(148 days)
The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis.
The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.
The provided text describes a 510(k) summary for the EMS AIR-FLOW MASTER device. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods in the manner typically expected for a detailed study report.
The text primarily focuses on:
- Device description and intended use: Detailing what the device is and what it's used for (non-surgical removal of subgingival plaque in pockets up to 5mm).
- Technological characteristics and substantial equivalence: Comparing the new device to a predicate device and explaining why it is substantially equivalent.
- Testing performed: Stating that electrical safety, electromagnetic compatibility, performance testing, and clinical data were provided.
Therefore, I cannot fulfill all aspects of your request as the specific information is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | "Test results demonstrate that the EMS AIR-FLOW MASTER fulfills the prospectively defined performance specifications and can be used safely and effectively for subgingival cleaning." |
Specific numerical acceptance criteria (e.g., minimum plaque removal percentage, maximum adverse event rate) and detailed performance metrics are not provided.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document only mentions "clinical data" was provided.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
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:
- No MRMC study is mentioned. This device is an air-polishing unit, not an AI diagnostic tool that requires human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical dental tool, not an algorithm.
7. The type of ground truth used:
- For a device like this, ground truth would typically refer to the clinical assessment of plaque removal and pocket depth reduction by a dental professional. However, the exact methodology for establishing this "ground truth" in the clinical data is not detailed.
8. The sample size for the training set:
- Not applicable/Not specified. This is a physical device, and the concept of a "training set" as used in AI/machine learning does not apply in this context unless referring to product development and testing cycles, which are not detailed here.
9. How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons above.
In summary: The provided document is a 510(k) summary, which is a regulatory filing. While it states that performance testing and clinical data were provided, it does not offer the granular detail regarding study design, acceptance criteria, sample sizes, or ground truth establishment that you are requesting. Such details would typically be found in the full study report, not in this summary document.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.