(244 days)
Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the file tip inside the canal.
E-LITE MAX & ELITE-INO:
The Endo Motor with E-LITE MAX and ELITE-INO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. It is designed to enlarge the root canal, facilitate dentin filling, or measuring the root canal length. The product is a portable device consist of a cordless hand-piece and a charge base, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.
There are three function features for E-LIT MAX and ELITE-INO:
- Root Canal enlargement: Prepare the root canal with apex locator function.
- Apex Location: Measure the length of the root canal.
- Multi-function: Measuring the length while root canal preparation.
The device can save 9 programs, each program can set different parameters according to the user.
E-LITE PRO:
The Endo Motor with E-LITE PRO is a low-speed rotating oral equipment mainly used for root canal preparation. It is designed to enlarge the root canal or facilitate dentin filling. The product is a portable device having a cordless hand-piece with a charging adapter, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.
There is only one function features for E-LITE PRO:
- Root Canal enlargement: Prepare the root canal, without apex locator function.
The device can save 9 programs, each program can set different parameters according to the user.
The Endo Motor must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor is intended to be sterilized prior to use.
The compatible device can be used with Endo Motor is rotary instruments such as rotary root canal files, the working part of rotary instruments normally made of Nickel titanium (NiTi). These files are not included in the submission.
The provided FDA 510(k) clearance letter and summary for the "Endo Motor" (K242514) indicate that this is a dental handpiece and accessories, specifically an endodontic motor with root canal measurement capabilities. This type of device is not an AI/ML-enabled medical device and therefore the provided document does not contain the information typically found in an FDA submission for AI/ML devices regarding acceptance criteria, training data, ground truth establishment, or clinical study design (e.g., MRMC studies).
The document states: "No clinical test data was used to support the decision of substantial equivalence." This further confirms that a study validating an AI/ML component was not part of this clearance.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of a traditional medical device (an endomotor) against established electrical safety, EMC, usability, and functional standards, as opposed to the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information related to AI/ML device validation because it is not present in the provided document. The document describes compliance with recognized standards for traditional medical devices (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
However, I can extract the general "acceptance criteria" and "device performance" as understood for this type of non-AI device from the provided tables, focusing on the comparative aspects:
Acceptance Criteria and Device Performance (Based on traditional device comparison):
The acceptance criteria for the Endo Motor (E-LITE MAX, E-LITE PRO, ELITE-INO) are primarily established through a direct comparison to a predicate device (Guilin Woodpecker Medical Instrument Co., Ltd.'s Endo Motor, K203320) and compliance with relevant international standards for medical devices. The objective is to demonstrate that the proposed device is "substantially equivalent" in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (from Predicate Device or Standards) | Reported Device Performance (Proposed Device) | Judgment |
|---|---|---|---|
| General | |||
| Device Class | Class 1 | Class 1 | SE |
| Prescription Use | Prescription Use | Prescription Use | SE |
| Anatomical Sites | Root canal, Softened dentin | Root canal, Softened dentin | SE |
| Target Population | Patients in need of root canal surgery | Patients in need of root canal surgery | SE |
| Where Used | Dental Clinic, University, Hospital, other clinical settings | Dental Clinic, University, Hospital, other clinical settings | SE |
| Intended Use | Cordless endodontic treatment motorized handpiece with root canal measurement capability. Can be used for preparation and enlargement of root canals, or measuring canal length, and enlarging while monitoring file tip position. | Identical to predicate device. | SE |
| Safety & Performance | |||
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE |
| Usability Engineering | Compliance with IEC 62366-1 | Compliance with IEC 62366-1 | SE |
| Software | Compliance with IEC 62304 | Compliance with IEC 62304 | SE |
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | SE |
| Power Supply | Lithium battery (DC3.7) | Lithium battery (DC3.7) | SE |
| Charger Power Supply | AC100V-240V | AC100V-240V | SE |
| Frequency of Supply Voltage | 50Hz ~ 60Hz | 50Hz ~ 60Hz | SE |
| Components | Measuring wire, File clip, Lip hook, Touch probe, Tester, Spray Nozzle | Measuring wire, File clip, Lip hook, Touch probe, Tester, Spray Nozzle | SE |
| Safety Mechanism | Automatically stops or reversely rotates as soon as the file reaches the apical stop, to prevent perforation. | Automatically stops or reversely rotates as soon as the file reaches the apical stop, to prevent perforation. | SE |
| Micro Motor | Brushless | Brushless | SE |
| USB Ports | Yes | Yes | SE |
| Operation Mode | Continuous operation | Continuous operation | SE |
| Key Performance Parameters (with noted differences) | |||
| Dimension (Handpiece) | Ai-Motor: 28x33.7x199.2mm; Endo Radar Plus: 27.8x29x212mm | E-LITE MAX: φ32x150mm; E-LITE PRO: φ30x151mm; ELITE-INO: φ30x200mm | Note 1 (ergonomic design doesn't compromise safety/performance) |
| Weight (Handpiece) | Ai-Motor: 150g; Endo Radar Plus: 151g | E-LITE MAX: 110g; E-LITE PRO: 120g; ELITE-INO: 175g | Note 1 (weight reduction doesn't compromise structural integrity/performance) |
| Torque Range | 0.4 Ncm ~ 5 Ncm | E-LITE MAX: 0.6 | Note 2 (adjustable by operator; device complies with IEC80601-2-60 and has auto-reverse/stop) |
| Rotate Speed | 100 rpm~1200 rpm | E-LITE MAX: 150 | Note 3 (within predicate range; does not affect safety/effectiveness) |
| Primary Contra Angle Gear Ratio | 6:1 | E-LITE MAX: 16:1; ELITE-INO: 6:1; E-LITE PRO: 1:1 | Note 4 (tested; does not affect safety/effectiveness) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML model's performance on a dataset of patient cases. Instead, "tests" refer to engineering and biocompatibility validations of the physical device. Therefore, typical sample size metrics for AI/ML validation are not applicable here. The data provenance is implied by the testing standards (e.g., in-house testing by the manufacturer based on international standards). The nature of this submission indicates a retrospective comparison to an already cleared predicate device, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/ML device and does not involve human expert adjudication of medical image data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
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. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study is specifically relevant to AI/ML devices where the goal is to show the impact of the AI on human reviewer performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical endodontic handpiece, not a software algorithm.
7. The type of ground truth used
For this conventional medical device, "ground truth" refers to the established performance requirements defined by recognized standards (e.g., IEC, ISO) and the functional specifications of the predicate device. Compliance is demonstrated through laboratory testing of the physical device, rather than through expert consensus on medical data or pathology results.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.