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Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.

RCT GEL™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the carbamide peroxide. This action allows for pulp tissue, dentinal shavings and debris to float out.

The physical properties of RCT GEL™ and the predicate device are similar, i.e., pH values, viscosity, appearance, color, and odor,

This 510(k) submission is for the RCT GEL™, a dental instrument used for the chemical and mechanical cleansing of the root canal during endodontic therapy. The submission focuses on demonstrating substantial equivalence to a pre-1976 predicate device, RC Prep.

Here's an analysis of the provided information, specifically addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, explicit, quantifiable acceptance criteria and device performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy) are not present. This is a pre-amendment device submission, so the criteria for substantial equivalence are different from those for novel, high-risk devices or modern AI-powered devices.

The "acceptance criteria" here are implicitly focused on the similarity of the new device to the predicate in key characteristics, and the safety and efficacy of its intended use.

2. Identical concentrations of active ingredients.
3. Short duration of contact within the oral cavity.
4. Decomposition and thorough removal of the product from the canal space. |
   | Cleansing Action (Facilitation) | Allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. Oxygen bubbling through carbamide peroxide release assists in floating out pulp tissue, dentinal shavings, and debris. (Descriptive, not quantified) |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. There is no mention of a "test set" in the context of clinical performance data or a statistical study for this device. The submission relies on equivalence to a pre-amendment predicate device.
• Data Provenance: Not applicable. No clinical data or test data is mentioned. The claims are based on the known properties of the ingredients and the predicate device.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic or clinical outcomes, is not established for this type of submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. No test set or expert adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is a medical device (a gel), not an imaging or AI diagnostic tool, so an MRMC study is not relevant to its assessment.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No. This is not an algorithm or AI device.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is implicitly based on:
  • Prior knowledge/established use: The long history of safe and efficacious use of the predicate device (RC Prep) and the individual components in other dental products.
  • Chemical and physical property comparison: Direct comparison of the new device's pH, viscosity, appearance, color, and odor to the predicate.
  • Scientific understanding: The known mechanisms of action for its components (e.g., oxygen release from carbamide peroxide for cleansing).
    There is no de novo clinical trial or gold standard reference test data provided for RCT GEL™.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device, and thus does not have a "training set" in that context.

9. How Ground Truth for Training Set was Established

• How Ground Truth Established: Not applicable, as there is no training set for an AI/ML model.

In summary:

This 510(k) submission for RCT GEL™ is for a relatively simple dental product (a gel). Its approval is based on demonstrating substantial equivalence to a pre-1976 predicate device, RC Prep. This means the manufacturer largely relies on the known safety and efficacy of the predicate and the similar physical and chemical characteristics of RCT GEL™, rather than presenting extensive new clinical trial data or performance metrics that would be expected for a novel, higher-risk device, or an AI-powered diagnostic tool. The document explicitly states that additional biocompatibility testing is not required due to the established safety profile of the predicate and its components.

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