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HYBRID S70 is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.

The portable x-ray system HYBRID S70, is an x-ray generating device which is designed for dental examination. The device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.

The provided text is a 510(k) summary for the HYBRID S70 extra-oral x-ray system. It describes the device, its intended use, and compares its technological characteristics to a predicate device (Rextar X). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system for diagnostic performance.

The document explicitly states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices". This indicates that a clinical performance study (which would typically involve acceptance criteria, test sets, ground truth, expert readers, etc.) was not conducted or was deemed unnecessary for this submission. The submission focuses on substantial equivalence based on technological characteristics and compliance with safety and performance standards, rather than diagnostic accuracy or AI assistance.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them, as the provided text lacks this specific data.

To answer your request, if this were an AI-enabled device requiring such a study, the following information would typically be provided:

Hypothetical Answer (if the document had contained the requested information for an AI-enabled device):

The provided 510(k) summary for the HYBRID S70 does not contain information related to acceptance criteria or a study proving device performance on diagnostic accuracy, especially in the context of AI assistance or human-in-the-loop performance measurement. The submission appears to focus on demonstrating substantial equivalence based on the physical and operational characteristics of the x-ray system itself, adhering to safety and performance standards. The statement "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices" further supports that a full diagnostic performance study, which would involve the criteria you've outlined, was not deemed necessary for this specific submission.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or MRMC studies, as this information is absent from the provided text.

In a scenario where this information was present for an AI-enabled diagnostic device, here's how I would present it (illustrative example, not based on the provided text):

Hypothetical Example of Device Performance Study Information (Illustrative, NOT from the provided text):

The device is an AI-powered diagnostic system intended to assist radiologists in detecting dental caries from dental x-ray images.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 500 dental x-ray images (radiographs).
• Data Provenance: Retrospective data collected from multiple dental clinics across the United States. Patient demographics included a representative distribution of age and gender.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 independent board-certified Oral and Maxillofacial Radiologists.
• Qualifications: Each expert had a minimum of 10 years of clinical experience specializing in dental imaging interpretation.

4. Adjudication Method for Test Set

• Adjudication Method: 2+1. Initial blind independent review by two expert radiologists. In cases of disagreement between the first two readers, a third senior expert radiologist provided a final decision, which served as the ground truth.

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

• Was an MRMC study done? Yes.
• Effect Size: Human readers (dentists and general radiologists) demonstrated an average improvement in Area Under the Receiver Operating Characteristic (AUC) curve of 0.08 when assisted by the AI device compared to reading without AI assistance. This corresponds to an approximate 25% relative reduction in false negatives and a 15% relative reduction in false positives when AI assistance was used, leading to an overall improved diagnostic accuracy.

6. Standalone Performance

• Was a standalone (algorithm only) performance study done? Yes. The algorithm achieved a Sensitivity of 92.5% and a Specificity of 88.1% for the detection of dental caries.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus (adjudicated consensus of three experienced Oral and Maxillofacial Radiologists), supplemented by available pathology reports or follow-up clinical outcomes where accessible, to confirm the presence or absence of caries.

8. Sample Size for Training Set

• Training Set Sample Size: Over 10,000 dental x-ray images.

9. How Ground Truth for Training Set Was Established

• Ground Truth Establishment for Training Set: Images in the training set were annotated by a team of 5 dental professionals (dentists and experienced dental hygienists) under the supervision of a lead Oral and Maxillofacial Radiologist. A subset of these annotations was then reviewed and validated by a senior radiologist to ensure quality and consistency. Discrepancies were resolved through team discussion and expert consultation.

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PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.

The portable X-Ray system, PORT-X IV, is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is the X-ray equipment and uses it to diagnose the patient to acquire images. It also includes accessories, which are battery, recharging unit and hand switch.

The provided text is a 510(k) summary for the GENORAY Co., Ltd. PORT-X IV, a portable X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device (Metabiomed, Inc. REXTAR X) rather than presenting a study to prove the device meets specific acceptance criteria for AI/algorithm performance. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study are not applicable or cannot be extracted from this document.

However, I will extract what is available regarding general device performance and safety.

Here's the breakdown of the information based on the prompt and the provided text:

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

The document does not explicitly state "acceptance criteria" in a table format for AI performance. Instead, it details performance standards and safety criteria for an X-ray device based on federal and international standards.

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