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CephNinja software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners. Mobile application is not for diagnostic use.

CephNinja is a software-only dental image device which allows the user to digitize landmarks on a patient's digital lateral cephalometric x-ray image, trace cephalometric structures, conduct cephalometric analysis, and view cephalalometric results. CephNinja is imaging software designed for use in dentistry. The main CephNinja software functionality includes image visualization and cephalometric tracing and measurements. CephNinja is used by dental professionals for the visualization of patient images retrieved from a dental cephalometric imaging device scanner for assisting in case diagnosis, review, and treatment planning for orthodontic and orthognathic applications. If a suitable image file (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be used to define a number of structures and landmarks to establish specific anatomical features. The positions of specific landmarks are used to render tracing lines and calculate measurements used in orthodontic treatment planning. The software operates on standard Mac/iMac (OS Big Sur M1) hardware, and when not used for diagnostic purposes, iPhone/iPad (OS 9.0 or higher) hardware. When iMac hardware is used, images are displayed on the connected display/monitor. CephNinja is a standalone product.

The provided text describes a 510(k) premarket notification for a device named "CephNinja." The document outlines the device's intended use, technical characteristics, and a comparison to a predicate device (SmartCeph) and a reference device (Dolphin Blue Imaging 2.0). However, the document does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria in a structured format with specific performance metrics and statistical outcomes.

The section "J. Summary of Performance Testing" briefly mentions non-clinical bench testing and states that "all differences in individual angular and linear measurement values between the measurement methods must be within the clinically meaningful threshold of <2 degrees and <2 mm, respectively." This is the only specific quantitative acceptance criterion identified. The document states that the testing demonstrated that CephNinja produces "accurate, reliable, and precise output data" but does not provide the actual measured performance values (e.g., mean difference, standard deviation, number of measurements within the threshold, etc.).

Therefore, based solely on the provided text, I can extract the acceptance criterion but cannot fill in the details of the "reported device performance" beyond a qualitative statement of success. Many of the requested details about the study design (sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, training set details) are also not present in the document provided.

Here's a breakdown of the information that can be extracted and what is missing:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test set sample size: Not specified in the provided text.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not specified.
• Qualifications of experts: Not specified beyond "manual tracing" being the "conventional reference standard."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication method: Not specified. The ground truth method is described as "manual tracing," implying a single standard for comparison, but details on how this manual tracing itself was verified or adjudicated are absent.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study: Not mentioned or indicated in the provided text. The study described is a comparison of the device outputs (CephNinja's measurements) against a manual tracing standard, not a study evaluating human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The performance testing described ("evaluation of device outputs when compared to the conventional reference standard of manual tracing") implies a standalone evaluation of the algorithm's measurement accuracy, as it compares the device's output to a ground truth without human interpretation of the AI's results. However, the exact methodology is not detailed enough to confirm this definitively. The product is described as "software only."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of ground truth: "Conventional reference standard of manual tracing." This implies expert-derived measurements.

8. The sample size for the training set

• Training set sample size: Not specified in the provided text. The document focuses on performance testing, not details of model training.

9. How the ground truth for the training set was established

• Training set ground truth establishment: Not specified in the provided text.

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