(295 days)
The Guardian™ Burr Hole Cover System is intended for use during cranial surgery as an implantable 14 mm burr hole cover for the skull. It can also be used to secure a lead with a 1.29 mm (0.051 in) or 1.39 mm (0.055 in) diameter.
The GuardianTM burr hole cover system consists of three main features: base, clip, and cover. The GuardianTM burr hole cover system is used to close a cranial burr hole and can be used to secure an implanted compatible lead (1.29mm and 1.39mm). The burr hole cover is mated with the burr hole that is drilled in the patient's skull during the cranial surgery. The burr hole cover acts as a physical barrier protecting the exposed brain by covering the burr hole. The burr hole cover can also be used to provide temporary and permanent lead fixation.
There are ancillary components of the system (base holder with cranial screws, clip, insertion tool and screw driver) that aid in the placement of the burr hole cover system. The base holder is intended to align the base with the burr hole and to maintain the cranial screws in place in the package and during installation.
A clip insertion tool is intended to actuate the clip/insert and place it in the base. A screw driver is used to install the screws to the skull.
The provided text is a 510(k) summary for the Guardian™ Burr Hole Cover System, which is a medical device. This document details non-clinical bench testing and biocompatibility testing to establish substantial equivalence to a predicate device. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets the acceptance criteria in the context of AI, multi-reader, or standalone algorithm performance.
However, I can extract the acceptance criteria and results for the non-clinical performance and biocompatibility testing of the Guardian™ Burr Hole Cover System.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing & Biocompatibility)
The document primarily focuses on verifying the device meets "pre-determined acceptance criteria" through a series of non-clinical tests. The "Testing Scope and Rationale" column often implies the acceptance criteria (e.g., "confirm actuation," "confirm does not rotate," "confirm no damage," "confirm ability to permanently remain fixated," "demonstrated compliance to ISO standards"). The "Results" column indicates whether these criteria were met.
| Acceptance Criteria (Implied from "Testing Scope and Rationale") | Reported Device Performance |
|---|---|
| Bench Testing | |
| Preconditioning prior to subsequent preclinical testing. | All SJM devices preconditioned. |
| Confirm actuation of temporary restraint (with the insert) when using the handheld tool. | All SJM devices passed. |
| Confirm that the lead can be temporarily restrained by the insert. | All SJM devices passed. |
| Confirm that the insert does not rotate during temporary restraint. | All SJM devices passed. |
| Confirm the ability to remove a stylet, cannula, or guide tube when the insert is engaged. | All SJM devices passed. |
| Confirm that the insert (temporary restraint mechanism) can be actuated multiple times. | All SJM devices passed. |
| Confirm permanent restraint mechanism (cover) functions after worst-case vibration levels. | All SJM and NeuroPace devices passed. |
| Confirm no damage to lead electrical and mechanical components. | All SJM devices passed. |
| Confirm performance at a pre-specified vibration level. | All SJM devices passed. |
| Confirm performance during an application of shear force. | All SJM devices passed. |
| Confirm the temporary restraint mechanism (the insert) is resistant to removal once engaged. | All SJM devices passed. |
| Confirm the ability to permanently remain fixated to the mounting surface after worst-case vibration levels. | All SJM and NeuroPace devices passed. |
| Biocompatibility Testing | |
| Assess for potential cytotoxic effects (following ISO 10993-5). | The SJM BHC system demonstrated compliance to ISO 10993-5. |
| Assess for the potential to cause irritation (following ISO 10993-10). | The SJM BHC system demonstrated compliance to ISO 10993-10. |
| Assess for the potential to cause delayed contact dermal sensitization (following ISO 10993-10). | The SJM BHC system demonstrated compliance to ISO 10993-10. |
| Assess for the potential to cause acute systemic toxicity (following ISO 10993-11). | The SJM BHC system demonstrated compliance to ISO 10993-11. |
| Assess for the potential to cause a pyrogenic response (following ISO 10993-11). | The SJM BHC system demonstrated compliance to ISO 10993-11. |
| Assess for particulate load (following ISO 14708-3). | The SJM BHC system demonstrated compliance to ISO 14708-3. |
| Assess chemical characterization to demonstrate leachables are toxicologically acceptable (following ISO 10993-18 and ISO 10993-17). | The SJM BHC system demonstrated compliance to ISO 10993-18 and ISO 10993-17. |
| Sterilization and EO residuals evaluated (following ISO 11135:2007 and ISO 10993-7:2008). | All SJM devices passed, demonstrating compliance. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document repeatedly uses the phrase "All SJM devices passed" or "All SJM and NeuroPace devices passed" for the performance bench tests. Biocompatibility tests also refer to "the SJM BHC system" being assessed. However, specific numerical sample sizes for each test are not provided in this document.
- Data Provenance: The nature of these tests (bench testing, in vitro, and in vivo animal biocompatibility studies) indicates the data provenance is from laboratory and animal studies, not human clinical data. There is no information regarding country of origin, or whether it's retrospective or prospective in the sense of human subject studies. These are pre-market device tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this document. The tests described are objective, non-clinical performance and biocompatibility assessments, not studies requiring expert interpretation of results or ground truth establishment in the context of diagnoses or clinical assessments. Compliance with established ASTM, ISO, or internal St. Jude Medical test protocols would be the "ground truth."
4. Adjudication Method for the Test Set
- This information is not applicable to this document, as the tests are objective mechanical and biological assessments, not subjective interpretations requiring adjudication.
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 information is not applicable to this document. The device is a physical medical implant (burr hole cover system), not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this information is not applicable to this document. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- For Performance Bench Testing: The "ground truth" is defined by the pre-determined acceptance criteria and established engineering/physical principles applied in the test protocols (e.g., proper actuation, no rotation, no damage, consistent fixation, etc.).
- For Biocompatibility Testing: The "ground truth" is defined by compliance with internationally recognized standards, specifically referenced ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 14708-3, ISO 10993-18, ISO 10993-17, ISO 11135:2007, ISO 10993-7:2008).
8. The Sample Size for the Training Set
- This information is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable. Since there is no training set, there is no ground truth to be established for it.
§ 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).