(57 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.
Model Number: AEU-26L
Classification Name: 872.4200 Dental handpiece and accessories
Product Code: EKX handpiece, direct drive, ac-powered
Primary accessories exclusive to the AEU-26L system:
- a) AEU-26L Consol (Controller)
- b) AE-250L-30 Low Voltage Electric Motor
- c) On/Off Foot Pedal
- d) Motor holder attaching bracket
The AEU-26L is software controlled and has the following features:
- a) Allows adjustment of the motor speed from 300 to 30,000 RPM
- b) Allows setting the torque applied to the motor in gram/cm
- c) Allows selection of gear ratios for different geared E-Type handpieces
- d) Allows selection of forward or reverse drive rotation
- e) Allows reciprocating drive (forward/reverse cycling)
- Allows use of a foot pedal control to operate the attached handpiece motor
- Allows the user to define their own presets for speed (RPM) and torque (gram g)
- h) Allows for attaching geared handpieces that include optics for a light.
The AEU-26L device is a software-controlled dental handpiece system. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily through a comparison with predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the functional characteristics of the predicate devices. The reported device performance for the AEU-26L demonstrates its equivalence or superior performance to these predicates.
| Acceptance Criteria (from Predicate Devices) | Reported Device Performance (AEU-26L) |
|---|---|
| Motor Speed Adjustment: 300 to 30,000 RPM (from AEU-925) | 300 to 30,000 RPM Configurable |
| Torque Control: Yes, with torque accuracy (from AEU-925) | Yes, with Better than predicate device AEU-925 Torque accuracy |
| Gear Ratio Selection: 1:5, 1:4, 1:3, 1:2, 1:1, 35:1 to 3:1 Reduction (from AEU-925) | 1:5, 1:1, 8:1, 16:1 Reduction |
| Forward or Reverse Drive Rotation: Yes (from AEU-925) | Yes |
| Reciprocating Drive: Yes (from ATR TECNIKA) | Yes |
| Foot Pedal Control: Yes, electronic foot control (from AEU-925) | Yes, electronic foot control |
| User-Defined Presets (Speed & Torque): Yes (from AEU-925) | Yes |
| Attachment of Lighted Handpieces: Yes (from AEU-5000) | Yes |
| Safety Standards: Compliance with IEC 60601-1:1988 (thermal/electrical) | Met IEC 60601-1:1988 (thermal and electrical safety of AE-250L-30 motor) |
| EMC Requirements: Compliance with IEC 60601-1-2 | Met IEC 60601-1-2 (electromagnetic compatibility) |
| Motor-Specific Performance: Compliance with ISO 11498 | Met by application of ISO 11498 (Dental handpieces -- Dental low-voltage electrical motors) |
Notes on Performance Comparison:
- Torque Control: The AEU-26L claims improved torque accuracy compared to the AEU-925.
- Gear Ratios: The AEU-26L offers a different set of reduction ratios compared to the AEU-925, but still provides a range for various handpieces.
- Reciprocating Drive & Lighted Handpieces: These are new features to the AEU-26L compared to the AEU-925, and their performance is shown to be equivalent to the respective predicate devices (ATR TECNIKA and AEU-5000).
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical trial or a dataset for AI evaluation. Instead, the performance evaluation relies on "bench testing" and "comparative design verification methods" against predicate devices. This implies that the 'test set' consists of the AEU-26L device itself being tested against established industry standards and specifications of its predicate devices.
- Sample Size: Not explicitly stated as a numerical sample size of patients or images. The testing was performed on the AEU-26L device itself.
- Data Provenance: Not applicable in the traditional sense of patient data. The provenance is the performance characteristics of the device and its comparison to known predicate devices from Aseptico (AEU-925, AEU-5000) and ATR TECNIKA. The testing was likely conducted in a controlled laboratory or engineering environment. The study is retrospective in the sense that it compares features and performance to already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in a way that aligns with establishing ground truth for a test set, as this is a device performance study rather than an AI diagnostic study. The "ground truth" for the device's technical specifications and functionality would be the design requirements and the specifications of the predicate devices, established through engineering and regulatory processes.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process described for a test set in the context of diagnostic interpretation. The evaluation involved verifying the device's functional characteristics and compliance with technical 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
No MRMC comparative effectiveness study was done, as this is a medical device (dental handpiece) and not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. The AEU-26L is a hardware and software controlled dental handpiece system, not an algorithm being evaluated for standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the AEU-26L's performance is established by:
- Technical Specifications and Design Requirements: The device's own design specifications setting out its intended functionality (e.g., speed range, torque control, drive types).
- Predicate Device Specifications: The established and cleared performance characteristics of the Aseptico AEU-925, AEU-5000, and ATR TECNIKA devices with which the AEU-26L claims substantial equivalence for specific features.
- Industry Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and dental handpieces (ISO 11498).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.