(200 days)
The Pitkar Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware.
- Open and closed fracture fixation
- Pseudoarthrosis or non-union of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformities
- Correction of segmental or nonsegmental bony or soft tissue defects
- Post-Traumatic joint contracture which has resulted in loss of range of motion
The purpose of this submission is to request clearance for the new Pitkar Sixafix System. The Pitkar Sixafix System includes a web based software that is designed to assist the physician in performing precise deformity or fracture reduction and should always be used with hardware. The Sixafix System software receives inputs from measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity. To guide the surgeon, detailed information is provided in Software manual. The implantable components are manufactured from Stainless Steel per ASTM F138. The system will be provided in non-sterile configuration and will require steam sterilization prior to use.
This looks like a 510(k) premarket notification for a medical device called the "Pitkar Sixafix System," which is a metallic bone fixation appliance. The document describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the provided text does not contain information about acceptance criteria, specific device performance metrics (like sensitivity, specificity, accuracy), or any details about a clinical study involving human or even simulated test sets to prove the device meets acceptance criteria in the way you've outlined for an AI/software-based device.
This document focuses on:
- Device Description: A web-based software to assist physicians with deformity/fracture reduction, used with hardware (implants made of Stainless Steel and appliances from Aluminium).
- Indications for Use: Broad orthopedic applications for adults, children (3-12), and adolescents (12-21) where growth plates are fused or not crossed.
- Predicate Device: Smith & Nephew Inc. - Taylor Spatial Frame (K970748).
- Technological Characteristics: Similar design features, materials, and sterilization to the predicate device.
- Non-Clinical Tests:
- Software Verification and Validation: Mentions FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This generally refers to testing the software's functionality, reliability, and security, not its diagnostic accuracy or clinical effectiveness in a statistical sense.
- ASTM F1541-02: Standard Specification and Test Methods for External Skeletal Fixation Devices, covering mechanical tests like bending, axial load, and torsion. This assesses the physical hardware components, not the software's performance.
- Biocompatibility: Stated to meet ISO 10993-1 due to using commonly available materials with a long history of clinical use.
Therefore, based only on the provided text, I cannot complete your requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or comparative effectiveness for an AI/software device's diagnostic or clinical performance.
The "software" component appears to be a tool for calculating adjustments for a physical fixator based on physician measurements, rather than an AI/ML algorithm performing analysis or diagnosis from medical images or data. The "Software Verification and Validation" mentioned would likely pertain to ensuring these calculations are correct and the software functions as intended, not a statistical evaluation of diagnostic accuracy or clinical impact against a ground truth.
If this were an AI/ML device, the FDA would typically require a much more detailed clinical or performance study section with specific metrics and methodologies. This document is typical of a hardware device with a software component that aids in calculation/planning, rather than a diagnostic AI.
§ 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.