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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.

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

The document does not specify a separate "test set" sample size in the context of a dataset for an AI algorithm. The performance evaluation is based on non-clinical bench testing and a comparison of technical specifications and compliance with standards.

For image quality, it mentions "Sample clinical images" were used, but the specific number is not provided.

The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed.

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

For the image quality assessment portion, the document states: "Sample clinical images, evaluated by a clinical expert, demonstrated diagnostic quality output when device is integrated with recommended cleared x-ray receptor(s)."

• Number of experts: One ("a clinical expert")
• Qualifications of experts: "clinical expert" - no further specific qualifications (e.g., years of experience, specialty like radiologist/dentist) are provided in the excerpt.

4. Adjudication Method for the Test Set

Not applicable. There was only one "clinical expert" involved in the image quality evaluation, so no adjudication method (like 2+1 or 3+1) was necessary or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The study focuses on demonstrating substantial equivalence of the hardware device, not on the impact of an AI algorithm on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is an X-ray unit, not an AI algorithm. The software component mentioned is for the device's operational control and safety, not for diagnostic interpretation. Therefore, a standalone performance study in the context of an AI algorithm is not relevant here.

7. Type of Ground Truth Used

For the overall device, the "ground truth" for demonstrating safety and effectiveness relies on:

• Compliance with established international and national medical device standards (e.g., IEC 60601 series, ISO 10993-1, 21 CFR sections for diagnostic x-ray systems).
• Demonstration of equivalent technical specifications compared to a legally marketed predicate device.
• "Diagnostic quality output" from sample clinical images, assessed by a clinical expert. This expert assessment serves as the ground truth for image quality.

8. Sample Size for the Training Set

Not applicable. As the device is an X-ray unit and not an AI-powered diagnostic algorithm, there is no mention of a training set as would be used for machine learning.

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

Not applicable, as no training set for an AI algorithm is mentioned or relevant to this device's submission.

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