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510(k) Data Aggregation
(214 days)
I-ENDO DUAL
I-Endo Dual is indicated for use by dentists in standard endodontic procedures using endodontic files and endodontic drills.
The I ENDO DUAL is an electric motor-driven handpiece intended for root canal preparation procedures in the endodontic industry. It works in both reciprocating mode and continuous rotation.
The motor allows the dentist to program 10 settings of their choice for speed and torque control in rotating mode and to program 10 setting of their choice for speed and angles in reciprocating mode.
The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate and deactivate the motor.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "I-ENDO DUAL" dental motor.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (General Safety Norms) | Complies |
| IEC 60601-1-2 (EMC) | Complies |
| IEC 55011 (EMC Conducted RF emissions) | Complies |
| IEC 60529 (Degrees of protection by enclosures - IP Code) | Complies |
| IEC 61000-4-2 (EMC Electrostatic Discharge Immunity) | Complies |
| IEC 61000-4-3 (Radiated RF immunity) | Complies |
| IEC 61000-4-4 (Fast Transient Immunity) | Complies |
| IEC 61000-4-5 (Pulse immunity) | Complies |
| IEC 61000-4-6 (Conducted RF immunity) | Complies |
| IEC 61000-4-11 (Supply Voltage Hole Immunity) | Complies |
| ISO 11498:1997 (Dental handpieces, Dental low-voltage electrical motors) | Complies |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size in terms of the number of devices tested for the performance evaluations. It generally refers to "the I-ENDO DUAL" being tested.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing was performed by a "Notified Laboratory."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The study focuses on compliance with technical standards through laboratory testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and is not provided. The testing involves standardized laboratory measurements against defined technical standards, not expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The document describes technical performance testing against standards and a comparison to a predicate device based on technical characteristics and intended use, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm only) performance study was not done, as the I-ENDO DUAL is a physical dental motor, not an AI algorithm. The performance data relates to the device's adherence to safety and electromagnetic compatibility standards.
7. The Type of Ground Truth Used:
The "ground truth" used in this context refers to the specified technical requirements and limits defined within the cited international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 11498:1997). The device performance was compared against these predefined physical and electrical safety benchmarks.
8. The Sample Size for the Training Set:
This information is not applicable and is not provided. The I-ENDO DUAL is a physical medical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and is not provided, as the device is not an AI system requiring a training set.
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