(156 days)
The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).
The EPAD system consists of the following components/accessories:
EPAD Headbox EPAD Headbox Power Supply EPAD Tablet Computer (includes power supply and USB cable) Stimulator Left Blue Cable Assembly (110 inches) Stimulator Right Yellow Cable Assembly (110 inches) Acquisition Left Red Cable Assembly (91 inches) Acquisition Right White Cable Assembly (92 inches) Stimulator Left Blue Short Cable Assembly (67 inches) Stimulator Right Yellow Short Cable. Assembly (67 inches) Acquisition Left Red Short Cable Assembly (44 inches) Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing)
Upper Limb Electrodes package
Lower Limb Electrodes package
The EPAD Headbox contains a complete data acquisition system that has built-in amplifiers, analog to digital converters, and digital signal processors. User interface is via tablet touchscreen computer provided with the EPAD System and running the Android operating system. The EPAD software application is preloaded onto the tablet. Data can be transferred to an external computer for archiving purposes. Communication between the EPAD Headbox and tablet is via Bluetooth wireless or USB connection.
Electrode cables are provided for left and right stimulation and left and right acquisition, color coded for correct connection to the EPAD Headbox: Custom cutaneous electrodes for stimulus and acquisition are provided by SafeOp for use with the EPAD. A total of 11 electrodes are applied for full patient monitoring (upper and lower limbs). The SafeOp electrodes are wet qel, single patient use, disposable, and biocompatible for short term (
Here's a breakdown of the acceptance criteria and study information for the EPAD™ device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the EPAD™ primarily establishes substantial equivalence through a comparison with predicate devices and nonclinical testing that confirms safety and performance against established standards. Direct "acceptance criteria" for diagnostic performance (like sensitivity/specificity) are not explicitly stated for a clinical study comparing the AI's diagnostic ability to a gold standard. Instead, the acceptance is based on meeting technical specifications and demonstrating safety and effectiveness.
However, we can infer performance criteria from the non-clinical testing performed and the comparison to predicate devices. The "reported device performance" refers to the results of these tests.
| Category | Acceptance Criteria (Inferred/Stated from Predicates/Standards) | Reported Device Performance | Study proving compliance |
|---|---|---|---|
| Alert Algorithm Performance | Ability to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under minimal, moderate, and extreme noise conditions. | The EPAD was able to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under all noise conditions (minimal, moderate, and extreme). | Alert Algorithm Testing |
| Software Efficacy | All software requirements are fulfilled and all software hazards mitigated with no unresolved anomalies. | All software requirements have been fulfilled and all software hazards have been mitigated. There are no unresolved anomalies in the EPAD software. | Software verification and validation testing |
| Biocompatibility | Safe for short-term (50%) and increased latency (>10%) under all noise conditions." |
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the Alert Algorithm: The "ground truth" was defined by predefined quantitative thresholds for waveform changes: >50% amplitude reduction and >10% latency increase. This is a technical, rather than a clinical, ground truth.
- For other non-clinical tests (e.g., electrical safety, biocompatibility, signal quality), the ground truth is compliance with established engineering standards and specifications.
8. The Sample Size for the Training Set
- The summary does not provide information on a training set sample size. As a 510(k) submission for a device primarily focused on evoked potential recording and basic alert logic, it doesn't describe the development of a complex machine learning model requiring a distinct training set. If the alert algorithm involved any learned parameters, this information is not detailed.
9. How the Ground Truth for the Training Set was Established
- Not detailed / Not applicable as a distinct training set and its ground truth establishment are not discussed in this 510(k) summary. If the alert algorithm's thresholds were derived from clinical data, the method for establishing that ground truth is not provided.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).