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RX DC x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.

The subject device RX DC, in the new 65/70 kV version, is an extraoral source dental X-ray system intended for intraoral imaging. The subject device is a device comprises a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively:

• . A control unit equipped with wall plate, extension arm and wired/wireless control device;
• A tube head with x-ray tube; .
  X-rays are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology, X-ray emission at 70 kV and 8 mA (maximum power), and x-ray unit automatically calculates the best exposure time (from 0.02 s to 1.00 s) based on the selected tooth and patient size, as well as an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. RX DC, 65/70 kV version, is manufactured by CEFLA S.C. and available in several versions, and it can be sold under different brands and commercial names for commercial needs, as well as with different type of installation, and also different types of maximum anode voltage (65 kV or 70 kV). To identify the different variants of the RX DC product, CEFLA S.C. designed a reference system to identify any variant via the REF code.

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.

This document describes the 510(k) premarket notification for the RX DC dental X-ray unit. It focuses heavily on demonstrating substantial equivalence to predicate devices rather than setting specific, numerical acceptance criteria for a diagnostic performance study. The "acceptance criteria" here largely revolve around compliance with established standards and comparable physical measurements.

Here's the breakdown of the information you requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with explicit numerical acceptance criteria for diagnostic accuracy, sensitivity, or specificity commonly associated with AI/CAD devices. Instead, the acceptance criteria are implicit in demonstrating compliance with safety and performance standards, and showing equivalent dosimetric output to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no "test set" in the sense of a dataset for evaluating diagnostic performance (e.g., images for classification). The "tests" performed were non-clinical engineering and dosimetric tests.
• Data Provenance: The tests were conducted by CEFLA S.C. (the manufacturer) or their contracted labs. The company is based in Italy. The document doesn't specify if the dosimetric tests involved actual patient data or were conducted in a controlled laboratory environment with phantoms. Given the nature of dosimetric testing for X-ray units, it's highly likely to be laboratory-based and controlled.

3. 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 applicable as there was no ground truth determination by experts for a diagnostic performance test set. The evaluation focused on physical and electrical device characteristics and dosimetric output.

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

• This information is not applicable as there was no diagnostic performance test set requiring adjudication.

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 comparative effectiveness study was not done. This submission is for an X-ray imaging device itself, not an AI/CAD system designed to assist human readers. The clinical utility is in producing the images, not in interpreting them.

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

• No, a standalone algorithm performance study was not done. This device is an X-ray unit, not a diagnostic algorithm.

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

• This information is not applicable as there was no diagnostic performance evaluation requiring ground truth. The "ground truth" equivalent for the dosimetric test would be the established and verified output of the predicate device.

8. The sample size for the training set

• This information is not applicable as there is no AI/machine learning component requiring a training set mentioned in this 510(k) summary.

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

• This information is not applicable as there is no AI/machine learning component or training set mentioned.

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The Hyperion X5 device, 3D version machine, intended to:

I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.

The subject device Hyperion X5 is a dental radiographic imaging system, that consists of two image acquisition modes: panoramic and cone beam computed tomography (CBCT). Specifically designed for dental radiography of the teeth, jaws and oral structures, the subject device:

produces orthopanoramic images of the maxillofacial region and carry out diagnostic l. examination on teeth, dental arches and other structures in the oral cavity;

produces tomographic images of the oral cavity and maxillofacial structures and carry out II. diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones. Hyperion X5 has been developed according to FDA-Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".

The subject device can be sold under different brands and commercial names for commercial needs, without changing any of the safety, electrical and functional features.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" with numerical or categorical targets for performance metrics. Instead, it describes performance tests designed to demonstrate "substantial equivalence" to predicate devices. The implicit acceptance criterion is that the subject device's performance should be "substantially equivalent" to the predicate devices in the tested aspects.

Given this, the table below reflects what was tested and the reported outcome relative to the predicate devices.

Note: The document refers to "Images resolution (panoramic X-rays)" and then proceeds to discuss "3D performance evaluation" and "Clinical tests... in CBCT acquisition". It appears the "Images resolution" entry under non-clinical tests refers to 2D aspects, while the 3D aspects are covered separately.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Non-Clinical (Phantoms): The sample sizes are not explicitly stated as numbers of images or scans. Instead, it refers to the use of "a specific QUART phantom," "a specific geometric phantom," "an anthropomorphic phantom," and "phantom Catphan® 500." For the Catphan® 500, it mentions "a number of axial images extracted by the volumetric reconstructions." This suggests phantom data was used, not human subject data for these tests.
  • Clinical (Qualitative 3D CBCT): The sample size for the qualitative clinical evaluation is not explicitly stated as a number of cases or patients. It mentions examining images from "relevant clinical conditions: pediatric patient, Edentulous, third molar, Upper arch endodontics." This implies a selection of cases representing these conditions but the exact number isn't provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of any clinical data or whether the phantom studies were conducted in a specific country.
• Retrospective or Prospective: Not specified. For the "clinical tests," it's unclear if these were prospectively acquired or retrospectively analyzed images. Given the phrasing "images obtained with the two devices," it could imply either.

3. 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)

• The document does not detail how ground truth was established for the "clinical tests." It refers to "a qualitative evaluation of images obtained with the two devices focusing on relevant clinical conditions." It implies expert assessment for this qualitative evaluation but does not specify the number of experts, their qualifications, or the method used to establish ground truth or consensus.
• For the non-clinical phantom studies, the "ground truth" is inherently defined by the phantom properties and the physical measurements performed (e.g., resolution, geometry, MTF/NPS values). No human experts are involved in establishing this type of ground truth.

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

• The document does not describe any adjudication method for the qualitative clinical evaluation. It's unclear if multiple experts were involved and how discrepancies would have been resolved. For the quantitative phantom studies, adjudication by human experts is generally not applicable.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
• This device is an X-ray imaging system (hardware), not an AI algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context. The study focuses on demonstrating the imaging system's performance and equivalence to predicate devices, not on evaluating human reader performance or the impact of AI.

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

• This question is not applicable. The device is a "Computed tomography x-ray system" (hardware for image acquisition), not a standalone algorithm. The performance evaluation is of the imaging system itself.

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

• For Non-Clinical Tests: The ground truth was based on the objective physical properties of phantoms and established measurement methodologies for imaging parameters (e.g., resolution targets on a QUART phantom, geometric patterns on a geometric phantom, known properties of the Catphan® 500).
• For Clinical Tests (Qualitative): The document implies ground truth was established by expert judgment/qualitative evaluation of images from "relevant clinical conditions." However, the method, number of experts, and their qualifications are not detailed. It does not mention pathology or outcomes data.

8. The sample size for the training set

• This is not applicable. The Hyperion X5 is a conventional X-ray imaging system, not a machine learning or AI-driven algorithm that requires a "training set" in the context of AI model development.

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

• This is not applicable, as there is no training set for this type of medical device (conventional X-ray imaging system).

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