(62 days)
Astringedent Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord and/or the solution facilitates the insertion of the cord into the sulcus.
Astringedent Clear is a 12% w/w aluminum chloride solution in a non-viscous, aqueous vehicle. It leaves no residue or stain, making it ideal for use in the esthetic zone. It is packaged in two configurations: 30 mL IndiSpense, 30 mL bottle packaged with retraction cord. It is used both for obtaining clear dental impressions, as well as operative dental procedures requiring hemostasis and fluid control.
The provided document is a 510(k) premarket notification for a medical device called "Astringedent Clear." It outlines a comparison between the new device and a predicate device (Viscostat Clear). However, it does not contain a study or detailed data proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is a different regulatory pathway. The "acceptance criteria" here are aligned with showing that the new device is as safe and effective as the predicate device, despite some minor differences.
Here's an attempt to extract and frame the information you requested, based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide explicit "acceptance criteria" in a quantitative sense (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating similar technological characteristics and performance to the predicate device.
| Characteristic | Acceptance Criteria (Implied by Predicate - Viscostat Clear) | Reported Device Performance (Astringedent Clear) |
|---|---|---|
| Intended Use | Sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry, used with gingival retraction cord and/or Dento Infusor; facilitates cord insertion. | Identical: Sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry, used with gingival retraction cord and/or Dento Infusor; facilitates cord insertion. |
| Intended User | Dental professional | Dental professional |
| Chemical Characteristics | Active ingredient: Aluminum chloride gel | Active ingredient: Aluminum chloride solution (12% w/w) |
| Primary Container | 30 ml Indispense container, 1.2 mL syringe | 30 ml Indispense container, 30 ml bottle packaged with retraction cord |
| Physical Properties | Clear gel | Clear solution |
| Compatibility | Does not adversely affect bond strength when used as directed. | Does not adversely affect bond strength when used as directed. (Tested as "effect on bonding (shear bond strength)") |
| Time in Mouth | 1 - 3 minutes | 1 - 3 minutes |
| Viscosity | Viscous gel | Nonviscous solution (This is a distinguishing characteristic, claimed to allow easier/quicker soaking into cord) |
| Biocompatibility | Low cytotoxicity per ISO 10993-5, ISO 7405 | Not tested, but acceptable because it uses the "same active ingredient, similar formulation" as the predicate which was tested. |
| Other Performance | (Implied safe and effective for its purpose) | "Astringedent Clear has been tested for aluminum chloride content, wettability, effect on bonding (shear bond strength), and stability, and met all design input requirements." (Specific criteria/results not provided, but stated to have been met.) Validation that it functions as a hemostatic/retraction agent. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data for performance evaluation (e.g., a set of patient cases). The evaluation performed was "design verification testing" on the device itself.
- Sample Size: Not specified for the "design verification testing" (aluminum chloride content, wettability, shear bond strength, stability).
- Data Provenance: This is a submission to the FDA for a medical device. The data would be generated through in-house laboratory testing and potentially animal studies (though not explicitly mentioned for this product beyond biocompatibility standards). No information is provided regarding country of origin for any human data (as there appears to be none presented). The testing is prospective for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study assessing diagnostic accuracy or expert interpretation. Therefore, there is no "ground truth" established by experts in the context of a test set of cases.
4. Adjudication Method for the Test Set
Not applicable. There is no expert review or adjudication process described for clinical cases or diagnostic interpretations.
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 dental solution (astringent) and not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical chemical solution, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)
For the "design verification testing," the "ground truth" would be established by:
- Chemical standards/specifications: for aluminum chloride content.
- Physical property measurements: for wettability and stability.
- Laboratory-based testing standards: for shear bond strength (measuring adhesion of restorative materials to tooth structure after treatment with the solution).
- Biocompatibility standards (ISO 10993-5, ISO 7405): for cytotoxicity of the predicate device (and by extension, the new device due to similar formulation).
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Summary of the Study:
The "study" referenced in the document is a design verification testing and substantial equivalence demonstration comparing "Astringedent Clear" to its predicate "Viscostat Clear." The manufacturer, Ultradent Products, Inc., performed in-house testing to confirm that Astringedent Clear met "all design input requirements" and was comparable to the predicate device regarding its intended use, mechanism of action, and safety characteristics. Key findings supporting equivalence included:
- Identical intended use, intended user, and active ingredient (aluminum chloride).
- Similar delivery systems.
- Similar "time in mouth" (1-3 minutes).
- Testing for aluminum chloride content, wettability, effect on bonding (shear bond strength), and stability confirmed it met design requirements.
- Biocompatibility was deemed acceptable based on the predicate device's testing and the new device's similar formulation and active ingredient.
The primary difference noted was the new device's non-viscous solution consistency compared to the predicate's viscous gel, a change intended to improve ease of use (easier and quicker soaking into retraction cord). The regulatory pathway for this device is a 510(k) premarket notification, which relies on demonstrating substantial equivalence rather than independent proof of safety and effectiveness through extensive clinical trials for new device types.
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