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Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Life II is used to line cavity preparations before restoration.

Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lime-Lite II device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document primarily describes bench testing.
• The exact sample sizes for each specific physical/chemical test (e.g., number of specimens for compressive strength) are not provided.
• Data provenance (country of origin, retrospective/prospective) is not applicable as this is bench testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission relies on bench testing, not expert-adjudicated clinical data to establish ground truth. The "truth" in this context is the measured physical/chemical properties of the material against established standards for dental materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No human adjudication of clinical findings is described.

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:

• No. An MRMC comparative effectiveness study was not conducted. This device is a dental material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the bench tests is the objective measurement of the physical and chemical properties of the Lime-Lite II material, compared against the expected performance characteristics of a calcium hydroxide cavity liner and the properties of the predicate devices. These properties are established through standardized laboratory testing methods.

8. The sample size for the training set:

• Not applicable. This product is a dental material, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described.

9. How the ground truth for the training set was established:

• Not applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The provided document describes a bench testing summary for Lime-Lite ™ II to demonstrate its safety and effectiveness. The study's objective was to show that Lime-Lite ™ II performs as intended and is substantially equivalent to its predicate devices (Pulpdent Limelight and Scientific Pharmaceuticals Fluoroseal).

The study involved a series of standard laboratory tests to measure various physical and chemical properties of the Lime-Lite™ II material. These tests included:

• Light Cure Setting Time
• Working time in ambient light
• Depth of cure
• Compressive Strength
• Flexural Strength
• Density
• pH
• Water absorption
• Shelf-life

The acceptance criteria for several of these properties (Light Cure Setting Time, Working time, Depth of cure) appear to be defined performance thresholds (e.g., 5 minutes, 2 mm). For other properties like strength, density, pH, and water absorption, the document presents the measured values, implying that these values were found to be acceptable and comparable to the predicate devices, though explicit numerical acceptance criteria for each were not individually listed. The document states that the test results "demonstrate that Lime-Lite II performs as intended" and concludes that it is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed." This conclusion is reinforced by "organizational experience with Lime-Lite" and the successful, long-term use of predicate devices without adverse events.

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