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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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