(133 days)
The EZstim*III is a battery powered Peripheral Nerve Stimulator/Nerve Locator with two (2) indications for use:
(1) on the high (0.05 - 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia.
(2) on the low (0.05-5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.
The EZstim* III (Model ES500) is both a constant current Peripheral Nerve Stimulator (HIGH output current range) and a Peripheral Nerve Locator (LOW output current range). Output current range is determined by the model of patient lead cable connected to the unit.
- . When the Halyard NSL-5 patient lead cable is connected, the unit automatically sets to the HIGH output current range (0.05 to 80 mA), with no stimulus mode selected (null mode). When the user selects a stimulus mode (i.e., 1 or 2 Hz Twitch, 50 Hz Tetanus, 100 Hz Tetanus, Double-Burst, or Train-of-Four), the unit functions as a nerve stimulator for use in monitoring the effects of skeletal muscle relaxants on the neuromuscular junction.
- . When the Halyard RBW-5U patient lead cable is connected, the unit automatically sets to the LOW output current range (0.05 to 5.0 mA). In this range, the unit functions as a nerve locator for use in regional nerve block procedures.
The provided documentation describes the Halyard Health EZstim* III Peripheral Nerve Stimulator/Nerve Locator (Model ES500), which is a medical device. This device is not an AI/ML device, therefore, many of the requested criteria are not applicable.
Here's an analysis of the acceptance criteria and study information provided for this medical device, tailored to what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name and Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| IEC 60601 Safety Testing (Electrostatic Discharge, Radiated Immunity, Conducted RD Immunity, Magnetic Field Immunity, Radiated Emissions, Immunity to proximity field from RF wireless communication equipment, Conducted Disturbances Induced by RF Fields Immunity, Power Frequency Magnetic Fields Immunity, Leakage Current, Dielectric Voltage Withstand, Excessive Temperature, Humidity Preconditioning, Abnormal Operation and Fault Conditions) | Compliance with IEC 60601-1 (3.1 Edition) and IEC 60601-1-2 (4th Edition) | Pass |
| Software Verification (Validation in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)) | Software meets design requirements | Pass |
| Hardware Verification (Output current test, Beeper test, Battery removal test, Weight test, Internal temperature test) | Hardware and Software system functions as intended and design outputs meet design input | Pass |
| Packaging Verification (Distribution simulation testing per ASTM D4169-14: Temperature and Humidity Conditioning, Schedule A - Manual Handling (First Drop Sequence), Schedule C - Vehicle Stacking, Schedule F - Loose Load Vibration, Schedule E - Vehicle Vibration, Schedule J - Concentrated Impact, Schedule A – Manual Handling (Second Drop Sequence)) | Packaging maintains integrity during distribution simulation | Pass |
| Electrosurgery Test (Ensures device is electrosurgery compatible and operates as intended in High Output Current mode) | Device operates as intended in High Output Current mode during electrosurgery | Pass |
| Battery Life Test (Ensures duration of single 9V battery functions in accordance with established acceptance criteria for the ES500 device) | Battery life meets design input requirement | Pass |
| Battery Door Seal Integrity (Adhesive) Test (Ensures adhesive gasket in the battery door compartment maintains integrity after battery replacements) | Adhesive gasket maintains integrity after battery replacements | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of devices tested for EMC, number of software modules tested). It generally states that "testing of the EZstim* III Peripheral Nerve Stimulator/Nerve Locator was performed."
- Data Provenance: The tests are non-clinical (laboratory-based) and conducted to demonstrate compliance with recognized standards and internal design requirements. They are presumably prospective in the sense that the tests were designed and executed specifically for this device submission. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities or accredited test labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the device is a hardware medical device, and the evaluation relies on engineering and regulatory compliance testing rather than expert-derived ground truth as would be used for AI/ML diagnostic devices.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus, which are not relevant to the non-clinical engineering and regulatory compliance tests performed for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The EZstim* III is a peripheral nerve stimulator/locator, a hardware device with a direct physiological function, not an interpretative AI. No human reader assistance is involved in its direct function.
6. Standalone (Algorithm Only) Performance
- This question is not applicable. The device is not an algorithm; it is a physical hardware device with embedded software. The software verification test (mentioned in the table) assesses the software's functionality as part of the overall device system, but there is no "standalone algorithm" performance assessed separately from the device's hardware.
7. Type of Ground Truth Used
- The "ground truth" for the tests performed is based on engineering specifications, recognized international standards (IEC 60601-1, IEC 60601-1-2, ASTM D4169-14), and internal design input requirements. These are objective, measurable performance benchmarks rather than expert consensus, pathology, or outcomes data, which are typically used for diagnostic or predictive AI/ML models.
8. Sample Size for the Training Set
- This question is not applicable. The device is not an AI/ML algorithm that undergoes a "training phase." The "training set" concept is not relevant to its development and testing.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).