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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

Acceptance Criteria	Reported Device Performance
Biocompatibility: Meet ISO 10993 standards and establish biological safety.	Biocompatibility evaluation conducted within risk management framework and in compliance with ISO 10993 standards. Evaluation included relevant data sources related to biological safety of finished device testing of previously cleared product (K201678) and kit components with a history of safe biological use. Conclusion: Biological safety established.
Performance Testing (Bench): Demonstrate reproducibility in electrode insertion, stability of electrode array position, and removal from subcutaneous space. Also, pre-insertion and post-removal impedance testing should be performed.	A cadaver study was conducted using ten electrodes. Functions associated with electrode array insertion, stability, and removal were shown to perform as expected. Pre-insertion and post-removal impedance testing was performed. Conclusion: All 10 out of 10 electrode arrays performed successfully based on prespecified criteria.

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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