(246 days)
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.
The provided text describes an FDA 510(k) premarket notification for an "Endo Motor" device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical efficacy study with specific performance acceptance criteria against a defined ground truth.
Therefore, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way you've outlined for diagnostic AI/ML devices. Instead, it focuses on non-clinical tests to show conformity to standards and comparability to a predicate device.
However, I can extract the relevant information regarding performance claims and testing as best as possible from the provided text, especially concerning the "apex locator" function.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a device of this type:
Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)
The Endo Motor (Model: ZR-Rap) is a cordless endodontic treatment motorized handpiece with root canal measuring capability. The 510(k) submission aims to demonstrate substantial equivalence to a predicate device (Changzhou Sifary Medical Technology Co., Ltd. E-Connect S Endo Motor, K201993). The primary "acceptance criteria" in this context are conformity to relevant standards and comparable performance to the predicate, especially regarding the apex locator function.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (Proposed Device) | Remarks |
|---|---|---|
| Canal Enlargement Performance (Rotation Speed) | 150rpm-650rpm | This range is different from the predicate (120-1000 rpm) but the submission states: "The rotation speed of Endo Motor is within the speed range of the predicate device, and it has passed performance test, no affect on safety or efficacy." This implies the performance range is deemed acceptable and safe. |
| Canal Enlargement Performance (Torque) | 0.6N.cm-4N.cm | This range is different from the predicate (0.5N.cm-4N.cm) but is implied to meet performance expectations and safety, similarly to rotation speed. |
| Apex Locator Function Accuracy | -0.5mm to +0.5mm for Apex position. | This is explicitly stated as "Same" as the predicate device. This is the closest to a quantitative performance acceptance criterion mentioned for a functional aspect. |
| Biocompatibility | Materials conform to ISO10993. | Verified through non-clinical testing against a recognized standard. |
| Electromagnetic Compatibility (EMC) | Conform to IEC60601-1-2:2014 & IEC60601-1-2 | Verified through non-clinical testing against recognized standards. |
| Electrical, Mechanical, Thermal Safety | Conform to IEC60601-1 | Verified through non-clinical testing against a recognized standard. |
| General Dental Equipment Safety & Performance | Conform to IEC 80601-2-60:2019 | Verified through non-clinical testing against a recognized standard. |
| Handpieces and Motors Standards | Conform to ISO 14457:2017 | Verified through non-clinical testing against a recognized standard. |
| Software Documentation (for medical devices) | Moderate level of software documentation per FDA Guidance. | Software documentation was provided and assessed. |
| Reprocessing Validation (cleaning, disinfection, sterilization) | Reprocessing validation performed per FDA Guidance Document. | Validated to ensure the device components (Contra Angle, Lip Hook, File clip, Protective silicon cove) can be safely reprocessed, similar to the predicate's autoclavable components. |
| Comparative Root Canal Measurement Performance (for apex locator function) | Performed to evaluate the root canal length; results demonstrated substantial equivalence (implicitly met the predicate's -0.5mm to +0.5mm accuracy). | This is a specific test for the critical apex locator function. While the exact methodology and pass/fail criteria beyond matching the predicate are not detailed, the conclusion is that it supports substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "A Comparative Root Canal Measurement Performance Test to evaluate the root canal length" was performed. However, it does not specify the sample size (e.g., number of teeth, number of root canals, number of measurements) used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for an existing technology, such tests are often conducted in-house on extracted teeth or phantoms.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
The document does not specify the number of experts used, their qualifications, or if external experts were involved in establishing ground truth for the "Comparative Root Canal Measurement Performance Test." It implies that the test was conducted to compare its performance with existing methods or the predicate, but details on ground truth establishment are absent.
4. Adjudication Method
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI/ML diagnostic aids that assist human readers. The Endo Motor is a handpiece with an integrated apex locator, not a diagnostic AI/ML device that interacts with human readers for interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was done for the apex locator function, as indicated by "A Comparative Root Canal Measurement Performance Test to evaluate the root canal length." The stated performance for this function is an accuracy of "-0.5mm to +0.5mm for Apex position." The study directly assessed the device's ability to measure root canal length.
The other "standalone" performance studies were non-clinical tests demonstrating conformity to various safety and performance standards (e.g., ISO, IEC).
7. Type of Ground Truth Used
For the "Comparative Root Canal Measurement Performance Test," the document does not explicitly state the type of ground truth used. For an apex locator, common ground truths involve physical measurements taken after canal preparation (e.g., direct measurement with a caliper after sectioning a tooth or using a known reference point). It's likely an objective, physical measurement rather than expert consensus, pathology, or outcomes data, but this is an inference.
8. Sample Size for the Training Set
The concept of a "training set" is typically applicable to AI/ML models. Since this device is a traditional electromechanical medical instrument with integrated measurement capabilities rather than an AI/ML diagnostic tool, there is no mention or indication of a "training set" in the provided document.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set," this question is not applicable to the information provided in the document.
In summary: The submission relies on demonstrating conformity to international standards, comparing specifications and indications for use with a legally marketed predicate, and conducting specific non-clinical performance tests (like the root canal measurement performance test) to show substantial equivalence. It does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in clinical trials for novel diagnostic devices, especially those incorporating AI/ML.
§ 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.