(90 days)
The Cadwell Flex system is indicated for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.
The Cadwell Flex EEG/PSG system consists of: (1) acquisition hardware that can acquire, record, store, and transfer up to 32 channels of EEG data, 8 active-reference signal, and audio signals from a microphone, and has EzNet-module-compatibility, (2).software_that_allows_a_user to acquire, store, transmit, view and print data, and to create reports based on the data, (3) optional video recording, (4) an optional photic stimulator, and (5) a host electronic device (typically a PC) capable of running the software and interfacing with the acquisition, video recording, and photic stimulation devices.
The Cadwell Flex EEG/PSG system is capable of two modes of operation: (1) Ambulatory, where the acquisition hardware acquires, records, and stores physiological and/or environmental data to onboard mass-storage non-volatile memory, and said data is later transferred to a host electronic device, and (2) Clinical, where the host electronic device is connected to the acquisition hardware during data acquisition and recording, with mass-storage occurring on the host.
The Cadwell Flex EEG/PSG system software is capable of interfacing with additional software used to perform EEG/PSG waveform analysis.
Here's an analysis of the provided text regarding the Cadwell Flex device, focusing on acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the Cadwell Flex (K133356) does not explicitly state quantitative "acceptance criteria" for its performance in the typical sense of a medical device study (e.g., specific sensitivity, specificity, accuracy thresholds). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that the device is deemed acceptable if it performs comparably to or better than existing, legally marketed devices.
The "performance" is largely described by comparing its technical specifications and capabilities with those of its predicate devices.
| Characteristic | Predicate 1: EBNeuro BEmicro (K093728) | Predicate 2: Kilowin (K97214) | Cadwell Flex (Applicant Device) |
|---|---|---|---|
| Device class | Class II | Class II | Class II |
| Target Population | Pediatric through adult | Patients of all ages | Patients of all ages |
| Recording Modality | Attended and unattended | Attended | Attended or unattended |
| Use Environment | Hospital and home | Operating room or clinic | Hospital or home |
| Prescription Status | Available only on the order of a physician | By prescription only | By prescription only |
| Power | Battery powered or USB powered | AC power | Battery powered or USB powered |
| Number of EEG Channels | 21 | 24-64 | 32 |
| Other Inputs | 1 digital | 12 ECG and 1-16 EMG | 8 active/reference, 2 other |
| A/D Resolution | 16 bit | 16 bit | 16 bit |
| Sampling Rate | Up to 2048 samples/s | 3200 Hz | 3200 Hz |
| Impedance Check | Yes | Yes | Yes |
Conclusion regarding performance: The text states, "The Cadwell Flex system is substantially equivalent to [The Cativen Tres] in design, use, technology, and function." This implies that its performance is considered acceptable because it meets or exceeds the capabilities of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy, sensitivity, or specificity. Instead, the testing appears to be primarily engineering verification and validation.
The relevant section states: "Software and hardware verification and validation, and electromagnetic compatibility and safety testing were performed."
- Sample Size for Test Set: Not applicable in the context of a typical clinical performance study. The device's functionality was evaluated through engineering tests, likely involving a single or limited number of prototype devices and simulated or real-world signal inputs to verify its specifications.
- Data Provenance: The document does not specify the origin of any data used for performance testing beyond the statement of "software and hardware verification and validation." It implies internal company testing rather than external clinical data. It is not retrospective or prospective clinical data in the usual sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As there's no clinical "test set" for diagnostic performance being evaluated against a ground truth, there's no mention of experts establishing a ground truth. The evaluation focused on technical specifications and safety through engineering tests, not clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication of findings by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC study or any comparison of human readers' performance with and without AI assistance. The device is an EEG/PSG acquisition system, not an AI-driven interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. The Cadwell Flex is an EEG/PSG system designed to acquire and display physiological data for human interpretation. It is not an algorithm performing standalone diagnostic tasks. The "software" mentioned allows the user "to acquire, store, transmit, view and print data, and to create reports based on the data," and also "is capable of interfacing with additional software used to perform EEG/PSG waveform analysis," but the core device itself is not presented as an AI-driven interpretation tool.
7. Type of Ground Truth Used
Not applicable in the context of diagnostic accuracy. The "ground truth" for the engineering tests would be the established technical specifications, safety standards, and electromagnetic compatibility requirements.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset. It's a hardware and software system for data acquisition and display.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for this purpose.
§ 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).