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The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).

The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body.

The document describes the Digital NeuroPort Biopotential Signal Processing System, which is a physiological signal amplifier. The device's substantial equivalence to a predicate device (K090957, NeuroPort Biopotential Signal Processing System) is affirmed based on various performance data.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Test / Characteristic	Acceptance Criteria	Reported Device Performance
   NeuroPlex E Functional Testing
   Mating	Screws down on pedestal and LED turns green	Pass
   Crosstalk	Isolation resistance of 1kΩ at 500 V DC	Pass
   Label Durability	IEC 60601-1:2005/A1:2012, Edition 3.1 7.1.3	Pass
   Digital Accuracy	Appropriate voltages for different filters (0.02-10 kHz Wide, 0.3-7.5 kHz Standard); Peak-to-peak of 500mV ±10%	Pass
   Input Impedance	≥10MΩ	Pass
   Impedance Measurement	820 ± 15% kOhms and 170 ± 15% kOhms	Pass
   Current Rating	<1A	Pass
   Stability	All channels have neural data from a simulator after 90 attachments and detachments	Pass
   Attachment	Two-Finger Tightness	Pass
   Input Noise	≤3 RMS	Pass
   Crosstalk	<44mV	Pass
   Leakage	IEC 60601-1:2005/A1:2012, Edition 3.1	Pass
   Breakaway	<14lbf	Pass
   Digital Hub Functional Testing
   Input Power Supply	External, medical-grade	Pass
   FPGA Testing from Headstage	Accommodates up to 128 channels and channel priority starts with first channel and ends with fourth channel.	Pass
   Output Power Supply to Headstage	4.8V	Pass
   Full-Scale Analog Input	±8.192mV.	Pass
   Burn in Test	Hub can run continuously for 12 hours.	Pass
   Compatibility Test	Validated data packets received at hub and NeuroPlex E is powered.	Pass
   Digital Neural Signal Simulator (DNSS) Functional Testing
   Rechargeable Battery	Battery life is ≥10 hours.	Pass
   Power	Charge battery by Digital Data Cable or USB	Pass
   Digital	Digital Hub recognizes DNSS connected through Data Cable.	Pass
   System Functional Testing
   Synchronization	Timestamps aligned within 100 microseconds with maximum capacity of four 128-channel Es, four 128-channel hubs (only one digital data cable from one E to one hub), and two 256 NSPs.	Pass
   Channel Count	Facilitates up to 512 channels.	Pass
   Usability Testing
   IFU Readability	Users are able to configure intended settings, assemble the system, and perform maintenance activities all from instruction in the IFU.	Pass
   Impedance, Reference, and Ground Switching	Users are able to achieve each possible configuration prompted by the facilitator.	Pass
   Cleaning	Users do not damage the device during cleaning. Users identify the proper cleaning solutions. Users indicate that the instructions are sufficiently clear.	Pass
   Other Performance Data
   Electrical Safety/EMC	Compliance with IEC 60601-1:2012, Ed 3.1 and IEC 60601-1-2:2014, Ed 4.0	Compliant
   Biocompatibility	Endpoints assessed: cytotoxicity, irritation, or sensitization, per ISO 10993-1:2018 (for NeuroPlexE and pedestal)	Achieved
   Sterility	Sterilized with 100% EtO to a SAL of 10^-6, per ISO 11135-1:2014/07/15	Achieved
   Residuals (EtO)	EO levels < 4mg/24hr, ECH levels < 9mg/24hr; both < 60mg/30 days, per ISO 10993-7:2008/10/15	Achieved
   Shelf Life (Sterile)	18 months, validated by accelerated aging per ASTM F1980-16 for representative device Patient Cable. Packaging conforms to ISO 11607-1:2019, ASTM D4332-14, ASTM D4169-16, ASTM F1886-09/(R)2013, ASTM F2096-11, F88/F88M-15.	18 months achieved

