(58 days)
Pulpdent Cavity Preparation IV is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this "cleansing" step reduces micro leakage and sensitivity in teeth undergoing treatment or restorations. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate.
Pulpdent Cavity Preparation IV, an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces.
The provided documents are a 510(k) premarket notification for "PULPDENT Cavity Preparation IV." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data that would typically include detailed acceptance criteria and performance studies.
Therefore, the information required in your request regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies is not present in the provided text. The submission focuses on comparing the new device's composition and intended use to existing predicate devices to establish safety and effectiveness based on that comparison.
Here's a breakdown of what is in the document related to your request, and what is conspicuously absent:
1. A table of acceptance criteria and the reported device performance
- Absent. The document does not define specific acceptance criteria for performance metrics (e.g., bonding strength, antimicrobial efficacy, or clinical outcomes), nor does it report direct performance data for the device against such criteria. The "Safety and Effectiveness" section merely states that the materials are "accepted by the Council on Dental Therapeutics and have been used safely in dental procedures for decades." This refers to the general safety of the components, not the performance of the final device against defined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Absent. No clinical or laboratory test sets are described. The submission relies on substantial equivalence to predicate devices, not new performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Absent. There is no mention of expert involvement in establishing ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Absent. No test set or adjudication method is described.
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
- Absent. This device is a dental preparation solution, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related metrics are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Absent. Not applicable to this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Absent. No ground truth establishment is described as there are no new performance studies. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Absent. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Absent. No training set or associated ground truth establishment is mentioned.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a dental preparation solution. It does not contain the type of detailed performance study data, acceptance criteria, sample sizes, or expert involvement typically associated with clinical trials or AI/diagnostic device validation. The "study" here is implicitly a "comparison with predicate products" as mentioned in "Exhibit 5" (which is not provided in full but referenced).
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.