(535 days)
Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.
Cordless endo motor is a professional equipment for root canal preparation. It is a drive for contra angle headpiece which is designed to assist dentists and dental surgeons perform standard endodontic procedures. The endo motor consists of Cordless main unit, Charger station and Adapter. It is intended to use with FDA cleared contra-angle handpiece (transmission ratio of contra angle handpiece: 16:1) which would hold the drill bit or file. However the device do not included the contra angle handpiece and files. The Endo smart is equipped with rechargeable Li-ion battery, which can be recharged using the provided charge station. By means of the different buttons on the main unit, the user could control various functions in the device, such as On/off, Speed, Torque and auto-reverse/auto forward mode. The Endo motor is not sterile and cannot be autoclaved.
The provided document is a 510(k) summary for the Endo Motor Model: T-Fine-II. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies and setting specific acceptance criteria commonly seen for novel devices or highly complex AI/ML devices.
Therefore, the document does not contain the detailed information typically associated with acceptance criteria and a study proving a device meets these criteria for an AI/ML-based medical device. Specifically, it lacks information on:
- A table of acceptance criteria and reported device performance for an AI/ML system (as this is a mechanical dental device).
- Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods (as no clinical or AI-specific validation studies were conducted for this device beyond bench testing for electrical safety and EMC, and software verification/validation).
- MRMC studies, standalone algorithm performance, or specific ground truth types (pathology, outcomes data) relevant to AI/ML.
- Training set details for an AI/ML model.
What the document does provide in terms of "acceptance criteria" and "proof":
For this specific device, the "acceptance criteria" are compliance with relevant safety and performance standards for dental electrical equipment and demonstrating substantial equivalence to a predicate device. The "proof" involves a combination of bench testing and comparison.
Here's an interpretation based on the provided text, focusing on the available information:
1. Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):
| Acceptance Criteria (Inferred from regulatory requirements for this device type) | Reported Device Performance (from "Test Summary" and "Comparison to Predicate Device" sections) |
|---|---|
| Electrical Safety: Comply with general requirements for medical electrical equipment. | Complies with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, and IEC 80601-2-60:2012. |
| Electromagnetic Compatibility (EMC): Ensure device functions without unacceptable electromagnetic interference. | Complies with IEC 60601-1-2:2014. |
| Cleaning and Disinfection: Compatibility with specified cleaning/disinfection procedures. | Conducted according to AAMI TIR30 and AAMI TIR12. |
| Software Functionality: Software operates as intended and is safe. | Software verification and validation testing conducted. Determined to be of "moderate" level of concern. Documentation provided as recommended by FDA guidance. Display function validated in software evaluation report. |
| Substantial Equivalence: Device is as safe and effective as a legally marketed predicate device. | Compared to predicate device (Cordless ENDO-Handpiece "ENTRAN" K090931). Found very similar in design principle, intended use, indications for use, functions, material, and applicable standards. Minor differences (weight, displayed parameters, battery capacity, operating/storage temperature, torque range) do not raise new questions of safety or effectiveness as per the applicant's detailed notes and compliance with safety standards. Specifically, it provides auto reverse and stop function meeting IEC80601-2-60 requirements. |
| Intended Use: Device performs its intended medical function. | "Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal." (Same intended use as predicate, despite minor wording differences). |
| Performance (Mechanical/Functional): Basic mechanical parameters operate within acceptable ranges. | Torque: 0.3-3.0 Ncm (Predicate: 0.5-4.0 Ncm) – Minor difference noted but considered safe due to adjustability and auto-reverse/stop functions. Transmission ratio of electric contra angle: 16:1 (Same as predicate). Auto-control mode: Yes (Same as predicate). Settable functions: Speed, Torque, Auto-control (Same as predicate). |
2. Sample Sizes and Data Provenance:
- No specific sample sizes for test sets (patients/images) are mentioned because this device's validation is primarily through bench testing against engineering standards and comparison to a predicate, not clinical trials or AI/ML model validation with patient data.
- The document implies manufacturing is in Foshan, Guangdong, China (manufacturer location).
- The testing appears to be bench testing for engineering compliance, not retrospective or prospective clinical data collection.
3. Number of Experts and Qualifications:
- Not applicable. This information is relevant for studies establishing ground truth for AI/ML or clinical interpretation, which were not conducted or required for this device's 510(k) submission.
4. Adjudication Method:
- Not applicable. No clinical data interpretation requiring adjudication was performed or described.
5. MRMC Comparative Effectiveness Study:
- No. This type of study is for evaluating human reader performance with and without AI assistance, which is not relevant to this mechanical dental device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a mechanical Endo Motor, not an AI algorithm. Its software is for controlling the device's functions, not for diagnostic or predictive tasks that would have standalone performance metrics.
7. Type of Ground Truth Used:
- No "ground truth" in the AI/ML sense (e.g., pathology, outcomes data, expert consensus) was used. The validation relies on:
- Engineering Standards Compliance: The standards (IEC 60601 series, AAMI TIRs) themselves define the "ground truth" for safety and performance (e.g., passing electrical leakage tests, demonstrating specific torque output).
- Predicate Device Comparison: The predicate device (K090931) serves as a benchmark for "equivalent" safety and effectiveness.
8. Sample Size for Training Set:
- Not applicable. There is no AI/ML model being trained with patient data for this device.
9. How Ground Truth for Training Set Was Established:
- Not applicable. As there is no AI/ML model training, this step is irrelevant.
In summary, the provided document is a 510(k) summary for a Class I mechanical dental device. The "acceptance criteria" and "proof" presented align with the regulatory pathway for such devices, focusing on compliance with recognized electrical and mechanical safety standards and demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies or AI/ML validation.
§ 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.