(120 days)
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.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).