Search Results
Found 1 results
510(k) Data Aggregation
(686 days)
N2 is intended to supply power to and serve as a base for dental devices and accessories. This includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
The N2 is an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronicallycontrolled chair movements with software and water unit functions.
This document describes the N2, a dental operative unit, and its substantial equivalence to a predicate device (K183347), K3. The submission focuses on non-clinical testing for safety and performance rather than AI-driven image analysis. Therefore, many of the requested fields regarding AI performance, such as sample size for test/training sets, data provenance, number and qualification of experts, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.
The document details the device's technical characteristics, intended use, and indicates that no clinical studies were deemed necessary. The acceptance criteria and "reported device performance" are primarily demonstrated through compliance with various international standards and specific bench tests, rather than metrics like sensitivity, specificity, or accuracy which would be typical for an AI-enabled diagnostic device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance (Compliance/Result) |
|---|---|
| Biocompatibility Testing | |
| FDA Guidance Document | Evaluation conducted in accordance with FDA Guidance. |
| ISO 10993-1 (Biological Evaluation) | Evaluation conducted in accordance with ISO 10993-1. |
| ISO 10993-5 (Cytotoxicity) | Testing performed. |
| ISO 10993-10 (Skin sensitization, Oral Mucosa Irritation, or Skin Irritation) | Testing performed. |
| Cleaning and Sterilization Validation | |
| FDA Guidance for Reprocessing Medical Devices | Cleaning of 3-way syringe tip validated according to FDA Guidance. |
| ISO 17665-1, 2 (Sterilization) | Sterilization testing for steam sterilization performed, acceptable sterility assurance level (10⁻⁶) achieved for reusable 3-way Syringe. |
| ISO 16954:2015 (Dental Unit Waterline Biofilm Treatment) | Cleaning/disinfection method effectively cleaned the waterline. Routine (Daily) and shock treatment (2 weeks) performed and verified. |
| Electrical Safety and EMC | |
| IEC 60601-1:2005 + A1:2012 (Basic Safety) | Complied with IEC 60601-1. |
| IEC 80601-2-60:2012 (Dental Equipment Safety) | Complied with IEC 80601-2-60. |
| IEC 60601-1-2:2014 (EMC) | Complied with IEC 60601-1-2. |
| Usability Testing | |
| IEC 60601-1-6 Edition 3.1 2013-10 (Usability) | Usability testing conducted. |
| IEC 62366:2015 (Usability Engineering) | Usability testing conducted. |
| Software Validation | |
| FDA Guidance for Software in Medical Devices | Software (firmware, MODERATE level of concern) designed, developed, verified, and validated according to a software development process. Documentation provided. |
| Performance Test (Bench Test) | Performed, and test results met pre-set criteria. (Specific criteria not detailed in this summary, but generally implies functional performance as an operative dental unit, e.g., air/water pressure, chair movements, etc., as per the comparison table and functional description). The differences in Water Pressure, Patient Load, Chair Height, Back Rest, and unit type compared to the predicate device do not affect substantial equivalence, and safety was verified. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission describes a physical dental operative unit, not an AI/software device that processes medical image data or other patient-specific data for diagnostic or prognostic purposes. The "testing" refers to bench testing and compliance with electrical, mechanical, and safety standards for the device itself.
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 is not applicable. Ground truth, in the context of expert consensus, is typically established for diagnostic tasks where human interpretation is the gold standard. For this device, "ground truth" would relate to the physical and functional parameters meeting engineered specifications and safety standards, validated through direct measurement and compliance testing (e.g., measuring current, pressure, chair movement ranges).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, which is not relevant for the testing described here.
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 is not applicable. MRMC studies are conducted for systems that assist human readers in tasks like image interpretation. The N2 is a dental operative unit, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The N2 is a physical device with some electronic controls (firmware), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is primarily established by:
- Engineering Specifications: The pre-set criteria for bench tests, electrical safety, and mechanical performance are based on design specifications and industry standards.
- Regulatory Standards: Compliance with international standards such as IEC 60601-1, IEC 80601-2-60, ISO 10993, ISO 17665, and ISO 16954 forms the basis of "truth" for safety and essential performance.
- Manufacturer Recommendations: For cleaning/sterilization, the validation is against the manufacturer's recommended protocols.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of machine learning for this device. The software validation refers to standard software development, verification, and validation (V&V) processes for firmware, not AI model training.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
In summary, the provided document describes a 510(k) submission for a dental operative unit, which is a physical device. The "study" mentioned refers to non-clinical bench testing and compliance with various international electrical, mechanical, safety, and biocompatibility standards to demonstrate substantial equivalence to a predicate device. It is not an AI-enabled diagnostic or assistive device, so many of the requested fields regarding AI performance evaluation are irrelevant.
Ask a specific question about this device
Page 1 of 1