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CLAROX plus (Model: VX-100) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed X-ray tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients and pediatrics. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.

VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the Clarox Plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware). The device software is of Moderate level of concern and it is not based on the predicate software. The device uses a rechargeable battery to allow for the use of the VX-100 where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility. The VX-100 is an X-ray device with AC/DC adaptor. The handheld device features a main body (tube head), cone to limit the exposure range of the beam, cradle, and AC/DC adaptor. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a main body. This facilitates portability of the device. A beam-limiting cone is mounted to the device before use. The tube voltage is adjustable from 70kV to 100kV. Tube current is fixed 1.0mA. The exposure time is also manually adjustable by the operators. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, display, and an exposure button provide the primary operator interface. Exposures settings can be selected and displayed. The voltage and the exposure time varies based on patient type, detector type, and anatomical feature. Exposures can be completed using the exposure button. The VX-100 should be used with an X-ray detector, and the x-ray detector may be digital or analog, and it is not included in the VX-100 package.

The provided text pertains to a 510(k) premarket notification for a mobile X-ray system, CLAROX plus (Model: VX-100). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of comparative effectiveness with human readers or standalone algorithm performance.

Specifically, the document states:

• "Clinical testing was not necessary for the VX-100, based on the nature of the device (an x-ray generator marketed without image detector). Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence."

Therefore, the information requested for acceptance criteria and a study demonstrating device performance, as detailed in your prompt, is not available in the provided text. The document is concerned with regulatory clearance based on substantial equivalence through non-clinical performance and safety standards, rather than clinical efficacy against metrics like those used for AI/CAD devices.

If this were a device with AI components and clinical performance claims, the following information would be expected but is absent:

1. A table of acceptance criteria and the reported device performance: This would typically show metrics like sensitivity, specificity, AUC, or detection rates for a specific task (e.g., detecting a condition) and the target values for these metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned as there was no clinical study.
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): Not applicable as there was no clinical study with a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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 MRMC study was done, and no effect size is reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study was done or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as there's no mention of an algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily lists non-clinical performance data, referring to compliance with various IEC and ANSI standards related to medical electrical equipment, software, risk management, usability, and radiation protection for diagnostic X-ray equipment. This demonstrates basic safety and essential performance, but not clinical performance or efficacy in a diagnostic task.

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The CLAROX is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to ther device's size and/or lack of mobility. The CLAROX is an X-ray device with a AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.

The provided document is a 510(k) summary for the CLAROX dental X-ray system, which is an X-ray generator. It focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards, rather than clinical performance (e.g., diagnostic accuracy). Therefore, many of the requested sections related to clinical studies, ground truth, expert review, and MRMC studies are not applicable or not detailed in this document.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study to Prove Device Meets Criteria:

The document does not specify "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the CLAROX device itself. Instead, it demonstrates substantial equivalence to a predicate device (KaVo NOMAD Pro2 Handheld X-ray System) by comparing technological characteristics and showing compliance with international safety and performance standards.

The study that "proves the device meets acceptance criteria" is described as non-clinical testing and bench testing to demonstrate compliance with these standards and similar technological characteristics to the predicate device.

1. Table of acceptance criteria and the reported device performance

Since the "acceptance criteria" are not explicit performance metrics for diagnostic capability, but rather conformance to standards and comparable technical specifications, the table below will reflect the comparison between the subject device (CLAROX) and the predicate device (KaVo NOMAD Pro2) as presented in the document. The "reported device performance" refers to the specifications of the CLAROX device.

Note on Differences: While some specifications (e.g., weight, battery capacity, exposure time range, mA, kVp) differ, the document concludes that these differences do not raise new questions of safety or effectiveness and are within a range considered substantially equivalent for an extraoral X-ray source. For instance, the subject device has a lower weight and higher kVp compared to the predicate.

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

The document states, "Clinical testing is not necessary for the current submission, based on the device type (an x-ray generator) and based on the technological characteristics similar to the predicate system." Therefore, there is no test set of clinical images or patient data described in this submission. All testing was non-clinical (bench testing) to verify technical specifications and compliance with standards.

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

Not applicable, as no clinical test set with a ground truth established by experts was used.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used.

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

Not applicable. The CLAROX device is an X-ray generator, not an AI-powered diagnostic tool. Its submission is based on substantial equivalence as an X-ray source, not on improving human reader performance.

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

Not applicable, as the CLAROX is an X-ray generator, not an algorithm, and does not perform diagnostic interpretation.

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

Not applicable, as no clinical test set requiring ground truth for diagnostic accuracy was utilized. The "ground truth" in this context would implicitly be the validated specifications and performance of the predicate device and the requirements of the international standards.

8. The sample size for the training set

Not applicable. This device is an X-ray generator, not a machine learning algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

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