(103 days)
The PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only.
The PressOn™ Electrode Headset is intended to be used in medical environments where quick EEG electrode application is required. The device provides a workflow solution where the availability of technologists or other specialty-trained EEG staff is limited for applying EEG electrodes.
The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded into individual button applicators, which are positioned in predetermined locations and interconnected by elastic netting, altogether forming the headset. The predetermined electrode positions are arranged by generally referencing the 10-20 Positioning System, but with flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, and other separate devices. Like the predicate, the subject device is minimally invasive and does not directly contact neural tissues.
The PressOn™ Electrode Headset is placed on the patient's head and is oriented and secured using a nasion marker and chinstrap. The distal end of the device contains the array of PressOn™ electrodes in predetermined locations that are placed on the scalp by minimal insertion of the micro needles into the epidermis layer of the skin for use during monitoring procedures. The PressOn™ electrodes in the subject device are inserted in an identical fashion as the predicate device (K130220). Minor material and dimensional changes have been made to the original applicator to allow for multiple applicators to be connected to form the headset.
At the proximal end of the subject device is a multipin connector where the electrode leadwires terminate. The multipin connector interfaces with color-coded extension cables (identical to those used in another previously cleared Rhythmlink device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment.
The leadwires are constructed of ribbon cable arrays with electrode attachment points at various distances based on the predetermined locations. These features are designed with the intent for quick application by non-neurological based medical personnel with signal quality equivalent to predicate device [K130220].
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format that directly maps to "AI performance metrics" commonly seen in such tables (e.g., sensitivity, specificity, AUC). Instead, it discusses functional performance equivalency to a predicate device based on benchtop tests.
However, we can infer the acceptance criteria and reported performance from the "Summary of Non-Clinical Tests" section:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Electrical Continuity (Pass/Fail) | Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria") |
| Deployment force to eject electrode from applicator and apply to synthetic skin (Within range) | Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria") |
| Pull force required to remove the electrode from synthetic skin (Within range) | Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria") |
| Visual assessment of electrode insertion uniformity into synthetic skin (Acceptable) | Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria") |
| Dimensional assessment of electrode placement on head phantom (Within tolerance) | Passed (implied as "all benchtop performance testing passed predetermined acceptance criteria") |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."
Therefore:
- Sample size for test set: Not applicable (no clinical test set).
- Data Provenance: Not applicable (benchtop testing on synthetic materials, not human data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical tests were conducted and the "ground truth" was established based on engineering specifications and benchtop performance against predetermined criteria.
4. Adjudication Method for the Test Set
Not applicable, as no clinical tests were conducted involving expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No Clinical Tests were conducted." Therefore, no MRMC study was performed, and no effect size for human readers with and without AI assistance is reported. This device is a hardware electrode headset, not an AI algorithm.
6. Standalone (Algorithm Only) Performance Study
No. The device is a physical electrode headset, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant and not reported.
7. Type of Ground Truth Used
The "ground truth" for evaluating the device's performance was established via:
- Engineering specifications and predetermined acceptance criteria for mechanical and electrical properties.
- Comparison to the predicate device (K130220) for functional equivalency, implying the predicate's established performance served as a baseline.
- Benchtop measurements and visual assessments on synthetic skin and head phantoms.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device (electrode headset) and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).