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510(k) Data Aggregation
(323 days)
The device is intended to be used for endodontics (canal preparation and canal cleaning).
The prosed device is used by dental professionals for removal of dentine debris in root canals in the field of endodontics. A turbine hose from a dental unit that supplies the device with compressed air and water is attached of the device in order to use the device. The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site. The device consists of the handpiece including the connection to a hose and file holder.
The proposed device has two model 4H connects to the Midwest 4-hole turbine hose and the model K A connects to the KaVo MULTIflex® quick-disconnect coupling.
The associated accessories include:
- file holder to attach endodontics files
- replacement wrench for the holder
The proposed device and accessories are supplied non-sterile and must be sterilized in an autoclave prior to the first use and after every patient by the end-user.
The provided document is a 510(k) premarket notification for the AW-100 ultrasonic scaler. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a clinical study in the way typically required for AI/ML devices or new medical technologies.
Therefore, many of the requested points regarding sample size, expert ground truth, adjudication methods, MRMC studies, and training set details are not applicable to this type of submission as they were not required or performed.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against the applicable international standard ISO 18397:2016 for powered scalers. The document states that the device passed all performance criteria outlined in this standard.
| Acceptance Criteria (from ISO 18397:2016 - details not fully described in the document) | Reported Device Performance (AW-100) |
|---|---|
| Output frequency (as per ISO 18397:2016) | 2000 to 3000 Hz (measured at 0.28 MPa air pressure) – Passed |
| Amplitude (as per ISO 18397:2016) | Tested at 0.28 MPa air pressure – Passed |
| Resistance to autoclave sterilization | Tested as per relevant standards – Passed |
| Corrosion resistance | Tested as per relevant standards – Passed |
| Basic safety and performance requirements (as per relevant standards) | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
| Risk management | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
| Biocompatibility testing | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
| Reprocessing validation | Evaluated in accordance with elements of applicable international standards for medical devices – Passed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or cases. Non-clinical bench testing was performed on the AW-100 device.
- Data Provenance: Not applicable. This was a non-clinical bench performance study, likely conducted by the manufacturer, Micron Corporation, in Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical bench testing is typically established by engineering measurements and compliance with standard specifications, not by expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was non-clinical bench testing against industry standards.
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
Not applicable. This device is an ultrasonic scaler, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance was compliance with the technical specifications and safety requirements outlined in international standards, specifically ISO 18397:2016 (Dentistry – Powered scaler) and ISO 9168:2009 (Dentistry -- Hose connectors for air driven dental handpieces). This involves objective measurements of physical parameters such as frequency, amplitude, and material properties.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable.
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(191 days)
The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.
The prosed device is used by dental professionals for removal of dental plaque and calculus, and for cleaning in periodontics, endodontics and prosthetics.
To use the device, a hose from a dental unit that supplies the device with compressed air and water is attached to the back end of the device.
The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site.
When compressed air enters inside of the vibrator in the device, it generates mechanical vibration at the working tip attached to the front end of the device. The working tip contacts teeth and in certain cases, gum of the patient.
The removal of plaque and calculus or cleaning is performed by utilizing the vibration. The device consists of the handpiece, connection to a hose and working tips.
The associated accessories include:
- tips for removal of plaque and calculus
- holder tips to attach endodontics files or tooth cleaning brushes
- tooth cleaning brushes
- tip replacement wrench
The proposed device and accessories are supplied non sterilized in an autoclave prior to the first use by the end-user.
The Micron Corporation Y-MIC is an air-driven dental scaler for removing plaque and calculus. The provided document is a 510(k) premarket notification. The purpose of this notification is to demonstrate that the Y-MIC is substantially equivalent to a predicate device, the Sybron Dental Specialties, Inc. SONICflex 2003 (K080089).
The acceptance criteria for the Y-MIC are based on its substantial equivalence to the predicate device and compliance with general controls for medical devices. The study conducted to prove the device meets these criteria is a non-clinical performance and safety evaluation. The document explicitly states that no clinical tests were performed or needed because there were no changes in the indication for use compared to the predicate device.
Here's the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and passing specific non-clinical tests. The "reported device performance" reflects the results of these non-clinical tests.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| General Safety and Compliance with Applicable Standards | The device passed all compliance tests in accordance with elements of applicable international standards for medical devices categorized as dental air scalers. This included evaluation of basic safety requirements, risk management, biological evaluation, and reprocessing of medical devices. |
| Device Performance Features | The device passed all performance criteria for: |
- Frequency output (about 6,000 Hz, matching predicate)
- Amplitude
- Resistance to autoclave sterilization
- Corrosion |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Not applicable; the device is air-driven and not electric-powered, similar to the predicate device. Therefore, it is not subject to IEC 60601 standards, and no testing for electrical safety or EMC was performed. |
| Software Functionality | Not applicable; the device is not software-controlled and incorporates no software, similar to the predicate device. Therefore, there are no concerns about software. |
| Intended Use | The device is intended to remove plaque and calculus in areas of dental scaling, and for use in periodontics, endodontics, and prosthetics by dental professionals. This matches the intended use of the predicate device, supporting substantial equivalence. |
| Technological Characteristics | Operates utilizing the same principle as the predicate: vibration generated by compressed air supplied from a dental unit. - No use of electricity as an energy source.
- Creation of mechanical vibration by utilizing compressed air.
- Use of mechanical vibration to achieve treatment effect.
- Frequency output of vibration about 6,000 Hz.
- Working tips attached to the front end.
- Connector located at the rear end to connect to the dental unit.
- Handpiece design like dental handpieces.
- No use of software to activate and/or control the devices.
- Both supplied non-sterile. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to non-clinical tests on the device itself (hardware), not clinical trials involving human subjects or data sets. Therefore, concepts like "test set sample size" in the context of patient data, data provenance (country of origin), or retrospective/prospective studies are not applicable. The tests were performed on the device prototypes/units in a laboratory setting. The submitting company is Micron Corporation, located in Japan, suggesting the testing likely occurred there or through a contracted lab.
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)
This question is not applicable as there was no "test set" of patient data requiring expert ground truth establishment for a diagnostic or prognostic performance evaluation. The evaluation was a non-clinical assessment of the device's physical and functional performance against engineering standards and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there was no "test set" of patient data requiring adjudication of expert interpretations.
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
This question is not applicable. The device is an ultrasonic scaler for dental cleaning and is not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical dental instrument, not an algorithm. Standalone algorithm performance is irrelevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was based on engineering specifications, performance standards, and comparison to the characteristics of the predicate device. For instance, the "ground truth" for frequency output was the specified approximate 6,000 Hz, verified by measurement. For sterilization resistance, it would be the device maintaining functionality after standard autoclave cycles. There was no biological "ground truth" like pathology or outcomes data in this submission as it was a non-clinical evaluation.
8. The sample size for the training set
This question is not applicable. There was no "training set" as this device is a physical instrument, not a machine learning algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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