(53 days)
The I.T.S. Fibula Plate PROlock with Angular Stability is a titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula.
Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the distal fibula. Other indications include corrective osteotomy and open and closed fractures.
The system is not intended for spinal use.
The I.T.S. Fibula Plate PROlock with Angular Stability is a low-profile left and right titanium plate in three lengths with various length cortical and/or cancellous locking self-tapping stabilization screws. The fibula plate is made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
The provided text describes a medical device, the I.T.S. Fibula Plate PROlock with Angular Stability, and its 510(k) summary for clearance by the FDA. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices, not on demonstrating specific performance metrics against defined acceptance criteria through a clinical study.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or an MRMC study based on the provided text.
Here's why and what information is present:
- Acceptance Criteria and Reported Device Performance: This information is completely absent. The document is about regulatory clearance based on substantial equivalence, not performance testing.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of this is mentioned. The clearance is based on the device's design, materials, and intended use being similar to already marketed devices. The document does not describe a clinical study in the way you've outlined.
Information that is available in the provided text:
- Device Name: I.T.S. Fibula Plate PROlock with Angular Stability
- Intended Use/Indications for Use: Titanium implant fracture fixation system for repairing bone fractures located from the middle to the distal third of the fibula, including metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions, corrective osteotomy, and open and closed fractures. Not intended for spinal use.
- Materials: Plate from CP Titanium (ASTM F 67-00), screws from 6-4 Alloyed Titanium (ASTM F 136-02).
- Regulatory Pathway: 510(k) premarket notification.
- Substantially Equivalent Devices (Predicates): Synthes Semi-Tubular Plate, Synthes Small Fragment System, Synthes 4.5mm LCP Straight Reconstruction Plates, Synthes LCP Distal Tibia Plates, Synthes One-Third Tubular DCL Plate, Synthes Curved Reconstruction Plate, Synthes Medial Distal Tibia Plates, Zimmer Periarticular Plating System, Acumed Lower Extremity Congruent Plate System.
In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a report on a study demonstrating performance against acceptance criteria.
§ 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.