(268 days)
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
The motor turned by the power converted into DC24V by controller delivers its turning power to the bur through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
The provided text describes a 510(k) summary for the Saeyang Microtech ENDO e class device, which is a dental handpiece and accessories. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that a clinical study would typically assess. Instead, the "acceptance criteria" for this 510(k) revolve around compliance with established safety and performance standards for dental devices and demonstrating substantial equivalence to legally marketed predicate devices.
The "reported device performance" is essentially a description of the device's features and its compliance with relevant standards.
| Acceptance Criterion (Implicit in 510(k)) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1: 1988 +A1 1991,+A2 1995 (Medical Electrical Equipment) | Complied |
| Compliance with ANSI/AAMI/IEC 60601-1-2: 2007 (Electromagnetic Compatibility) | Complied |
| Compliance with ISO 3964:1982 (Dental Handpieces - Connections) | Complied |
| Compliance with ISO 7494-1:2004 (Dental Units - Part 1: General Requirements) | Complied |
| Compliance with ISO 7785-2:1995 (Dental Handpieces - Part 2: Dental Low-Speed Handpieces) | Complied |
| Compliance with ISO 11498:1997 (Dentistry - Torque measurement for endodontic handpieces) | Complied |
| Sterilization Validation Passed | Validation performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards. |
| Software Validation Passed | Validation performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards. |
| Speed Accuracy Testing Passed | Testing performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards. |
| Temperature Rise Testing Passed | Testing performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards. |
| Substantial Equivalence to Predicate Devices | The ENDO e class has similar characteristics and intended use as previously cleared devices (AEU-26L, TCM Endo V, ATR TECNIKA). The subject device is substantially equivalent to the predicate devices in intended use, operation, safety and function across key features like motor speed, torque setting, reciprocating drive, foot pedal control, and programmable presets. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set in the sense of patient data. The "tests" were non-clinical bench tests and compliance with standards. The data provenance would be from manufacturing and engineering tests conducted by Saeyang Microtech in Korea.
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)
Not applicable, as no clinical testing with patient data or expert-adjudicated ground truth was performed or required for this type of 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring ground truth adjudication from experts was used.
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 a dental handpiece (a physical tool), not an AI-powered diagnostic or assistive software. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was derived from the specifications and requirements of the international and national standards (e.g., IEC 60601-1, ISO 3964) and the performance characteristics of the predicate devices for comparison. For example, for speed accuracy testing, the ground truth would be the expected or specified speed, and the device's measured speed would be compared against that.
8. The sample size for the training set
Not applicable, as this is a physical device and not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.