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Preparation of tooth material prior to restoration by etching of the surface.

The device described in this 510(k) consists of a water-based gel containing 40% phosphoric acid.

The provided text describes a 510(k) premarket notification for a dental product called "Etch Gel" from DMG America, LLC. It focuses on demonstrating substantial equivalence to a predicate device based on physical properties, material composition, packaging/delivery mechanism, and indications for use.

Crucially, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way one would describe for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity, or human expert performance improvement).

This 510(k) is for a physical, chemical product (dental etching gel) and not for a software or AI/ML device. Therefore, the typical "acceptance criteria," "test set," "ground truth," "expert adjudication," or "MRMC study" concepts as outlined in your prompt are not applicable to this type of submission.

The "study" described in this document is a non-clinical performance evaluation focused on demonstrating the chemical composition and physical properties (pH, viscosity, specific gravity) are equivalent to the predicate device.

Here's why the prompt's specific requirements cannot be fulfilled from the provided text:

• 1. Table of acceptance criteria and reported device performance: This document doesn't list quantitative performance metrics like accuracy or sensitivity for the device's function in a clinical setting against a specified acceptance threshold. It lists physical characteristics.
• 2. Sample size used for the test set and data provenance: There's no "test set" in the context of an AI/ML model for this product. The evaluation is on the product's physical properties.
• 3. Number of experts used to establish ground truth and qualifications: Ground truth for a chemical product's physical properties is established through standardized laboratory testing, not expert consensus.
• 4. Adjudication method: Not applicable.
• 5. MRMC comparative effectiveness study: Not applicable, as this is not an AI/ML device assisting human readers.
• 6. Standalone performance: This section typically refers to AI algorithm performance without human interaction. Not applicable here.
• 7. Type of ground truth: The ground truth for this product's evaluation is its inherent physical and chemical properties measured in a lab.
• 8. Sample size for the training set: Not applicable; there is no AI/ML training set.
• 9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The "study" presented is a non-clinical performance evaluation comparing the "Etch Gel" device to its predicate device based on fundamental physical and chemical properties to establish substantial equivalence.

Acceptance Criteria (Implied for this type of device, not explicitly stated with thresholds in the summary):

The implied acceptance criteria are that the chemical composition, physical properties (pH, viscosity, specific gravity), product packaging/delivery mechanism, and indications for use of the "Etch Gel" are the same as or equivalent to those of the predicate device (Zenith 40% Phosphoric Acid Gel).

Reported Device Performance:

The document states: "The Etch Gel is either the same as or equivalent to the predicate device in terms of these technological characteristics and non-clinical performance data." This is a qualitative statement of equivalence rather than quantitative performance data against specific thresholds.

No other requested information regarding test sets, experts, adjudication, MRMC, or training sets is available as it pertains to AI/ML device evaluation metrics.

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