(160 days)
The LeForte System II is intended for use in selective trauma of mid-face, reconstruction procedure and selective orthognathic surgery of the maxilla and chin.
The LeForte System II is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The LeForte System II is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67: Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136: Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The Self-tapping screws, Self-drilling screws & Self-tapping locking screws diameter is from 1.3 to 2.7mm and lengths is from 2mm to 20mm. It also includes various manual surgical instruments such as drill bits, driver shafts, depth gauge, bender and hand body, etc.. The LeForte System II is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the user prior to surgery.
The provided text describes a 510(k) premarket notification for the "LeForte System II," a bone plate and screw system, and includes a summary of non-clinical bench tests for showing substantial equivalence to predicate devices. However, it does not describe an AI or algorithm-based device.
Therefore, the requested information regarding acceptance criteria and studies for an AI/algorithm device (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) cannot be extracted from this document, as it pertains to a physical medical device (bone plates and screws) rather than a software-based or AI-driven system.
The document focuses on:
- Device Description: Rigid fixation system of plates and screws.
- Materials: Pure Titanium and Titanium Alloy (Ti-6Al-4V) meeting ASTM standards.
- Indications for Use: Selective trauma of mid-face, reconstruction procedure, and selective orthognathic surgery of the maxilla and chin.
- Technological Characteristics: Comparison to predicate devices regarding design features, materials, and operating principle.
- Non-Clinical Test Summary: Bench tests performed to verify design specifications and compliance with ASTM F 382-99 (Metallic Bone Plates) and ASTM F 543-07 (Metallic Medical Bone Screws).
- Tests for Plates: Dimension test, Bending strength test.
- Tests for Screws: Dimension test, Driving torque test, Axial pull-out test, Torsion test.
- Substantial Equivalence: A detailed table comparing the subject device to primary and reference predicate devices across various attributes like indications for use, plate design, plate thickness, hole shape, screw type and diameter, screw length, material, surface coating, sterilization, and single use.
Since the device is a physical implant, not an AI or algorithm, the acceptance criteria and study details requested for AI performance are not relevant and thus not present in the document.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.