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To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

The Vycor Medical Surgical Access Systems include 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 variety of devices include:

• Brain Access System including three models of varying shapes and sizes.
• TC model (elliptical diameters 2.1cm or 1.7cm, lengths 3,5,7, or 9 cm)
• EC model (3.4 cm diameter, 3,5, 7 cm lengths)
• SF model (channel 2.2cm or 2.5cm, length 3,5, or 7 cm)
• Spinal Access System
• (aperture widths are 2.6 to 5.4 cm, and 3 or 5cm access channel height)
  Each 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 port is transparent to allow direct visualization of the underlying retracted anatomical structures. The retractors are light weight, non-conductive, and are compatible with Lelya positioning clamps to provide fixation and reduce accidental movement.
  The spinal access device can access the spine for surgical procedures. The spinal access device has three components including the introducer, port, and fixation screws. The fixation screws are used to hold the device in place during the surgery. The fixation screws are temporarily screwed into surrounding bone tissue during the surgical procedure.

The provided text is a 510(k) Summary for the Vycor ViewSite Surgical Access System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or performance data from a study that would directly describe how the device meets such criteria.

The "Performance Data" section (labeled {1}) states: "The device complies is composed of materials that either have a long history of usage in the medical community or have passed biocompatibility testing requirements." This indicates that the safety and effectiveness are primarily supported by material biocompatibility and comparison to existing, legally marketed devices (predicate devices), rather than a specific clinical performance study with defined acceptance criteria and statistical outcomes.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study results because this information is not present in the provided document. The purpose of this 510(k) summary is to demonstrate substantial equivalence to predicate devices, not to present novel clinical performance data with specific acceptance thresholds.

Here's an explanation of why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Device Performance Table: No such table or specific performance metrics with acceptance criteria are detailed. The document relies on substantial equivalence to predicate devices rather than direct performance measurement against pre-defined criteria.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Info: These details are relevant to clinical performance studies, especially those involving AI or diagnostic devices. Since the Vycor ViewSite Surgical Access System is a surgical retractor, its clearance is not based on such studies for the claims made. The document does not describe any such studies.
• Type of Ground Truth: Not applicable here as no performance study is described in this context.

In summary, the provided 510(k) summary focuses on demonstrating that the Vycor ViewSite Surgical Access System is substantially equivalent to existing, legally marketed predicate devices, thereby establishing its safety and effectiveness without requiring a new, comprehensive clinical performance study with predefined acceptance criteria and statistical analysis.

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