchor is, its components (PLGA copolymer and β-TCP anchor, UHMWPE suture), and how it's implanted.
- Intended Use: Fixation of suture (soft tissue) to bone in various anatomical locations (shoulder, foot/ankle, knee, elbow, hand/wrist, hip).
- Predicate Device Comparison: A detailed table comparing the subject device to several predicate devices (K171299, K192032, K192484, K213008) across various attributes like indications for use, materials, dimensions, fixation mechanism, suture characteristics, and sterilization.
- Performance Data: Mentions "Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues, shelf-life testing, pyrogenicity testing and endotoxin monitoring. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices."
Crucially, there is no mention of:
- AI/ML components: The device is a physical biocomposite anchor, not a software algorithm.
- Clinical study or diagnostic performance metrics: The performance data refers to bench testing for physical and material properties, not clinical outcomes, sensitivity, specificity, or AUC for a diagnostic tool.
- Ground truth, expert readers, sample sizes for AI models, or MRMC studies. These are concepts relevant to evaluating AI/ML diagnostic or predictive devices, which the Fixone Biocomposite Anchor is not.
Therefore, I cannot fulfill the request as the provided input does not contain the necessary information about acceptance criteria and a study proving an AI/ML device's performance. The device described is a traditional medical implant, and its evaluation focuses on physical and biological equivalence, not AI performance.
§ 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.