(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.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.