Search Results

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.

Ask a specific question about this device

For use as an aid in the diagnosis of dental caries.

This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.

The provided 510(k) summary for the KaVo DIAGNOdent® 2190 does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria. The document states that the conclusion of substantial equivalence is "based on indications for use, bench, invitro, and clinical studies, as well as EMC and electrical safety testing," but it does not provide the details of these studies or the performance metrics used.

Therefore, I cannot fulfill your request for detailed information on acceptance criteria, sample sizes, expert qualifications, or specific study designs as this information is not present in the provided text.

Based solely on the provided text, the following information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The document lists a comparison of general characteristics between the predicate (DIAGNOdent® 2095) and the new device (DIAGNOdent® 2190), indicating that for most aspects, the new device is "SAME" or has minor modifications (e.g., integrated probe, slightly different laser power, LCD numbers instead of LED numbers).

Ask a specific question about this device

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 K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface. Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood.

The provide 510(k) summary does not contain sufficient information to describe the acceptance criteria and study that proves the device meets the acceptance criteria as requested. Specifically, the document mentions "in-vitro and preclinical studies" and "clinical studies" were conducted but does not provide details on the study design, sample sizes for test sets, data provenance, ground truth establishment, or specific performance metrics and their acceptance criteria.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in the provided text.
• Reported Device Performance: The document only states that "in-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements" and that "the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface." It also notes that "the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood." No specific metrics (e.g., sensitivity, specificity, accuracy, precision) or numerical results are provided for the device for the subgingival calculus detection.

2. Sample size(s) used for the test set and the data provenance:

• Sample Size: Not provided.
• Data Provenance: Not provided. The studies cited are general scientific papers, not necessarily the specific studies conducted for this 510(k) submission.

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

• Not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not provided.

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 mentioned. The device is for direct detection, not AI assistance for human readers.

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

• The device is a "Laser Fluorescence Caries Detection Device" (specifically, a periodontal probe accessory). It functions as a diagnostic tool that provides a reading, which a human then interprets. The summary doesn't describe an "algorithm only" performance study in the way AI would be evaluated. However, the in-vitro and preclinical studies would likely represent a standalone assessment of the device's ability to detect calculus. Specifics are lacking.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Implied for the in-vitro studies that the "ground truth" would be the known presence of calculus in the samples tested. For preclinical studies, it would likely be confirmed by expert visual inspection or other established diagnostic methods. However, the specific method is not explicitly stated.

8. The sample size for the training set:

• Not applicable as this is not described as an AI/machine learning device requiring a training set. The device operates on direct physical principles (laser fluorescence).

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

• Not applicable.

Ask a specific question about this device

Ask a specific question about this device