(29 days)
For use as an aid in the detection and localization of subgingival dental calculus.
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.
| Feature / Performance Area | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Indications for Use | Aid in detection and localization of subgingival dental calculus, same as predicate. | SAME |
| Overall Safety & Effectiveness | Comparable to predicate device. | Substantially equivalent to predicate. |
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.
§ 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.