(4 days)
Pit and fissure sealant
Eco-S™ is a single part, light curing, pit and fissure sealant. It is based on methacrylate resin chemistry. It can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.
The provided text describes a 510(k) summary for a dental sealant called "Eco-S™". It makes claims of substantial equivalence to a predicate device (3M Clinpro™ Sealant, K992326) based on similar technological characteristics and physical properties. However, the document does not describe acceptance criteria or a study that rigorously proves the device meets specific performance metrics in a clinical or standalone study context.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics: Similar device design, appearance, main materials, and indication for use as predicate device (3M Clinpro™ Sealant, K992326). | Eco-S™ has similar technological characteristics (device design, appearance, main materials, indication for use) as the predicate device. |
| Physical Properties: Similar shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness as predicate device. | Eco-S™ has similar physical properties (shear bond strength, ambient light sensitivity, cure time, depth of cure, uncured film thickness) as the predicate device. |
| Safety: Biocompatibility and compliance with applicable International and US regulations. | Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations. |
Important Note: The document frames "acceptance criteria" as similarity to a predicate device rather than specific quantitative thresholds for performance.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set or data provenance because it primarily relies on demonstrating similarity to a predicate device through physical and technological characteristics. There is no mention of clinical data or a test set in the traditional sense for evaluating AI or diagnostic device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there is no test set or mention of expert-established ground truth for evaluating the device's performance against clinical outcomes or diagnoses. The evaluation relies on comparing physical and technological properties to a predicate device.
4. Adjudication method for the test set
This information is not applicable as there is no test set or clinical study described that would require an adjudication method.
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
This information is not applicable. The device is a pit and fissure sealant, a dental material, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic or AI devices is not directly relevant here. The "ground truth" for this device's acceptance is based on its physical and technological similarity to a legally marketed predicate device (3M Clinpro™ Sealant, K992326) and compliance with safety regulations (biocompatibility).
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm and therefore does not have a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm and therefore does not have a training set.
Summary of the Study/Evaluation described:
The document describes a Predicate Device Comparison as the primary method to demonstrate safety and effectiveness.
- Study Design: The submission asserts that Eco-S™ has "similar technological characteristics" and "similar physical properties" to the predicate device (3M Clinpro™ Sealant, K992326).
- Performance Metrics Compared: Device design, appearance, main materials, indication for use, shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness.
- Safety Evaluation: Biocompatibility tests were performed, and the device is stated to comply with applicable International and US regulations.
The study presented is not a traditional clinical trial or an evaluation of an AI algorithm's performance. Instead, it's a demonstration of substantial equivalence through comparison of material properties and characteristics to a previously approved device.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.