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The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (

The Microdeep® Micro-Macro Depth Electrode is a single patient use, sterile and disposable device. The Microdeep® Micro-Macro Depth Electrode is invasive as it is placed in contact with nerve tissue (brain) and must only be used during an SEEG procedure with Anchor Bolts. The Microdeen® Micro-Macro Depth Electrode is intended to connect to the user's recording. monitoring and stimulation equipment using the Connection System. This product is intended to be used only by physicians in the area of biopotential recording, monitoring and stimulation / response studies who are trained in intracranial neurophysiology. The DIXI Medical Microdeep® Micro-Macro Depth Electrode is comprised of the following components: Macro-contacts, Micro-contacts, Microdrive for micro-contacts, Cap, Connectors for micro and macro-contacts.

The provided 510(k) summary for the DIXI Medical Microdeep® Micro-Macro Depth Electrodes details the results of non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Verification of electrode water tightness
• Verification of cap maintenance on the electrode sheath
• Verification of the antirotation function of electrode cap
• Verification of tensile strength of electrode macro-contacts | Pass |
  | Electrical Characteristics | - Verification of the electrical characteristics (contacts continuity, contacts resistance, absence of short-circuit, insulating resistance)
• Verification of the electrode integrity and electrical functionality after stimulation under worst case charge density | Pass |
  | Device Integrity | - Verification of the absence of alteration of the packaging
• Verification of the absence of alteration of the electrode | Pass |
  | Comparative Testing | - Comparative test of the tensile strength of the micro-contacts between the predicate device and the subject device
• Verification of the integrity and the mechanical functionality of the predicate device and the subject device after clinical simulation of use | Pass |
  | Biocompatibility - Cytotoxicity | Non-cytotoxic (per ISO 10993-5) | Non-cytotoxic |
  | Biocompatibility - Sensitization | Non-sensitive (per ISO 10993-10) | Non-sensitive |
  | Biocompatibility - Irritation or intracutaneous reactivity | Negligible irritation (per ISO 10993-10) | Negligible irritation |
  | Biocompatibility - Acute systemic toxicity | Non-toxic (per ISO 10993-11) | Non-toxic |
  | Biocompatibility - Material-mediated pyrogenicity | Non-pyrogenic (per USP) | Non-pyrogenic |
  | Biocompatibility - Sub-acute toxicity | Non-toxic (per ISO 10993-11) | Non-toxic |
  | Biocompatibility - Genotoxicity – Mouse Lymphoma Assay | Non-genotoxic (per OECD guideline No. 490 and ISO 10993-3) | Non-genotoxic |
  | Biocompatibility - Genotoxicity – Bacterial Reverse Mutation | Non-genotoxic (per OECD guideline No. 471 and ISO 10993-3) | Non-genotoxic |
  | Biocompatibility - Indirect (extract) hemolysis | Non-hemolytic (per ASTM F756 and ISO 10993-4) | Non-hemolytic |
  | Biocompatibility - Implantation and neurotoxicity | No or minimal reaction (per ISO 10993-6) | No or minimal reaction |
  | Sterilization | Sterility Assurance Level (SAL) of 10^-6, EO residuals per ISO 10993-7 (per ISO 11135:2014) | SAL of 10^-6 demonstrated; device meets EO residuals |
  | Shelf-life | Shelf-life established based on accelerated and real-time aging | 4 years established |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each non-clinical test. The tests were performed in a laboratory setting by DIXI Medical. The data provenance is internal to DIXI Medical (France). All data appears to be prospective as it details performance and safety studies conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The tests performed are non-clinical, laboratory-based engineering, material, and biological evaluations. There is no "ground truth" derived from expert review in the clinical sense for these types of tests. The "ground truth" for these tests is the defined engineering specifications, material properties, and biological safety standards (e.g., ISO, USP, ASTM, OECD guidelines).

