(385 days)
To aid the dental professional in visualization of carious lesions
The LumiCare™ device is an oral rinse solution containing starch-based particles tagged with fluorescein. A specific volume is swished in the mouth, followed by a water rinse and air drying of teeth prior to exposure of the teeth to a blue light source with an irradiance of 450 mW/cm2 and wavelength of 450-470 nm. The clinician completes the clinical examination by observing fluorescence through light orange filter accessories, including protective eyewear, to aid the visualization of dental caries.
Here's a breakdown of the acceptance criteria and the study information for the LumiCare™ Caries Detection Rinse, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for sensitivity, specificity, or other performance metrics. Instead, it states that the device's performance was evaluated for "a high degree of reproducibility" and "performance comparable to the predicate device." Without explicit criteria, the table below reflects what was reported rather than pre-defined acceptance thresholds.
| Performance Metric | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Sensitivity | Not explicitly stated (implied: comparable to predicate) | Demonstrated high degree of reproducibility and performance comparable to the predicate device. |
| Specificity | Not explicitly stated (implied: comparable to predicate) | Demonstrated high degree of reproducibility and performance comparable to the predicate device. |
| Reproducibility | Not explicitly stated (implied: high degree) | Demonstrated a high degree of reproducibility. |
| Biocompatibility | Not explicitly stated (implied: safe for intended use) | LuminCare™ rinse is biocompatible for use as intended (based on risk assessment and ISO 10993 testing). |
| Shelf Life | Not explicitly stated (implied: suitable duration) | 2 years (based on accelerated testing). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Sensitivity and Specificity testing was completed on extracted teeth using histologic reference standard..."
- Sample Size: The exact number of extracted teeth used for the test set is not specified in the document.
- Data Provenance: The document does not specify the country of origin. The data is retrospective in nature, as it was conducted on extracted teeth rather than live patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document does not specify the number of experts used.
- Qualifications of Experts: The document does not specify the qualifications of the experts who established the ground truth (e.g., "histologic reference standard" implies histological analysis, typically performed by pathologists or histotechnicians, but specifics are missing).
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing the ground truth from the extracted teeth. It simply states "using histologic reference standard," which implies histological analysis was the definitive ground truth, not a consensus or adjudication among multiple reviewers of the device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted." The "Simulated Use Testing" performed by clinicians on a manikin model with extracted teeth focused on "ease and effectiveness of use within the clinical workflow" rather than a comparative effectiveness of diagnostic accuracy against human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a "Caries Detection Rinse" that "aids the dental professional in visualization." This indicates it's a diagnostic aid for human interpretation, not an algorithm that performs analysis in standalone mode. Therefore, a standalone algorithm-only performance test is not applicable and was not reported. The "Sensitivity and Specificity testing" assessed the performance of the rinse itself in highlighting carious lesions, which then would be viewed by a human.
7. The Type of Ground Truth Used
The type of ground truth used for the sensitivity and specificity testing was histology ("histologic reference standard").
8. The Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or machine learning model. The LumiCare™ Caries Detection Rinse is a chemical diagnostic aid, not an AI/ML-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, this question is not applicable.
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.