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SULTAN TOOTH ROOT DESENSITIZER is intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin.

SULTAN TOOTH ROOT DESENSITIZER is identical to the predicate devices. This product is manufactured by Novamin Technology Inc. and is then relabelled/repackaged. SULTAN TOOTH ROOT DESENSITIZER is a two-phase product designed to minimize sensitivity and promote clinical healing following periodontal debridement.

This document is a 510(k) premarket notification for a medical device, the SULTAN TOOTH ROOT DESENSITIZER. It does not contain information about specific acceptance criteria or a study proving that the device meets those criteria. Instead, it describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be filled directly from the provided text.

Here is what can be extracted and inferred from the provided text:

Acceptance Criteria and Reported Device Performance

Not directly stated. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting specific performance metrics against defined acceptance criteria.

Study Details

The document states that the SULTAN TOOTH ROOT DESENSITIZER was "tested for toxicity, irritation, and sensitization and found to be biocompatible." However, it does not provide details about the specific study design, methodology, or results of these tests, nor does it present a clinical study to demonstrate its effectiveness for rapid relief of hypersensitivity.

The core argument for safety and effectiveness is based on the device being "identical to the predicate devices" and that "all of the components found in SULTAN TOOTH ROOT DESENSITIZER have been used in the legally marketed predicate devices."

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document mentions "tested for toxicity, irritation, and sensitization" but gives no details about sample size or data provenance for these tests, nor for any clinical effectiveness study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. This information is typically relevant for studies involving qualitative assessments or diagnostic accuracy, which are not detailed here.

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

   • Not applicable. No clinical study with adjudicated ground truth is described.

4. 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:

   • Not applicable. This device is a tooth root desensitizer, not an AI software, and no MRMC study is mentioned.

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

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

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

   • For the biocompatibility tests: The "ground truth" would likely be established by standard biological safety testing protocols, comparing results against established safety limits for toxicity, irritation, and sensitization. Specific outcomes data for these tests is "biocompatible."
   • For the claim of effectiveness (rapid relief of hypersensitivity): The document relies on substantial equivalence to predicate devices which have established their effectiveness, rather than reporting new outcomes data for this specific device.

7. The sample size for the training set:

   • Not applicable. This type of information is relevant for machine learning models, which is not what this device is.

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

   • Not applicable. (See above)

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