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The Digital ClarusScope System and Digital NeuroPEN System are intended for use in neurosurgery, endoscopic neurosurgery, and ventriculoscopy for visualization of ventricles and structures within the brain during neurological surgical procedures, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

The Digital ClarusScope System and Digital NeuroPEN System are neurological endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for neurological procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application: the other fitting is an irrigation extension tube with a female Luerlock connector.

The provided text describes the regulatory clearance of the Clarus Medical Digital ClarusScope System and Digital NeuroPEN System, but it does not contain the specific acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical performance study results.

The document details non-clinical performance data and a comparison to predicate and reference devices to establish substantial equivalence. It lists various tests performed, such as dimensional verification, mechanical strength, functional tests like fluid patency and image output, simulated use, sterility validation, shelf-life, environmental conditioning, distribution, biocompatibility, electrical safety, and electromagnetic compatibility.

However, it explicitly states:
"H. Non-Clinical Performance Data: The Digital ClarusScope, Digital NeuroPEN, and Digital Control Module have been thoroughly tested through verification of product specifications and user requirements. The following quality assurance and performance measures were applied during the development of the systems:
...

• Performance Testing (Verification):
  • Endoscope dimensional verification
  • o Mechanical strength requirements
• Functional Tests
  • Endoscope fluid patency o
  • O System image output
• Simulated Use Test
  • o Interconnection testing between endoscope and control module and accessories
  • Compatibility with introducer O
  • Compatibility of endoscope working channel with accessory devices O"

This section indicates that performance testing was conducted for verification, but it does not provide:

1. A table of acceptance criteria and reported device performance against those criteria.
2. Details of a clinical study with patient data, ground truth establishment, or expert reviews, which would be typical for proving performance in a diagnostic or image-interpretation context (e.g., accuracy, sensitivity, specificity).
3. Information regarding sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing clinical ground truth.
4. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess human reader improvement with AI assistance (the device is a visualization system and not explicitly described as an AI-enabled diagnostic aid in this document).
5. Details on standalone algorithm performance.
6. The type of ground truth used for performance evaluation in a clinical context.
7. Sample size or ground truth establishment for a training set, as this document focuses on the device performance and not the performance of an embedded AI algorithm that would typically require such training data.

Based on the provided text, the device primarily focuses on visualization and mechanical/electrical safety and functionality, not on diagnostic accuracy based on image interpretation by an algorithm. Therefore, the information requested regarding acceptance criteria and clinical study details for diagnostic performance is not present in this document.

The document's conclusion of "Substantial Equivalence" is based on "performance testing, design and non-clinical testing," which aligns with the details provided in section H.

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