(106 days)
RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
RETRACT is a dental product capable of controlling gingival bleeding, temporarily displacing the marginal gingiva and temporarily drying the gingival sulcus around a tooth. The paste allows the dental clinician to perform operative procedures without interference from moisture or excess soft tissue. RETRACT is supplied in 0.5 ml syringes with a hand plunger, intra-oral tips, Instructions for Use & MSDS.
This Preamarket Notification (510(k)) is for the RETRACT Gingival Retraction/Hemostatic Paste.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance study to meet those criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the device is deemed acceptable if it has similar indications, principles of operation, and technological characteristics to legally marketed devices, and the minor differences do not raise new questions of safety or effectiveness.
Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence):
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (Comparison to Predicates) |
|---|---|
| Indications for Use | "similar indications" to predicate devices (TRAXODENT, EXPASYL, RACEGEL). |
| Principles of Operation | "similar principles of operation" to predicate devices. |
| Technological Characteristics | "similar technological characteristics" to predicate devices. |
| Aluminum Chloride Concentration | Approximately 22% aluminum chloride, which falls within the range of predicate devices (15% - 25%). |
| Primary Fillers/Thickening Agent | Uses "clay or similar materials" as primary fillers/thickening agent, similar to TRAXODENT and EXPASYL. |
| Safety and Effectiveness | "minor differences in the device do not raise any new questions of safety or effectiveness." |
| Biocompatibility | "biocompatible based on the directed usage, the known material profiles, and the extensive usage history of the constituents." Other ingredients are "food grade (or better)". |
2. Sample Size and Data Provenance
The document does not describe a specific clinical or performance study with a defined sample size for a test set. The evaluation is based on comparing the device's characteristics and ingredients to existing predicate devices already on the market. Therefore, there is no mention of a "test set" in the traditional sense, or data provenance.
3. Number of Experts and Qualifications for Ground Truth
Since no independent study with a test set was conducted to establish ground truth, there is no information provided on the number or qualifications of experts used for this purpose.
4. Adjudication Method
As there was no specific test set requiring ground truth establishment, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted, as the device approval pathway was based on substantial equivalence and not a comparative effectiveness study involving human readers or AI assistance. The device is a paste, not an imaging or diagnostic AI system.
6. Standalone Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted. This device is a dental material, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is implicitly the established safety and effectiveness profile of the predicate devices. The new device is deemed acceptable because its characteristics align with or are similar to those already proven safe and effective in the market. It's an expert judgment based on prior approvals and material science, rather than a new "ground truth" derived from patient outcomes or pathology for this specific device.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or machine learning. The "training" for this type of device development would involve research and development to formulate the paste and ensure its chemical and physical properties are suitable, often based on existing knowledge of similar materials.
9. How Ground Truth for the Training Set Was Established
Since there is no explicit "training set" as understood in algorithm development, there's no information on how its "ground truth" was established. The development of the device would rely on established scientific principles for material formulation, chemical compatibility, and efficacy of known hemostatic and gingival retraction agents, guided by regulatory requirements and industry standards.
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