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The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (

The NeuroPort System, when connected to the NeuroPort Array Electrode, supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort Array is not modified by this 510(k) submission. The NeuroPort Electrode Array has 100 electrode contacts on a substrate of 4mm. The NeuroPort Electrode array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Electrode Array passes neural activity of the brain cortex to the NeuroPort System through a Patient Cable assembly. The modification described within this 510(k) submission is summarized as: a) the addition of an impedance test switch to the Patient Cable, b) a hardware change to support automated impedance testing of the NeuroPort Electrode Array, and c) a software change to support automated impedance testing of the NeuroPort Electrode Array.

This document describes the 510(k) submission for a modified NeuroPort System, focusing on the addition of an automated impedance test function. It is a modification to an existing device, and the submission primarily addresses the verification and validation of these specific changes.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it indicates that "Testing is completed. No safety or effectiveness concerns remain." for the automated impedance test modification.

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

The document does not specify a sample size for a test set. The testing performed was related to "Software verification and validation" and "Hardware verification of design output meeting design input requirements" for the impedance test modification. These typically involve internal testing and validation rather than a clinical "test set" in the traditional sense for AI/machine learning. The data provenance is internal to Cyberkinetics, Inc., and is retrospective in the sense that it evaluates the modifications to an existing device.

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

This information is not provided. Given the nature of the modifications (software and hardware changes for an impedance test), the "ground truth" would likely be established through engineering specifications, functional requirements, and direct measurement/testing by qualified engineers and validation specialists within the company.

4. Adjudication Method for the Test Set

This information is not provided because the type of study described does not involve a "test set" requiring expert adjudication in the context of diagnostic or interpretive accuracy.

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

No MRMC comparative effectiveness study was mentioned. The device modification is for an automated impedance test, not an AI-assisted diagnostic or interpretive tool intended for human readers.

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

The device is the NeuroPort System with an automated impedance test. The "algorithm only" performance would be its ability to accurately and reliably perform the impedance test as designed. The document states "Testing included: 1. Software verification and validation, 2. Hardware verification of design output meeting design input requirements." This implies standalone testing of the automated function.

7. The Type of Ground Truth Used

For the software and hardware verification, the ground truth would be based on:

• Design Input Requirements: The original specifications and intended functionality of the impedance test.
• Engineering Specifications: Technical documentation detailing how the impedance test should operate.
• Direct Measurement/Comparison: For hardware, this would involve comparing outputs to known standards or expected values. For software, it would involve executing test cases and verifying expected behavior.

8. The Sample Size for the Training Set

No information is provided about a "training set." The device modification involves an automated impedance test, which does not typically rely on machine learning or AI models that require a training set in the conventional sense. The software and hardware are designed and verified against specifications, not trained on data.

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

As no training set is mentioned or implied, this information is not applicable.

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The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (

The NeuroPort™ Array System (Neuroport Electrode) is comprised of a base approximately 4 mm x 4 mm dimensionally with 100 microelectrodes. Each microelectrode is approximately 1 mm long. The lead connects the microelectrode array to the percutaneous pedestal connector.

The request asks for a description of acceptance criteria and the study proving the device meets those criteria, based on the provided text. However, the provided text is a 510(k) summary and FDA clearance letter for the NeuroPort™ Cortical Microelectrode Array System, largely relying on substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, specific performance metrics beyond biocompatibility and recording electrical activity) are not explicitly available in the provided document.

Here's the information that can be extracted or reasonably inferred from the text:

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, the core "acceptance criteria" are implied by the performance data, which aims to demonstrate substantial equivalence to the predicate device.

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The NeuroPort™ NSP System is intended for temporary (

The Neuroport Neural Signal Processing (NSP) System is intended for recording and monitoring. Its functionality includes routine brain activity recording, monitoring, retrieval and replay. The Neuroport supports up to 96 channels of recording and is comprised of the following hardware components: Patient Cable, Amplifier, CPU and a Display monitor. The Neuroport System also includes the following software functions: acquisition, amplification and display.

This K042626 submission for the NeuroPort™ NSP System does not describe specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study with a test set, ground truth establishment, or clinical performance evaluation against such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (BMSI 5000 (Nicolet), Ceegraph (Bio-Logic), and EMU 128 (XLTek)) primarily through:

• Intended Use Comparison: Stating that the NeuroPort™ NSP System has similar indications for use (temporary recording and monitoring of brain electrical activity) as the predicate devices.
• Functionality Comparison: Asserting that the functionality (recording, amplification, digitization, monitoring, retrieval, display) is identical to the predicate devices.
• Compliance with Safety Standards: Listing compliance with relevant safety standards for intra-operative and hospital monitoring settings (IEC 60601-2-26, IEC 60601-1-2, UL 2601-1, CAN/CSA-C22.2 no. 601.1-M90).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, or comparative effectiveness studies, as these types of data were not presented in this 510(k) summary for the NeuroPort™ NSP System. The device's "performance data" as mentioned in the summary refers to its compliance with safety standards, not to the diagnostic or analytical performance often seen with AI/clinical decision support devices.

Since this device is a neural signal amplifier and not an AI-powered diagnostic tool, the typical AI study parameters (e.g., sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance) are not applicable or reported in this 510(k) summary.

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