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x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.

The device is operated and used by dentists, radiologists and other legally qualified health care professionals.

x-mind dc consists of the following parts:

• 1 X-ray control unit (timer)
• 2 Wall plate and horizontal bracket
• 3 Pantograph type arm (scissor arm)
• 4 X-ray source assembly (tubehead)
• 5 Collimator cone (Beam Limiting Device)

The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.

The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.

The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.

x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).

The provided text outlines the 510(k) summary for the x-mind dc (and Owandy-RX DC) device, which is an extraoral source X-ray system intended for intra-oral radiographic exams. The core of the summary demonstrates substantial equivalence to a predicate device, Endograph DC (K130109), and a reference device, PHOT-X II, MODEL 303 (K042260).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device in the sense of performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, it details the device's technical specifications and compliance with various international and national standards and regulations. The "acceptance criteria" here are implicitly the successful adherence to these standards, demonstrating safety and essential performance comparable to the predicate device.

To frame this in the requested format, we can list key technical specifications and their comparison to the predicate/reference devices, which serve as the "performance" verification. The ultimate "acceptance criterion" is the determination of substantial equivalence by the FDA.

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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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This 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.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the "RX DC" device.

The document is a 510(k) premarket notification letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, product classification, and general controls. It also includes the "Indication for Use" for the device.

However, it does not contain the specific details requested in your prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This kind of detailed performance study information is not typically included in the FDA's 510(k) clearance letter itself, but would be part of the documentation submitted by the manufacturer to the FDA for review.

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