(140 days)
The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.
The proposed AIR-FLOW PLUS Prophylaxis Powder is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) as a preservative. This prophylaxis powder is intended to be used with all currently available EMS dental handpieces for AIR-FLOW and PERIO-FLOW treatments. The addition of CPC is to preserve the powder from bacterial contamination by humidity and microorganisms when the container is opened. Clinical studies have not been conducted to demonstrate that the presence of CPC in this device results in improved clinical outcomes.
The principle of operation of the proposed AIR-FLOW PLUS Prophylaxis Powder is identical to predicate and reference device powder is mixed with air and water in the dental handpiece nozzle to create a mechanically abrasive stream used in polishing procedures.
The device in question is the AIR-FLOW PLUS Prophylaxis Powder. It is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) used with EMS dental handpieces for cleaning and preparation of teeth. The provided document is a 510(k) summary for this device, determining its substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific numerical acceptance criteria in a table. Instead, it describes functional testing and biocompatibility assessments, concluding that "All tests were successfully performed and all acceptance criteria were met". Based on the descriptions, the implicit acceptance criteria are:
| Acceptance Criteria Category | Reported Device Performance | Study Type |
|---|---|---|
| Shelflife | Met 24 months real-time aging requirements. | Real-time aging study |
| Biocompatibility | - Cytotoxicity: Passed requirements. | - Sensitization: Passed requirements. |
| Subgingival Performance (Cleaning) | More efficient at cleaning painted metal plates compared to the PERIO (predicate) powder. | Comparison testing: Cleaning test |
| Subgingival Performance (Abrasivity) | Equivalent abrasivity to the PERIO (predicate) powder (based on erosion of PEEK). | Comparison testing: Abrasivity test |
| Supragingival Performance (Cleaning Efficiency) | More efficient than the SOFT (reference device) powder and similar to other marketed supragingival powders (CLASSIC, COMFORT, SOFT) in cleaning painted metal surfaces. | Comparison testing: Cleaning efficiency test using an automated test bench |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of test specimens, number of repetitions) for any of the performance tests.
- Shelflife testing: Not specified.
- Biocompatibility testing: Not specified (e.g., number of cell culture replicates, number of animal subjects if applicable).
- Comparison testing (Subgingival and Supragingival): Not specified (e.g., number of metal plates, number of PEEK samples, number of cleaning cycles).
The data provenance is from E.M.S. Electro Medical Systems S.A. (Switzerland), the manufacturer. The studies appear to be prospective in nature, as they were conducted specifically to support the 510(k) submission for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is not an AI/ML device that generates diagnoses or predictions. Therefore, the concept of "ground truth" established by experts in the context of clinical interpretation (e.g., radiologists interpreting images) does not directly apply. The "ground truth" in this context refers to the defined objective outcomes of the physical and chemical tests.
- Shelflife: Determined by laboratory testing following established protocols (e.g., stability assays over time).
- Biocompatibility: Determined by standardized laboratory tests conforming to ISO 10993-1, interpreted by qualified toxicologists or biocompatibility experts. The number of such experts is not specified.
- Comparison Testing: The "ground truth" for cleaning efficiency and abrasivity is based on objective laboratory measurements (e.g., visual assessment of paint removal, weight loss of PEEK, calculated cleaning efficiency). The "experts" in this case would be the laboratory personnel conducting and analyzing the tests, ensuring adherence to protocols and accurate data collection. Their specific qualifications and numbers are not mentioned.
4. Adjudication Method for the Test Set
Given that the studies are primarily about physical and chemical performance, and not diagnostic or interpretive tasks, a formal "adjudication method" like 2+1 or 3+1 by multiple clinical experts is not applicable. The results are based on objective measurements and established laboratory protocols. Any potential "adjudication" would involve internal quality control processes to ensure test validity and reliability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in diagnostic tasks, where the impact on human performance is measured. This device is a dental prophylaxis powder, and its performance is evaluated based on physical and chemical properties, not diagnostic accuracy or human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone AI/ML algorithm performance study was not done. This device is a physical product (prophylaxis powder), not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the AIR-FLOW PLUS Prophylaxis Powder is based on objective laboratory measurements and established physical/chemical standards:
- Shelflife: Measured degradation or stability of the product over time.
- Biocompatibility: Results of standardized toxicology and irritation assays.
- Cleaning efficiency: Quantifiable removal of a paint layer from a metal plate using an automated test bench.
- Abrasivity: Measurable erosion of a standard material (PEEK).
This is not expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather factual, measurable outcomes from controlled experiments.
8. The Sample Size for the Training Set
This question is not applicable. The AIR-FLOW PLUS Prophylaxis Powder is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The product's formulation and manufacturing processes are likely developed through research and development, but this is distinct from training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI/ML algorithm.
§ 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.