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CLEARFIL SE BOND is indicated for the following applications:

1. Direct filling restorations using light-curing composite or compomer
2. Cavity sealing as a pretreatment for indirect restorations
3. Treatment of hypersensitive and/or exposed root surfaces
4. Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured composite resin
5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retentive materials.

Here's an analysis of the provided text regarding the acceptance criteria and study for CLEARFIL SE BOND, based on the information available in the 510(k) summary.

It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA. These summaries typically demonstrate substantial equivalence to previously cleared devices rather than presenting full clinical trial results with detailed acceptance criteria and standalone performance studies in the way a pharmaceutical drug or a high-risk medical device might. Therefore, some of the requested information (like specific effect sizes for MRMC studies, sample sizes for test sets, and detailed expert qualifications) is not explicitly present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

While specific numerical values for acceptance thresholds are not provided, the reported performance is that the device met the implicit criterion of "substantial equivalence" in bond strength to the predicate device. |
| Chemical Ingredients and Safety: Chemical ingredients are identical or substantially equivalent to predicate devices and have a history of safe use. | The document states: "The chemical ingredients are identical or substantially equivalent to the predicated devices. These chemical ingredients have been used in similar products which have been marketed for many years, therefore they are safe." The safety of the chemical ingredients is affirmed by their historical use in equivalent predicate devices (CLEARFIL LINER BOND 2V (K974486), PANAVIA F (K983361), ESTENIA (K982164)). |
| Design, Composition, and Function: Device is similar and substantially equivalent in design, composition, and function to predicate devices. | The document explicitly states: "This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial." This is a general statement of equivalence rather than a specific performance metric. The device is also described as a "simplified system of CLEARFIL LINER BOND 2V". |
| Intended Use: Device performs as intended for specified indications. | The Indications For Use are listed and the claim is that the device is "substantially equivalent" for these uses to predicate devices. Implicitly, it is deemed to perform for: 1) Direct filling restorations, 2) Cavity sealing, 3) Treatment of hypersensitive/exposed root surfaces, 4) Intraoral repairs of fractured crowns, and 5) Surface treatment of prosthetic appliances. The "substantially equivalent" claim implies that it performs comparably to the predicate devices for these indications. |

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

The 510(k) summary does not specify the sample size used for the bond strength evaluations (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for these evaluations. These details are typically part of a more extensive study report, not a 510(k) summary.

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

This information is not provided in the 510(k) summary. Bond strength testing is usually a laboratory-based biomechanical evaluation, not typically reliant on "expert ground truth" in the way image interpretation or diagnostic accuracy studies might be. Therefore, experts in establishing ground truth in that context would not be applicable here. The "ground truth" would be the measured bond strength values themselves.

4. Adjudication Method for the Test Set

Not applicable for this type of biomechanical bond strength evaluation. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or diagnostic results, not for objective laboratory measurements like bond strength.

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

This is not applicable. The device is a "Resin-based dental adhesive system," a physical material used in dentistry, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

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

This is not applicable. As stated, the device is a dental adhesive system, not an algorithm. The "standalone performance" in this context would be the measured bond strength of the product itself under controlled laboratory conditions, which the document indicates was evaluated by comparing it to predicate devices.

7. The Type of Ground Truth Used

For the bond strength evaluations, the "ground truth" would be the measured bond strength values themselves, obtained through standardized laboratory testing methods (e.g., universal testing machine pulling apart bonded substrates). This is a direct physical measurement.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.

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

This is not applicable, as there is no "training set" for this type of device.

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

Not Found

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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