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K Number
K032627
Device Name
ULTRADENT CITRIC ACID 10% SOLUTION
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
2003-11-12

(78 days)

Product Code
KJJ
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ultradent Citric Acid 10% Solution is used just prior to obtigation to etch the canal walls, especially ape to allow optimum seal.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification letter from the FDA regarding a dental device called "Ultradent Citric Acid 10% Solution," which is a root canal cleanser. The letter primarily focuses on the FDA's determination of substantial equivalence to existing predicate devices, allowing it to be marketed.

However, a 510(k) summary for a device like a root canal cleanser, especially one classified as unclassified, does not typically include detailed clinical acceptance criteria or a study design as you've requested for AI/ML-based devices.

Here's why and what information can be extracted/inferred:

  • Nature of the Device: This is a chemical solution used in a dental procedure, not an imaging or diagnostic AI-powered device. Its "performance" is typically assessed through chemical properties, stability, and compatibility within the root canal environment, rather than metrics like sensitivity, specificity, or AUC as seen in AI studies.
  • Regulatory Pathway (510(k)): The 510(k) pathway is about demonstrating substantial equivalence to a legally marketed predicate device. This often relies on comparing technical characteristics, materials, intended use, and sometimes non-clinical performance data (e.g., pH, concentration, microbiology) rather than extensive human clinical trials with intricate ground truth panels and MRMC studies.
  • "Unclassified" Status: Since it's unclassified, it means there isn't a specific regulation number or class (Class I, II, or III) for this type of device, which further points away from the need for complex clinical efficacy studies typically required for higher-risk devices or novel technologies.

Therefore, I cannot provide the detailed information requested in your prompt because the provided document (an FDA clearance letter for a 510(k)) does not contain such a study or acceptance criteria in the context of AI/ML device performance.

However, I can extract the following relevant information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria: Not explicitly stated as performance metrics like sensitivity/specificity. For a substantial equivalence claim, the acceptance criteria are typically met if the device has the "same intended use as the predicate device" and "same technological characteristics as the predicate device" or "different technological characteristics from the predicate device and the new characteristics do not raise new questions of safety and effectiveness, and the device is as safe and effective as the predicate device."

  • Reported Device Performance: The document states the device name is "Ultradent Citric Acid 10% Solution" and its intended use is "to etch the canal walls, especially ape [apex] to allow optimum seal." No specific numerical performance metrics are provided in this regulatory letter itself. The equivalence is established against a predicate device.

    Acceptance Criterion (Inferred from 510(k) process)Reported Device Performance (Inferred from 510(k) clearance)
    Intended Use: Same as predicate device.Ultradent Citric Acid 10% Solution is used just prior to obturation to etch the canal walls, especially ape [apex] to allow optimum seal. (Matches typical use of citric acid solutions in endodontics).
    Technological Characteristics: Equivalent to predicate device (e.g., composition, concentration, pH).Ultradent Citric Acid 10% Solution (implied to be 10% citric acid). Details not in this letter, but were submitted in the K032627 application.
    Safety & Effectiveness: As safe and effective as predicate device.Device found "substantially equivalent" to legally marketed predicate devices, implying safety and effectiveness.
    Biocompatibility: (Common for devices in contact with tissue)Not detailed in this letter, but likely assessed in the K032627 submission to be equivalent to predicate.
    Sterility: (If applicable)Not detailed in this letter, but likely assessed in the K032627 submission.

Regarding the other points you requested for AI/ML devices, this letter does not contain that information:

  1. Sample size for the test set and data provenance: Not applicable/provided. This device is not an AI/ML product.
  2. Number of experts used to establish the ground truth...: Not applicable/provided. Ground truth using expert clinicians for AI performance is not relevant here.
  3. Adjudication method: Not applicable/provided.
  4. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable/provided.
  5. Standalone (algorithm only without human-in-the loop performance) study: Not applicable/provided.
  6. Type of ground truth used: For a chemical solution, "ground truth" would relate to its chemical properties, stability, and efficacy in dissolving/etching, assessed via laboratory or non-clinical studies. This letter does not detail those.
  7. Sample size for the training set: Not applicable/provided (no AI training set).
  8. How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided document is an FDA 510(k) clearance letter for a non-AI dental solution, not a clinical study report for an AI/ML-based device. Therefore, the specific details you requested regarding clinical acceptance criteria and AI study methodologies are not present.

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