(70 days)
USE ETCH-DETECT TO DETECT RESIDUAL DECAY (DENATURED PROTEIN) WHILE ETCHING DENTINE IN THE "TOTAL ETCH" TECHNIQUE.
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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.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.