(37 days)
The NeuroPort™ Electrode (SIROF) 1.0 mm and 1.5 mm are indicated for temporary (
The NeuroPort™ Electrode (SIROF) detects the electrical activity of cortical neurons during sub-chronic-monitoring procedures for less than thirty consecutive days. All of the components in the NeuroPort™ Electrode (SIROF) are passive and are intended exclusively for recording applications: monitoring brain electrical activity, defining the location of the epileptogenic foci and brain mapping.
The NeuroPort™ Electrode (SIROF) consists of high impedance electrodes. The NeuroPort™ Electrode (SIROF) has 100 electrode contacts on a silicon substrate of 4mm by 4mm.
The electrodes provide the patient contact device. The electrodes connect the users recording and monitoring equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording and monitoring understand the use of depth electrodes.
This document describes the NeuroPort™ Electrode (SIROF), a depth electrode used for temporary recording and monitoring of brain electrical activity. The submission is a Special 510(k) for modifications to a previously cleared device (K070272).
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility in conformance with ISO 10993 guidelines | "Biocompatibility testing was conducted in conformance with ISO 10993 guidelines" (Implied acceptance) |
| Sterility Validation in conformance with EN ISO 11737-1 | "Sterility Validation was conducted in conformance with EN ISO 11737-1 sterilization process demonstrated a spore (BI) kill to achieve a sterility assurance level (SAL) of 1x10-6" (Meets acceptance) |
| Performance (Impedance Measurement) | "Impedance measurement was used as a performance metric which allows a quantitative measurement of the quality of the electrode solution interface. Testing of the modified NeuroPort™ Electrode has demonstrated that the NeuroPort™ Electrode (SIROF) fulfills prospectively defined performance criteria and that the modified system meets user needs." (Implied acceptance based on meeting "prospectively defined criteria" and "user needs") |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes material and performance testing for the device itself, not a clinical study involving human subjects or data derived from human subjects for a "test set" in the context of an AI/ML device.
- Sample Size for Test Set: Not applicable in the context of this device submission (no clinical study with a test set of patient data). The samples referred to are physical device units for material and performance testing.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable. The tests are laboratory-based and relate to device materials and manufacturing processes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. As noted above, this is a device modification submission for a physical medical device, not an AI/ML algorithm requiring expert-established ground truth for a test set of medical data.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" of medical data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This is not an AI/ML device and therefore no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to industry standards and specifications for medical device performance and safety:
- Biocompatibility: ISO 10993 guidelines.
- Sterility: EN ISO 11737-1 standards for achieving a sterility assurance level (SAL) of 1x10-6.
- Performance (Impedance): "Prospectively defined performance criteria" relating to impedance measurements. The specific numerical criteria are not provided in this summary but would have been part of the full submission.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no "training set" or corresponding ground truth establishment methodology for such a set.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).