2. Sample size used for the test set and the data provenance:
   The document focuses on engineering performance testing, usability testing, and bench testing, rather than studies involving patient data or clinical datasets. Therefore, information about a "test set" in the context of clinical data (e.g., medical images, physiological recordings from patients for algorithm evaluation) is not provided. The samples used for testing are the physical components of the device (NeuroPlex E, Digital Hub, Digital Neural Signal Simulator (DNSS), and the full system). The provenance of these test samples is not explicitly stated beyond being the components of the "Digital NeuroPort Biopotential Signal Processing System." The types of tests conducted are typically performed retrospectively using manufactured device units in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable to the type of testing described. The document describes engineering, electrical, mechanical, and usability tests for a physiological signal processing system. Ground truth in this context is established by engineering specifications, international standards (e.g., IEC, ISO, ASTM), and predefined functional requirements, not by expert interpretation of patient data. For usability testing, "users" are involved, but their specific qualifications (e.g., specific clinical experience) or number are not detailed beyond "users" being able to interact with the device and its instructions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are typically used in clinical studies when establishing ground truth from multiple expert interpretations of patient data. The current document reports on bench testing, functional verification, and safety compliance, where results are measured against objective criteria from standards or specifications.

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. The Digital NeuroPort Biopotential Signal Processing System is a device for recording, processing, and display of biopotential signals. It is not described as an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists, cardiologists) in making diagnoses. Therefore, an MRMC study or AI-assisted performance improvement analysis is outside the scope of this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. As noted above, the device is a signal processing system, not an AI algorithm intended for standalone diagnostic performance evaluation. The "performance data" presented is about the physical and electrical functioning of the device components and the system as a whole, not about an algorithm's diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the functional and safety tests, the "ground truth" or reference values are defined by:

   • International Standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-1, ISO 11135-1, ISO 10993-7, ISO 11607-1, ASTM D4169-09, ASTM D4332-14, ASTM F88/F88M-15, ASTM F1886-09/(R)2013, ASTM F1980-16, ASTM F2096-11.
   • Engineering Specifications: e.g., isolation resistance (1kΩ), digital accuracy (500mV ±10%), input impedance (≥10MΩ), current rating (<1A), input noise (≤3 RMS), Synchronization within 100 microseconds, channel count (up to 512), battery life (≥10 hours), output power supply (4.8V), full-scale analog input (±8.192mV).
   • Functional Demonstrations: e.g., "Screws down on pedestal and LED turns green" for mating, "All channels have neural data from a simulator after 90 attachments and detachments" for stability.
   • Usability Objectives: Users' ability to configure settings, assemble the system, perform maintenance, or use cleaning solutions correctly.

8. The sample size for the training set:
   Not applicable. This device is not an AI/ML algorithm that requires a training set of data. The "training" in this context refers to the manufacturing and testing of hardware and software against pre-defined specifications.

9. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" in the context of AI/ML for this device. The development and validation of the device components and system are based on engineering principles and regulatory standards.

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Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Cortical Electrode (Per FDA Classification)

This document is a Traditional 510(k) Summary for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). It asserts substantial equivalence to a predicate device (AD-TECH Subdural Cortical Electrodes) rather than claiming specific performance criteria and a study to meet them. Therefore, the requested information on acceptance criteria and a study proving the device meets them cannot be directly extracted as it would for a claim of new performance.

However, I can interpret the document's content to provide related information about the device's safety and effectiveness testing where it implicitly establishes "acceptance criteria" through conformance to recognized standards and successful test results.

Here's a breakdown of the available information, structured to align as closely as possible with your request:

Acceptance Criteria and Device Performance (Indirectly Derived from Safety and Performance Testing)

The document focuses on demonstrating substantial equivalence to a predicate device, which means proving the new device is as safe and effective as the legally marketed predicate. The "acceptance criteria" are generally implied to be compliance with relevant standards and successful completion of various tests, demonstrating that the device performs as intended and does not raise new questions of safety or efficacy.

