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1. 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)

2. 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

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.

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The Sealant (Infiltrant) is indicated for:

• Sealing of Pit and Fissures .
• Sealing/facing of damaged enamel surfaces .
• . Covering of caries predilection sites during orthodontic treatment
• Sealing of secondary teeth .
• Sealing of deciduous teeth .

The HCI Etching Gel is indicated for etching of enamel.

The purposed Infiltration Kit consists of two components, a light curing 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 HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The document discusses:

• A 510(k) summary for an "Infiltration Kit" (sealant and etching gel).
• Product description and indications for use.
• Predicate devices for comparison.
• A statement that the submission is an Abbreviated 510(k) as described in FDA's guidance document "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
• A conclusion stating the device is safe and effective based on indications for use, technological characteristics, and comparison to predicate devices.
• The FDA's decision letter determining substantial equivalence.

An Abbreviated 510(k) relies on conformance to recognized standards, special controls, or guidance documents rather than presenting new clinical study data to demonstrate safety and effectiveness. Therefore, the detailed information about study design, sample sizes, expert qualifications, and ground truth establishment that you've requested is typically not found in such a submission unless specifically required by a recognized standard or guidance document for a particular performance attribute.

Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device