(76 days)
The Satellite is intended to acquire EEG data from patients that are stationary or ambulatory, regardless of whether they are inside or outside a medical-care facility.
The Satellite is a portable, battery-powered, digital electroencephalographic (EEG) data recorder that is designed to be carried in a hip belt worn by the patient. The intended use of this device is to record the patient's EBG while the patient is ambulatory or at home. Recorded EEG data is stored in a removable hard disk drive, which the medical practitioner can then remove from the data recorder and connect to a standard personal computer. The personal computer is then used to review and analyze the EEG data, generate reports, and provide longer-term storage for the EEG data. The personal computer also performs various system utility functions on the data recorder, such as programming the user-selectable parameters, and measuring the electrical impedance of the EEG electrode connections. A battery pack and charger also accompany the data recorder. These items are designed so the battery pack cannot be recharged while it is powering the data recorder, so the data recorder (which may be attached to the patient) cannot be connected to the AC-powered charger. The device is intended to complement Nicolet's existing line of EEG systems, including the Voyageur digital EEG system (K921927B) and BMSI long-term EEG monitoring system (K891405A). Neither of these devices currently provides the capability for ambulatory or athome EEG data recording, however, both will record and playback EEG data that is similar to the data recorded by the Satellite.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nicolet Satellite device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "sensitivity > X", "specificity > Y", "accuracy > Z%"). Instead, the acceptance criteria are implicitly defined by the claim of substantial equivalence to predicate devices. The performance is reported in qualitative terms relating to this equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as legally marketed predicate devices (Cadwell Easy Ambulatory K946094, Bio-Logic Ceegraph Traveler K954954, and Nicolet's larger EEG products like BMSI K891405A). This implies no new significant safety risks from ambulatory use or the device's design. | "There were no adverse effects or complications affecting patients." |
| "…substantially equivalent, in terms of safety… to the specifications published for the predicate devices." | |
| "…substantially equivalent, in terms of safety… to much larger Nicolet EEG products." | |
| Effectiveness: Device performs as well as or better than legally marketed predicate devices in its intended use (recording EEG data from ambulatory or home patients). This implies the recorded data quality is comparable and sufficient for clinical interpretation for diagnostic purposes. | "The device performed substantially as expected." |
| "…substantially equivalent, in terms of… effectiveness, to the specifications published for the predicate devices." | |
| "…substantially equivalent, in terms of… effectiveness, to much larger Nicolet EEG products." | |
| Nonclinical tests used "actual human EEG recordings, and included examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." | |
| Technological Characteristics: Device possesses virtually identical technological characteristics (design, material, chemical composition, energy source, bandwidth, channel count, time/amplitude resolution, user-adjustable parameters, compliance with performance standards) to predicate devices. This forms the basis for the substantial equivalence claim. | "The technological characteristics of the new and predicate devices are virtually identical." |
| "Each device has a similar bandwidth and channel count, a similar time- and amplitude-resolution, and a similar set of user-adjustable parameters." | |
| "Each device has similar performance specifications, and is designed to comply with substantially the same voluntary performance standards." | |
| Intended Use: Device performs its intended function (recording EEG data for later review and analysis to assist a medical practitioner in diagnosing EEG-related conditions) without obscuring vital information, eliminating complementary information, or creating new indications for use compared to predicate devices. Device failure would not significantly alter or delay treatment. | "The Satellite is intended to record EEG data while a patient is ambulatory or at home..." |
| "…intended to involve competent human intervention before any impact on human health occurs..." | |
| "The device does not obscure information or data that is available to the user; it does not eliminate the use of complementary information..." | |
| "…any failure of the device to perform as intended would be extremely unlikely to significantly alter or delay the treatment of any patient..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Non-Clinical Tests: Not explicitly stated as a number. The text mentions "EEG test data derived from actual human EEG recordings, and included examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." This implies a set of diverse, pre-recorded human EEG data but doesn't quantify the number of cases or recordings.
- Sample Size for Clinical Tests: Not explicitly stated. The text notes that "clinical tests were performed to solicit comments from actual users and to assess the performance of the device under actual-use conditions." This suggests a qualitative assessment with an unspecified number of users/patients.
- Data Provenance: The text does not specify the country of origin. The test data for non-clinical evaluation was "derived from actual human EEG recordings." For clinical tests, the data was from "actual-use conditions," implying real patients. Both appear to be prospective data collection (for the specific purpose of testing the Satellite), but for the non-clinical tests, the "actual human EEG recordings" could have been retrospective archival data used prospectively for testing. However, this is not clarified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The summary states that the device is "intended to involve competent human intervention" and that "clinical judgment and experience must be used to check and interpret the system's output." This implies that the 'ground truth' for evaluating the device's ability to record and present data for seizure, spike, and waveform identification would ultimately be based on the interpretation of qualified medical professionals (e.g., neurologists or neurologists specializing in electrophysiology), but this is not explicitly stated as how ground truth was established for the specific test set.
4. Adjudication Method for the Test Set
Not specified. Given the nature of the device (a data recorder, not an interpretive AI), direct adjudication methods like 2+1 or 3+1 typically used for diagnostic interpretations are less relevant. The evaluation focused on the device's ability to faithfully record various EEG phenomena for subsequent human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not conducted. The comparison was primarily against the specifications and characteristics of predicate devices, not through a direct comparative study with human readers using or not using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done
Yes, in essence. The primary evaluation described is a standalone performance test of the device as an EEG data recorder. The device records data, and its performance is judged on its ability to capture and store that data accurately, making it available for human review. It is explicitly stated that the device "is intended to involve competent human intervention before any impact on human health occurs (i.e., clinical judgment and experience must be used to check and interpret the system's output)." This confirms that the device itself is not providing a diagnosis or interpretation algorithm that would be judged in a standalone fashion against a ground truth diagnosis. Its "performance" is its ability to record and present the data.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be based on expert consensus/identification within the "actual human EEG recordings". The test data included "examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." The 'ground truth' here is the presence of these known phenomena within the source recordings, and the device's ability to accurately capture and represent them. This isn't pathology or outcomes data, but rather a recognized pattern within electrophysiology as interpreted by experts.
8. The Sample Size for the Training Set
Not applicable/provided. The Nicolet Satellite is an EEG data recording device, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its function is to accurately capture analog electrical signals and convert them into a digital format for storage and later review. It does not learn or make diagnostic interpretations.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, the device does not use a training set as it is not an AI/ML system.
§ 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).