(90 days)
Bisco Etchants consist of semi-gel phosphoric acids. The principle uses of the Bisco Etchants are: 1. Etching and cleaning of dentin and enamel 2. Cleaning of restorative surfaces prior to bonding
The Bisco Etchants are phosphoric acid semi-gels that effectively remove the smear layer, etch and produce the necessary microretentive surface for successful bonding.
This document describes the 510(k) submission for "Bisco Etchants," which are phosphoric acid semi-gels used for etching and cleaning dentin and enamel, and cleaning restorative surfaces prior to bonding. The core of the submission revolves around demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria or conducting a comprehensive study with performance metrics in the way a new, complex AI or diagnostic device would.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of traditional medical device submission.
Here's an attempt to answer the questions based on the provided document:
Device: Bisco Etchants (Phosphoric Acid Semi-Gel)
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria with specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated in this 510(k) summary for Bisco Etchants. The primary "acceptance" is based on demonstrating substantial equivalence to predicate devices. The performance is qualitatively reported based on the chemical properties and intended function.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Summary Statements) |
|---|---|
| Indications for Use equivalence: Device performs the same intended functions as predicate devices. | "The principle uses of the Bisco Etchants are: 1. Etching and cleaning of dentin and enamel, 2. Cleaning of restorative surfaces prior to bonding." (Matches predicate's purpose) |
| Technological Characteristics equivalence: Device shares similar physical and chemical properties. | "All components of the Bisco Etchants are found in legally marketed predicate devices." |
| "The Bisco Etchants are based upon many similar technological characteristics..." | |
| Safety and Efficacy Equivalence: Device is as safe and effective as predicate devices. | "Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to legally marketed predicate products." |
| "The conclusion of the safety evaluation is that the Bisco Etchants are safe for its intended use." | |
| "...chemical properties... demonstrated that the concentration of phosphoric acid used is sufficient to clean and to expose dentin tubules, demineralize and thus create the necessary microretentive surface for successful bonding." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This 510(k) summary does not describe a "test set" in the context of a clinical performance study with a specific sample size of patients or cases. The evaluation is based on chemical properties and comparison to predicate devices, not on a clinical trial with a defined test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. As there is no described test set or clinical study requiring expert-established ground truth, this information is not relevant to this submission.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or associated adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Not Applicable. This is a submission for a dental etchant, not an AI or diagnostic imaging device. An MRMC study is not mentioned or relevant to the information provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a chemical product, not an algorithm. Standalone performance as typically defined for AI or diagnostic devices is not relevant.
7. The Type of Ground Truth Used
- Chemical/Material Properties and Clinical Application Principles: The "ground truth" implicitly used for this type of device relies on established scientific understanding of phosphoric acid's effects on dental tissues (dentin and enamel), its ability to clean surfaces, and its role in creating microretentive surfaces for bonding. The substantial equivalence relies on demonstrating that the applicant device achieves these known effects similar to predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set is described.
Summary of the K101485 Submission:
This 510(k) summary (K101485) for "Bisco Etchants" focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Ecliptomer K0945604 and Bisco Etchants K052012). The submission relies on comparing the applicant device's indications for use, technological characteristics (chemical properties, specifically the concentration of phosphoric acid), and safety profile to those of the predicate devices. The document states that "side by side comparisons clearly demonstrate that the applicant device is substantially equivalent" and that the chemical properties "demonstrated that the concentration of phosphoric acid used is sufficient to clean and to expose dentin tubules, demineralize and thus create the necessary microretentive surface for successful bonding." The FDA's letter confirms substantial equivalence for the stated indications for use.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.