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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:

1. 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.
2. 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.

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For use as an aid in the detection and localization of subgingival dental calculus.

This submission is for a modification of a device system cleared under K042394, the DIAGNOdent® 2095 with periodontal probe, and Diagnodent Pen, K051909. The modification is in the form of adding a periodontal probe to the Diagnodent Pen product.

The provided text for device K0600080 is a 510(k) summary and not a full study report or clinical trial document. Therefore, it does not contain detailed information about specific acceptance criteria, study sizes, ground truth establishment, or specific performance metrics as would be found in a comprehensive clinical study.

The document primarily focuses on establishing substantial equivalence to a predicate device, the DIAGNOdent® 2095 (K042394), by demonstrating that the new device, DIAGNOdent® 2190 with Periodontal Probe, has the "SAME" indications for use and similar technical specifications. The conclusion statement mentions "bench, in-vitro, and clinical studies" were conducted, but no details of these studies or their results are provided in this extract.

As a result, I cannot provide a detailed table of acceptance criteria versus reported performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, or training set details from the information given.

However, based on the principle of establishing substantial equivalence, we can infer that the implicit acceptance criterion would be that the device performs at least as well as the predicate device in its intended use, or that any differences do not raise new questions of safety or effectiveness.

Here is what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred): Performance comparable to the predicate device (DIAGNOdent® 2095, K042394) for "detection and localization of subgingival dental calculus." The document does not specify quantitative acceptance criteria for clinical performance. It relies on demonstrating similarity in technology and intended use.
• Reported Device Performance: Not explicitly stated in quantitative terms. The document concludes that "In all important respects, the DIAGNOdent® 2190 with periodontal probe is substantially equivalent to the DIAGNOdent® K042394." This implies similar performance, but no specific metrics are given.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified, beyond the mention of "bench, in-vitro, and clinical studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified.

4. Adjudication method for the test set

• Not specified.

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

• Not specified. This device is a laser fluorescence device, not an AI system, so this type of study would not be applicable in the context of "human readers improve with AI vs without AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable as it's a diagnostic device in the hands of a practitioner, not a standalone algorithm. Its performance is inherent in its ability to detect fluorescence indicating calculus.

7. The type of ground truth used

• Not specified. Given the indication for "detection and localization of subgingival dental calculus," ground truth would likely involve direct visual inspection by an expert, tactile probing, or potentially histological examination of extracted teeth/calculus if an in-vitro study was involved.

8. The sample size for the training set

• Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its detection mechanism is based on physical principles (laser fluorescence) rather than learned patterns from data.

9. How the ground truth for the training set was established

• Not applicable/specified, for the same reasons as #8.

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