(94 days)
The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours).
IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).
IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes.
The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter.
The electrodes placement in IceCap Product line is done accordingly to the 10/20 system.
The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors.
IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).
IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.
The IceCap product line does not perform comparative effectiveness studies with human readers or standalone algorithm performance studies. The device is a cutaneous electrode, and its evaluation focuses on safety and performance according to relevant standards, not on AI-driven diagnostic accuracy.
Here's a breakdown of the acceptance criteria and supporting studies for the IceCap product line:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Topic | Description/Standard | Device Performance (IceCap product line) |
|---|---|---|
| Indications for Use | For use as EEG electrodes by Healthcare Professionals on patients with neurological disorders for short or long-term EEG record (up to 72 hours). Specific weight and head circumference ranges for IceCap 2 and IceCap Neonate. | Meets stated indications for use, including up to 72 hours of use, matching predicate device (2). |
| Safety Standards | Compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). | Conforms to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2: 2014 + A1 (2020), IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020. |
| Biocompatibility | Materials in contact with the patient must be biocompatible (ISO 10993-1). | Biocompatible and compliant with ISO 10993-1 Fifth edition 2018-08. |
| Duration of Use | Up to 72 hours of continuous use. | Qualifies for 72 hours of use. |
| Fit to Form and Usability | Ability to accommodate different head sizes and proper installation. | Qualified via fit to form test and usability test for installation. |
| Signal Quality (Implied) | The number of electrodes and material composition should not negatively impact the quality of EEG signal. | Qualified via impedance test and general quality of signal. |
| Material Composition | Specific materials used for electrodes and adhesives. | Materials listed (PET, Ag/AgCl inks, insulation inks, stiff PETG film, skin/silicone adhesive, graphical ink, protective polyolefin foam on acrylic adhesive) are biocompatible. |
| Storage Life | Expected shelf life of the device. | 12 months. (Matches predicate 2, but shorter than predicate 1. This difference does not affect safety and effectiveness.) |
| Single Use/Sterility | Non-sterile, single-use device. | Single use, non-sterile. |
| Montage System | Conforms to the 10/20 System for electrode placement. | 10/20 System. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for specific test sets (e.g., for fit-to-form, impedance, or usability tests). It mentions that the "clinical data were not necessary to determine substantial equivalence," indicating that animal or human subject testing for diagnostic or comparative effectiveness was not performed as a primary means of establishing substantial equivalence for this type of device.
The document does not provide information on the country of origin of the data or whether the data was retrospective or prospective. The studies primarily involve non-clinical performance and safety testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As this device is an EEG electrode, the primary "ground truth" for its performance is its ability to meet electrical and biocompatibility standards, and to effectively acquire EEG signals as confirmed by non-clinical tests. There is no mention of human experts being used to establish a ground truth for a diagnostic outcome, as the device itself does not provide diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. The evaluation performed is based on compliance with harmonized standards and engineering tests, not on human-based adjudication of diagnostic outcomes.
5. 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
Not applicable. The IceCap product line is an EEG electrode, not an AI-powered diagnostic tool. Therefore, MRMC studies with human readers are not relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware component (EEG electrode) and does not involve a standalone algorithm for performance evaluation in a diagnostic context.
7. The type of ground truth used
The ground truth used for evaluating the IceCap product line is based on established engineering standards and regulatory requirements for medical devices, particularly for cutaneous electrodes. This includes:
- Performance standards: e.g., electrical impedance, signal integrity (implied by "general quality of signal").
- Safety standards: e.g., electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability for medical electrical equipment in the home healthcare environment (IEC 60601-1-11).
- Biocompatibility standards: (ISO 10993-1) for materials in contact with the patient.
- Functional tests: Fit-to-form, usability for installation.
The "truth" is whether the device meets these specified, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set or ground truth for training.
§ 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).