(74 days)
- The Sealant (Infiltrant) is indicated for:
- -Sealing of pits and fissures
- -Sealing/facing of damaged enamel surfaces
- -Covering of caries predilection sites during orthodontic treatment
- -Sealing of secondary teeth
- -Sealing of deciduous teeth
- Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries
- Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces)
- HCI-Etching-Gel is indicated for:
- -Etching of enamel
The DMG USA Infiltration Kit consists of two components, a light curing methacrylate resin-based Sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the Sealant application and as second component an HCl-Etching-Gel. As preliminary step the HCl-Etching-Gel is used for etching of enamel. The Sealant (Infiltrant) is a low viscosity light-curing dental resin, which is a protective coating for tooth surfaces predisposed to caries or on early non-cavitated Jesions. Other uses include sealing of pits and fissures, damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Infiltration Kit:
Acceptance Criteria and Device Performance Study for Infiltration Kit (K100062)
The provided document describes the substantial equivalence of the "Infiltration Kit" to predicate devices, primarily focusing on a labeling change to expand its indications for use. The study described is a limited in-vitro test for substantial equivalence, not a comprehensive clinical trial establishing new performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Comments / Method of Assessment |
|---|---|---|---|
| Technological Equivalence (to K081493) | Identical chemical composition | Identical chemical composition | Direct comparison stated in the document. |
| Technological Equivalence (to K091632) | Chemical composition "so close" to predicate. | Chemical composition "so close" to predicate. | Basis for limiting further testing. |
| Viscosity (compared to K091632) | Not explicitly stated as a numerical acceptance criterion, but implied to be "close enough" for substantial equivalence. | Less than a 5% difference in viscosity between DMG USA device and the 3M ESPE predicate device. | In-vitro test for substantial equivalence. |
| Depth of Cure (compared to K091632) | Not explicitly stated as a numerical acceptance criterion, but implied to be "close enough" for substantial equivalence. | Identical in terms of depth of cure. | In-vitro test for substantial equivalence. |
Note: The document explicitly states: "Because the DMG USA Infiltration Kit and 3M ESPE SPK Sealant materials are so close in chemical composition, the substantial equivalence testing provided in this submission is limited to viscosity and depth of cure for the two materials." This suggests that the acceptance criteria for these two parameters were simply a demonstration of close equivalence to the predicate, rather than predefined absolute thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document describes in-vitro testing for viscosity and depth of cure.
- Sample Size for Test Set: Not explicitly stated. The document mentions "limited to viscosity and depth of cure for the two materials," implying multiple measurements for each, but the exact number of samples is not provided.
- Data Provenance: The nature of in-vitro testing suggests it was performed in a laboratory setting. No country of origin is specified, but given the sponsor (DMG USA, Inc. in Attleboro, MA), it's highly probable the testing was conducted in the USA or a facility associated with the manufacturer. The data is prospective as it was generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to the provided document. The study described is an in-vitro test comparing physical properties (viscosity, depth of cure) of two dental materials for substantial equivalence. Ground truth in this context would typically refer to established scientific standards or the performance of the predicate device itself, not expert interpretation of results by human observers.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for studies involving human interpretation, often in image analysis or clinical endpoint assessment, where disagreement among reviewers needs resolution. This study is an in-vitro comparison of material properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes in-vitro comparisons of material properties, not a study involving human readers' performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This section is not applicable. The device is a "Sealant, Pit & Fissure, and Conditioner" (a dental material), not an algorithm or AI-powered system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this substantial equivalence submission is the performance of the predicate device (3M ESPE SPK Sealant, K091632) for the properties of viscosity and depth of cure. The goal was to demonstrate that the Infiltration Kit's performance for these properties was equivalent to or very close to that of the already legally marketed predicate device.
8. The Sample Size for the Training Set
This section is not applicable. The device is not an AI/ML model that requires a training set. The study described is an in-vitro comparison of dental materials.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable. As the device is not an AI/ML model, there is no training set and therefore no ground truth establishment for a training set.
§ 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.