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510(k) Data Aggregation
(238 days)
The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
The DIXI Medical Microdeep Depth Electrode ("Microdeep Depth Electrode" or "Electrode") is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Microdeep Depth Electrodes are used under the supervision of a physician (physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes) and are intended to connect to the user's recording, monitoring and stimulation equipment. This information is then used for defining the location of epileptogenic foci and brain mapping.
The DIXI Medical Microdeep Depth Electrode is intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. The device was found substantially equivalent to predicate devices based on non-clinical performance data, including a human cadaver study.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implantation Accuracy | The mean difference in errors between the Microdeep Depth Electrode and the predicate device was 2.87mm. This is less than the non-inferiority margin of 3.6mm. Therefore, the implantation accuracy endpoint has been met. |
| Tracking Accuracy | The data demonstrates the ability of the DIXI Medical Microdeep Depth Electrode to travel within the track previously created by the DIXI Medical stylet. There were three targets with a 1mm difference and one target with a 3mm difference, resulting in a mean and standard deviation of 0.12mm +/- 0.47mm. |
| Verification testing | Demonstrated conformance to design specifications. (Details not provided in the extract) |
| Biocompatibility testing | Demonstrated conformance to design specifications. (Details not provided in the extract) |
| Packaging, shelf life and transit testing | Demonstrated conformance to design specifications. (Details not provided in the extract) |
| EO Sterilization Validation | Demonstrated conformance to design specifications. (Details not provided in the extract) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The number of cadaver heads used for the implantations is not explicitly stated, but it mentions "Cadaver heads were implanted with equal number of electrodes" for both the test device and the predicate. The number of electrodes is also not specified.
- Data Provenance: Human cadaver study. The country of origin is not specified, but the applicant (DIXI Medical) is from France. The study is prospective in the sense that it was conducted specifically for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study involved a comparison of physical implantation and tracking, rather than an assessment requiring expert interpretation of medical images or diagnoses.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for studies involving expert review and disagreement resolution, such as image interpretation. Since this was a physical cadaver study assessing direct measurements of implantation and tracking accuracy, an adjudication method for ground truth establishment is not applicable in the traditional sense. The "ground truth" here would be the physical measurements taken from the cadaver heads.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic AI devices where human readers interpret medical data. The study detailed here is a bench/cadaver study assessing physical device performance.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
Yes, a standalone study was done in the context of the device's physical performance. The data on implantation accuracy and tracking accuracy were obtained directly from the interaction of the device with the cadaver heads, not as part of a human-in-the-loop diagnostic process. The "device performance" in this context refers to its mechanical and functional characteristics.
7. Type of Ground Truth Used
The ground truth used was based on direct physical measurements of implantation location and tracking ability within the human cadaver heads. This is analogous to "measurement data" or "physical outcome data."
8. Sample Size for the Training Set
This information is not applicable as the DIXI Medical Microdeep Depth Electrode is a physical medical device, not an AI algorithm that requires a training set. The "study" refers to performance testing of the physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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