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The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.

Device Description

The DeltaScan Patch is a single use EEG electrode Patch, used exclusively with the DeltaScan Monitor. The DeltaScan Patch is used with the DeltaScan Monitor to enable the acquisition of EEG signals. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.

The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.

AI/ML Overview

The provided text describes the DeltaScan Patch, a cutaneous electrode intended to record EEG signals in conjunction with the DeltaScan Monitor. However, the document primarily focuses on the substantial equivalence argument to a predicate device (Covidien BIS Sensors, K143506) and the safety testing (biocompatibility, electrical safety, mechanical testing, and shelf-life).

Crucially, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch. Therefore, it does not contain information about acceptance criteria for device performance in terms of signal capture quality or diagnostic accuracy, nor does it describe a study proving the device meets such criteria. The "performance data" section primarily refers to safety and functional verification, not clinical performance for its primary intended use of recording EEG signals (beyond "it transfers the electrical signals as intended").

Given this limitation in the input, I cannot populate all sections of your requested table and study description definitively. I will outline what can be inferred from the provided text, and explicitly state where information is missing due to the nature of the FDA submission for this device.

Acceptance Criteria and Reported Device Performance

As noted, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for recording EEG signals. The performance data provided relates to safety, materials, and mechanical integrity.

Acceptance Criteria (from provided text)	Reported Device Performance (from provided text)
Biocompatibility: Meet ISO 10993-1:2018 requirements for a surface contacting device (<24 hours each day)	All parts of the DeltaScan Patch R2 with REF 009.000.B that are directly in contact with the patient's skin have passed the acceptance criteria defined per ISO 10993-1:2018 requirements.
Electrical Safety: Not Applicable (not Medical Electrical Equipment per EN ISO 60601-1)	The DeltaScan Patch is not considered Medical Electrical Equipment as defined by the EN ISO 60601-1. Its use does not depend on essential performance according to EN ISO 60601-1.
Software V&V: Not Applicable (does not contain software)	N/A
Mechanical Testing (Labels): Legible, durable, compliant, compatible with packaging	The labels on the packaging were tested to verify be legible, durable, compliant with regulations, and compatible with the packaging.
Mechanical Testing (Packaging): Compatible with labeling, can be shipped without damage	The packaging was tested to verify to be compatible with the labeling, and can be shipped without damage.
Shelf Life: 9 months	The stated shelf life of 9 months is mainly based on the degradation of the two frontal electrodes. This is verified and documented in the Verification Report based on accelerated aging. (Real time aging in progress, may show longer shelf life in future.)
Electrical Signal Transfer: Transfers electrical signals as intended	The Verification Report provides sufficient proof that it transfers the electrical signals as intended. (This is a functional claim, but no specific performance metrics or studies are described for how well or with what fidelity it transfers EEG signals, beyond the implication that it works sufficiently for its intended use in conjunction with the DeltaScan Monitor, which presumably has its own performance validation). The report concludes that it "shows that it performs as intended, is safe and effective for its intended use, and provides similar safety and effectiveness results to the predicate device."

Study Details (Based on the provided text)

Since the document states "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch itself, the following sections will reflect the lack of such clinical performance study data in this submission. The "studies" mentioned are largely engineering verification and validation for safety and functional aspects.

Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified for the number of samples, but "all parts of the DeltaScan Patch R2" were tested.
- Mechanical Testing (Labels & Packaging): Not specified.
- Shelf Life: Not specified for the number of patches or test duration, but based on accelerated aging.
- Electrical Signal Transfer ("Verification Report"): Not specified.
- Data Provenance: The studies appear to be internal verification and validation studies conducted by the manufacturer (Prolira B.V.). No information on country of origin of data or retrospective/prospective nature is given beyond the type of studies (e.g., accelerated aging).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical performance study with expert ground truth data is described for the DeltaScan Patch itself. The "ground truth" for the verification activities would be established by industry standards (e.g., ISO 10993-1) and internal engineering specifications.
Adjudication method for the test set:
- Not applicable as no clinical performance study requiring expert adjudication is described.
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:
- No MRMC study was done. The DeltaScan Patch is an EEG electrode, not an AI-powered diagnostic device, and thus this type of study is not relevant to its primary submission. The document explicitly states "No dedicated clinical study is needed to validate the device performance" and that the patch does not contain software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The DeltaScan Patch is a hardware component (an electrode); it is not an algorithm. Its function is to acquire signals for a separate device (DeltaScan Monitor, K222680).
The type of ground truth used:
- For Biocompatibility: Established by adherence to ISO 10993-1:2018 standards and their defined acceptance criteria.
- For Mechanical Testing (Labels & Packaging): Established by internal specifications for legibility, durability, compliance, and shipping integrity.
- For Shelf Life: Established by accelerated aging protocols and internal specifications for electrode degradation.
- For Electrical Signal Transfer: Established by internal verification that the patch "transfers the electrical signals as intended." Specific metrics or objective "ground truth" (e.g., comparison to a gold-standard EEG recording) for signal fidelity are not detailed in this summary.
The sample size for the training set:
- Not applicable. The DeltaScan Patch is a hardware device; it does not involve machine learning algorithms requiring a training set.
How the ground truth for the training set was established:
- Not applicable (no training set as it's a hardware device).

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