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Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative material. The Acid Etchant will be available in gel and liquid form. The gel form will be contained in syringes and the liquid form will be contained in dropper bottles. Applicator tips will be provided with the gel form. The Acid Etchant contains water, 37% phosphoric acid (CAS# 7664-38-2), silica and green dye. The silica is used as a thickener. The amount of silica will determine the flow behavior and viscosity of the Acid Etchant. The green dye is to provide contrast to the tooth's color. The combination of the flow behavior, delivery system and green dye provides and facilitates accurate and controlled application of the Acid Etchant during orthodontic treatment.

The provided document describes a premarket notification (510(k)) for a dental device called "Acid Etchant." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving clinical performance through extensive comparative studies as would be seen for new, high-risk devices or AI-driven diagnostics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or detailed ground truth establishment.

Instead, the submission focuses on non-clinical performance testing and comparison to a predicate device to demonstrate substantial equivalence.

Here's what can be extracted and why the other information is not present:

Key Findings from the Document:

• Device Name: Acid Etchant

• Predicate Device: E Dental Products e-1 Etchants (K152110)

• Regulatory Class: Class II (Product Code KLE)

• Indications for Use: "Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials."

• Clinical Performance Testing: "No clinical performance testing has been conducted." (Page 5-3, Section "Clinical Performance Testing")

• Non-Clinical Performance Testing: The following tests were conducted:

  1. Performance Test in Accordance with ISO 29022:2013
  2. Viscosity Testing
  3. pH and Acid Content Testing
  4. Compatibility Testing

• Basis for Substantial Equivalence:

  • Same intended use.
  • Same technological characteristics (delivery system, flow behavior, consistency, % Phosphoric Acid, pH, and similar materials).

• Performance Data Reported (Non-Clinical Bench Testing):

  Device Name	Average Bond Strength [N/mm²]	Viscosity (Pas):	Calculated pH:	% Phosphoric Acid:
  Acid Etchant (Gel)	27.20	10.8	1.6	37.5
  Acid Etchant (Liquid)	26.91	0.54	1.6	37.6
  E Dental Products e-1 Etchants (Predicate)	26.71	7-4.7	1.6	37*
  *Stated value from manufacturer

Explanation of Missing Information:

1. Acceptance Criteria & Device Performance Table (as requested for clinical validation): The document does not provide clinical acceptance criteria because no clinical performance testing was conducted. The "performance data" table above reflects non-clinical bench testing comparing physical and chemical properties, not clinical outcomes or AI performance metrics.
2. Sample Size for Test Set & Data Provenance: Not applicable, as no clinical test set was used for validating clinical performance or AI. The non-clinical tests would have their own sample sizes (e.g., number of bond strength tests), but these are not explicitly detailed in the summary beyond the reported averages.
3. Number of Experts & Qualifications / Adjudication Method: Not applicable, as no human expert-based ground truth was established for a clinical or AI performance study.
4. MRMC Comparative Effectiveness Study: No MRMC study was done, as explicitly stated "No clinical performance testing has been conducted." This device is a chemical etchant, not an AI or imaging diagnostic requiring human-in-the-loop evaluation.
5. Standalone (Algorithm Only) Performance: Not applicable. This is a dental material, not an AI algorithm.
6. Type of Ground Truth Used: For the non-clinical tests, the "ground truth" is laboratory measurement against specified standards (e.g., ISO 29022:2013 for bond strength, direct chemical measurements for pH and acid content). There is no "expert consensus" or "pathology" ground truth as would be used for diagnostic devices.
7. Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable. This device is not an AI/ML product requiring training data.

In summary, this document is a 510(k) for a dental material (Acid Etchant), demonstrating substantial equivalence through non-clinical bench testing and material comparisons, not through clinical trials or AI performance evaluations that would involve the detailed criteria requested in the prompt.

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A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

Thixotropic dental etchant gel with 37% phosphoric acid

The provided text is a 510(k) summary for a dental etchant gel, not a study involving AI or complex medical device performance metrics like sensitivity, specificity, or reader studies. Therefore, many of the requested categories related to AI systems, clinical trials, and expert adjudication are not applicable.

However, I can extract the relevant information regarding the acceptance criteria (comparative performance to a predicate device) and the study that "proves" the device meets these criteria, based on the provided text.

Device Name: Jade 37% Phosphoric Acid Etchant Gel

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

The acceptance criteria for the Jade 37% Phosphoric Acid Etchant Gel are based on demonstrating substantial equivalence to its predicate device, Seity 37% Phosphoric Acid Etchant Gel (K112597). This equivalence is primarily established through comparisons of technological characteristics and bench testing results.

Note: While viscosity and pH values are not identical, the submission asserts that bench testing demonstrates the equivalence of Jade to the predicate device, implying these differences are not clinically significant for the intended use and do not raise new issues of safety or efficacy. The conclusion specifically states that "Even though the chemical compositions are not identical, bench testing has demonstrated that Jade has comparable material properties and performance."

2. Sample size used for the test set and the data provenance

The document describes "bench testing" without specifying a particular sample size for each characteristic tested. The data provenance is derived from these bench tests, which are laboratory-based and not tied to patient data or specific countries of origin in this context. It's prospective in the sense that Dharma Research likely conducted these tests specifically for this 510(k) submission.

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

Not applicable. This is not a study involving expert consensus for ground truth but rather laboratory measurements comparing physical and chemical properties.

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

Not applicable. There was no expert adjudication in the context of clinical outcomes or imaging reviews.

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 an AI-assisted device or a diagnostic imaging device.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" here is the established properties and performance of the legally marketed predicate device (Seity 37% Phosphoric Acid Etchant Gel, K112597) and the measured chemical/physical properties of both the predicate and the new device through laboratory bench testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

Seity 37% Phosphoric Acid Etchant Gel

This document is a 510(k) clearance letter from the FDA for a dental etchant gel. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document describes a dental etchant gel, which is a chemical product, not a software device or an AI/ML-based medical device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth, and AI/ML performance are not applicable to the information provided in this document.

The letter focuses on regulatory approval based on substantial equivalence to existing products, rather than performance studies as would be required for novel medical devices or AI/ML systems. No information about a study proving the device meets acceptance criteria in the context of an AI/ML device is present.

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