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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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The Model MCT-1 EXF is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial 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 two- and threedimensional images. The device is operated and used by physicians, dentists, and x-ray technologists.

The MCT-1 EX F is an X-ray CT using the limited cone beam. MCT-1 EX F makes diagnosis be possible due to its high resolution three dimensional images for small diagnosis be possible add to the extremely complex morphology of the hard tissue of the head and neck region. High resolution images are obtained in the same short period as that of the Panoramic Radiology. Low X-ray radiation dosage is realized and the overall system structure is assembled to be compact unit. The J.MORITA. MFG. CORP. has manufactured the MCT-1EX as the original model of such kind of X-ray scanner, and modify the device for MCT-1 EX F by replacing the image receptor , XII for FPD ( Flat Panel Detector).

The provided 510(k) summary for the "3D Accu-I-tomo XYZ Slice View Tomograph MCT-1 EX F" is a submission for a modified device, primarily claiming substantial equivalence to a previously cleared device (MCT-1 EX, K030450) by replacing the image receptor. Therefore, the information provided focuses on demonstrating equivalence rather than establishing new performance criteria through a standalone study with acceptance criteria.

The submission does not contain specific acceptance criteria or an explicit study proving performance against such criteria in the way one might expect for a de novo device or a device claiming entirely new capabilities. Instead, it relies on the predicate device's established safety and effectiveness and notes that the technological change (replacement of the image receptor) does not raise new issues of safety or effectiveness.

However, based on the provided text, we can infer how "performance" is addressed within the context of demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

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

• The document does not specify a separate test set or sample size used for a performance study.
• The primary justification for equivalence relies on the technological similarity and the minor modification of the image receptor.
• Data Provenance: Not applicable in the context of specific a clinical performance study. The device itself is manufactured by J. Morita Mfg. Corp.

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

• Not applicable. No expert review or ground truth establishment for a specific test set is described. The submission focuses on technical equivalence rather than a clinical performance study requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

• Not applicable. As there is no described test set or expert review, no adjudication method is mentioned.

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. An MRMC study was not conducted or mentioned. This device is a CT imaging system, not an AI/CAD device for diagnostic assistance. The focus is on the imaging hardware itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This is an imaging device, not an algorithm. Therefore, a standalone algorithmic performance study is not relevant to this submission.

7. The Type of Ground Truth Used

• Not applicable. The submission does not describe a performance study that uses "ground truth" in the clinical sense (e.g., pathology, outcomes data, or expert consensus) for assessing diagnostic accuracy. The safety and effectiveness are established by demonstrating substantial equivalence to the predicate device, which presumably was evaluated via standard methods for CT scanners (e.g., image quality metrics, dose measurements) when it was originally cleared.

8. The Sample Size for the Training Set

• Not applicable. This device is an imaging hardware system, not an AI/machine learning model that requires a training set.

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

• Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth.

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The 3D Accu-I-tomo is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial 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 two- and three-dimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.

The C-arm assembly is mounted to the support column, which has an x-ray control panel for loading factors, an emergency stop switch, and a remote control for patient positioning. The C-arm assembly includes an image intensifier and an x-ray head with a beam-limiting device. The control box, which includes operational lights and an x-ray emission button, is typically placed in a separate room from the rest of the system. The patient chair includes an armrest and a headrest to fix the patient's head during the x-ray emission. An optional headrest for ENT applications is available which can be replaced with the headrest for dental applications.

A Windows-based personal computer is connected to the 3D Accu-I-tomo, on which is installed "3DXD" driver software and "3DX Integrated Information System" application software. For the network environment, "3DXD" driver software and "3DX Integrated Information System" are installed in the server computer and "3DX Integrated Information System" is installed in the client computer. The Windows-based personal computer is not manufactured by J. Morita Manufacturing Corp.

The 3D Accu-I-tomo operates in either CT mode or Fluoroscopic mode. In CT mode, it generates three-dimensional images that make possible precise diagnosis of the head and neck areas. It produces high resolution images and uses less x-radiation in comparison with conventional computed tomography x-ray systems. Fluoroscopy is available using the same x-ray head and image intensifier that are used for the CT mode. Fluoroscopy is mainly used with a contrast medium for ENT applications and surgery of the TM Joint. The same device can provide three-dimensional images and fluoroscopy. Both two- and three-dimensional images are taken for diagnosis before and after surgery. The fluoroscopic setting has three modes: a fluoroscopic moving image mode, a still image mode, and a testing mode. In the testing mode, it can take but not save a moving image.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets them. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and compliance with regulatory standards, rather than presenting a detailed performance study with acceptance criteria.

However, based on the information provided, we can infer some general areas of performance that were assessed and the types of tests conducted:

Inferred Acceptance Criteria and Reported Device Performance (General):

Detailed Information Not Available in the Provided Text:

The provided 510(k) summary does not contain the following specific information regarding a detailed study:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present. The document mentions "image quality testing" was passed but provides no details on the study design or data characteristics.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
4. 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: This information is not present. The device is a tomograph (imaging hardware with associated software for reconstruction and viewing), not specifically an AI-driven diagnostic aid that would typically be evaluated with MRMC studies for reader performance improvement.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device's software is integral to image reconstruction and display, but the document doesn't describe an "algorithm-only" performance evaluation in a diagnostic context.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present for any specific image quality or diagnostic performance study.
7. The sample size for the training set: This information is not present. The document refers to "software validation" and "development process for the device's firmware; and driver software and application software," which implies testing and development, but not specifically machine learning model training.
8. How the ground truth for the training set was established: This information is not present.

Summary of Study Information Available:

The document primarily focuses on regulatory compliance and substantial equivalence to predicate devices (Siemens Medical Systems' Siremobil C02, Siemens Siremobil Iso-C 3D Imaging Option, and NIM s.r.l.'s NewTom Model QR-DVT 9000).

The "study" or testing mentioned includes:

• Software Validation: This confirms the development process, requirements, hazard analysis, and adherence to procedures for firmware, driver, and application software.
• Compliance Testing: For safety standards like UL2601-1, IEC 60601-1, and anticipated 21 CFR Subchapter J.
• Image Quality Testing: Stated that it "passed," but no details on the methodology, metrics, or independent evaluation are provided.

In conclusion, while the document asserts that the device meets certain high-level performance attributes (high-resolution images, less radiation, successful software validation, image quality pass), it does not provide the specific details of a clinical or technical study that would delineate precise acceptance criteria alongside detailed performance metrics, sample sizes, expert qualifications, or ground truth establishment. This is typical for a 510(k) summary demonstrating substantial equivalence for an imaging device whose core technology is well-established.

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