(22 days)
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for lavage and debridement of root canals and as an irrigant for root canal instrumentation.
Pulpdent SODIUM HYPOCHLORITE SOLUTION is a dental sodium hypochlorite solution used for root canal lavage and debridement and as an irrigant for root canal instrumentation. Pulpdent SODIUM HYPOCHLORITE SOLUTION is 5.25 % sodium hypochlorite in water.
The provided text describes a 510(k) premarket notification for a dental product, "PULPDENT Sodium Hypochlorite Solution." The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving specific acceptance criteria in the context of device performance metrics often seen in AI/ML or diagnostic device submissions.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document.
Here's an analysis based on the provided text, indicating where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Composition | Substantially equivalent to predicate products for composition (5.25% sodium hypochlorite in water). | Stated to be 5.25% sodium hypochlorite in water, same as predicate. |
| Intended Use | Substantially equivalent to predicate products for intended use (root canal lavage and debridement, irrigant for root canal instrumentation). | Stated to be used for root canal lavage and debridement, and as an irrigant for root canal instrumentation, same as predicate. |
| Safety | Considered safe in concentrations less than 7.5% and when applied to intact tissue, referencing the American Dental Association Council on Accepted Dental Therapeutics. | Implied to meet safety standards by being 5.25% sodium hypochlorite, which is below the 7.5% threshold. |
| Effectiveness | Aqueous solutions of 2.5% and 5% sodium hypochlorite reportedly equally effective in dissolving pulpal debris when used as root canal irrigants, referencing the American Dental Association Council on Accepted Dental Therapeutics. | Implied to be effective by being a 5.25% sodium hypochlorite solution, which is similar to the "equally effective" concentrations mentioned. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a test set or experimental data in the way a clinical study would for a diagnostic device. The "study" here is primarily a literature review and comparison to predicate devices.
- The "data provenance" is a citation from the American Dental Association Council on Accepted Dental Therapeutics, which is a published professional standard rather than specific patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" and thus no ground truth established by experts in the context of a clinical performance study. The "ground truth" for safety and effectiveness is derived from established dental literature and consensus, as cited from the American Dental Association.
4. Adjudication method for the test set
- Not applicable. No test set or direct expert adjudication of results is mentioned.
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 chemical solution, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a chemical solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's safety and effectiveness relies on expert consensus and established scientific literature regarding sodium hypochlorite solutions in dentistry, as promulgated by the American Dental Association Council on Accepted Dental Therapeutics. It is not based on pathology, outcomes data, or a specific patient-level ground truth generated for this submission.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device. The basis for safety and effectiveness comes from general scientific and clinical knowledge of the substance.
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this submission.
N/A