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The Vycor Viewsite Brain Access System (VBAS) is intended to provide for access and allow for visualization of the surgical field during brain and spine surgery.

The Vycor Medical Surgical Access System (VBAS) includes a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region. The subject device is comprised of the modified version of the predicate device cleared under #K060973 together with the optional Alignment clip (A)C component.

The models designated with post characters "AC" includes the Alignment Clip ("AC") included separately in the packaging. This is available for all models other than the 6mm size. The AC may be optionally attached to aid in centering third party navigational and image guided system ("IGS") pointers or probes ("pointer").

Like the predicate, the subject device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues.

The AC optional component was designed to make the VBAS easier to use with IGS by enabling the IGS pointer to be centered and held in place:

• . Designed to accommodate a range of commonly-used pointers
• . Securely clips onto the VBAS device when used
• Provides insertion direction to center the pointer in the device and ensure vertical alignment
• Provides locking mechanism to securely hold the pointer in place and therefore enable the pointer and VBAS to be one integrated unit freeing up one of the surgeon's hands

The provided text is a 510(k) premarket notification summary for the Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC). It describes the device, its indications for use, technological comparison to a predicate device, and non-clinical tests performed to demonstrate substantial equivalence.

However, the document does not describe a study that proves a device meets acceptance criteria related to AI/Machine Learning performance, such as those that would typically involve:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC) for an AI model.
• Sample sizes for test sets in the context of AI models.
• Number of experts and their qualifications for establishing ground truth for AI model test sets.
• Adjudication methods for AI model ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies comparing human readers with and without AI assistance, or effect sizes for such studies.
• Standalone performance (algorithm only) of an AI model.
• Types of ground truth for AI models (e.g., pathology, outcomes data).
• Sample size for training sets of AI models.
• How ground truth for training AI models was established.

Instead, this document details the testing performed for a physical medical device (a self-retaining retractor for neurosurgery) to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. The tests are typical for physical devices and include:

• Shelf Life Testing / Functional Testing
• Packaging Validation
• Human Factors / Usability Testing
• Sterilization Validation
• Biocompatibility (not performed, as identical materials to predicate were used)

Therefore, I cannot extract the requested information regarding AI/Machine Learning criteria and studies from this document. The document explicitly states "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed: Not applicable." This indicates that the device's clearance was based on engineering and usability testing, not performance metrics related to an AI algorithm.

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The Expandable Port is intended to provide access, allow visualization of the surgical field, and retraction of soft tissue during neurological cranial surgery.

The device is indicated for use in surgery during which subcortical access is required.

The MindsEye Expandable Port is a single use, minimally invasive intracranial medical device designed to provide access and allow visualization to the surgical field while retracting subcortical soft tissues during neurological cranial surgery. Its design allows the user to place the port while collapsed in its minimal form for atraumatic access to the subcortical space. After placement, the port can be expanded radially to create a working channel to the target surgical location. The user is able to expand the port to the desired working channel diameter appropriate for the surgical plan then collapse the port upon surgical completion for safe removal. The working channel diameter may be adjusted as needed by the user throughout surgery.

The MindsEye device is expected to be used in conjunction with other standard, commercially available intracranial medical devices, such as an aspirator, micro/endo/exoscope, irrigation, electrosurgical systems/tools and/or hemostatic agents. In addition, MindsEye is compatible with existing optical navigation systems for accurate target acquisition and may be attached to other commercial retraction systems according to user preference.

The MindsEye device is made of biocompatible, medical grade materials (metals and polymers) with no software or electrical components. The MindsEye device and its components are provided sterile and not reusable.

MindsEye is comprised of the following components and is available in three lengths (Table 1).

• Port with attached Sheath
• Obturator and Guide
• Optional Support System consisting of support clips, post, and legs

The provided text is a 510(k) summary for the MindsEye™ Expandable Port, a medical device. It does not include information about acceptance criteria or a study proving the device meets those criteria, as one would typically see for performance claims related to diagnostic accuracy or clinical effectiveness.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, biocompatibility, sterility, and shelf-life performance. The device is a physical tool used by surgeons, not an AI/ML-driven diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested points are not applicable to the information contained in this 510(k) summary. I can, however, extract the information that is present regarding testing and validation.

1. A table of acceptance criteria and the reported device performance

The document provides a "Summary of Testing" rather than a formal table of acceptance criteria with numerical performance targets. The acceptance criterion for each test is simply "Pass," indicating that the device met the required standards for that specific test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests described are non-clinical (e.g., in-vitro, material durability, packaging), not clinical studies involving human patients or complex data sets. Therefore, typical "sample sizes" for test sets of clinical images or patient data, or data provenance (country, retrospective/prospective) are not applicable or detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth for these non-clinical tests would be established by standardized testing protocols and laboratory measurements, not by expert consensus from medical professionals.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple expert readers to resolve disagreements in interpretations (e.g., of medical images). The tests described are non-clinical, laboratory, and engineering tests.

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

This information is not applicable/provided. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. The MindsEye™ Expandable Port is a physical surgical retractor, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable/provided. Standalone performance studies are for AI algorithms. The MindsEye™ Expandable Port is a physical surgical device.

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

For the non-clinical tests, the "ground truth" implicitly refers to established scientific and engineering standards and validated test methodologies. For example, for biocompatibility, the ground truth for "non-cytotoxic" is determined by the results of standardized cytotoxicity assays within acceptable limits. For physical properties, it would be the pre-defined engineering specifications and ASTM/ISO standards.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. (See response to #8).

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