(112 days)
The A'TOMIC™ Nitinol Fixation System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The A'TOMIC Nitinol Fixation System is intended for single use only.
The A TOMICTM Nitinol Fixation System, which consists of the A TOMIC™ Nitinol Fixation System implant and associated instruments, is intended for use for fixation and compression and supports several surgical techniques (e.g., fracture, osteotomy, joint arthrodesis, and fixation of bone fragments). The staples are made of implant-grade Nitinol (ASTM F2063-18) and are designed to exhibit superelastic properties at room temperature. This allows for continued compression to be applied across bone segments, thus enhancing long-term stability, and promoting fusion. Implants are passivated per ASTM F86 following machining to create a surface oxide layer that is resistant to corrosion which ensures the biocompatibility of the implant. Each staple is pre-loaded on an inserter for implantation and sterile packed. The staples are available in multiple sizes, varying by bridge length and leg length, to accommodate individual patient anatomy. Single-use disposable instrumentation is provided to assist in the surgical placement of the A TOMICTM Nitinol Fixation System implant. Reusable instrumentation will also be available as an option for the surgeon and facility.
This FDA 510(k) premarket notification describes the A'TOMIC™ Nitinol Fixation System, a medical device for bone fixation. However, it does not contain a study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical performance with human readers and AI.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (BME Speed™ Implant) through a comparison of technological characteristics and non-clinical mechanical performance testing.
Therefore, many of the requested details such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets are not applicable to this type of regulatory submission. The information provided is primarily related to the device's physical and mechanical properties.
Here's an breakdown of the information that is available in the document, tailored to your request, with an emphasis on what is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) and "reported device performance" are not directly addressed in this 510(k) for a fixation system. Instead, the "acceptance criteria" are implied by the standards and the performance of the predicate device for mechanical and material properties. The "reported device performance" refers to the results of the non-clinical mechanical tests demonstrating it meets these standards and is comparable to the predicate.
| Performance Metric (Acceptance Criteria) | Reported Device Performance (A'TOMIC™ Nitinol Fixation System) |
|---|---|
| Mechanical Performance: | |
| Static Four Point Bend (per ASTM F564-17) | Results demonstrate sufficient mechanical performance for intended use and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.) |
| Static Pull-out (per ASTM F564-17) | Results demonstrate sufficient mechanical performance for intended use and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.) |
| Corrosion Resistance: | |
| Cyclic Corrosion (per ASTM F2129-19a) | Results demonstrate sufficient performance and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.) |
| Biocompatibility/Safety (Implied): | |
| Pyrogen and Endotoxins Testing (per ANSI/AAMI ST72) | Results demonstrate sufficient performance and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.) |
| Material Composition (Substantial Equivalence): | |
| Implant Material: Nitinol | Same as predicate. (ASTM F2063-18 grade in device description) |
| Sterility Assurance Level (SAL): | |
§ 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.