(248 days)
GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.
Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Gingi-Aid Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
This document is a 510(k) Premarket Notification from the FDA regarding the Gingi-Aid Gel. It focuses on demonstrating the substantial equivalence of the Gingi-Aid Gel to an existing predicate device, rather than providing details on acceptance criteria and performance data for a new, AI-based device that would typically involve the comprehensive testing requested.
Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/CADe device, specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. This document is for a dental gel, not an AI/CADe device. The "performance" is based on chemical and physical properties and intended use.
- Sample sized used for the test set and the data provenance: Not applicable in the context of AI/CADe. The "testing" here involves biocompatibility, bench testing for aluminum chloride content, and shelf-life testing, not a clinical study on a large test set of images or patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/CADe device is usually established by medical experts (e.g., radiologists, pathologists). This is a chemical product.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/CADe sense. The "ground truth" for this device would be established by chemical analysis and standard biocompatibility testing.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
However, I can extract the following information relevant to the submission:
1. Device Description and Characteristics (replacing "Acceptance Criteria" with "Key Characteristics" and "Performance" with "Reported Data"):
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Vista Clear, K193389, and ViscoStat Clear, K123215). The "acceptance criteria" are implicitly met by demonstrating that the Gingi-Aid Gel is chemically and functionally similar and safe.
| Key Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Data (Gingi-Aid Gel) |
|---|---|---|
| Device Identification | 25% Aluminum Chloride in water-based gel | 25% Aluminum Chloride in a water-based, viscous gel |
| Primary Active Ingredient | Aluminum Chloride | 25% Aluminum Chloride |
| Formulation | Viscous Gel | Viscous gel |
| Intended Use | Gingival retraction, bleeding/oozing control (with cord) | Intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus. |
| Environment of Use | Healthcare facility/Dental office | Healthcare facility/Dental office |
| Target Population | Healthcare professionals | Healthcare professionals |
| Prescription/OTC | Prescription Use | Prescription Use |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Mechanism of Action | Physical displacement of gingival tissue, facilitates cord insertion | Placement of the viscous gel results in physical displacement of gingival tissue from the tooth. Material also facilitates insertion of the cord into the sulcus. |
| pH | Similar to predicate (ViscoStat Clear: 2.65) | 2.62 (Compared to ViscoStat Clear's 2.65, demonstrating similarity) |
| Packaging Configuration | 1.2mL pre-filled syringe; 30mL syringe | 1.2mL pre-filled syringe with applicator tips; 30mL syringe with empty 1.2mL syringes and applicator tips. |
| Sterility | Non-sterile | Non-sterile (Gingi-Aid Gel is not supplied as sterile.) |
| Shelf-Life | At least 24 months | 24 months (Based on accelerated testing; real-time aging being performed to support shelf life). |
| Recommended Contact Time | 1-3 minutes | 1-3 minutes |
| Biocompatibility | Low cytotoxicity, no skin sensitization/irritation | Biocompatibility testing performed according to ISO 10993-1. Device demonstrated low cytotoxicity, no skin sensitization or skin irritation. (Testing included Cytotoxicity, Skin Sensitization, Skin Irritation). |
| Aluminum Chloride Content | Similar to predicate | Gingi-Aid Gel has been tested for aluminum chloride content and is found to be similar to predicate device. |
2. Study Design and Data Provenance (for this specific device which is NOT AI/CADe):
- Sample size and Data Provenance: Not applicable in the context of a clinical study for AI/CADe. The "study" here involves lab testing.
- Bench Testing: Gingi-Aid Gel's aluminum chloride content was compared to the predicate device.
- Biocompatibility Testing: Performed according to ISO 10993-1. (Specific sample sizes for these tests are not provided but are standard for material testing).
- Shelf-Life Testing: Accelerated testing supported 24 months, with real-time aging ongoing.
- The "data provenance" is from in-house lab testing by the manufacturer (Belport Company, Inc. / Gingi-Pak). The document does not specify country of origin for the data, but the submission is to the US FDA. The nature of these tests is not "retrospective" or "prospective" in a clinical trial sense, but rather lab-based validation.
3-9. Information Not Applicable to this Type of Device (Gingi-Aid Gel is not an AI/CADe device):
As explained above, questions concerning experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, direct patient ground truth, and training set details are entirely irrelevant to this submission, which is for a dental chemical product. The substantial equivalence is based on comparing its physical, chemical, and functional properties to similar, already-cleared predicate devices.
N/A