(136 days)
Ionosit Seal is a dental pit and fissure sealant intended to be used to seal the pits and fissures of occlusual non-carious posterior teeth.
A one-component light cured liquid resin. Lightly filled with a fluoride containing glass powder.
This document describes the safety and effectiveness of IONOSIT SEAL PIT & FISSURE SEALANT. It primarily relies on in-vitro testing and comparison to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly set by the performance of the predicate device, Fluoro-Shield. The study aims to demonstrate substantial equivalence to the predicate device in terms of physical properties.
| Characteristic | Acceptance Criteria (Predicate: Fluoro-Shield) | Reported Device Performance (Ionosit Seal) | Meet Criteria? |
|---|---|---|---|
| Compressive Strength (mpa) | 270 | 230 | No (lower) |
| Tensile Strength (mpa) | 109 | 107 | Yes (similar) |
| Tensile Modulus (mpa) | 3,200 | 3,000 | Yes (similar) |
| Shear Bond Strength (mpa) on Etched Enamel, 60 sec. etch | 22 | 25 | Yes (higher) |
| Change in Volume: Immediately | - 0.22% | - 0.22% | Yes |
| Change in Volume: After 24 hrs | - 0.21% | - 0.21% | Yes |
| Change in Volume: After 7 days | - 0.07% | + 0.12% | No (different trend) |
| Water Uptake (ISO 4049) | 30 mg/mm³ | 50 mg/mm³ | No (higher) |
| Water Solubility (ISO 4049) | 0 mg/mm³ | 0 mg/mm³ | Yes |
Note: While some values for Ionosit Seal are quantitatively different from Fluoro-Shield, the submission claims "it was equivalent to Fluoro-Shield" in "critical areas of adhesion and leakage," implying the differences are considered acceptable for substantial equivalence. The document doesn't explicitly state numerical acceptance thresholds.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The tables show single values for each property, implying either a single measurement or an average of an unspecified number of measurements.
- Data Provenance: The study was conducted by Daniel Chan, DMD, MS, DDS, at The University of Texas Health Science Center at San Antonio Dental School, USA. The data is from in-vitro tests only, not from human subjects. The text describes it as a "reprint," suggesting it was a previously conducted study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is an in-vitro comparison of physical properties of dental sealants, not a clinical study requiring expert assessment of ground truth. The "ground truth" here is the measured physical properties of the materials.
4. Adjudication method for the test set
Not applicable. This was an in-vitro laboratory test of material properties, not a clinical study involving human assessment or adjudication of results.
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
Not applicable. This is a submission for a dental material (pit and fissure sealant), not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The in-vitro testing represents a standalone evaluation of the material's physical properties.
7. The type of ground truth used
The "ground truth" for this study is derived from standardized in-vitro laboratory measurements of physical properties (e.g., compressive strength, tensile strength, shear bond strength, volume change, water uptake, water solubility). The predicate device's performance established the benchmark for comparison.
8. The sample size for the training set
Not applicable. This is not an AI device or a machine learning study. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of submission.
§ 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.