(86 days)
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
3M™ Clinpro™ Prophy Paste is composed of an abrasive, a flavorant, a colorant, and also contains fluoride.
The provided text is a 510(k) summary for a dental product, 3M™ Clinpro™ Prophy Paste. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study with specific acceptance criteria, test sets, and expert evaluations as would be expected for a diagnostic AI device.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because it's not relevant to this type of device and regulatory submission.
However, I can extract what is available and explain why other information is absent.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Goal: | Substantially equivalent to predicate devices. |
| Technological Characteristics: | Similar to predicate devices (Hawe Cleanic® Prophylaxis Paste, Nupro® Prophylaxis Paste with Fluoride) in that all contain an abrasive, flavorant, colorant, and fluoride. |
| Bench Test Results: | Demonstrated similarity to predicate devices in: |
- Stain removal
- Surface roughness
- Relative dentin and enamel abrasion |
Explanation: The document does not specify quantitative acceptance criteria (e.g., "stain removal must be >X%"). Instead, it states that the device has "similar technological characteristics" and that "comparative results of the bench tests" further validate this similarity. The acceptance criterion is implied to be "demonstrating similar performance" to the predicate devices in these specific bench tests, allowing the FDA to determine substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- The studies mentioned are "bench tests" (laboratory tests), not clinical studies involving human patients or data from a specific origin.
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)
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified.
Explanation: As this involves bench testing of a dental paste (material properties), expert clinical consensus is not the method for establishing "ground truth." The "ground truth" for these tests would be the measured results of the predicate devices for comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified.
Explanation: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data to establish a consensus (ground truth). This is not relevant to laboratory bench testing of a dental paste.
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
- MRMC Comparative Effectiveness Study: No.
- Effect Size: Not applicable.
Explanation: The device is a prophylactic dental paste, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable.
Explanation: This is not an algorithm or AI device; it's a physical dental product. Standalone performance refers to the performance of an AI algorithm without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the bench tests would be the measured performance of the predicate devices in stain removal, surface roughness, and relative dentin and enamel abrasion. The new device's performance is compared directly to these established benchmarks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Explanation: "Training set" refers to data used to train machine learning models. This is a physical product, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
Explanation: As there is no training set, this question is not relevant.
§ 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.