Search Results

NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.

The NeuroLine Disposable Cranial perforators (NLO-x/y-z) are single-use cutting devices that are packaged sterile and are used to perforate the skull bone. The perforator functions automatically, which means that it employs a clutch mechanism to automatically disenqage once perforation is accomplished and as the drill ceases to find resistance to bone.

The perforator has Hudson type connection and can connect to all the driver units with Hudson connection.

Perforators are offered in three different sizes: 6/9 mm, 7/13 mm and 11/14 mm. Sizes indicate hole diameters to be made by perforators in millimeters.

Perforators are also differentiated based on the thickness of skull bone. The NLO-x/y-3.0 perforators are used on skulls at least 3 mm thick, whereas NLO-x/y-1.5 ones are used on skulls at least 1.5 mm thick.

The provided text describes the regulatory clearance for a medical device, the NeuroLine Disposable Cranial Perforator with Hudson End, and details the performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document is a 510(k) summary for a mechanical device (a surgical drill), not an AI/ML-driven device or diagnostic tool.

Therefore, the information required to answer your questions about acceptance criteria and studies proving the device meets them, specifically in the context of AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies, is not present in the provided text.

The document discusses:

• Acceptance Criteria (for a mechanical device): These are implicitly met by "Pass" results in the performance testing section. The specific criteria are related to Biocompatibility (ISO 10993), Sterilization and Packaging validation (ISO 11137-1/2, ISO 11607-1/2), and Bench Testing for automatic stop function, maximum number of uses, drilling time, and device geometry.

• Study Proving Device Meets Criteria: This refers to the "Performance Testing" section:

  • Biocompatibility: Tests conducted in accordance with ISO 10993.
  • Sterilization and Packaging Validation: Tests conducted in accordance with ISO 11137-1, ISO 11137-2, ISO 11607-1, and ISO 11607-2.
  • Bench Testing: Evaluated automatic stop function mechanism, maximum number of uses, drilling time, and device geometry.

None of the following questions can be answered from the provided text as they pertain to AI/ML device evaluations, which is not the subject of this document:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The device is not an AI/ML device. The "Pass" results are reported for mechanical and biological performance.
2. Sample sizes used for the test set and the data provenance: Not relevant for this mechanical device.
3. Number of experts used to establish the ground truth... and qualifications: Not relevant. No "ground truth" in the AI/ML sense is established. Performance is measured against mechanical specifications.
4. Adjudication method for the test set: Not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant.
7. The type of ground truth used: Not relevant in the AI/ML context. Performance against mechanical specifications is the "truth."
8. The sample size for the training set: Not relevant. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not relevant.

In summary, the provided document is about a hardware medical device (a cranial perforator) and its regulatory clearance based on mechanical, sterility, and biocompatibility testing, not an AI/ML or diagnostic software device.

Ask a specific question about this device