(27 days)
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:
- Primary/Secondary Brain Tumors
- · Vascular Abnormalities/Malformations
· Intraventricular Tumors/Cysts
The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts.
The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor.
The provided text focuses on the 510(k) premarket notification for the NICO BrainPath device, specifically for an updated version (K172433) compared to a predicate device (K150378). This is a submission for device substantial equivalence, not a study proving the device meets acceptance criteria in terms of diagnostic performance or clinical outcomes for an AI/algorithm-based medical device.
Therefore, many of the requested criteria regarding AI/ML device performance evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this document.
However, I can extract the acceptance criteria and "performance" findings relevant to a medical device's physical and functional properties, as presented in this 510(k) submission.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):
The document describes non-clinical testing performed to demonstrate that modifications to the NICO BrainPath still meet applicable design and performance requirements and support substantial equivalence to the predicate device. The "acceptance criteria" can be inferred as the expected "Pass" or "Non-cytotoxic," "Non-sensitizer," "Non-irritant" results for the respective tests.
| Testing | Acceptance Criteria (Implied) | Reported Device Performance (Result/Conclusion) |
|---|---|---|
| Cytotoxicity - MEM Elution: 72 hour incubation | Non-cytotoxic | Non-cytotoxic |
| Sensitization - Maximization (2 extracts) | Non-sensitizer | Non-sensitizer |
| Irritation - Intracutaneous Reactivity (2 extracts) | Non-irritant | Non-irritant |
| Simulated Use to demonstrate the BrainPath has the ability to interface with third-party Instruments and meets design input requirements | Pass | Pass |
| Packaging & Shelf Life – shipping/distribution simulation, environmental conditions, aging, visual packaging inspection, bubble and seal strength packaging testing, and functional testing following aging, environmental and shipping simulation | Pass | Pass |
| Specification Review | Pass | Pass |
| Cleaning Validation (Reusable Devices) – Establishment of cleaning validation per miles soil test using bioburden endotoxin and protein testing | Pass | Pass |
| Sterility Validation (Reusable Devices) – Steam autoclaving, IUSS, and hydrogen peroxide gas plasma | Pass | Pass |
| Sterility Validation (Single-Use) – B&F testing, VDmax for SAL 10-6, along with routine Endotoxin testing | Pass | Pass |
| Sterilization Tray Drop Test | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of devices tested for biocompatibility, number of packaging units, etc.). It generally states "All" devices/components were subjected to relevant tests.
- Data Provenance: The data provenance is internal to NICO Corporation's testing and validation processes. The document does not mention the country of origin of "data" in a patient/clinical sense, as this is laboratory/engineering testing. It is retrospective in the sense that the testing was conducted prior to the 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the data presented. The document describes laboratory and engineering tests (e.g., biocompatibility, sterilization, simulated use, packaging). "Ground truth" in the context of expert consensus (like for image interpretation in AI) is not relevant here. Compliance with established standards (e.g., ASTM, ISO standards for biocompatibility) would be the "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to the data presented. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretative variability exists. For engineering tests, results are typically objective Pass/Fail or numerical measurements against defined specifications.
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 question is not applicable. This device is a physical surgical tool (self-retaining retractor), not an AI/ML-based diagnostic or assistive software that interacts with human "readers" or interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a physical surgical tool, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is adherence to established engineering specifications, validated test methodologies, and recognized industry standards (e.g., for biocompatibility, sterility, packaging integrity). For example, a "Pass" for sterility validation means the device met the acceptance criteria for a Sterility Assurance Level (SAL) of 10-6.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of an AI/ML device. The device is a physical product, and its design is based on engineering principles and previous versions (predicate device).
9. How the ground truth for the training set was established:
- This question is not applicable. As there is no training set for an AI/ML algorithm, this concept does not apply. The "ground truth" for the device's design and manufacturing is established through defined product specifications, design control processes, and compliance with quality system regulations (e.g., 21 CFR Part 820).
§ 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).