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical laboratory tests, not clinical studies requiring adjudication of output. The results of the tests are objectively measured against pre-defined criteria in the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (electrode) and relies on non-clinical performance and safety data, as well as a comparison of technological characteristics to a predicate device, rather than a clinical effectiveness study involving human readers and AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrode, not an AI or algorithm-based system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is established by:

• Engineering specifications and standards: For dimensional, mechanical, and electrical characteristics, the "ground truth" is the established design specifications and performance metrics for the device, validated against recognized engineering principles and testing methods.
• International Standards (ISO, ASTM, OECD) and Pharmacopeia (USP): For biocompatibility, sterilization, and shelf-life, the "ground truth" is defined by the requirements and acceptance criteria outlined in specific international standards and guidelines (e.g., ISO 10993 series, ISO 11135, USP).

8. The Sample Size for the Training Set

Not applicable. This device is an electrode, not an AI or algorithm-based system, so there is no training set in the context of machine learning.

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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The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping.

The DIXI Medical Intraoperative Subdural Electrode (Strips and Grids) is an intra-cranial electrode used intraoperatively on the surface of the brain. The device is designed for electroencephalography (EEG) recording and brief stimulation for brain mapping purposes. The DIXI Medical Intraoperative Subdural Electrode consists of circular contacts sandwiched between two layers of silicone substrate. The brain contacting side of the silicone substrate body has material removed to expose an amount of contact surface area. Insulated wires extend from each contact through a flexible tube which terminates in connectors for direct connection to user's equipment.

The device in question is the DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids), which are intended for intraoperative use (less than or equal to 24 hours) for recording and stimulating electrical signals on the brain's surface to support brain mapping.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical and biocompatibility testing. The acceptance criteria are implicit in the "Objective" column for non-clinical tests and the "Conclusion" column for biocompatibility tests, which all show a "Pass" result indicating the device met the predefined safety and performance standards for each test.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document mentions that nonclinical testing was conducted on specific product references: C10-04CIOM, C10-08AIOM, and C10-16CIOM, C10-16AIOM for biocompatibility. However, it does not specify the exact number of units of each product that were tested for each individual test. It also refers to testing on "baseline and aged devices," with aged devices undergoing three sterilization cycles, accelerated aging (5 years), extreme climatic conditions, and transport tests, implying multiple units were used for aging studies.
• Data Provenance: The document does not explicitly state the country of origin of the data. It is a submission by DIXI Medical, located in France. The testing was conducted according to international standards (ASTM and ISO). The data is from nonclinical, pre-market testing, not patient-derived data (retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable. The studies described are non-clinical (device performance and biocompatibility) and do not involve expert-established ground truth in the context of clinical decision-making or diagnosis. The "truth" or acceptance criteria are based on established engineering and biological safety standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on patient data. The current studies are bench tests and animal studies (for biocompatibility).

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 relevant for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI. The DIXI Medical Intraoperative Subdural Electrodes are physical medical devices for electrical signal recording and stimulation, not for diagnostic image interpretation or AI-driven analysis.

6. Standalone Performance Study:

Yes, standalone (algorithm only without human-in-the-loop performance) studies were done for the device's physical and electrical characteristics and biocompatibility. The reported "Pass" results for all tests indicate the device met its predefined performance and safety criteria independently. The non-clinical and biocompatibility tests were conducted directly on the device itself or its materials.

7. Type of Ground Truth Used:

The "ground truth" for these tests refers to established engineering specifications, regulatory standards, and biological safety limits. For example:

• Nonclinical Testing: Ground truth is defined by the expected electrical (e.g., ability to transmit signal, resistance), dimensional, and mechanical properties of the device as per its design and intended use, validated against engineering standards.
• Biocompatibility Testing: Ground truth is based on the biological response limits defined by standards like ISO 10993, ensuring materials are non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic, non-hemolytic, and non-toxic.

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The development of the device would have involved iterative design and testing, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated in point 8.

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The DIXI Medical Microdeep Depth Electrodes are intended for temporary (

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 (

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