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The Axonpen System is indicated for the illumination of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

The Axonpen System consists of a neuroendoscope (Axonpen) and a monitor (Axonmonitor) to view the image from the distal end of the Axonpen. The Axonpen is a steerable, single-use, neuroendoscope with an integrated camera and LED light source. It has a working channel for third-party tools, irrigation, and aspiration. The distal end is steerable and can be extended. The Axonmonitor is a combination of the Axonbox (firmware) and a third-party tablet for viewing and recording images. It is battery operated.

This document is a 510(k) summary for the Axonpen System, which is a neurological endoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically proving the device meets those acceptance criteria in the way described in the request using clinical performance metrics. The provided information is primarily focused on design, materials, and safety testing to support equivalence.

However, based on the provided text, here's an attempt to extract and infer the requested information, acknowledging that a full clinical study with specific performance acceptance criteria for diagnostic/treatment efficacy is not detailed in this 510(k) summary.

Acceptance Criteria and Study for ClearMind Biomedical's Axonpen System (K201308)

The provided 510(k) summary for the Axonpen System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and various bench and biocompatibility tests. It does not detail specific performance acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or clinical outcomes that would typically be found in a clinical study proving a device meets such criteria. Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful completion of bench testing to demonstrate functionality and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) summary, specific numerical performance metrics are not explicitly stated as "acceptance criteria" for clinical efficacy. The performance reported primarily relates to safety, functionality, and compliance with standards.

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

The 510(k) summary does not mention a clinical test set with human subjects. The "test set" primarily refers to bench tests and in-vitro studies. Therefore:

• Sample Size for Test Set: Not applicable for a clinical test set. For bench/material tests, specific sample sizes are not provided in this summary.
• Data Provenance: The tests conducted (biocompatibility, electrical safety, aspiration, optical, etc.) are generally laboratory-based studies. The document does not specify country of origin for this testing, nor does it specify "retrospective or prospective" as these are not clinical studies.

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

This information is typically relevant for clinical studies involving expert review of images or interpretations. Since no human-based clinical test set is described, this section is not applicable to the provided document.

4. Adjudication Method for the Test Set

As no clinical test set requiring expert interpretation is detailed, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence based on design, materials, and engineering performance, not on direct comparison of reader performance with and without AI assistance.

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

The Axonpen system includes an integrated camera and display (Axonmonitor) for visualization, implying a human-in-the-loop for interpretation and surgical decisions. There's no indication of an "algorithm-only" standalone performance evaluation in the context of diagnostic or treatment decision-making (e.g., using AI for automated pathology detection).

7. The Type of Ground Truth Used

For the various bench and material tests mentioned:

• Biocompatibility: Ground truth is established by standardized testing methodologies (e.g., cell viability in cytotoxicity, immune response in sensitization) and established regulatory limits defined by ISO standards.
• Aspiration Functionality: Ground truth is the observable outcome of successful aspiration of fluid and clots without damage, assessed by direct observation in bench models.
• Optical Performance: Ground truth for optical quality refers to measurable physical properties related to image quality (e.g., resolution targets, color accuracy charts).

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth in this document since it doesn't describe a clinical study where such ground truths would be applied to a diagnostic or treatment outcome.

8. The Sample Size for the Training Set

The Axonpen system, as described, does not appear to be an AI/machine learning device that would typically have a "training set" of data in the manner of deep learning algorithms for image analysis. Its functions (illumination, visualization, aspiration) are mechanically and optically driven. Therefore, this is not applicable.

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

Since there is no mention of a training set for an AI/machine learning component, this question is not applicable.

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