(42 days)
The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).
The Dome Electrode is an accessory designed for recording of biopotential signals. It is a non-invasive electrode that records biopotential signals from the surface of the skin. It has a standard mating thread that enables connection to electrical conductors of compatible devices. The Dome Electrode contains the following components: 316L Stainless Steel Dome Electrode, Stainless Steel Size 4-40 Nut, Stainless Steel Flat Washer, Stainless Steel Split ("Lock") Washer.
I am sorry, but the provided text does not contain the information required to compose the answer in the requested format. The document is an FDA 510(k) premarket notification for a medical device (Dome Electrode) and primarily focuses on demonstrating substantial equivalence to a predicate device.
Specifically, the text does not contain details about:
- Acceptance Criteria Table with Reported Device Performance: No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned, nor are quantitative performance results against such criteria for the Dome Electrode itself in terms of signal processing or diagnostic accuracy. The "Result" column in the Non-Clinical Performance Data section only states "Pass" for various internal mechanical and electrical tests.
- Sample Size for Test Set and Data Provenance: While "Signal Detection Test" and "Validation – Compatible Device" are listed, the document does not specify the sample size (number of subjects, number of electrode placements, duration of recording) for these tests, nor the origin of the data (country, retrospective/prospective).
- Number of Experts and Qualifications for Ground Truth: There is no mention of experts establishing ground truth for any test set or their qualifications. The device is a cutaneous electrode for EMG, not an AI diagnostic tool requiring expert consensus for interpretation.
- Adjudication Method: Not applicable as there's no mention of expert review or consensus.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for AI systems assisting human readers in interpreting images or data. The Dome Electrode is a physical medical device (electrode) and not an AI algorithm. Therefore, no MRMC study was conducted or reported.
- Standalone Performance (Algorithm Only): The device is an electrode, not an algorithm. Standalone performance for an algorithm is not applicable.
- Type of Ground Truth Used: The ground truth for electrode performance would typically be the physical properties of the electrical signals detected. There's no mention of a "ground truth" in the context of expert consensus, pathology, or outcomes data, as would be common for AI/diagnostic devices. The internal tests (voltage continuity, signal detection) likely assess the electrode's ability to pick up and transmit electrical signals, with "Pass" indicating it meets specifications.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: The device is hardware, not a machine learning model. Therefore, there is no "training set" in the context of AI.
The document primarily focuses on:
- Biocompatibility Testing: Conformance to ISO 10993 standards (cytotoxicity, sensitization, irritation) with "passing results."
- Physical and Electrical Performance: Internal tests for mechanical fit, voltage continuity, and signal detection, all reported as "Pass."
- Comparison to a Predicate Device: Detailed comparison of technological characteristics (dimensions, materials, connection type, indications for use, mechanism of action) to establish substantial equivalence.
Given the nature of the device (a cutaneous electrode) and the content of the 510(k) submission, the study design and reporting requirements are very different from those for an AI/ML-based diagnostic device. The document states, "No human clinical testing was required to support the medical device as it was designed to conform to IEEE 2010-2012 Recommended Practice for Neurofeedback Systems. Cutaneous electrodes have been on the market for many years with proven safety and efficacy." This explicitly indicates that complex clinical studies, particularly those involving human interpretation or AI performance metrics, were not part of this submission for this particular device.
§ 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).