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510(k) Data Aggregation
(216 days)
Indicated for relief of discomfort from dentin sensitivity.
CrystLCare™ PRO Biorestorative, Fluoride-Plus is a flavored dental strip which contains calcium, phosphate, and fluoride which are stabilized with a modified starch. The single-use strip is topically applied to the outer surface of a tooth or teeth that are experiencing dental sensitivity. The strip dissolves in salivator elease these minerals which then will precipitate crystals that form a layer over the tooth surfaces. This physically occludes exposed dentinal tubules and enamel porosities to relieve discomfort. The modified starch helps to stabilize the calcium, phosphate, and fluoride mineral components so that they can persity into the dentinal tubules.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CrystLCare™ PRO Biorestorative, Fluoride-Plus device.
Observation: The provided text is a 510(k) summary for a medical device (CrystLCare™ PRO Biorestorative, Fluoride-Plus) and does not describe acceptance criteria for a study that proves the device meets those criteria. Instead, it describes non-clinical tests used to demonstrate substantial equivalence to a predicate device, which is the basis for 510(k) clearance.
The typical structure of a 510(k) submission means that detailed acceptance criteria and study methodologies, as one might find in a clinical trial report, are usually not fully disclosed in this summary document. The information provided focuses on demonstrating equivalence to an existing device rather than establishing new performance criteria.
Therefore, I will extract the information that is present and note where the specific details requested are not available in this document.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., target occlusion percentage) are not explicitly stated for the non-clinical tests. Instead, the performance is described in terms of equivalence to the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (CrystLCare™ PRO Biorestorative, Fluoride-Plus) |
|---|---|
| Occlusion of Dentinal Tubules: Should show similar occlusion of dentinal tubules and enamel porosities as the predicate device. | Occlusion of Dentinal Tubules: Scanning Electron Micrographs (SEMs) of dentin samples treated by CrystLCare™ PRO were compared to SEMs of dentin treated with Relief© ACP Oral Care gel (predicate). The micrographs showed similar occlusion of the dentinal tubule. Occlusion was achieved by the deposition of a fluorohyapatite layer onto the surface of the tooth. |
| Fluoride Release: While not a strict "acceptance criteria" for equivalence, the release should be safe and effective. | Fluoride Release: Determined that fluoride exposure from CrystLCare™ PRO was lower than the predicate device, but "questions of safety or effectiveness are not raised." This implies the lower release is still considered sufficient and safe. |
| Formation of Fluorohydroxyapatite Layer: Should form a similar layer. | Formation of Fluorohydroxyapatite Layer: Demonstrated by Electron Dispersive X-ray (EDX) spectroscopy and X-Ray Diffraction (XRD) analysis, confirming the deposition of a fluorohyapatite layer. |
| Biocompatibility: Should be biocompatible. | Biocompatibility: Biocompatibility testing demonstrated that the device is as safe and effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Non-clinical):
- Sample Size: Not explicitly stated. The text mentions "dentin samples" and "micrographs of dentin samples." The exact number of samples or experimental replicates is not provided in this summary.
- Data Provenance: Not specified. This was a non-clinical, in-vitro study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Ground Truth for Non-Clinical Tests: Given that the study involves Scanning Electron Microscopy, EDX, and XRD analysis, the "ground truth" would be established by the results of these analytical techniques, interpreted by experts in materials science, microscopy, and potentially dentistry.
- Number of Experts: Not specified. It's likely that internal experts or contracted lab personnel conducted and interpreted these analyses.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. For non-clinical, analytical studies like SEM, EDX, and XRD, interpretation relies on the technical expert performing and validating the analysis, rather than a consensus-based adjudication method typical of human-reader studies for medical imaging.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size of human readers with/without AI assistance: Not applicable. This device is a dental product (cavity varnish), not an AI-powered diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not applicable. This is a physical dental device, not an algorithm or software. The "performance" described is the device's physical and chemical action (occlusion, mineral deposition).
7. Type of Ground Truth Used
- Ground Truth: For the non-clinical tests, the ground truth was established by:
- Analytical Results: Direct observation via Scanning Electron Micrographs (SEM) for physical occlusion, and elemental/structural analysis via Electron Dispersive X-ray (EDX) and X-Ray Diffraction (XRD) for chemical composition and crystal formation.
- Comparison to Predicate: The performance was assessed relative to a legally marketed predicate device, with the predicate's established performance serving as a benchmark for equivalence.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a material science product; there is no "training set" in the context of machine learning or AI.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set.
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(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.
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