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The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.

The portable x-ray system (Models: MINIX-V, MINIX-S) is an x-ray generating device which is mainly designed for dental examination (teeth and jaw). Operating principle is that the high voltage electricity is getting into x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and penetrates teeth and jaw, and makes x-ray images through image receptors (chemical film or digital sensor). Once the power is supplied from the rechargeable lithium-ion polymer battery pack, the inverter generates high frequency and high voltage. Boosted and rectified DC high voltage (MINIX-V: 70kV, MINIX-S: 60kV) is loaded onto the x-ray tube, and the tube generates x-ray. Micro control unit (MCU) and other control parts function to display data on LCD and control the system by the input information from user interface. When operator controlled (fixed amount of) x-ray is exposed to patient's teeth and jaw, clinician can examine the parts with processed images from intra-oral image receptors (analog film, digital phosphor plate or digital sensor). The Portable X-ray System (Models: MINIX-V, MINIX-S) is composed of an x-ray generating part with an x-ray tube, a device controller (Control PCB), a power controller (Power PCB), an user interface (LCD window), a beam limiting part (x-ray emitting cone), a backscatter shield, and a remote control switch (hand-switch). The Portable X-ray System (Models: MINIX-V, MINIX-S) is a diagnostic x-ray system, which is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, x-ray tube, electrical protective devices, and other elements. The system with high frequency x-ray provides sharp and clear images, and the total lead protection seal protects patients and dentists from leakage or scattered radiation from the device.

The provided documentation does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML system. The device described, "Portable X-ray System (Models: MINIX-V, MINIX-S)," is an X-ray generating device for dental examinations. The submission focuses on demonstrating substantial equivalence to predicate devices based on safety, electrical, mechanical, and X-ray performance standards, rather than evaluating the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these are relevant to AI/ML device evaluations which are not described in this document.

The document states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices," further indicating that image analysis performance (which would typically involve AI/ML) was not the focus of this submission for substantial equivalence.

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The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The Portable X-ray System (Model: BIOX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose teeth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates teeth and jaw, and makes X-ray images on a receptor (chemical film or digital sensor). The Portable X-ray System (Model: BIOX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.

The provided document describes a 510(k) premarket notification for a medical device, the Portable X-Ray System (Model: BIOX). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for detecting a particular condition).

Instead, the acceptance criteria and proof provided relate to the device's technical specifications, safety, and performance as an X-ray source, ensuring it is as safe and effective as the predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and compliance with various IEC standards. The "reported device performance" refers to the BIOX model's specifications.

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

The document does not describe a clinical study in the form of a diagnostic image interpretation trial with a "test set" of patient data. The "tests" mentioned are:

• Bench testing
• Clinical evaluation (not detailed, but likely referring to a general assessment of functionality and safety, not a diagnostic accuracy study).

Therefore, there is no sample size for a test set of patient cases or information about data provenance in the context of diagnostic performance. The testing was focused on engineering and performance parameters of the X-ray device itself.

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

Not applicable. As no diagnostic accuracy study with a "test set" and "ground truth" for patient conditions was described, no expert consensus was established for such a purpose.

4. Adjudication method for the test set

Not applicable. There was no diagnostic accuracy study described that would require an adjudication method for case interpretations.

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 comparative effectiveness study was done. The device is an X-ray source, not an AI-powered image analysis tool. Its purpose is to produce images, not to interpret them or assist human readers with AI.

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

Not applicable. The device is an X-ray source, not an algorithm, and does not operate in a "standalone" or "human-in-the-loop" performance context related to AI.

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

The document does not describe the establishment of ground truth for diagnostic purposes. The "ground truth" in this context is the physical and electrical performance parameters of the X-ray machine itself, which are verified through various engineering tests and compliance with recognized standards.

8. The sample size for the training set

Not applicable. Since this is an X-ray imaging device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for this purpose.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as a combination of:

• Bench Testing: This likely involved engineering tests to verify the device's electrical, mechanical, and radiation output specifications (e.g., kVp, mA, exposure time accuracy, radiation leakage).
• Clinical Evaluation: While not detailed, this would typically involve assessing the device's functionality, ease of use, and ability to produce clinically usable images in a practical setting. This is distinct from a diagnostic accuracy study.
• Compliance with Standards: The device was tested and found to comply with a series of international standards:
  • UL/IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
  • IEC 60601-1-3 (Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment)
  • IEC 60601-2-7 (Particular requirements for the safety of high voltage generators of diagnostic X-ray generators) - likely a typo in the original document, often 2-7 is related to X-ray tubes
  • IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
  • IEC 60601-2-32 (Particular requirements for the safety of associated equipment of X-ray equipment)
  • EN/IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)

The conclusion states that "The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices." This implies that the BIOX device met the safety and performance benchmarks set by the predicate device and the relevant international standards.

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The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The Portable X-ray System (Model: DIOX-602, PROX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger.

The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor).

The Portable X-ray System (Model: DIOX-602, PROX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral xray source for producing diagnostic x-ray images using intra-oral image receptors.

Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: DIOX-602, PROX) provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.

The provided text is a 510(k) summary for the DIGIMED Portable X-Ray System. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications rather than specific performance acceptance criteria or a detailed study proving the device meets them.

Therefore, many of the requested details, especially those related to AI algorithm performance, sample sizes for training/test sets, expert adjudication, and ground truth establishment, are not present in this document, as the device is an X-ray system, not an AI-powered diagnostic tool.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or performance metrics for diagnostic accuracy in the way an AI algorithm study would. Instead, it relies on demonstrating substantial equivalence to an existing predicate device based on technical specifications and safety/EMC testing.

Study Proving Device Meets Acceptance Criteria:

The document states: "The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices."

And "EMS testing was conducted by EMC Compliance Co., Ltd. for DIOX-602 and SGS Testing Korea Co., Ltd. for PROX in accordance with Standard EN/IEC 60601-1-2. All test results were satisfactory."

This indicates that the "study" was primarily bench testing for technical specifications and EMC (Electromagnetic Compatibility) testing to ensure compliance with relevant IEC standards (e.g., IEC 60601 series). A clinical evaluation was also performed, but no details are provided about its design, methodology, or results beyond the general statement of safety and effectiveness.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The "clinical evaluation" is mentioned, but no details on where or how the data was collected. Given the manufacturers are Korean, it's possible some data was from Korea, but this is speculative.
• Retrospective/Prospective: Not specified.

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

• This information is not provided. As this is an X-ray hardware submission, not an AI diagnostic algorithm, the concept of "ground truth" derived from expert consensus on images is less central. The "clinical evaluation" would likely focus on image quality and safety, possibly involving dentists or technicians evaluating the images produced.

4. Adjudication Method:

• Not specified.

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

• No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. Standalone (Algorithm Only) Performance:

• No. This is an X-ray hardware system, not an algorithm. Standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

• For the "clinical evaluation," the ground truth implicitly would be the diagnostic quality of the X-ray images produced by the device, evaluated by trained professionals, and compared to the images produced by the predicate device and the clinical needs of dentistry. This is not explicitly pathology or outcomes data but rather an assessment of image utility for diagnosis.
• For the technical and safety testing, the "ground truth" is adherence to the specified technical parameters (e.g., kVp, mA, exposure time accuracy) and compliance with international standards (IEC 60601 series) as verified by tests performed in certified labs.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable/Not specified. As there is no AI component, there is no training set and therefore no ground truth established for it.

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