(269 days)
This is an EEG electrode set intended for routine clinical settings where rapid placement of a large number of EEG electrodes is desired. Patient population from infants up to any age.
WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in Chin-strap (placed under the chin). Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 different cap sizes.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "WaveGuard Net EEG Cap." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven system.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" requested in the prompt are typically associated with performance validation studies for software or AI/ML-based medical devices, often requiring clinical or technical performance metrics against a defined ground truth.
This 510(k) summary primarily addresses:
- Device Description: What the device is (EEG electrode cap with saline-soaked electrodes).
- Intended Use: For routine clinical EEG settings.
- Comparison to Predicate Device: How it's similar and different from a previously cleared device (WaveGuard EEG Cap K110223). Key differences noted are electrode material (Coated Ag vs. Sintered Ag/AgCl), cap material (Silicone Mesh vs. Lycra), and Magnetic Resonance compatibility (MR unsafe vs. MR safe).
- Non-Clinical Testing: This section refers to performance standards and biocompatibility testing for the device itself (like electrical safety, material safety), not against an AI/algorithm's predictive accuracy or diagnostic performance. The listed standards (e.g., ISO 10993 series, 21 CFR PART 898) relate to safety, material characteristics, and electrical performance of electrodes/cables.
Therefore, based on the provided text, it is not possible to extract the information requested in the prompt, as the document does not describe a performance study for an AI/algorithm-driven device with accuracy, sensitivity, or specificity metrics.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance for an AI/algorithm. The document discusses performance standards for an electrode cap (e.g., electrical safety, biocompatibility), not a software's classification or prediction accuracy.
- Sample size used for a test set or data provenance for an AI/algorithm validation.
- Number of experts or their qualifications for establishing ground truth for an AI/algorithm test set.
- Adjudication method for an AI/algorithm test set.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a physical electrode cap, not an AI or software assistant for human readers.
- Information on standalone (algorithm-only) performance. Again, this is a physical device.
- The type of ground truth used in the context of an algorithm's performance. The "ground truth" for this device would relate to its physical and electrical properties meeting specified standards.
- Training set sample size for an AI/algorithm.
- How ground truth for the training set was established for an AI/algorithm.
The document's "Performance Data / Summary of Non-Clinical Testing" section refers to:
- 21 CFR PART 898—Performance Standard for Electrode Lead wires and Patient Cables: This regulation sets electrical safety and performance standards for the physical components of the EEG cap.
- Biocompatibility testing (ISO 10993 series): This ensures the materials in contact with the patient are safe (non-toxic, non-irritating, etc.).
These are standard regulatory requirements for all medical devices like EEG caps, not specific to the validation of AI/ML software.
§ 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).