(51 days)
The DIFOTI USB 2.0 System (DIFOTI System for Dental Examinations, Model B) is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
The device known as the DIFOTI USB 2.0 System, also known as the DIFOTI System for Dental Examinations, Model B, is a dental examination system that utilizes visible light from an internal diode laser source. delivered with fiberoptic technology, for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic (CMOS) camera is used to capture the image(s). The light and the camera are connected via a USB 2.0 cable to a small PC that serves for data acquisition and storage, and the computer monitor is used for image visualization.
The provided text states that "Safety and performance testing included image quality evaluation, software hazard analysis, in-vitro vs. in-vivo performance evaluation, and software verification and validation." However, it does not provide specific acceptance criteria or detailed results of these studies, nor does it provide information regarding sample sizes, expert qualifications, adjudication methods, or ground truth establishment relevant to the device's performance characteristics.
Therefore, I cannot populate the table or answer the questions with the requested level of detail based solely on the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Not provided in text) | Reported Device Performance (Not provided in text with specific metrics) |
|---|---|
| Specific performance metrics for caries detection (e.g., sensitivity, specificity, accuracy) are not detailed. | The text only generally states that the device was found to be "safe and effective for its intended use" based on various evaluations. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided.
- Data Provenance (Country of origin, retrospective/prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set:
- Adjudication Method: Not provided.
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:
- MRMC Study: Not indicated. The device description does not explicitly mention AI or human-in-the-loop assistance for the task, rather it presents as an imaging system for visualization.
- Effect Size: Not applicable/not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device is described as an "examination system" that provides "visualization" of caries. While it captures images, the text doesn't explicitly detail an automated algorithmic detection or diagnosis, making the concept of "standalone performance" in the AI context difficult to assess from this document. It appears to be a tool for human examiners.
7. The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. The "in-vitro vs. in-vivo performance evaluation" suggests comparison against some form of diagnostic standard, but the specific nature of this (e.g., comparison against histological confirmation, clinical consensus, etc.) is not detailed.
8. The sample size for the training set:
- Sample Size (Training Set): Not provided. (Note: This type of device, from 2004, is unlikely to have had a "training set" in the modern machine learning sense, as it appears to be a direct imaging and visualization tool rather than an AI-driven diagnostic algorithm).
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not provided. (See note for point 8).
Summary of available information:
The 510(k) summary focuses on establishing substantial equivalence to predicate devices and generally stating that the device is "safe and effective." It lists various testing activities (image quality, software hazard, in-vitro/in-vivo performance, software V&V) but does not provide the specific quantitative results, methodologies, or data characteristics (like sample sizes, ground truth details, or expert involvement) that would be needed to answer your questions comprehensively. This level of detail is often found in the full 510(k) submission, not typically in the summary provided for the public.
§ 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.