(91 days)
Butler NuCare™ Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare™ Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.
Butler NuCare™ Prophylaxis Paste with NovaMin® is a product that is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Butler NuCare™ Prophylaxis Paste with NovaMin® is also designed to physically occlude dentinal tubules for the immediate relief of tooth sensitivity, post-scaling and root planing. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Here's an analysis of the provided text, focusing on acceptance criteria, study details, and related information, formatted as requested.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it makes a general statement about efficacy.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| None explicitly quantified. | "Butler NuCare™ Prophylaxis Paste with NovaMin® occludes a significant number of tubules when compared with controls." |
| "no evidence of any hazardous effects to the patient if the product is used as directed." | "Many different biocompatibility tests have been performed on the NovaMin® particulate, the active ingredient... The results of these tests indicate there is no evidence of any hazardous effects to the patient if the product is used as directed." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The text only mentions "a bovine table overalian block model" for the tubule occlusion efficacy study.
- Data Provenance: The tubule occlusion study used a bovine (cattle) model, not human data. The location or timeline (retrospective/prospective) of this study is not mentioned. The biocompatibility tests are also not described in terms of sample size or provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described (tubule occlusion in a bovine model) does not appear to involve human expert ground truth for interpretation. Biocompatibility tests rely on laboratory standards and results rather than expert consensus on interpretation of device performance against ground truth in a clinical sense.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the in vitro (bovine block model) tubule occlusion study and biocompatibility tests, an adjudication method for human readings would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The study described evaluated the device's performance (in vitro tubule occlusion) against controls, not in the context of human readers with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a prophylactic paste, not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device's performance was evaluated for tubule occlusion and biocompatibility.
7. The Type of Ground Truth Used
- For Tubule Occlusion Efficacy: The ground truth was established by comparing the device's ability to occlude tubules against "controls" in a bovine table overalian block model. This implies a quantitative measurement of tubule occlusion compared to a baseline or non-treated sample, rather than expert consensus, pathology, or outcomes data from human subjects.
- For Biocompatibility: The ground truth is based on standard biocompatibility test methodologies and thresholds, which determine whether there is "evidence of any hazardous effects."
8. The Sample Size for the Training Set
This information is not applicable as the device is a dental prophylaxis paste, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.