(856 days)
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.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| ΔF average value | Met the standard | Confirmed clinical performance equivalence. |
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.
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.