(268 days)
The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dentomaxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
The X800N consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The X800N has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
This document describes the 510(k) premarket notification for the J. Morita USA, Inc. 3D Accuitomo 150N Model X800N, an X-ray system for panoramic, cephalometric, and CBCT imaging. The primary purpose of this submission is to obtain clearance for a new ENT (Ear, Nose, and Throat) indication for an already cleared device, the Veraview X800 (K#171012).
An important note for this response: The provided text details the device itself and its equivalence to a predicate device, as well as the clinical evaluation performed for the new indication for use. However, it does not describe acceptance criteria for an AI/CADe device's performance. The clinical evaluation described here is to demonstrate the image quality of the X800N for ENT diagnosis is comparable to existing devices, not to validate an AI algorithm's diagnostic performance against specific metrics like sensitivity or specificity. Therefore, many of the requested points regarding AI acceptance criteria and studies cannot be addressed from the given text.
Here's an analysis based on the provided information, addressing what is present and noting what is absent:
Acceptance Criteria and Study for the 3D Accuitomo 150N Model X800N (K201378)
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a medical imaging device (CT scanner) and not an AI/CADe device, the "acceptance criteria" presented are related to image quality and comparability to predicate devices, rather than performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). The study aims to demonstrate that the image quality of the X800N is sufficient for the expanded ENT indication.
| Criterion Type | Acceptance Criteria (Stated Goal) | Reported Device Performance (Study Results) |
|---|---|---|
| Clinical Acceptability for ENT Diagnosis | The CT images obtained by the X800N for general examination and diagnosis of the ENT area should be substantially equivalent to or better than those obtained by the reference devices (X550 and MCT-1) for this indication. | All evaluators ranked the images of the X800N as "Excellent Quality for Diagnosis" or "Acceptable Quality for Diagnosis." The overall results for X800N were reported as "better than that of the X550" and "comparable to the MCT-1." This supports sufficiency for ENT diagnosis. |
Missing Information: There are no quantitative acceptance criteria for AI algorithm performance (e.g., specific thresholds for sensitivity, specificity, F1-score, or agreement rates) because this is not an AI/CADe device submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states that "skull phantoms made from resin molding on real human dry skulls" were used. It does not provide the specific number of phantoms or images in the test set.
- Data Provenance:
- Country of Origin: The images were obtained in "J. Morita's facility." The company (J. Morita USA, Inc.) is located in Irvine, CA, USA, suggesting the facility is likely in the USA. The manufacturer is "J. MORITA MFG. CORP." (not specified where this is located, but typically these are from Japan for J. Morita).
- Retrospective or Prospective: The use of phantoms implies a prospective acquisition specifically for this evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The text states, "Experienced doctors who are using CBCT for their ENT medical practice subjectively evaluated images..." It does not specify the exact number of doctors.
- Qualifications: "Experienced doctors who are using CBCT for their ENT medical practice." Specific experience (e.g., years, board certification) is not detailed beyond "experienced" and "using CBCT for their ENT medical practice."
4. Adjudication Method for the Test Set
- Adjudication Method: The text indicates that experts "subjectively evaluated images" and "ranked by the evaluators according to five categories." It does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus, or independent arbitration) if there were discrepancies between evaluators. It implies individual evaluations were then aggregated to determine overall results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: While multiple readers (the "experienced doctors") evaluated multiple "cases" (skull phantoms/images), this was not an MRMC study comparing human performance with and without AI assistance. It was a subjective evaluation by human readers of image quality from different devices.
- Effect Size: Not applicable, as there was no AI assistance and no comparison of human reader performance with/without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is an imaging system, not an AI algorithm. The "performance" being evaluated is the image quality produced by the system for human interpretation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this evaluation was essentially expert subjective evaluation of image quality and diagnostic suitability. The phantoms themselves provide a known anatomical structure, which serves as a "true" anatomical baseline against which the image quality is judged for its clarity and accuracy for ENT diagnosis. It is not "pathology" or "outcomes data" in the traditional sense, but rather "fitness for purpose" as judged by experts.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an imaging system, not an AI algorithm that requires a training set. The device's "training" involves engineering and design, informed by physics and medical requirements, not machine learning from image datasets.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no AI training set for this device.
Summary of Scope and Missing AI-Specific Details:
The provided document describes a 510(k) submission for a conventional medical imaging device (CBCT scanner) with an expanded indication for use (ENT). The "clinical testing" performed was an evaluation of the image quality produced by the device, judged subjectively by medical experts, to demonstrate its suitability for the new indication compared to existing cleared devices.
Crucially, this document does not pertain to an AI/CADe device or an AI algorithm’s performance validation. Therefore, many of the requested points related to AI acceptance criteria, training sets, and human-in-the-loop studies (beyond clinicians interpreting images) are not present in the provided text. The "acceptance criteria" here are implicitly showing that the images are of sufficient quality for an experienced clinician to make a diagnosis, similar to images from currently cleared devices.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.