(90 days)
To provide for access and allow for visualization of the surgical field during brain and spinal surgery.
The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).
The provided document is a 510(k) Summary for the NICO Brain Port device, which is a medical device for neurosurgery. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing.
However, this document does not contain information about a study that establishes acceptance criteria for device performance or proves the device meets those criteria in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Therefore, I cannot provide the detailed information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) because such clinical study information is not present in the provided text.
The closest information related to testing and validation is found under the "Summary of Non-Clinical Testing/Statement of Equivalence" section:
Summary of Non-Clinical Testing (as described in the document):
The document states that "Multiple tests concerning product functionality, biocompatibility, packaging and sterilization have been performed to ensure that the Brain Port device is as safe and as effective as the predicate device."
Specific tests included:
- Radiation sterilization validation on sterile components.
- Cleaning method and sterilization validation of reusable components.
- Packaging drop testing.
- Simulated shipping, aging, and environmental stress testing.
- In Vitro Cytotoxicity testing.
- Irritation and Delayed-Type Hypersensitivity biocompatibility testing.
- General functional, mechanical, dimensional, and performance testing against pre-determined specifications.
- Simulated use testing consisting of inserting the Brain Port into a medium representative of brain tissue.
Ground Truth Used: The ground truth for this non-clinical testing would be the pre-determined specifications for the device's functionality, mechanical properties, dimensions, and performance, as well as established standards for biocompatibility, sterility, and packaging integrity. For simulated use, the "medium representative of brain tissue" served as the test environment.
Sample Sizes: The document does not specify sample sizes for any of these non-clinical tests.
Data Provenance: This is non-clinical, in-vitro, and simulated data, not human patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.
Expert Involvement: The document does not mention the number or qualifications of experts used to establish ground truth or conduct these non-clinical tests, beyond the general statement of "pre-determined specifications."
Adjudication Method: Not applicable to the described non-clinical testing.
MRMC Comparative Effectiveness Study: Not performed or mentioned in the document.
Standalone Performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is inherent to its design and how it is used by a human surgeon.
Training Set: Not applicable to a physical medical device. The "training" for such a device comes from engineering design, material science, and prior knowledge of similar predicate devices.
In summary, the provided text details a 510(k) submission focused on demonstrating substantial equivalence through non-clinical testing, rather than a clinical study with acceptance criteria for device performance in human subjects.
§ 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).