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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:

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.

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The PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), Evoked Potential (EP), or as Ground and Reference in an EEG or EP recording.

Not Found

The provided text is a 510(k) premarket notification document from the FDA regarding a medical device called the "Persyst PressOn™ Electrode." This document determines the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The text primarily focuses on:

• FDA's substantial equivalence determination: Stating that the device is substantially equivalent to predicate devices.
• Regulatory information: Such as regulation numbers, product codes, and applicable CFR sections.
• Manufacturer information: Including the company name and contact person.
• Indications for Use statement: Describing the intended use of the Persyst PressOn™ Electrode for recording Electroencephalograms (EEG), Evoked Potentials (EP), or as ground and reference in EEG/EP recordings.

Therefore, I cannot provide the requested table or information about the study, as these details are not present in the provided input.

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The PressOn™ electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.

The PressOn electrode is a single-use, disposable EEG electrode. The electrode is very small, with a footprint of approximately 0.6 cm and a very thin (~0.004 inch) height profile. It is made from a super-elastic Nitinol and is flexible. The electrode has 3 legs (a tri-pod configuration) that each terminate in micro-teeth that penetrate the top layers of the scalp dermis during subdermal electrode placement.

The PressOn electrode is used in conjunction with an accessory PressOn lead that is provided non-sterile and is reusable. The lead is approximately 48" in length and is used to connect one of the PressOn electrodes to a commercially available EEG monitor. The EEG monitor/ equipment is not part of the PressOn device offering.

This a 510(k) Premarket Notification for the PressOn™ electrode. The document states that the device is "substantially equivalent to legally marketed needle electrodes that are in commercial distribution". Therefore, no specific acceptance criteria or studies proving device performance against such criteria are explicitly detailed in this document, as the FDA has determined it is substantially equivalent to a predicate device.

The document indicates that the device underwent "biocompatibility, bench and performance testing and demonstrated acceptable results in all testing." However, the details of what these acceptable results were, the specific acceptance criteria, or the study methodologies and data, are not provided for the electrode.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method: Not available.
5. MRMC comparative effectiveness study: Not applicable, as this is a physical medical device (electrode), not an AI-assisted diagnostic tool.
6. Standalone performance study: Not available, "performance testing" is mentioned but no details.
7. Type of ground truth used: Not applicable as there is no diagnostic outcome being evaluated.
8. Sample size for the training set: Not applicable as there is no mention of a training set or a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

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