(266 days)
This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
This device is a cordless torque driver used for connecting and disconnecting dental implant abutments used in dentistry. The torque driver function includes adjustment of spinning direction (forward and reverse), speed and torque. The maximum torque is 35 Ncm. The device consists of a torque driver, a charge adapter and a charge cradle.
This application describes the MEG-TORQ device, a cordless motor handpiece system for tightening and loosening abutment screws on dental implants. The FDA's 510(k) clearance (K161500) is based on the device being substantially equivalent to the predicate device, ISD900 (K110278), manufactured by NAKANISHI Co., Ltd.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" as a set of quantified thresholds for performance metrics. Instead, "performance data" describes tests performed to affirm the device's safety and functionality in relation to established standards and its predicate device. The conclusion of these tests is that the device meets these standards and is therefore "substantially equivalent."
| Performance Aspect | Standard/Test Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | ISO 14457:2012 Dentistry Handpieces and motors | All test results support substantial equivalence to the predicate devices. |
| Sterilization Validation | ANSI/AAMI ST79, ISO17665-1, ISO 17665-2, ISO 11138-1, and ISO11138-3 | All test results support substantial equivalence to the predicate devices. |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-6, EN 60601-1-2, EN 61000-3-2, EN 61000-3-3 | All test results support substantial equivalence to the predicate devices. |
| Abutment Screw Shear (due to higher RPM) | Maximum speed and torque test | The test results showed that this difference does not raise a concern in this regard (i.e., higher RPM does not shear off the abutment screw). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for the non-clinical performance tests. The testing appears to be primarily laboratory-based engineering and performance verification against standards and the predicate device's specifications. The data provenance is implied to be from the manufacturer, MICRO-NX Co., Ltd. (REPUBLIC OF KOREA), as they conducted and submitted the tests. The tests performed are retrospective in the sense that they are conducted on the final device design to demonstrate compliance, rather than during an iterative development process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. The "ground truth" here is compliance with technical standards and the functional performance outlined in the predicate device's specifications. These are established through recognized testing methodologies rather than human expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers are interpreting images or data, and disagreements need to be resolved to establish ground truth. The tests described are objective engineering and performance tests against defined standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was provided in the submission." This type of study would involve human readers (e.g., dentists) using the device and evaluating its effectiveness compared to alternatives, potentially with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The MEG-TORQ is a physical medical device (a dental handpiece), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.
7. Type of Ground Truth Used:
The ground truth used for demonstrating substantial equivalence is based on:
- Standards Compliance: Meeting the requirements of recognized international and national standards (ISO 14457, ANSI/AAMI ST79, ISO17665-1/2, ISO 11138-1/3, IEC 60601-1/1-6, EN 60601-1-2, EN 61000-3-2/3-3).
- Predicate Device Specifications: The functional and safety characteristics of the legally marketed predicate device (ISD900, K110278).
- Engineering Verification: Direct measurement of physical performance (e.g., torque output, speed, "abutment screw shear" test) against expected values or parameters to ensure safe and effective operation within the intended use.
8. Sample Size for the Training Set:
Not applicable/provided. As this is a mechanical device, there is no "training set" in the context of an AI algorithm or model. The device development would involve engineering design and testing prototypes, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable/provided. See point 8.
§ 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.