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This is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. Not for mammographic use.

The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.

The provided text describes a 510(k) summary for the Bel-Cat Dental Cone Beam CT device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics of the device itself. Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets, how ground truth for the training set was established) are not explicitly present in the provided information.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implied to be "as safe and effective as the predicate device" and having "few technological differences, and no new indications for use." The device's performance is demonstrated through a comparison of its specifications to the predicate device.

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

The document states that "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices," and mentions "bench test data as well as external laboratory testing to applicable standards." However, no specific sample size or details about the data provenance (e.g., country of origin, retrospective/prospective) for any "test set" are provided. The submission focuses on technical specifications and equivalence, not a clinical trial with a defined test set.

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

Not provided. This type of information is not typically included in a 510(k) summary for a device demonstrating substantial equivalence through technical specification comparison, especially if no specific clinical test set is detailed.

4. Adjudication method for the test set

Not provided. As no specific clinical test set with human assessments is described, no adjudication method would be presented.

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 reported. This device is a diagnostic imaging system, not an AI-assisted interpretation device. The submission focuses on the safety and effectiveness of the imaging system itself, not the improvement of human readers with AI assistance.

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

Not applicable/Not provided. This is a hardware device (CT scanner). The concept of "standalone algorithm performance" does not apply directly to this type of medical device submission.

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

Not explicitly detailed. The "ground truth" for demonstrating substantial equivalence appears to be established through engineering specifications, performance tests (bench and laboratory), and implied clinical consensus on the diagnostic utility of the images produced, as it is equivalent to an already marketed device. There's no mention of specific pathology or outcomes data from a new clinical study.

8. The sample size for the training set

Not applicable/Not provided. This device is a conventional CT scanner, not a machine learning or AI-based system that undergoes "training."

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

Not applicable/Not provided. As there is no "training set" for this type of device, no ground truth establishment method for it is relevant.

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The BELRAY II, Model 097 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.

extraoral source dental radiographic x-ray unit

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental x-ray unit, which outlines its regulatory classification, indications for use, and compliance requirements. It does not include details about device performance tests, acceptance criteria, study methodologies, or expert reviews as you've requested.

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Alphard Model X178 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Alphard series 3D X-ray CT realizes wide area imaging by adopting the principle of cone beam CT and using high-resolution wide area flat panel detector (FPD). Alphard series enables dentist to take wide range imaging from small area to wide area with appropriate imaging mode according to various treatment objects. Combination of advanced FPD (dynamic range: 14bit) and micro focus X-ray tube provides high resolution CT image from soft tissue to hard tissue. Our original software AsahiVision freely displays high picture quality 3D image and MPR image.

The provided text is a 510(k) summary for the Alphard Model X178 Dental Cone Beam CT system. This document focuses on demonstrating substantial equivalence to existing legally marketed devices rather than establishing specific performance acceptance criteria and a detailed study proving those criteria are met for the new device.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) is not present in the provided 510(k) summary.

The document implicitly "proves" the device meets acceptance criteria by demonstrating substantial equivalence to predicate devices through a comparison of indications for use and technical specifications. The acceptance criterion is essentially that the device is "as safe and effective" as the predicates.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit via Substantial Equivalence): The primary "acceptance criteria" presented is that the Alphard Model X178 Dental Cone Beam CT system is substantially equivalent to the predicate devices (K052587 and K063622) in terms of safety, effectiveness, technological characteristics, and indications for use.

Reported Device Performance: The document provides technical specifications for the Alphard and compares them to the predicate devices. The "performance" is considered adequate if these specifications fall within acceptable ranges relative to the predicates, implying similar image quality and functional capabilities.

Conclusion on Equivalence: "After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Alphard Model X178 Dental Cone Beam CT System is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."

The following information is not provided in the 510(k) summary:

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

• Not specified. The document mentions "bench, test laboratory and clinical testing" and "user testing data" but does not provide details on sample sizes, types of data (e.g., patient cases vs. phantoms), or provenance (country, retrospective/prospective).

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

• Not specified. Given the nature of a substantial equivalence submission for imaging hardware, a detailed expert-based ground truth assessment of diagnostic performance (as would be seen in an AI software submission) is typically not required or detailed in this summary.

4. Adjudication method for the test set

• Not specified.

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. This is a hardware submission, not an AI or software submission. An MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

• No. This is a hardware submission. "Standalone performance" in the context of an algorithm is not applicable here.

7. The type of ground truth used

• Not specified in detail. The document mentions "bench, test laboratory and clinical testing." For hardware, ground truth typically involves physical measurements, phantom studies for image quality metrics (resolution, noise, contrast), and potentially clinical assessments of image interpretability (without a formalized ground truth process for diagnostic accuracy as for AI).

8. The sample size for the training set

• Not applicable/Not specified. This pertains to an imaging device itself, not an AI algorithm requiring a training set. The device produces images based on physical principles, not a trained model.

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

• Not applicable/Not specified. See point 8.

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