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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.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. This document describes non-clinical mechanical and material testing, not a study involving a test set of data (e.g., medical images) to assess diagnostic accuracy or clinical outcomes. The "test set" here refers to the samples of the device used for mechanical and material tests. The specific number of devices tested for each mechanical test is not provided in this summary.
• Data Provenance: Not applicable. The data is generated from laboratory mechanical and material tests performed on the physical device. Country of origin of data is not relevant in this context. The study is a non-clinical, prospective testing of prototypes or production samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this type of device and submission. The tests are mechanical and material property assessments against established standards.

4. Adjudication Method for the Test Set

• Not applicable for the reasons stated above.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This type of study is relevant for comparing the performance of diagnostic tools (e.g., AI systems) with and without human assistance, which is not the purpose of this 510(k) submission for a bone fixation system.

6. Standalone Performance

• Not applicable in the context of an "algorithm only without human-in-the-loop performance." This device is a physical implant. Its "standalone performance" refers to its mechanical and material integrity as an implant. The non-clinical tests assess this.

7. Type of Ground Truth Used

• Not applicable in the sense of expert consensus, pathology, or outcomes data for diagnostic accuracy. For the mechanical and material tests, the "ground truth" is defined by the objective physical and chemical properties and performance as measured against recognized industry standards (e.g., ASTM F564-17, ASTM F2129-19a, ANSI/AAMI ST72).

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device requiring data for algorithm development.

9. How the Ground Truth for the Training Set Was Established

• Not applicable for the reasons stated above.

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