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The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.

Qraycam PRO is a fluorescence caries detection aid, designed to assist dentists and dental specialists in identifying caries areas during oral health examinations. The device produces images that can be displayed on an LCD screen attached to the main body or on a computer monitor.

The provided text describes the Qraycam PRO device and its FDA 510(k) clearance. The information regarding acceptance criteria and the study proving it is extracted primarily from the "8. Performance data" section.

Acceptance Criteria and Device Performance:

The document mentions one specific performance criterion that was evaluated: the ΔF average value. This value is a measure of the fluorescence change, which is central to QLF-D (Quantitative Light-induced Fluorescence - Digital) technology used for caries detection.

Study Details:

The study referenced is a non-clinical bench test that evaluated the comparative performance between the Qraycam PRO (subject device) and the predicate device (Inspektor™ PRO).

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

• Sample size: Not explicitly stated. The document mentions "using the same teeth" for comparison, implying a set of teeth, but the specific number is not provided.
• Data provenance: The data is from a non-clinical bench test. The country of origin is not specified but is presumably where AIOBIO Co., Ltd. (South Korea) conducted its internal testing. The study is retrospective in the sense that it compares a new device against an established predicate device's performance characteristics.

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

This information is not provided in the document. The study is a non-clinical bench test assessing a technical performance parameter (ΔF average value), not a clinical trial with human expert-based ground truth.

4. Adjudication method for the test set:

This information is not provided. As it was a non-clinical bench test focused on a technical parameter, an adjudication method in the context of expert review would not be 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study described is a non-clinical bench test comparing the subject device's performance to a predicate device based on a technical parameter (ΔF average value). There is no mention of human readers or AI assistance in the context of this performance evaluation.

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

The device (Qraycam PRO) is described as an "aid in the diagnosis," indicating it is an assistive tool for dentists. The performance evaluation focuses on the device's ability to measure the ΔF average value, confirming its capability to function as intended. While the device itself processes images and utilizes QLF-D technology, the document does not distinguish between a standalone algorithm-only performance and its use as an aid. The "Qraycam PRO software" is mentioned for image analysis, implying an algorithmic component, but its standalone performance in isolation from clinical interpretation is not separately reported.

7. The type of ground truth used:

The ground truth for the non-clinical bench test appears to be based on the established standard for the ΔF average value, which is a quantitative measure derived from QLF-D technology. The document states that "the ΔF average value, the performance criterion, was found to meet the standard." This suggests a quantitative, objective measure rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

The document does not provide information about a training set. The descriptions relate to a performance evaluation of the final device, not the development or training of an AI model within it.

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

Since no training set information is provided, how its ground truth was established is not applicable based on the given text.

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Qraypen is to be used as an intraoral video source and is indicated for individuals who may benefit from the addition of video images in intraoral dental examinations.

Qraypen, a Dental Intraoral Camera, provides digital color images of intraoral anatomy during oral health examinations by dentists or dental sub-specialists. The output of the images can be shown through a computer monitor. This product is designed only for the use in dentistry and may only be used by trained medical personnel. The Qraypen is not made as a caries detection device. Therefore, Qraypen is not claimed as a caries detection device.

• (1) Main components of Oraypen
  Oraypen is a hand-held device that consists of Oraypen Handpiece, Cradle, Cradle screw, USB 2.0 Cable, Adapter, and User manual. The Qraypen is connected to a compatible Windows PC and power supply by USB 2.0 type cable.

• (2) Design features

  • a) An intraoral camera that is capable of both blue and white LED color imaging
  • b) Integral LED that allows the color of light to be changed
  • c) Automatic focusing
  • d) Compatible with any viewer program that meets the standards of USB video device class (UVC) 1.0 or higher

• (3) Three modes are available:

  • a) White light mode: Qraypen captures images with white LED color light
  • b) Blue light mode: Oraypen captures images with blue LED color light
  • c) Orange light mode: Qraypen captures images with white and Blue LED color light in succession

The provided text is a 510(k) summary for the AIOBIO Co., Ltd. Qraypen, a Dental Intraoral Camera. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, device performance metrics, or the study design for proving these criteria.

Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance (1), sample size and data provenance (2), number and qualifications of experts for ground truth (3), adjudication method (4), multi-reader multi-case study details (5), standalone performance (6), type of ground truth used (7), training set sample size (8), or how the training set ground truth was established (9).

The document primarily discusses:

• Device Description: What the Qraypen is, its components, design features, and technical specifications (blue and white LED imaging, automatic focusing, compatibility with UVC viewers).
• Indications for Use: Used as an intraoral video source for dental examinations.
• Comparison to Predicate Device (CDR-CAM): Highlights similarities in indications for use, target population, anatomical sites, environment of use, intended users, design, focus range, light source, camera connection, system components, portability, and standards met. It also notes differences like power supply, focus type, imager type, principle/method of operation, software, and disinfection methods.
• Summary of Non-Clinical Performance Testing: Lists compliance with various standards for Electromagnetic Compatibility (EMC), Electrical Safety, Software Verification and Validation, Photobiological Safety, and Cleaning and Disinfection Validation. It also mentions bench testing for barrier sleeves but without specific performance metrics.
• Biocompatibility Testing: Stated that no biocompatibility testing was conducted because the device does not directly or indirectly contact the patient's body, as a disposable sleeve covers the camera.

The document does not provide any quantitative performance data such as sensitivity, specificity, accuracy, or any metrics that would constitute "acceptance criteria" and "reported device performance." It also doesn't detail any clinical studies, reader studies, or how ground truth was established for performance evaluation with respect to diagnostic accuracy or other performance parameters.

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