(101 days)
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm burr hole. Secondarily, the NeuroPace Burr Hole Cover also can be used to support a 1.3 mm indwelling lead.
The NeuroPace® Burr Hole Cover (model 8110) (also referred to as "the device") includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. The cap is an assembly comprised of a cap and a gasket. The cap is pressed into the base covering the opening in the base and securing a single 1.3 mm lead. The Burr Hole Cover requires three bone screws (1.5 to 1.8 mm).
The screws and driver are not included in the device's packaging. The contents of the unopened, undamaged package are sterile and non-pyrogenic.
The Burr Hole Cover is provided sterile (for single-use only) and consists of one model / size. The device is meant to be a permanent implant.
The Burr Hole Cover incorporates materials commonly found in medical devices that are known to be biocompatible. The cap and base are made from a synthetic polymer and the gasket is made from silicone.
The Burr Hole Cover is MR/CT scanning compatible and is sterilized using ethylene oxide gas (EtO).
The Burr Hole Cover does not include any software, incorporate any medicinal substances or contain any color additives.
The NeuroPace® Burr Hole Cover (model 8110) is a medical device designed to cover a 14 mm burr hole following cranial surgery and to support a 1.3 mm indwelling lead. The device's acceptance criteria and performance were assessed through non-clinical testing rather than clinical studies with human subjects.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes performance testing conducted to demonstrate compliance with product requirements. The acceptance criteria are implicit in the successful completion of these tests, indicating the device met the specified engineering and safety standards. Since the document does not present quantitative metrics for "performance" as one might expect from a diagnostic AI, the performance is stated as "compliance" or "demonstrated."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional / Geometry | Compliant (demonstrated through performance testing) |
| Device Usability | Compliant (demonstrated through performance testing) |
| Lead Compatibility | Compliant (demonstrated through performance testing) |
| Lead Movement | Compliant (demonstrated through performance testing) |
| Fixation / Retention | Compliant (demonstrated through performance testing) |
| Cranial Rigidity | Compliant (demonstrated through performance testing) |
| Biocompatibility | Demonstrated in accordance with ISO 10993-1 |
| Sterility | Compliant (demonstrated through performance testing) |
| Pyrogenicity | Compliant (demonstrated through performance testing) |
| MR/CT Scanning Compatibility | Compliant (demonstrated through performance testing) |
| Packaging / Shelf Life | Compliant (demonstrated through performance testing) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was deemed necessary to support substantial equivalence." This means there was no human test set in the traditional sense of a clinical study. The "test set" consisted of physical devices undergoing various laboratory and engineering tests. The data provenance is from non-clinical laboratory testing conducted by NeuroPace Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was performed, there were no human experts establishing ground truth for a patient-based test set. The "ground truth" here is based on engineering specifications, regulatory standards, and established material science properties. The experts involved would have been the engineers, material scientists, and regulatory affairs personnel responsible for designing, testing, and submitting the device, operating under the established guidelines and standards (e.g., ISO 10993-1).
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set was used, there was no need for an adjudication method involving experts making clinical decisions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a passive implantable medical device, not an AI or diagnostic software tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical implant, not an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation was based on:
- Engineering Specifications and Design Requirements: The device was designed to meet specific dimensions, material properties, and functional criteria (e.g., lead compatibility, fixation strength).
- Regulatory Standards: Compliance with international and national standards for medical devices, such as ISO 10993-1 for biocompatibility, ISO 11607-1 for packaging, and various ASTM and AAMI standards for material testing and sterilization.
- Predicate Device Characteristics: The device's performance was also assessed against the known characteristics and approved uses of the predicate device (Image-Guided Neurologics Burr Hole Cover, K001096) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
In summary, the NeuroPace® Burr Hole Cover is a physical implantable device, and its acceptance criteria and "performance" were established and demonstrated through rigorous non-clinical laboratory testing against established engineering specifications and regulatory standards, rather than through clinical trials, expert consensus, or AI performance metrics. Its substantial equivalence to a legally marketed predicate device was a key aspect of its clearance.
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).