Detailed Information on Studies:

1. Sample sizes used for the test set and the data provenance:

   • Biocompatibility (Implantation Test): Performed on "Subdural Rabbit Brain". The exact number of rabbits used is not specified in this document. Data provenance is implied to be laboratory testing.
   • Cleaning/Disinfection (Patient Cable): No specific sample size for the "test set" (i.e., number of cables) is mentioned, but the methods were "British soil, CaviWipes, and CaviCide" and "Low-level disinfection with CaviWipes and CaviCide". Data provenance is laboratory testing.
   • Other tests (Hemolysis, Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, BET/LAL, Electrical, Mechanical, Packaging): The document refers to various standards (e.g., ISO, ASTM, AAMI TIR) that typically specify sample sizes for these types of tests. However, the specific sample sizes used by Blackrock Microsystems for each test are not detailed in this 510(k) summary. The studies are laboratory-based.
   • Retrospective or Prospective: All listed testing appears to be prospective laboratory testing or material characterization, rather than human clinical studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this device and submission. The "ground truth" for these types of tests (biocompatibility, electrical, mechanical, sterilization, packaging) is established by adherence to recognized scientific and engineering standards and methodologies, not by expert interpretation of clinical data or images. The "experts" would be the scientists and engineers conducting the tests and verifying compliance with the standards, whose qualifications are implied by their ability to conduct such highly specialized testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable as the tests are analytical/performance-based, not interpretative (like image reading for diagnostic devices). Results are compared against predefined acceptance criteria from standards, not adjudicated by human readers.

4. 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:

   • This is not applicable. The Blackrock NeuroCoG Subdural Cortical Electrodes are physical medical devices (electrodes and cables) used for recording and stimulation. They are not AI-powered diagnostic devices, and no human reader interpretation or AI assistance is involved in their direct function.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. The device is a passive electrical conductor and does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the various tests mentioned is based on established scientific and engineering principles, recognized international standards (ISO, ASTM, AAMI), and predefined acceptance limits derived from these standards. For example, for biocompatibility assays, the ground truth is the chemical and biological response of materials as measured by standardized laboratory methods (e.g., cell viability in cytotoxicity, hemolytic index in hemolysis). For electrical and mechanical tests, it's the physical properties meeting defined specifications.

7. The sample size for the training set:

   • This is not applicable. The device is a passive physical medical device and does not utilize a "training set" in the context of machine learning or AI algorithms. Its design and manufacturing are based on engineering principles and materials science.

8. How the ground truth for the training set was established:

   • This is not applicable, as there is no "training set" for this device.

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The NeuroPort™ Electrode (SIROF) 1.0 mm and 1.5 mm are indicated for temporary (<30 days) recording and monitoring of brain electrical activity.

The NeuroPort™ Electrode (SIROF) detects the electrical activity of cortical neurons during sub-chronic-monitoring procedures for less than thirty consecutive days. All of the components in the NeuroPort™ Electrode (SIROF) are passive and are intended exclusively for recording applications: monitoring brain electrical activity, defining the location of the epileptogenic foci and brain mapping.

The NeuroPort™ Electrode (SIROF) consists of high impedance electrodes. The NeuroPort™ Electrode (SIROF) has 100 electrode contacts on a silicon substrate of 4mm by 4mm.

The electrodes provide the patient contact device. The electrodes connect the users recording and monitoring equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording and monitoring understand the use of depth electrodes.

This document describes the NeuroPort™ Electrode (SIROF), a depth electrode used for temporary recording and monitoring of brain electrical activity. The submission is a Special 510(k) for modifications to a previously cleared device (K070272).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes material and performance testing for the device itself, not a clinical study involving human subjects or data derived from human subjects for a "test set" in the context of an AI/ML device.

• Sample Size for Test Set: Not applicable in the context of this device submission (no clinical study with a test set of patient data). The samples referred to are physical device units for material and performance testing.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable. The tests are laboratory-based and relate to device materials and manufacturing processes.

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

Not applicable. As noted above, this is a device modification submission for a physical medical device, not an AI/ML algorithm requiring expert-established ground truth for a test set of medical data.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" of medical data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This is not an AI/ML device and therefore no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to industry standards and specifications for medical device performance and safety:

• Biocompatibility: ISO 10993 guidelines.
• Sterility: EN ISO 11737-1 standards for achieving a sterility assurance level (SAL) of 1x10-6.
• Performance (Impedance): "Prospectively defined performance criteria" relating to impedance measurements. The specific numerical criteria are not provided in this summary but would have been part of the full submission.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth establishment methodology for such a set.

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