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QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The QuickRayPRO shall be operated by healthcare professionals , who are educated and competent to perform the acquisition of dental intra-oral radiographs. The QuickRayPRO can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.

QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images.

I am sorry, but the provided text does not contain information on acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the QuickRayPRO device, which is a dental intra-oral radiology image acquisition system, and primarily discusses regulatory aspects and indications for use. Therefore, I cannot generate the requested table and information.

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The MobileX Portable X-ray System 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 receptors. Its use is intended for both adults and pediatric subjects.

Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

MobileX Portable X-ray System of Denterprise International, Inc., is a handheld xray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient.

The software is designed for a button operated device to be used by a user and a display window to be observed by the user. The software is for controlling the operation of the hardware according to the user operation that is required for this device. This software is new but this type of software is common for use in the handheld x-ray systems.

The provided document is a 510(k) summary for the MobileX Portable X-ray System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment, especially concerning diagnostic performance (e.g., sensitivity, specificity), cannot be fully extracted from this document. The document describes non-clinical performance data confirming safety and effectiveness compared to the predicate, primarily through engineering and regulatory standards rather than a clinical multi-reader, multi-case study or standalone algorithm performance.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task). Instead, it focuses on adherence to engineering and regulatory standards, and technological equivalence to a predicate device.

2. Sample Size for Test Set and Data Provenance

The document explicitly states "Clinical data was not needed to support substantial equivalence."
The "Non-Clinical Performance Data" section lists various engineering and regulatory tests. These tests are generally performed on a small number of engineering samples or prototypes of the device itself rather than a "test set" of patient data.

• Sample Size for Test Set: Not applicable in the context of clinical or diagnostic performance on patient data, as no such study was conducted or reported. For engineering tests (e.g., electrical safety, radiation leakage), the "sample size" typically refers to the number of devices tested, which would be very small (e.g., 1-several units).
• Data Provenance: Not applicable for patient data. Engineering tests were performed in Korea (manufacturer: Remedi Co., Ltd., Korea; electrical test: KCTL, Inc. Laboratories, Inc., Korea). These are non-patient, non-clinical tests.

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

This information is not applicable as no clinical "test set" of patient data requiring expert-established ground truth for diagnostic performance evaluation was used. The evaluation focused on engineering compliance and equivalence.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical "test set" requiring adjudication of ground truth was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an X-ray source (hardware), not an AI-powered diagnostic software. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. This is an X-ray device, not a diagnostic algorithm.

7. The type of ground truth used

This information is not applicable in the context of diagnostic performance (e.g., expert consensus, pathology, outcomes data), as no such study was performed. The "ground truth" for the device's performance was its adherence to established engineering standards (e.g., IEC, ISO, CFR) and demonstration of equivalent physical and technical characteristics to the predicate device.

8. The sample size for the training set

This information is not applicable. This is a hardware device submission, not an AI/Machine Learning algorithm that requires a "training set" of data.

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

This information is not applicable as there was no training set.

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QuickRay HD is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.

The QuickRay HD dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.

The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.

The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².

QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12.

The type of x-ray systems that integrate with the QuickRay HD sensor are wall-mounted xray generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time.

This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver.

The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.

Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them. It's important to note that this document is a 510(k) summary for a premarket notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial. As such, some of the requested information (like detailed MRMC studies or large-scale multi-expert ground truthing) may not be explicitly present or required for this type of submission.

The device in question is the QuickRay HD Intraoral Sensor.

Acceptance Criteria and Device Performance Study for QuickRay HD Intraoral Sensor

Context: The QuickRay HD Intraoral Sensor is an intraoral digital X-ray system intended for radiographic examination to assist in diagnosing diseases of the teeth, jaw, and oral structures. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (Opteo, K133271) and an identical device cleared later (EDLENi Intra-oral Sensor, K150823), rather than extensive new clinical performance studies, which is typical for Class II dental imaging devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) submission, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, meaning the QuickRay HD must perform comparably or better than the predicate, especially in terms of image quality and safety. The performance is assessed through bench testing and by comparing technological characteristics.

Note: The document explicitly states that the EDLENi Intra-oral Sensor (K150823) is identical to the QuickRay HD, providing further support for substantial equivalence.

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

• Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patients or images for a comparative clinical study. The performance assessment is primarily based on:
  • Bench Testing: Conformance to standards (IEC 62220-1 for performance, IEC 60601-1/1-2 for electrical/EMC, IEC 60529 for IP Code). These involve standardized phantom or controlled laboratory tests rather than patient images as a "test set."
  • Clinical Image Examination: "Clinical images were examined" by Dr. Parham. The number of images or cases examined is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the "clinical images" examined by Dr. Parham, but given the location of Dr. Parham (Ormond Beach, FL), it implies the data is from the United States. The study type appears to be retrospective in nature ("clinical images were examined"), rather than a prospectively designed clinical trial.

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

• Number of Experts: Only one expert is explicitly mentioned: "Dr. Parham".
• Qualifications of Experts: Dr. Parham is described as "a qualified practitioner in Ormond Beach, FL." No further specific qualifications (e.g., years of experience, specific board certifications like radiologist) are provided in this summary, other than the implication of being a dental professional.

4. Adjudication Method for the Test Set

• Adjudication Method: None explicitly stated or implied. The assessment was done by a single "qualified practitioner."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission relies on bench testing and a single expert's review of clinical images to demonstrate substantial equivalence, not a direct human reader performance comparison with and without AI assistance. Therefore, no effect size for human readers improving with AI assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: The QuickRay HD is an imaging sensor, not an AI algorithm. Its "performance" is inherently tied to its ability to capture images suitable for human diagnosis. Therefore, the concept of a "standalone (algorithm only)" performance study doesn't directly apply here in the typical AI sense. The bench tests (DQE, MTF, NNPS) represent the inherent technical performance of the device itself (analogous to "standalone" in a hardware context) before image interpretation by a human.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "clinical images," the ground truth was expert consensus / expert opinion, specifically from "Dr. Parham," who found them "diagnostically relevant and reliable." For the technical performance aspects (resolution, DQE, etc.), the ground truth was based on physical measurements and conformance to established international standards (e.g., IEC 62220-1).

8. The Sample Size for the Training Set

• Training Set Sample Size: The QuickRay HD is a hardware device (intraoral sensor) with associated firmware and image management software. It is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. Therefore, there is no stated training set sample size. The electronics and firmware are reported to be from Hamamatsu and the software from Apteryx, and these components have presumably undergone their own development and testing processes, but no specific training data for the sensor itself for a machine learning purpose is relevant or mentioned.

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

• Ground Truth for Training Set: As the device is not an AI/ML algorithm requiring a training set, the concept of "ground truth for the training set" is not applicable in this context. The "truth" for this device lies in its physical and electrical engineering specifications and its ability to produce images that meet diagnostic quality standards established by experts and industry benchmarks.

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The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

This document is a 510(k) clearance letter from the FDA for a dental X-ray generator, the "Dental X-Ray Z70." It discusses regulatory aspects but does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from the provided text.

The letter explicitly states that the FDA's "substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It is primarily a regulatory clearance and not a detailed study report.

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