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510(k) Data Aggregation
(288 days)
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
The EasyMed InstrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve.
The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).
The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA.
All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination.
This document describes the validation of the EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EasyMed Peripheral Nerve Stimulator are based on compliance with specific electromagnetic compatibility (EMC) standards. The reported device performance indicates that the device passed all these tests.
| Test Type | Test Requirement | Reported Device Performance |
|---|---|---|
| Radiated Emission (30 MHz to 1 GHz) | EN 60601-1-2: 2007 | Pass |
| ESD Susceptibility | EN 60601-1-2: 2007 | Pass |
| Radiated Immunity (90 MHz to 2.5 GHz) | EN 60601-1-2: 2007 | Pass |
| Power-frequency magnetic field immunity | EN 60601-1-2: 2007 | Pass |
Beyond these EMC specific tests, the document also mentions that "All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination." However, the specific acceptance criteria for these physical tests are not detailed in the provided text.
2. Sample Size and Data Provenance
The provided document does not specify the sample size used for the tests mentioned in the "Performance Data" section.
The provenance of the data is not explicitly stated as "country of origin of the data" or "retrospective or prospective." However, given EasyMed Instruments Co., LTD. is located in China, it's reasonable to infer that the testing likely occurred in China. The testing described appears to be prospective testing of the device itself, rather than retrospective analysis of clinical data.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This document describes performance testing for an electrical medical device (peripheral nerve stimulator) against engineering standards (e.g., electromagnetic compatibility). The nature of this testing does not involve establishing ground truth based on expert review of medical images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As the testing described is for engineering performance rather than clinical data interpretation, there is no adjudication method involved. The results are binary (Pass/Fail) based on predefined technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This validation is for a medical device (a peripheral nerve stimulator), not an AI algorithm.
6. Standalone (Algorithm Only) Performance
Not applicable. This document describes the validation of a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests described is the established technical requirements and limits defined by the international standards (e.g., EN 60601-1-2, EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8). The device's performance is measured against these objective, verifiable criteria.
8. Sample Size for the Training Set
Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
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