(458 days)
The Canary System is intended to be used by qualified dental professionals as an aid in the detection and monitoring of dental canes, and as an intra-oral camera to record anatomical details.
The Canary System is indicated as an aid in the detection and monitoring of dental caries and as an intraoral camera to visualize and record anatomical details.
The Canary System is intended to be used by qualified dental professionals as an aid in the diagnosis of dental caries, and as an intra-oral camera to visualize and record anatomical details.
The Canary System™ uses a low powered 660 nm wavelength laser to examine the tooth surface. When this laser light is shone on the tooth the laser light is scattered and absorbed. An absorbed portion of the light is converted into heat and emits thermal infrared (Photothermal Radiometry, PTR) and another part of the light excites the tissue and emits optically converted light (Luminescence; LUM), which shows the difference between what appears to be healthy tooth structure and areas suspected of being carious tooth structure. Compared to a healthy tooth, areas suspected of being canous or possibly having other defects such as micro cracks absorb more light and generate higher PTR signals and lower LUM signals. The Canary System is very safe because the temperature rise on the tooth surface by the laser is only 1 - 2℃, which is much lower temperature than hot beverages.
Modulated laser light hitting the tooth surface generates a thermal diffusion (heat transfer) wave. The depth that this wave can penetrate is determined by the modulation frequency. Even though its sensitivity is lower than PTR, modulated light scattering also gives information from deep inside the enamel by luminescence. The Canary System can detect suspect areas, up to a depth of 5mm because The Canary System uses a 2Hz frequency modulation that penetrates deeper than higher frequencies (100s or 1000s Hz) and the detected PTR/LUM signals deliver integrated information from the surface to the penetration depth.
The measured PTR and LUM signals are combined into a Canary Number. As the suspicion of a carious lesion develops, the Canary Number increases. With remineralization treatment, or lesion reduction in size, the Canary Number appears to decrease.
The Canary System is associated with a photographic image of the tooth surface being examined. The images are displayed on an accompanying monitor for immediate chair-side review with the patient. Images are also shown in Canary Reports incorporating Canary Numbers and color codes for the examined teeth. The Canary software is able to record and store the Canary Numbers, images of the surfaces examined, along with the dentist's treatment recommendation.
The provided document describes "The Canary System," a device intended as an aid in the detection and monitoring of dental caries and as an intra-oral camera. However, it does not explicitly state acceptance criteria in a quantitative manner or present a detailed study proving the device meets specific performance criteria. The document focuses on demonstrating substantial equivalence to predicate devices, outlining technical specifications and general capabilities rather than rigorous performance metrics against a defined standard.
Therefore, many of the requested details, such as specific acceptance criteria, reported performance values against those criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods for a standalone or MRMC study, are not explicitly provided in the given text.
Below, I will extract and infer information where possible based on the provided text, and explicitly state when information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide explicit quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or ROC AUC thresholds) that The Canary System must meet. Instead, it relies on demonstrating comparable functionality and technical specifications to predicate devices. The "performance" described leans towards descriptive capabilities rather than quantitative metrics from a clinical study.
| Acceptance Criteria (Implied/Functional) | Reported Device Performance (as described in the document) |
|---|---|
| Aid in the detection and monitoring of dental caries | The Canary System detects suspect areas up to 5mm depth using a 2Hz frequency modulation of a 660nm laser. It combines Photothermal Radiometry (PTR) and Luminescence (LUM) signals into a "Canary Number." |
- Canary Numbers 70 suggest possible advanced decay.
- Canary Numbers 21-70 suggest early lesion/decay (treatment depends on location and patient risk factors).
It can examine interproximal, pit & fissure, smooth surface caries, possible caries around restorations, and possible subsurface caries lesions. It can detect areas of suspect incipient caries. |
| Function as an intra-oral camera to visualize and record anatomical details | Images are displayed on an accompanying monitor for immediate chair-side review. Images are also shown in Canary Reports incorporating Canary Numbers and color codes. The software records and stores Canary Numbers and images.
Camera: CMOS, Resolution: 640 x 480 pixels. |
| Safety (e.g., temperature rise) | The temperature rise on the tooth surface by the laser is only 1 - 2℃, which is much lower than hot beverages, indicating safety. |
| Output a report for patients and providers | YES – Reports generated for patients and dentists, which can be printed or stored on The Canary for later review. |
| User Interface | Graphical, numeric and audible tones. Visual image of surface under examination and surface that was examined previously. |
| Sterilization and Disinfection | Disposable, one-time use plastic sleeve and plastic tip. The unit and cables can be disinfected with alcohol-based solutions. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "This conclusion [substantial equivalence] is based on indications for use, bench, in vitro studies, as well as EMC, laser and electrical safety testing."
- Sample Size for Test Set: Not specified in the provided text. The term "in vitro studies" is mentioned, implying a test set of some kind was used, but details on its size are absent.
- Data Provenance: Not specified. It only mentions in vitro studies, implying laboratory-based data, but details on its origin (e.g., country, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The focus is on the device's standalone capabilities and its equivalence to predicate devices, not on human-AI collaboration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the document discusses the device's performance in a standalone context. The description of Canary Numbers, the detection of carious lesions, and the technical specifications are all referring to the algorithm's direct output ("The Canary Number is a combination of the PTR and LUM amplitude and phase readings..."). While it aid dental professionals, the metrics and descriptions provided are for the device independently producing its output.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For in vitro studies on dental caries, common ground truths include:
- Histology/Pathology: Microscopic examination of tooth sections to confirm the presence and depth of caries.
- Micro-CT or other imaging: High-resolution scans to assess lesion presence.
- Clinical (visual/tactile) assessment combined with radiography: Often used for clinical studies, but for in vitro studies, more definitive lab-based methods are common.
Given the mention of "in vitro studies," pathology or micro-CT would be likely forms of ground truth, but this is an inference as the text does not specify.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document does not describe the development or training of the algorithm; it focuses on the device's functionality and comparison for regulatory submission.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not specified. As with the training set size, the document does not delve into the development methodology of the algorithm.
§ 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.