(15 days)
The BIS SRS is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, pre-gelled 4 electrode array with a patented Zipprep design that is applied directly to the patient's forehead to record electro-physiological signals. The electrodes have a standard snap construction. There is an electronic smart card memory device in the multiple use cable. The SRS will be packaged as a set, composed of 100 disposable electrode arrays along with 1 multiple use cable.
This document is a 510(k) summary for the Aspect Medical Systems BIS SRS (Semi-reusable sensor), which is a cutaneous electrode for recording electrophysiological signals.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not specify explicit acceptance criteria or quantifiable device performance metrics in terms of diagnostic accuracy, sensitivity, specificity, or other clinical outcomes for the BIS SRS. The submission focuses on substantial equivalence based on technical and functional similarities to predicate devices.
The document states:
"Electrical and mechanical testing was conducted. Results indicate the device is safe for its intended use."
This is a general statement about safety and does not provide specific performance data or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any human subject test set or clinical study for performance evaluation that would involve a sample size. The testing appears to be limited to "electrical and mechanical testing."
- Sample Size for Test Set: Not applicable/Not mentioned.
- Data Provenance: Not applicable/Not mentioned, as no human subject data for performance claims is presented.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Since no human subject testing or clinical performance study is described, there is no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no human subject test set requiring ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The submission focuses on substantial equivalence to predicate devices rather than comparative effectiveness with human readers or an AI-assisted workflow.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This device is an electrode, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's function is to enable the recording of electrophysiological signals, not to interpret them or make diagnoses autonomously.
7. Type of Ground Truth Used
Not applicable, as no clinical performance study requiring ground truth is described for this device. The regulatory submission primarily relies on technical and material equivalence to predicate devices.
8. Sample Size for the Training Set
The device itself is a piece of hardware (an electrode). It does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this hardware device.
In summary, the provided 510(k) document is concerned with demonstrating substantial equivalence of a new medical device (an electrode) to already cleared predicate devices, based on its design, materials, manufacturing, and intended use. It does not contain information typically found in submissions for AI/ML-based devices regarding clinical performance studies, acceptance criteria, sample sizes for test/training sets, or expert ground truth establishment.
§ 882.1750 Pinwheel.
(a)
Identification. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.