(49 days)
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm bur hole. Secondarily, the NeuroPace® Burr Hole Cover also can be used to support a 1.3 mm indwelling Jead.
The NeuroPace® Burr Hole Cover (model 8110) includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. 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 NeuroPace® 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 base is made from a synthetic polymer and the cap 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 provided document, K141368, is a 510(k) premarket notification for the NeuroPace® Burr Hole Cover, Model 8110. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data or detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, the information regarding acceptance criteria, specific study design elements (like sample sizes, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), is not explicitly present in this summary document. The document primarily relies on non-clinical testing and comparison to the predicate device to establish substantial equivalence.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is not available:
Acceptance Criteria and Device Performance
The document doesn't explicitly list numerical acceptance criteria or performance metrics in a table format that would typically be associated with AI/software device evaluation. Instead, it states that the modified device was subjected to various non-clinical tests to demonstrate functional equivalence and safety.
| Category of Testing | Reported Device Performance/Conclusion |
|---|---|
| Dimensional / Geometry | Successfully performed, indicating the device meets its design specifications. |
| Functionality at Operation | Successfully performed, indicating the device functions as intended during use. |
| Lead Compatibility | Successfully performed, confirming compatibility with the 1.3 mm indwelling lead. |
| Lead Movement | Successfully performed, indicating appropriate control or restriction of lead movement. |
| Retention | Successfully performed, indicating the device maintains its position. |
| Cranial Rigidity | Successfully performed, indicating the device provides adequate structural support to the cranium. |
| Biocompatibility | Materials are biocompatible and are the same as used in the predicate device. |
| Sterility | Evaluations confirmed non-pyrogenicity and product sterility, and that bioburden and residual levels demonstrated compliance with recognized performance standards. (Sterile (SAL 1 x 10^-6)). |
| MR/CT Compatibility | Yes. |
| Shelf Life | 1 year. |
| Substantial Equivalence | The modified NeuroPace® Burr Hole Cover is substantially equivalent to the legally marketed predicate NeuroPace® Burr Hole Cover (K123163). No new issues of safety or effectiveness are raised. |
Study Details (Not Applicable/Available for this submission type)
Since this is a 510(k) submission for a physical medical device (burr hole cover) and not a software or AI/ML-based device, most of the requested details related to performance evaluation against ground truth, expert consensus, and sample sizes for diagnostic accuracy are not applicable or not provided in this type of regulatory document. The focus is on non-clinical testing demonstrating physical and material properties, and functionality consistent with its intended use and predicate device.
- Sample size used for the test set and the data provenance: Not applicable in the context of a diagnostic dataset. The "test set" here refers to physical devices undergoing engineering and material testing. No specific sample sizes for these tests are detailed in this summary, nor is data provenance in the sense of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/ML diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would be established engineering specifications and material properties, against which the physical device is tested.
- The sample size for the training set: Not applicable, as no algorithm is being "trained."
- How the ground truth for the training set was established: Not applicable.
In summary, the K141368 document demonstrates substantial equivalence through non-clinical testing of the physical, material, and functional characteristics of the NeuroPace® Burr Hole Cover, Model 8110, compared to its predicate device. It does not involve AI/ML components, clinical studies for diagnostic accuracy, or associated performance metrics and ground truth evaluations often seen in software as a medical device (SaMD) submissions.
§ 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).