(188 days)
The indication for use of Seal Block PRO is to relieve sensitive teeth. Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by: Hot, Cold, Sweet, Acidic, Dental whitening agents. Seal Block PRO can also be used to relieve sensitivity: Prior to temporization (placement of provisional restorations). Prior to permanent cementation of indirect restorations. Prior to placement of direct restorations. When root surfaces are exposed.
Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents.
Seal Block is applied using an applicator to the sensitive tooth/teeth. It forms calcium oxalate crystals that occlude dentinal tubules resulting in desensitization of natural dentition.
The provided 510(k) summary for K123653, "Seal Block Tooth Desensitizer," states that the device's substantial equivalence to predicate devices (BisBlock, Super Seal, and Super Seal Tooth Desensitizer) is based on "Technological Characteristics" and "Performance Data" which primarily involve in vitro testing and chemical composition comparison. It does not describe acceptance criteria in the typical sense of quantitative performance metrics from a clinical study, nor a comparative effectiveness study involving human readers.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the form of specific thresholds (e.g., sensitivity > X%, specificity > Y%) for clinical performance, as one might find for diagnostic AI devices. Instead, the device's performance is demonstrated through comparison to predicate devices and in vitro R&D testing. The acceptance is based on demonstrating substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Chemical Composition Equivalence | Seal Block (Pro and OTC) has "Oxalate Solution" and is "Water Based," matching predicates. |
| Physical/Mechanical Property Equivalence (e.g., viscosity, SEM comparison) | Seal Block has "Low viscosity" and "SEM Comparison" data matches predicates where available. |
| Dentin Permeability Reduction (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| Shear Bond Strength (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| pH (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| Biocompatibility | Evaluation conducted; concluded safe based on evaluation and ADA Oral Toxicity Study (10 rats, 14 days). |
| Safety and Efficacy (Overall Conclusion) | Concluded to be safe and efficacious based on substantial equivalence to predicates and provided data. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size:
- For physical/mechanical properties and dentin permeability, shear bond strength, and pH, the sample sizes for these in vitro R&D tests are not specified in the document.
- For biocompatibility, an "ADA Oral Toxicity Study" was conducted on 10 rats.
- Data Provenance: The R&D testing was conducted "in the lab," implying an in-house (Bisco, Inc.) development and testing environment. The ADA Oral Toxicity Study would likely have been conducted in a specialized laboratory for animal testing. The document does not specify a country of origin beyond "U.S.A." for Bisco, Inc. All data appears to be prospective in nature, as it was generated specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable, as no human expert-driven ground truth was established for a test set in the context of device performance as described. The device's performance is assessed through in vitro and animal studies, not by human interpretation.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring human adjudication for diagnostic or interpretive performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a desensitizer, not an interpretive AI diagnostic tool.
- Effect Size of AI Assistance: Not applicable.
6. Standalone Performance Study
- Standalone Study: Yes, performance data on "Seal Block" was generated through in vitro R&D testing (dentin permeability reduction, shear bond strength, pH) and an animal study (biocompatibility on 10 rats). This represents the algorithm-only performance for the device's stated function (blocking pain by occluding dentinal tubules). There is no "human-in-the-loop" component described for the device's direct function.
7. Type of Ground Truth Used
- Ground Truth Type:
- For chemical composition and physical/mechanical properties, the ground truth is established by chemical analysis and physical measurements (e.g., rheology for viscosity, microscopy for SEM).
- For dentin permeability, shear bond strength, and pH, the ground truth is established by laboratory measurements taken under R&D protocols.
- For biocompatibility, the ground truth is based on the results of the "ADA Oral Toxicity Study" in rats, which measures biological responses to the device material.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is based on its chemical formulation and physical properties, tested directly in lab settings and animal models.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.