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MCT-1EX-1F8/F17 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.

Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.

The Model MCT-1EX-1F8/F17 is a x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento maxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both twor and threedimensional images.

The MCT-1EX-1F8/F17 is an x-ray imaging device that acquires 360 degree rotational sequence of the head and neck areas, mainly for dentistry. The imaging data are once stored at three dimensional matrix of the examined volume, and are reconstructed by image processing through the Personal Computer, then finally displayed as both two and three dimensional images on the monitor.

It consists of rotation arm part, main body part, base part and accessories including personal computer and software.

This MCT-1EX-1F8/F17 is a slightly modified device from the MCT-1EXF ( K#052587) of J.MORITA MFG. CORP replacing the solid state x-ray imaging device of "Flat Panel Detector (FPD)" with some other additional modifications.

This 510(k) summary (K073645) for the J. Morita USA Inc.'s 3D Accu-I-tomo XYZ Slice view Tomograph Model: MCT-1EX-1F8/F17 contains very limited information regarding performance criteria and study details. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (MCT-1EXF, K052587) based on similarities in intended use, technological characteristics, and operating principles, rather than presenting a detailed performance study with defined acceptance criteria.

Therefore, it is not possible to provide a table of acceptance criteria and reported device performance from the provided text, nor can a detailed study analysis be performed. The document explicitly states: "The MCT-1EX-1F8/F17 covered by this submission is developed from our legally marketed device, MCT-1EXF (K#052587), modified slightly by replacing FPD to enlarge the radiographic area by using larger field of FPD, without any significant changes for the other components or performances." This indicates that the safety and effectiveness are largely assumed by the substantial equivalence to the predicate, rather than through independent, new performance studies with specific statistical criteria.

However, I can extract the general claims about performance and the basis for these claims as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, no specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, resolution in specific metrics) are stated, nor are specific performance metrics reported for the new device. The submission relies on demonstrating substantial equivalence to the predicate device. The "Performance spec." row in the comparison table mentions "International standards," but does not specify which standards or what performance level was achieved.

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

• The document does not describe a specific test set or any sample size used for performance evaluation of the new device.
• The data provenance is not mentioned because a separate performance study for the new device is not detailed. The submission relies on the predicate device's established performance.

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

• Not applicable. No independent test set with expert-established ground truth is described for the new device.

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

• Not applicable. No independent test set is described.

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:

• No MRMC study was done or mentioned. This device is an imaging system, not an AI-assisted diagnostic tool.

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

• Not explicitly described. The device is an X-ray imaging system; its "performance" is inherently based on the images it produces for human interpretation. There isn't an "algorithm only" performance reported in the context of diagnostic output separate from physician use.

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

• Not applicable. No independent performance study requiring ground truth is detailed for the new device. The ground truth for the predicate device's performance, if ever assessed, is not specified here.

8. The sample size for the training set:

• Not applicable. This device is an X-ray imaging system, not a machine learning or AI algorithm in the context of this submission. Thus, there is no "training set" in the sense of data used for algorithm development or machine learning.

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

• Not applicable. As above, no training set is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is primarily a comparative analysis demonstrating "substantial equivalence" of the new device (MCT-1EX-1F8/F17) to a legally marketed predicate device (MCT-1EXF, K052587). The core argument is based on the new device being a "slightly modified device" with component changes (specifically, replacing the Flat Panel Detector, FPD, to enlarge the radiographic area) that do not "raise any new issues of safety or effectiveness."

The evidence provided to support substantial equivalence includes:

• Similar Intended Use: Both are "head and neck three dimensional X-ray Computed Tomography" devices for diagnostic support in dentistry and other specified anatomical areas.
• Similar Technological Characteristics: Both are cone beam x-ray CT systems with similar construction (except for the FPD and rotating arm design), image receptors (FPD), and operational principles.
• Identical/Similar Safety Standards: Both meet "International standards" for performance and have identical or similar electrical, thermal, and radiation safety characteristics.
• Claim of "Higher Image Quality": Note-3 under the comparison table states: "The enlarged sizes of radiographic areas are obtained with higher image quality such as high speed, high fidelity or high resolution other than standard mode." This is a qualitative claim without specific metrics or a comparative study detailed in the summary.

In conclusion, this 510(k) submission does not contain a traditional performance study with explicit acceptance criteria and corresponding results for the new device. Instead, it leverages the established safety and effectiveness of a predicate device through a claim of substantial equivalence for a slightly modified product.

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