(15 days)
The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.
The Sensor is a single patient use, disposable, pre-gelled 4 electrode array that is applied directly to the pediatric patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.
This 510(k) premarket notification for the BIS Pediatric Sensor by Aspect Medical Systems, Inc. does not contain a study to prove that the device meets specific acceptance criteria based on performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K001980 and K002734).
Here's an analysis of the provided text in relation to your request:
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A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria or report performance data for the BIS Pediatric Sensor. The submission asserts that the device is "substantially equivalent" to predicate devices, implying similar performance. -
Sample size used for the test set and the data provenance:
No test set, performance study, or associated sample size is mentioned in the document. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
There is no mention of experts or ground truth establishment for a test set, as no performance study is detailed. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set or performance study is described. -
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 device is a physical sensor, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or mentioned. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a sensor for recording biological signals, not an algorithm. The assessment is for its physical design and functionality related to signal acquisition, not algorithmic performance. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No ground truth is discussed, as no performance study requiring such data is presented. The "ground truth" for this type of device typically revolves around its ability to accurately and reliably capture the intended physiological signal (EEG), which would be assessed through standard engineering and clinical validation tests, but these are not detailed in this summary. -
The sample size for the training set:
Not applicable. This device is a hardware sensor, not a machine learning model, so there is no "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning model.
Summary of the document based on your questions:
The 510(k) summary focuses on demonstrating that the BIS Pediatric Sensor is "substantially equivalent" to two predicate devices (K001980 and K002734). The key points for this determination are:
- Intended Use/Indications for Use: Same as predicate devices (recording electrophysiological signals in pediatric patients).
- Fundamental Scientific Technology: Same operating principle (flexible tines disk, hydrogel) and basic design as predicate devices.
- Materials and Shelf Life: Same as predicate devices.
- Differences: Smaller size and different basepad shape compared to the Enhanced Sensor to better accommodate smaller heads, and the addition of a 4th electrode and corresponding shape change for the Pediatric Sensor. These modifications are explicitly stated to "not raise new questions of safety or effectiveness."
No specific performance studies with acceptance criteria or reported performance metrics are included in this 510(k) summary. The FDA's clearance (JUL - 6 2004) is based on the finding of substantial equivalence.
§ 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).