(270 days)
Entropy EasyFit Sensor is intended to be used for adults and pediatric patients older that 2 years with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable.
Cutaneous sheet electrode to be used with GE Entropy measurement devices.
The GE Entropy EasyFit Sensor is a cutaneous sheet electrode intended for use with GE Entropy measurement devices to record physiological signals (such as EEG) in adults and pediatric patients older than 2 years.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or a direct comparison table. However, the summary of clinical tests indicates that the device's performance was evaluated against predicate devices.
| Acceptance Criterion (Inferred from Report) | Reported Device Performance |
|---|---|
| Usability substantial equivalence to predicate device(s) | Concluded to be substantially equivalent to predicate device(s). |
| Signal quality substantial equivalence to predicate device(s) | Concluded to be substantially equivalent to predicate device(s). |
| Safety substantial equivalence to predicate device(s) | Concluded to be as safe as predicate device(s). |
| Effectiveness substantial equivalence to predicate device(s) | Concluded to be as effective as predicate device(s). |
2. Sample Size for the Test Set and Data Provenance:
The document mentions a "clinical validation test" performed "in hospital environment" but does not specify the sample size or the country of origin of the data. The study appears to be prospective, as it was a validation test performed on the proposed devices.
3. Number of Experts and Qualifications:
The document does not specify the number of experts used or their qualifications for establishing ground truth, as the focus was on demonstrated equivalence through a clinical validation study rather than expert consensus on specific diagnoses.
4. Adjudication Method:
The document does not mention any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
The document does not mention a MRMC comparative effectiveness study. The study described is a clinical validation test against predicate devices, focusing on usability and signal quality for substantial equivalence, not on human reader improvement with AI assistance.
6. Standalone Performance:
The submission highlights "integration testing (System verification)" and "Performance testing (Verification)," which implies testing of the device's standalone functionality. The clinical validation focused on the performance of the sensor itself (signal quality, usability) in a clinical setting when used with GE Entropy measurement devices, effectively evaluating its standalone contribution within the intended system.
7. Type of Ground Truth Used:
The ground truth used for the clinical validation test seems to be derived from the performance and characteristics of the legally marketed predicate devices (K082540 GE Entropy Sensor and K061907 Entropy Sensor). The goal was to demonstrate "substantial equivalence" to these established devices in terms of usability and signal quality.
8. Sample Size for the Training Set:
The document does not specify any training set size. This is expected, as the Entropy EasyFit Sensor is a hardware device (electrode) and not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no mention of a training set for an AI/ML algorithm. The device is a sensor, and its evaluation focuses on its physical and electrical characteristics and performance in a clinical setting compared to its predicates.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).