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510(k) Data Aggregation
(779 days)
ELEC ENGINE (Model: ISE-170L)
The ELEC ENGINE (Model: ISE-170L) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control.
With external power supply being provided, this device operates the main body through switching AC power to DC power and it performs dental implant surgery with handpiece being connected for rotation power generated through turning BLDC motor.
The provided document is an FDA 510(k) clearance letter for a dental handpiece and accessories, the "ELEC ENGINE (Model: ISE-170L)". It focuses on establishing substantial equivalence to a predicate device, not on proving clinical performance through a comparative effectiveness study involving AI or human readers.
Therefore, the information regarding acceptance criteria, study design for proving performance, expert involvement, and specific performance metrics for AI-driven devices (like an MRMC study, effect size, standalone performance, or ground truth establishment relevant to AI/diagnostic support) is not present in this document. The document describes a traditional medical device clearance based on equivalence to an existing device, focusing on electrical, mechanical, biocompatibility, and reprocessing safety and performance standards.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria or reported performance in the context of an AI/diagnostic device's accuracy or efficacy. Instead, it lists standards the device conforms to for safety and basic mechanical performance.
| Category | Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|---|
| Electrical & Mechanical Safety | Conformance to IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment), IEC 60601-1-2 (Electromagnetic compatibility), and IEC 80601-2-60 (Particular requirements for dental units) | "The device passed all the tests based on pre-determined Pass/Fail criteria." (Implies adherence to standard requirements) |
| Reprocessing Validation | Conformance to ISO 17664-1 (Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices) and ISO 17665-1 (Sterilization of health care products - Moist heat) | "The device passed all the tests based on pre-determined Pass/Fail criteria." (Implies adherence to standard requirements) |
| Biocompatibility Testing | Conformance to ISO 10993-1 (Biological evaluation of medical devices), ISO 10993-5 (Tests for in vitro cytotoxicity), ISO 10993-23 (Tests for irritation), and ISO 10993-10 (Tests for irritation and skin sensitization) | "The device passed all the tests based on pre-determined Pass/Fail criteria." (Implies adherence to standard requirements) |
| Performance Testing | Conformance to ISO 14457 (Dental handpieces and motors) | "The device passed all the tests based on pre-determined Pass/Fail criteria." (Implies adherence to standard requirements, e.g., torque, speed, and other operational parameters) |
| Usability Testing | Conformance to IEC 60601-1-6 (Usability) and IEC 62366-1 (Application of usability engineering to medical devices) | "The device passed all the tests based on pre-determined Pass/Fail criteria." (Implies adherence to standard requirements for safe and effective use) |
| Equivalence (Operational) | Max. torque: 70mNcm; Speed: 200-40,000 rpm; Conformance to E-type(ISO3964) shanks | Matched predicate device specifications: Max.70mNcm torque, 200-40,000 rpm speed, E-type(ISO3964) shanks. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. For a device like this, testing would typically involve a certain number of manufactured units or components selected to demonstrate compliance with the listed standards. It's not based on patient data sets like an AI algorithm.
- Data Provenance: Not applicable in the context of clinical data. The tests are technical/engineering verifications rather than clinical studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. The "ground truth" here is compliance with engineering standards and specifications, not clinical diagnoses or interpretations. These tests would be conducted by qualified engineers and technicians.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Performance is determined by meeting pre-defined thresholds and specifications from the relevant international standards (e.g., IEC, ISO).
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
- MRMC Study: No. This document describes a mechanical/electrical dental device, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical and electrical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, international performance standards, and safety requirements (e.g., electrical safety, mechanical robustness, biocompatibility, reprocessing efficacy). It is not derived from clinical data, pathology, or outcomes.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As it's not an AI model, there is no training set or associated ground truth establishment.
In summary: The provided FDA 510(k) clearance letter details the regulatory approval of a traditional dental device. The "acceptance criteria" and "study" described are focused on proving the device's safety, performance characteristics, and substantial equivalence to a legally marketed predicate device through engineering and quality standard adherence, not through clinical performance studies involving AI or diagnostic accuracy metrics.
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