(323 days)
For use as an aid in the diagnosis of dental caries
SmarTooth (STL-02-BK) is an optical dental caries diagnostic device that uses a laser to help diagnose dental caries. The SmarTooth (STL-02-BK) is composed of a portable hardware main body with batteries, a main body holder, and a mobile application. The hardware components provide a laser source, an LED indicator, and a zero point adjustment (calibration) unit to aid in the detection and monitoring of dental caries lesions in teeth. The software component provides a meter with a digital read-out between 0 and 99. The hardware device is a pen-type device consisting of a laser diode that generates a laser and a photodiode sensor to detect fluorescent light. Both the sensor and laser diode are mounted at the tip of the device to be introduced into the mouth of the patient for scanning of the teeth. The tooth is exposed to irradiation of a 650 nm wavelength laser by this device, and a value from the detected fluorescent light is displayed to refer to the diagnosis of dental caries. The information from the scanner is handled by the Software, which holds the interface to the user.
As a battery-operated, portable laser source with a photodiode sensor, the subject device is designed for handheld operation. The dental probe is a replaceable, single-use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The main body holder is used to calibrate the device before measuring the teeth.
The main body is powered by a 1.5-volt AA-type alkaline battery. This unit has two LED lamps (status and measurement), one power button, one laser output, and a beeper sounds one time when pushing the power button for 1 second to turn on and 3 seconds to turn off the device. The main body should be paired with the zero point adjustment unit on the main body holder before use to calibrate the necessary optical zero point. Users can start the measurement by clicking the "Measure" button on the application screen.
Unfortunately, the provided text does not contain the information requested about the acceptance criteria and the study that proves the device meets those criteria.
The document is an FDA 510(k) clearance letter and a 510(k) summary. These documents primarily focus on:
- Substantial Equivalence: Comparing the new device (SmarTooth) to a legally marketed predicate device (KaVo DIAGNOdent 2190).
- Technological Characteristics: Highlighting similarities and differences between the new device and the predicate.
- Non-Clinical Testing: Listing standards met for electrical safety, EMC, biocompatibility, and software validation.
- Absence of Clinical Testing: Stating that clinical testing was not necessary due to the nature of the device and sufficient bench testing.
Therefore, I cannot provide the detailed information requested in the prompt, such as:
- A table of acceptance criteria and reported device performance: This information is not present. The document states "Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence," implying that the performance was likely compared to the predicate's known operating characteristics rather than against specific, predefined acceptance metrics with reported values.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment: Since no clinical study was performed or needed for this 510(k) submission, none of this information is available or relevant to the data provided. The "performance test - bench" section is very brief and does not offer these details.
In summary, based only on the provided text, there is no clinical study described that proves the device meets specific acceptance criteria in the manner requested. The clearance was based on demonstrating substantial equivalence through non-clinical testing and similarity to a predicate device.
§ 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.