(26 days)
The EEG Sensor (BIS Sensor +) is applied directly to the patient's skin to enable recording of electrophysiological (such as EEG) signals.
The Aspect Medical Systems, Inc. EEG Sensor (hereafter referred to as the Aspect Sensor, Aspect EEG Sensor, or BIS Sensor +), is a rectangular shaped, pre-gelled array of three (3) Zipprep ® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal/temporal area. The Aspect Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with Aspect monitors. The main body of the Aspect Sensor, which houses two (2) electrodes, is placed on the forehead. The satellite area, which houses one (1) electrode, is placed over the temple area. The Aspect Sensor collects EEG signals from these areas, and the differential signal from the temple to the center of the forehead is used to calculate the BIS. The area and distance between electrodes was chosen for ease of application, and to obtain maximum amplitude of the EEG signal, with a minimum of artifact. The "Zipprep" patented electrode design is constructed using flexible tines mounted on a polyethylene basepad with an adhesive. The flexible tines, surrounded by hydrogel, are used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines and forms a conductive bridge with the skin. The Aspect Sensor connects to a monitor at a single point (tab) that is low profile and easy to insert and remove. The tab has an electronic smart card memory device that contains configuration and identification information. This allows better tracking/traceability of the product for Aspect, as well as communicating product information to the user. All materials are biocompatible, and have been tested in accordance with ISO 10993. Skin contacting materials are the same as the Predicate Device.
The provided text describes a 510(k) submission for the "Aspect Medical Systems EEG Sensor" (also referred to as the Aspect Sensor, Aspect EEG Sensor, or BIS Sensor +). This submission is for a cutaneous electrode, which is a Class II device.
The submission focuses heavily on demonstrating substantial equivalence to a predicate device (Aspect Medical Systems Zipprep EEG Sensor, 510(k) #K961821). The key difference in the new device is the addition of a "smart card memory device" for enhanced configuration, tracking, and traceability.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it states that "All tests passed in accordance with their specification." This implies that the acceptance criteria were defined by the specifications of each test conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with electrical specifications | All electrical tests passed in accordance with specification |
| Compliance with mechanical specifications | All mechanical tests passed in accordance with specification |
| Compliance with software specifications (related to smart card) | All software tests passed in accordance with specification |
| Compliance with hardware specifications (related to smart card) | All hardware tests passed in accordance with specification |
| Compliance with EMI standards (related to smart card components) | All EMI tests passed in accordance with specification |
| Biocompatibility (for skin-contacting materials) | All materials are biocompatible, and have been tested in accordance with ISO 10993. Skin contacting materials are the same as the Predicate Device. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the electrical, mechanical, software, hardware, or EMI testing. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective data) as these tests are likely laboratory-based engineering and performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The testing described is primarily engineering and performance testing of the device's components and characteristics, not ground truth establishment for a diagnostic output.
4. Adjudication method for the test set.
This information is not applicable and not provided. The testing described is primarily engineering and performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an EEG sensor, a data collection component, not a diagnostic algorithm that would typically involve human readers interpreting AI output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" component in the sense that it collects EEG signals. However, "standalone performance" in the context of AI/algorithm evaluation usually refers to the performance of a diagnostic algorithm without human input. This submission does not describe such an algorithm; it describes an EEG sensor. The device's performance is gauged through electrical, mechanical, and biocompatibility testing.
7. The type of ground truth used
The ground truth for the testing conducted (electrical, mechanical, software, hardware, EMI, biocompatibility) is based on engineering specifications and established standards (e.g., ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the typical diagnostic sense for this type of device submission.
8. The sample size for the training set
This information is not applicable and not provided. The device is a hardware sensor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for this hardware device.
Summary of the study:
The study described is an engineering and performance evaluation aimed at demonstrating the substantial equivalence of the "Aspect Medical Systems EEG Sensor" to its predicate device. This was achieved through a series of tests:
- Electrical Testing: To ensure the sensor meets electrical performance specifications.
- Mechanical Testing: To ensure the sensor's structural integrity and functionality.
- Software Testing: Specifically for the components affected by the new "smart card memory device."
- Hardware Testing: Specifically for the components affected by the new "smart card memory device."
- EMI Testing: For the components affected by the new "smart card memory device," to ensure electromagnetic compatibility.
- Biocompatibility Testing: According to ISO 10993, to ensure the materials contacting the patient's skin are safe.
All tests reportedly "passed in accordance with their specification." The primary change from the predicate device was the addition of a smart card memory device, and testing focused on the implications of this change. The submission is a 510(k), which seeks to establish substantial equivalence for a medical device, not to prove clinical efficacy or diagnostic accuracy through large-scale clinical trials in the way an AI algorithm might require.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).