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510(k) Data Aggregation
(57 days)
INTEGRA ELECTRODE TUNNELING NEEDLE
The INTEGRA™ Electrode Tunneling Needle aids in externalizing the leads of the Integra Cortical Electrodes to avoid contamination with patient fluids.
The INTEGRATM Electrode Tunneling Needle is a single use device intended to be used for externalizing the leads of the Integra Cortical Electrodes away from the craniotomy site for patients undergoing brain mapping procedures. The INTEGRATM Electrode Tunneling Needle creates a passage under the scalp through which the electrode leads can pass to a separate exit site without contaminating the lead contacts with patient fluids. The device consists of a stainless steel trocar with a plastic tunneling sheath attached to contain the leads during passage.
The Integra™ Electrode Tunneling Needle is a single-use device designed to externalize the leads of Integra Cortical Electrodes away from the craniotomy site during brain mapping procedures. The device creates a passage under the scalp, allowing electrode leads to pass to a separate exit site without contamination from patient fluids. It consists of a stainless steel trocar with a plastic tunneling sheath.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leads are well contained within the plastic tunneling sheath during tunneling. | "Functional testing ensured all the samples had the leads well contained within the plastic tunneling sheath during tunneling with no evidence of contamination/contact with animal tissue." |
| No evidence of contamination/contact with patient fluids (specifically, animal tissue in testing). | "Functional testing ensured all the samples had the leads well contained within the plastic tunneling sheath during tunneling with no evidence of contamination/contact with animal tissue." |
| Tunneling device does not adversely affect the electrode leads (e.g., resistance remains within acceptable limits). | "Testing was completed to check the resistance of the electrode before and after tunneling to ensure that the tunneling device did not adversely affect the electrode. All the test results were found to be in accordance with the passing criteria dictated in the Design Verification Protocol and the Product Specification." While specific numerical "passing criteria" for resistance are not provided, the statement indicates that all tested devices met these internal criteria. |
| The device meets all functional Design Output requirements consistent with Design Input. | "Performance Testing and Testing Results: The testing verified that the functional Design Outputs are consistent with the Design Input requirements for the INTEGRATM Electrode Tunneling Needle." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set. It refers to "all the samples" and "all the test results," indicating that multiple devices were tested. The testing involved "animal tissue," suggesting the provenance of the data is a pre-clinical, in vivo or ex vivo animal study rather than human data. The study appears to be prospective as it's described as "functional testing" and "testing was completed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to the reported testing. The "ground truth" here is objective physical performance (lead containment, absence of contamination, electrical resistance). There is no mention of expert human interpretation being required to establish these physical facts.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., radiology reads) where there can be disagreement among experts. The reported testing focuses on objective physical measurements and observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used
The ground truth used for the performance testing was objective physical measurements and observations based on the functional performance of the device. This included:
- Visual confirmation of lead containment within the sheath.
- Visual confirmation of the absence of contamination/contact with animal tissue.
- Objective electrical resistance measurements of the electrode leads before and after tunneling.
8. The sample size for the training set
Not applicable. This device is a simple mechanical instrument, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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