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• 1. Etching of enamel and dentin
• 2. Cleaning of dental restorative materials

The subject device is an etching gel that consists of 35% phosphoric acid aqueous solution and colloidal silica. It allows for precise and selective placement thanks to its flowable but not runny consistency. This device is filled in a syringe made of polypropylene and polyethylene. The etching agent is applied to tooth surface through a nozzle attached to tip of the syringe. The nozzle is made of polypropylene and stainless steel(SUS304).

The provided document describes the K-ETCHANT Syringe, an etching gel, and its substantial equivalence to predicate devices. It does not contain information about a study with acceptance criteria and reported device performance in the format requested. The document focuses on demonstrating substantial equivalence through testing against predicate devices rather than establishing specific acceptance criteria for the new device's performance.

Therefore, I cannot populate the table or provide specific details regarding sample sizes, expert qualifications, or ground truth methods as those are not present in the given text.

However, based on the provided text, I can infer the types of tests performed to demonstrate equivalence:

Types of Tests Performed (to demonstrate equivalence, not against specific acceptance criteria for the new device):

• pH: Compared the pH value of the subject device to predicate devices.
• Enamel and dentin decalcification: Compared the etching pattern of the subject device to predicate devices.
• Tensile bond strength of a bonding agent to etched tooth surface: Compared the bond strength after using the subject device to that after using predicate devices.
• Tensile bond strength of a bonding agent to various prosthetic restorations treated by an etching agent: Compared the bond strength after using the subject device to that after using predicate devices.

General Findings from Equivalence Testing (not acceptance criteria performance):

• pH: The pH value of the subject device was "equivalent to those of the predicate devices."
• Enamel and dentin decalcification: The etching pattern treated by the subject device was "equivalent to those by the predicate devices."
• Tensile bond strength (tooth surface): Not statistically (P>0.05) different from the corresponding measured value of the predicate device.
• Tensile bond strength (prosthetic restorations): Not statistically (P>0.05) different from the corresponding measured value of the predicate device.

Missing Information:

The document does not provide the following information required for your request:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria (e.g., minimum pH range, specific decalcification depth, or minimum bond strength values) are defined for the new device. The performance is reported in comparison to predicate devices, focusing on "equivalence" and "no statistical difference."
2. Sample sizes used for the test set and the data provenance: No sample sizes for the tests are mentioned (e.g., number of tooth samples, number of restorations). Data provenance (country of origin, retrospective/prospective) is also not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As the tests involve physical and chemical measurements rather than subjective assessments, there is no mention of "experts" establishing ground truth in the context of diagnostic interpretation.
4. Adjudication method: Not applicable for these types of physical/chemical performance tests.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as this is a dental material, not an AI-assisted diagnostic device.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable.
7. Type of ground truth used: Not applicable as the tests are measuring physical and chemical properties. The "ground truth" for comparison is the performance of the predicate devices.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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