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As a Universal Self-Etching Adhesive Bonding System, BONDEASIER SE SYSTEM is indicated to be used as a universal dental adhesive to etch, prime and bond to a tooth structure and meth(acrylic) dental composite.

The subject device is a combination of chemical and light-cured self-priming adhesive in a solvent formulation. Bondeasier SE device is not technique sensitive. It requires painting the tooth surface followed by blowing with air to remove the solvent and placing 1-2 layers of 2-3mm of filled light cure Bondeasier SE Adhesive Resin. Lastly, the final curing of each layer of Bondeasier Adhesive Resin is done with a dental curing light.

The information provided shows that the device, American Dental Products BONDEASIER SE SYSTEM, is a dental adhesive. The study submitted for its acceptance is a "side by side bonding test" comparing it to a predicate device, Bisco's "One step". This is not a study typically assessed using acceptance criteria like sensitivity, specificity, or AUC, as it's a comparison of material properties rather than diagnostic or prognostic performance. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Note: The specific numerical acceptance criteria for shear bond strength are not provided in the summary, nor are the specific numerical results. The document states that the results are reported "in tabular form and in details into this application" suggesting they were provided to the FDA, but not included in this summary document. The acceptance criterion is implicit: the device's shear bond strength should be substantially equivalent to the predicate device, Bisco's "One step".

Study Details

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

• Sample Size: Not explicitly stated in the provided text for the bonding tests.
• Data Provenance: The study was conducted by American Dental Products Inc. There is no information about the country of origin of the data (e.g., teeth used) or whether it was retrospective or prospective.

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

• Not Applicable. This type of study does not involve human expert interpretation of images or other data to establish ground truth. The "ground truth" here is the physical measurement of bond strength on tooth structures.

3. Adjudication method for the test set:

• Not Applicable. This is not a study where human interpretation is being adjudicated.

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:

• No. This is not an MRMC study and does not involve AI assistance.

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

• No. This is a comparison of two dental bonding systems, not an algorithm.

6. The type of ground truth used:

• Physical Measurement / Mechanical Test Results: The ground truth is established through physical measurements of bond strength on tooth structures, comparing the device's performance to an already legally marketed predicate device.

7. The sample size for the training set:

• Not Applicable. There is no mention of a "training set" as this is a non-clinical material performance study, not an AI or machine learning model.

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

• Not Applicable. See above.

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CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.

Not Found

This document is a 510(k) summary for the American Dental Products Caries-Detector Plus. It states that the product's efficacy is comparable to or better than other brands on the market, as shown by third-party testing. However, it does not provide detailed information about the acceptance criteria, the specific study conducted, or any of the other information requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The document is too high-level and lacks the specific details about the study design, sample sizes, ground truth establishment, or expert involvement.

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USE ETCH-DETECT TO DETECT RESIDUAL DECAY (DENATURED PROTEIN) WHILE ETCHING DENTINE IN THE "TOTAL ETCH" TECHNIQUE.

Not Found

The provided text is a 510(k) summary for the "American Dental Products Etch-Detector." It states that the product's efficacy is comparable to or better than other brands on the market, based on "Third party testing." However, it does not provide specific acceptance criteria or details about the study that proves the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not provided in the document. The document only generically states "comparable or better than other brands."
• Reported Device Performance: Not provided in a quantifiable manner. It only states "efficacy of our products is comparable or better than other brands."

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

• Sample Size: Not provided.
• Data Provenance: Not provided. The document mentions "Third party testing" but offers no details about who conducted the testing, where, or when.
• Retrospective/Prospective: Not specified.

3. 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 provided. The nature of "ground truth" for a device that detects "residual decay (denatured protein) while etching dentine" would likely involve laboratory or clinical assessment of dental surfaces, but no details are given.

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

• Not provided.

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 device is a "Etch-Detector," which appears to be a chemical indicator or similar tool, not an AI or imaging device that would involve human "readers." The concept of "human readers" improving with "AI assistance" does not fit the description of this product.

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

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

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

• Not provided.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning device. If "training set" refers to development or validation testing, no sample size is given.

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

• Not applicable.

Summary of what is available from the document:

• Device Name: American Dental Products Etch-Detector
• Claimed Performance: Efficacy is comparable or better than other brands on the market.
• Evidence Basis: "Third party testing."
• Safety Information: Contains ingredients proven safe, but Phosphoric Acid Gel can cause blindness if in contact with eyes; requires professional handling with gloves, avoiding contact with skin, tissue gum, and eyes, following instructions and Material Safety Data Sheet.
• Indications for Use: To detect residual decay (denatured protein) while etching dentine in the "Total Etch" technique.

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HB-35 DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE TEETH

Not Found

The provided text is for a 510(k) summary for a dental desensitizer product and does not contain the information requested about acceptance criteria or a study proving device performance in the context of an AI/human-in-the-loop system.

The document discusses:

• A 510(k) summary for a dental desensitizer with fluoride (HB-35 Desensitizer with Fluoride).
• Claims of comparable efficacy to other market brands based on "third-party testing" (without providing details of the testing).
• Safety information related to its ingredients (Fluoride, Quals) and handling instructions.
• The FDA's decision of substantial equivalence to pre-amendment devices, allowing it to be marketed.

Therefore, I cannot populate the table or provide the requested details because the information is not present in the given text. This submission is for a traditional medical device, not an AI-powered diagnostic or assistive technology.

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