(144 days)
The Disposable EEG cable is intended for non-invasive use with recording and monitoring equipment, active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).
The Disposable EEG cable, which is cutaneous electrodes connected to lead wires, is noninvasive, single use electrodes intended to be used on normal, healthy, clean, intact skin for recording purposes. In other words, the Disposable EEG cable is used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP). The Disposable EEG cable is delivered non - sterile and are available in disposable version.
The request asks for specific details about the acceptance criteria and study proving a device meets them. However, the provided text is an FDA 510(k) clearance letter for a "Disposable EEG cable", which is a Class II device.
The document states that a clinical study was not required for this device, and the evaluation for substantial equivalence was based on bench performance testing and biocompatibility testing. This type of device (a cable and electrode) does not involve complex algorithms or AI assistance, which are the typical contexts for the detailed performance studies outlined in the prompt (e.g., MRMC studies, training/test sets, expert adjudication, effect sizes).
Therefore, I cannot provide the requested information regarding:
- Acceptance criteria table and device performance: The document only refers to compliance with standards for electrical safety and biocompatibility, not specific performance metrics in the context of an AI/algorithm-based device.
- Sample size for test set and data provenance: No test set in the sense of an algorithm evaluation.
- Number of experts and qualifications: No expert review panels for ground truth establishment.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable as there's no AI component or human reader interpretation being improved.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: No training set as there's no AI/algorithm.
- Ground truth for training set: Not applicable.
The document confirms that this device is a simple medical device (a cable with electrodes) and not a software/AI-based medical device.
What the document does provide regarding performance:
- Biocompatibility testing: Conducted using ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests.
- Electrical safety: Conformance with AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, mod).
- Performance test: Carried out according to "" and ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes.
In summary, the provided text does not contain the information required to answer the prompt, as the device in question is a simple medical cable and not an AI/algorithm-driven device evaluated through the types of studies described in the prompt.
§ 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).