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• 1. Porcelain inlay cementation
• 2. Composite resin inlay cementation
• 3. Jacket crown cementation with porcelain or composite resin

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The provided text is a 510(k) clearance letter from the FDA for a dental cement product called "CLEARFIL DC Cement." This document does not contain information about acceptance criteria or a study proving device performance.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not on meeting specific performance criteria demonstrated through clinical studies in the same way a PMA (Premarket Approval) would require. The letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) from the provided document. This type of information would typically be found in a separate study report or regulatory submission, not in the FDA clearance letter itself.

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This device is used as a sealing material for pit and fissure. This intended use is same to that of similar products which are identified in the paragraph 4.

This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.

This document describes the safety evaluation of TEETHMATE F-1, a pit and fissure sealant. It focuses on the biocompatibility of a new ingredient, TMDPO, as well as the leachables from the cured resin. The study is a series of in vitro and in vivo toxicology tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Acute Toxicity of TMDPO: Mice were used. Specific number not provided, but typically a small group for LD50 determination.
• Subacute Toxicity Test: Rats were used. Specific number not provided, but typically a group for control and various doses.
• Genotoxicity Test (Ames Test): Bacterial species (Escherichia coli WP2 uvrA and Salmonella typhimurium TA100, TA1535, TA98, TA1537) were used. These are in vitro tests, not animal or human subjects.
• Amount of TMDPO Leached from Cured Resin: Two pieces of cured resin (10mm Φ × 5mm) were tested separately for each condition (37°C and 50°C). This is an in vitro test.
• Acute Toxicity of Leachables: ICR mice were used. The number of mice is not explicitly stated, but implied to be sufficient for a toxicity study. Approximately 44 cylindrical specimens of cured resin (3mm Φ × 3mm) were used per gram of specimen for extraction. This is an in vivo test.

Data Provenance: All studies were conducted by Kuraray Co., Ltd. or The Kitasato Institute, both located in Japan. The studies appear to be prospective toxicology and biocompatibility evaluations specifically designed for this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document describes toxicology and biocompatibility studies, not clinical efficacy or diagnostic accuracy studies that would typically involve a "ground truth" established by experts in that context. The "truth" in these studies is derived from laboratory measurements (e.g., LD50, ppm leached) and observed biological responses (e.g., animal health, genetic mutations). The expertise lies in toxicology and laboratory science, and the institutions conducting the tests (Kuraray Co., Ltd. and The Kitasato Institute) are expected to have qualified scientists and technicians to perform these studies according to standard protocols.

4. Adjudication Method for the Test Set

Not applicable. This is a toxicology and material leaching study, not a study involving human interpretation of data requiring adjudication.

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

Not applicable. This is not a diagnostic device or an AI-assisted device. It is a dental material (pit and fissure sealant).

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" in these studies is based on:

• Toxicological endpoints: Survival, organ/tissue changes, genetic mutations as per established toxicology protocols.
• Chemical analysis: Quantification of leached substances using analytical techniques like high-pressure liquid chromatography (HPLC).
• Biocompatibility standards: Assessment against known biological responses to materials.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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