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The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.

The Veraview X800 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 dento-maxillofacial 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 dentists and other legally qualified professionals for pediatric and adult patients.

Device Description

The Veraview X800 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 Veraview X800 has three main radiographic modes as follows:

Panoramic tomography including linear tomography and scanogram -
Cephalometric radiography -
-Cone beam computed tomography

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the J.Morita USA, Inc. Veraview X800, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Predicate Device)	Device Performance (Veraview X800)
Panoramic - spatial resolution	Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm	Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm
Panoramic - noise	Low contrast resolution on IEC 61223-3-4: min. diameter 2.0 mm (at High speed mode)	Low contrast resolution on IEC 61223-3-4: min. diameter 2.0 mm (at High speed mode)
	Low contrast resolution on IEC 61223-3-4: min. diameter 1.0 mm (at High resolution mode)	Low contrast resolution on IEC 61223-3-4: min. diameter 1.0 mm (at High resolution mode)
Cephalometric - spatial resolution	Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm	Line pair resolution on IEC 61223-3-4: min. 2.5 LP/mm
Cephalometric - noise	Low contrast resolution on IEC 61223-3-4: min. diameter 2.5 mm	Low contrast resolution on IEC 61223-3-4: min. diameter 2.5 mm
CBCT - spatial resolution	min. 10% MTF at 2.0 LP/mm (at standard mode)	min. 10% MTF at 2.0 LP/mm (at standard mode)
	min. 10% MTF at 2.5 LP/mm (at high resolution mode)	min. 10% MTF at 2.5 LP/mm (at high resolution mode)
CBCT - noise	The standard deviation of the gray scale of the center region of the Contrast phantom shall be less than 12.5 (10% of the full scale).	The standard deviation of the gray scale of the center region of the Contrast phantom shall be less than 12.5 (10% of the full scale).
System MTF (FOV 4x4 High Resolution)	2.25 lp/mm @10% (Predicate FOV 5x5 High Resolution)	2.5 lp/mm @10% (FOV 4x4 High Resolution)
CMOS flat panel pixel size	100 μm x 100 μm (Predicate)	0.1 mm x 0.1 mm
Effective exposure time (CBCT)	1.2 - 12.5 s (Primary Predicate) / 1.7 - 20 s (Reference Predicate)	Scout: 0.5, 1.0 s; CBCT: 9.4, 17.9 s; 17.9 x 2 for FOV 15 x 14
CBCT Reconstruction Time	1-3 min. (Predicates)	1-6 min. (depending on the computer specification)

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

The document states that non-clinical testing was conducted. This typically refers to physical phantom testing and bench testing rather than testing on a "test set" of patient data. Therefore, information about patient data sample size or provenance is not applicable/provided in this 510(k) summary for the performance verification. The data provenance would be from laboratory or manufacturing testing environments.

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

Since the testing was non-clinical and involved phantom measurements and compliance with standards, there are no experts mentioned as establishing ground truth for a patient test set. The ground truth is inherent in the physical phantoms and the established scientific principles of the standards (e.g., IEC 61223-3-4).

4. Adjudication Method for the Test Set:

Not applicable, as no patient-based "test set" requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "There were no clinical tests performed for Veraview X800." Therefore, an MRMC study using human readers was not conducted.

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

This device is an X-ray imaging system, not an AI algorithm for image interpretation. Therefore, a "standalone algorithm performance" study is not applicable in the context of this 510(k) summary. The performance metrics evaluated are for the image acquisition and reconstruction capabilities of the device itself.

7. The Type of Ground Truth Used:

The ground truth used for the performance evaluation was established through recognized international standards and physical phantom measurements. For example:

Spatial Resolution: Measured using line pair phantoms as per IEC 61223-3-4.
Noise and Low Contrast Resolution: Measured using contrast phantoms as per IEC 61223-3-4.
MTF (Modulation Transfer Function): Measured using standardized methods to assess the system's ability to transfer contrast at different spatial frequencies.

8. The Sample Size for the Training Set:

This device is a hardware X-ray system that produces images. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense for image interpretation. Therefore, information about a training set sample size is not applicable/provided.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set discussed for an AI/ML algorithm.

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