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iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (

The iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (

The document describes the iCE-SG2 Subcutaneous Electrode Kit and its substantial equivalence to a predicate device (iCE-SG Subcutaneous Electrode Arrays, K201678). The acceptance criteria and the study that proves the device meets them are primarily focused on biocompatibility and performance (bench), as this is a medical device for recording electrical signals from the brain.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 10 electrodes were used in the cadaver study for performance testing.
• Data Provenance: The document does not explicitly state the country of origin. The study was a "cadaver study," implying human cadavers, and is presented as part of a U.S. FDA 510(k) submission, suggesting it was conducted to U.S. regulatory standards. It is a prospective evaluation of the new device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. The performance criteria (reproducibility of insertion, stability, removal, and impedance measurements) are objective and measured directly, not subject to expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as a traditional ground truth based on expert consensus was not established for the performance testing. The assessment of successful performance was based on pre-specified objective criteria.

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. This device is an electrode kit for recording electrical signals, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance study was based on objective, pre-specified criteria and measurements from the cadaver study (e.g., successful insertion, stability, removal, and impedance values). For biocompatibility, it was based on compliance with ISO 10993 standards and a history of safe biological use for components.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI algorithm.

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iCE-SG Subcutaneous Electrode Arrays are intended for temporary (

The iCE-SG Subcutaneous Electrode Arrays are intended for use with recording and monitoring equipment for the purpose of recording electroencephalograph (EEG) signals. The subject device allows for continuous EEG monitoring in the subcutaneous space. The iCE-SG Subcutaneous Electrode Arrays can connect to commonly used electrophysiology systems. The subject device is provided sterile and for single patient use in hospitals by healthcare professionals (HCPs).

A kit includes the following components:

1. Preparation box
2. Insertion kit box
3. Two iCE-SG electrode boxes

Here's an analysis of the acceptance criteria and supporting study for the iCE-SG Subcutaneous Electrode Arrays, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it details various tests to demonstrate safety and equivalence to a predicate device. The "results" column below reflects the outcomes reported for these tests, which were deemed sufficient for demonstrating substantial equivalence.

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The iCEWav Neuromonitoring Platform (iCEWav) is intended to monitor the state of the brain by recording and displaying EEG signals and can also receive and display a variety of vital signs and other measurements from third-party devices.

The iCEWav Neuromonitoring Platform is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment including the intensive care unit, operating room, emergency room, and other clinical settings where brain monitoring may be indicated. The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition.

The iCEWav Neuromonitoring Platform (iCEWav) is a clinical neuromonitoring system designed to streamline the collection and integration of high-fidelity electroencephalographic (EEG) data and matched systemic physiological data to assist clinicians caring for patients with brain injury.

The iCEWav Neuromonitoring Platform includes a computer hardware element and associated touchscreen monitor that are affixed to a wheeled cart approved for use in the clinical environment. The computer hardware system is attached via USB connection to a third-party EEG amplifier system. A separate storage basket is included on the cart for storage of the EEG amplifier when not in use. The computer hardware element includes a range of standard USB. Ethernet and serial ports to allow for connection with a range of third-party physiological monitoring systems found in the clinical environment.

The iCEWav Neuromonitoring Platform encompasses in-house iCEWav software that serves to gather EEG and systemic data, automate functions of device performance to allow ease-of-use by clinicians, combine data in a format that allows for seamless real-time and retrospective evaluation, and provide a Graphical User Interface that allows a clinician to evaluate data according to preferences of the clinician.

EEG data collection utilizes disposable third-party clinical EEG electrodes connected to a thirdparty clinical EEG amplifier, with resulting digital signals transmitted to the iCEWav computer hardware element. In parallel, correlative physiological data (heart rate, blood pressure, etc.) from third-party monitors are transferred into the system using standard data connections (serial, Ethernet or USB). Time-locked EEG and systemic physiological data are made available for real-time display as well as local hardware-based storage. Using iCEWav, a clinician can simultaneously monitor aspects of systemic physiology and brain electrical activity to help identify and interpret ongoing clinical developments which may have negative effects on brain health.

EEG data can be displayed as raw waveforms or can be displayed using a range of quantitative measures including Compressed Spectral Array (CSA), Total Power, Alpha/Delta Ratio, Burst Suppression Ratio, and Asymmetry Index. Data can be viewed as it is collected in real time; alternatively, stored data can be reviewed retrospectively. EEG and physiological data can be viewed in parallel fashion. Scaling parameters for each data variable as well as the time window to be reviewed can be controlled by a clinical user.

The iCEWav system has several features to optimize ease of use. The patient Admission procedure includes a step-by-step walkthrough process to assist the user in configuring the EEG system and perform initial electrode impedance testing to ensure correct connection to the third-party EEG amplifier. The system provides several options for baseline EEG recording montages that the user can select to streamline the initiation of EEG recording. The user can also easily customize the recording montage. The system automatically detects availability of data inputs from other third-party physiological monitors that are connected to the system hardware and offers the user the list of the available inputs to be selected for display. The system offers the option for continuous impedance checking of connected electrodes through the third-party EEG amplifier, and for convenience the user may select to remove channels demonstrating poor impedance from the raw and quantitative EEG displays.

During or following a period of recording, patient data may be accessed and reviewed from local storage.

The provided text is a 510(k) summary for the iCEWav Neuromonitoring Platform. It aims to demonstrate substantial equivalence to predicate devices, rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the document does NOT contain information regarding:

• A table of acceptance criteria and reported device performance: The document presents a "Substantial Equivalence Technical Characteristics" table, which compares features of the iCEWav platform to predicate devices, but it does not specify quantitative acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) and then report actual device performance against those criteria.
• Sample size and data provenance for a test set: There is no mention of a test set, sample size, or whether the data was retrospective or prospective.
• Number and qualifications of experts for ground truth: No experts are mentioned as establishing ground truth for a test set.
• Adjudication method for the test set: Not applicable as no test set or ground truth establishment by experts is described.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe any study involving human readers or AI assistance, nor does it discuss effect sizes.
• Standalone (algorithm only) performance: The device is a neuromonitoring platform that processes and displays data, not an algorithm providing a diagnostic output for which standalone performance would typically be evaluated in this context.
• Type of ground truth used: No ground truth based on expert consensus, pathology, or outcomes data is described.
• Sample size for the training set: There is no mention of a training set or corresponding sample size.
• How ground truth for the training set was established: Not applicable as no training set is described.

In summary, this document does not describe a study to prove the device meets acceptance criteria related to its performance in a clinical setting (e.g., diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence of the iCEWav Neuromonitoring Platform's technical characteristics and intended use to existing legally marketed predicate devices.

The bulk of the relevant information provided in the document focuses on:

• Device Description: The iCEWav Neuromonitoring Platform gathers, processes, and displays EEG and systemic physiological data.
• Indications for Use: Intended to monitor the state of the brain by recording and displaying EEG signals and vital signs from third-party devices for patients of all ages in hospital settings. It explicitly states, "The system provides no function that will directly prevent, mitigate, screen, treat or diagnose a specific disease or condition."
• Substantial Equivalence Comparison (Tables 1-4): This section directly compares the iCEWav platform with two predicate devices (Moberg Research's Component Neuromonitoring System and Persyst 13) across various features such as device class, intended user, indications for use, clinical application, hardware components, data input and display, patient admission process, data storage, and quantitative EEG parameter calculation. The "Comment" column consistently states "Equivalent," indicating that the manufacturer believes the new device performs similarly to the predicate devices in these aspects.

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