(175 days)
The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth.
The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip.
The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement.
Here's a breakdown of the acceptance criteria and study information for the Electronic Caries Detector, based on the provided text:
Electronic Caries Detector Study Information
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity | 92% (compared to biopsy) |
| Specificity | 100% (compared to biopsy) |
Note: The document does not explicitly state "acceptance criteria" but rather presents performance metrics from a comparative study to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document states that the testing included:
- In vitro performance testing on extracted teeth
- In vivo performance testing on teeth before and after extraction
However, it does not specify the sample size for either of these test sets, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. The term "in vivo" implies prospective collections from human subjects, and "in vitro on extracted teeth" would be a lab-based study with human teeth.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with or without AI assistance. The device description suggests it's a direct measurement tool, not an AI-assisted diagnostic.
6. Standalone Performance Study (Algorithm Only)
The provided text describes performance testing of the device itself, stating "In vitro performance testing on extracted teeth" and "In vivo performance testing on teeth before and after extraction." The reported sensitivity and specificity values are for the device's performance when compared to biopsy. This indicates a standalone performance study of the device's measurement capabilities.
7. Type of Ground Truth Used
The ground truth used for the reported performance metrics (sensitivity and specificity) was biopsy. The document states, "Performance: When compared to biopsy: 92% sensitivity, 100% specificity." It further notes, "Ortek believes that biopsy is considered the current gold standard and the performance scores are more significant compared to visual-tactile readings."
8. Sample Size for the Training Set
The document does not provide information on a separate training set or its sample size. The testing described appears to be for validation/performance evaluation rather than machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is mentioned for a machine learning model, there is no information on how ground truth for a training set was established. The ground truth for the performance evaluation was established via biopsy.
§ 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.