(93 days)
The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient's forehead to record electrophysiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.
This 510(k) submission (K062692) is for a medical device called the "BIS Bilateral Sensor," a cutaneous electrode. The submission primarily focuses on establishing substantial equivalence to a predicate device (K002734, Aspect Enhanced XP BIS Sensor) rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance results directly related to an AI/algorithm.
The document indicates that the device is a simple cutaneous electrode for recording electrophysiological (EEG) signals. The "study" referenced in the 510(k) summary is a comparison of similarities and differences between the new device and the predicate device. It does not describe a clinical study in the format typically used to prove performance against acceptance criteria for an AI or algorithm-based device.
Therefore, many of the requested points for describing an AI/algorithm study are not applicable to this submission, as it's for a sensor, not an AI or algorithm.
Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent limitations due to the nature of the device and submission:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, no specific "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC are mentioned, as this is a sensor and not an AI/algorithm with such output. The "performance" described is in terms of substantial equivalence to the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Same indications for use | Met: "The indications for use remain the same as the Enhanced Sensor." |
| Same intended use | Met: "The intended use is the same as the predicate device." |
| Same fundamental scientific technology | Met: "The fundamental scientific technology remains the same as the Enhanced Sensor predicate device." |
| Incorporates the same basic design | Met: "incorporates the same basic design" |
| Same BIS channels (2) | Met: "2 channels of BIS" |
| Incorporates the same materials and biocompatibility | Met: "incorporates the same materials and biocompatibility" |
| Same shelf life | Met: "has the same shelf life" |
| Packaged using the same materials and processes | Met: "is packaged using the same materials and processes" |
| Incorporates smart card memory device | Met: "incorporates smart card memory device" |
| Modifications do not raise new questions of safety or effectiveness | Met: "Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness." (This is a claim made by the submitter, not an objective finding presented in the document.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as this submission relates to a physical device (sensor) and its substantial equivalence to a predicate, not a dataset-driven AI/algorithm performance study. No test set for an algorithm is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. There is no "test set" in the context of an AI/algorithm study described in this submission, and thus no ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No adjudication method is described as there is no test set for an AI/algorithm.
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
This information is not applicable. This is a submission for a sensor, not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a submission for a sensor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. There is no ground truth data described in the context of an AI/algorithm performance study.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/algorithm.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" and no ground truth establishment for it mentioned.
§ 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).