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510(k) Data Aggregation
(120 days)
Evo sEEG System
The Evo sEEG System is intended for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
The NeuroOne Evo sEEG System is comprised of the Evo sEEG Electrodes (which includes Anchor Bolt Cap and Stylet) accompanying Cable Assemblies, and the Evo Anchor Bolts. The Evo sEEG System components are provided sterile and are single use only. The Evo sEEG Electrodes are temporarily placed (less than 24 hours) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEG) procedures. The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other sEEG electrodes, including the predicate device. The sEEG electrodes are a 0.8 mm diameter polyimide electrode with platinum contacts and are available in varying numbers of contacts: 5 to 16 contacts, with an exploration length (recording depth) from 16 to 80 mm. The contact height is 2.0 mm and spacing is 1.5-3.2 mm apart. The Evo Anchor Bolts are available in 20 mm, 25 mm, 30 mm, and 35 mm lengths, can only be used and placed through a small 2.1 mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted.
The NeuroOne Evo sEEG System, a depth electrode for temporary brain electrical signal recording, monitoring, and stimulation, has been deemed substantially equivalent to its predicate device, the DIXI Medical Microdeep Depth Electrode. This determination is based on a comprehensive set of performance tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative acceptance criteria for each test. Instead, for all "Non-Clinical Performance Tests," "Biocompatibility" tests, and a "Simulated Use and Implantation Accuracy Study," the reported performance is a concise "Pass – All samples passed the acceptance criteria" or similar statements like "Pass - Non-cytotoxic," "Pass - Did not elicit a sensitization response," etc. This indicates that predefined criteria were met for each test, but the exact numerical thresholds are not provided in this summary.
Summary of Performance Testing and Results:
| Test Category | Test Name | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Tests | ||
| Dimensional | Electrode Outer Diameter | Pass – All samples passed the acceptance criteria |
| Electrode Working Length | Pass – All samples passed the acceptance criteria | |
| Electrode Recording Depth | Pass – All samples passed the acceptance criteria | |
| Electrode Contact Spacing | Pass – All samples passed the acceptance criteria | |
| Electrode Contact Size | Pass – All samples passed the acceptance criteria | |
| Electrode Tail | Pass – All samples passed the acceptance criteria | |
| Anchor Bolt Compatibility – Outer Diameter | Pass – All samples passed the acceptance criteria | |
| Mechanical Performance - Implantation | Anchor Bolt Placement Torque | Pass – All samples passed the acceptance criteria |
| Anchor Bolt Removal Torque | Pass – All samples passed the acceptance criteria | |
| Electrode Depth Setting | Pass – All samples passed the acceptance criteria | |
| Electrode Depth Setting - Sliding Force | Pass – All samples passed the acceptance criteria | |
| Electrode Through Anchor Bolt | Pass – All samples passed the acceptance criteria | |
| Electrode Stylet Removal | Pass – All samples passed the acceptance criteria | |
| Anchor Bolt Cap Torque | Pass – All samples passed the acceptance criteria | |
| Anchor Bolt Cap Torque Movement | Pass – All samples passed the acceptance criteria | |
| Electrode Migration | Pass – All samples passed the acceptance criteria | |
| Electrochemical Performance | Impedance | Pass – All samples passed the acceptance criteria |
| Reliability | Pass – All samples passed the acceptance criteria | |
| Stimulation | Pass – All samples passed the acceptance criteria | |
| Detection | Pass – All samples passed the acceptance criteria | |
| Kink Resistance | Pass – All samples passed the acceptance criteria | |
| Mechanical Performance – Monitoring | Electrode Rigidity | Pass – All samples passed the acceptance criteria |
| Anchor Bolt Cap Torque | Pass – All samples passed the acceptance criteria | |
| Anchor Bolt Cap Sealing | Pass – All samples passed the acceptance criteria | |
| Electrode Flexibility | Pass – All samples passed the acceptance criteria | |
| Mechanical Integrity | Anchor Bolt Compatibility – Torque | Pass – All samples passed the acceptance criteria |
| Anchor Bolt Retention | Pass – All samples passed the acceptance criteria | |
| Electrode Integrity | Pass – All samples passed the acceptance criteria | |
| Anchor Bolt Cap Integrity | Pass – All samples passed the acceptance criteria | |
| Guiding Stylet Integrity | Pass – All samples passed the acceptance criteria | |
| Electrical Safety | IEC 60601-1 requirements | Pass – All samples passed the acceptance criteria |
| Packaging | ISTA 3A and ASTM D-4169; DC13; AL1 | Pass – All samples passed the acceptance criteria |
| Shelf-Life | Simulated storage conditions | Pass – All samples passed the acceptance criteria |
| Sterilization | Minimum SAL of 10-6 (Ethylene Oxide) | Pass – All samples passed the acceptance criteria |
| Biocompatibility | Cytotoxicity (ISO MEM Elution) | Pass - Non-cytotoxic |
| Sensitization (ISO Guinea Pig Maximization) | Pass - Did not elicit a sensitization response | |
| Irritation (ISO Intracutaneous Irritation) | Pass - Requirements of the ISO Intracutaneous Reactivity Test have been met | |
| Acute Systemic Toxicity (ISO Acute Systemic) | Pass - The ISO Acute Systemic Injection Test have been met | |
| Material Mediated Pyrogenicity (ISO Rabbit Pyrogen) | Pass - Non-pyrogenetic | |
| Implantation (Ovine brain, Rabbit tibia) | Pass – Minimal or no reaction | |
| Hemolysis (ASTM Hemolysis) | Pass - Non-hemolytic | |
| Simulated Use & Implantation Accuracy | Human cadaver study | No significant difference between subject and predicate implantation accuracy |
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: The document consistently states "All samples passed the acceptance criteria" for these tests, implying multiple samples were tested for each. However, the exact sample sizes for each individual test are not specified.
- Simulated Use and Implantation Accuracy Study: The sample size is not explicitly stated, but it was a "human cadaver study." The data provenance is implied to be from a controlled laboratory setting (conducted by NeuroOne Medical Technologies Corp.) rather than clinical data from a specific country, and it is a prospective study (testing the device).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: These types of tests typically rely on established scientific and engineering standards and validated methodologies rather than expert consensus for ground truth. The "ground truth" would be the fulfillment of the specified technical criteria within the standards. Therefore, an explicit number of experts and their qualifications for establishing ground truth as one might see in a clinical algorithm study is not applicable here.
- Simulated Use and Implantation Accuracy Study: The document does not specify the number or qualifications of experts used to establish the ground truth for implantation accuracy in the human cadaver study. The comparison was made against the predicate device, implying that accuracy was measured objectively according to predefined metrics.
4. Adjudication Method for the Test Set:
- For the non-clinical tests, the adjudication method is via comparison to predefined acceptance criteria within established standards (e.g., ISO, ASTM, IEC). This is typically an objective pass/fail assessment rather than a human adjudication process.
- For the "Simulated Use and Implantation Accuracy Study," the adjudication method is not explicitly stated. The conclusion that "no significant difference" was found implies a statistical comparison of measured implantation accuracy between the subject and predicate devices. No human adjudication process (like 2+1 or 3+1) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The study focused on demonstrating substantial equivalence through technical and performance characteristics, and a simulated use study comparing the subject device to a predicate, not on human reader performance with or without AI assistance. The device itself is an implantable electrode, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
This concept is not relevant to the Evo sEEG System, as it is a physical medical device (electrode) and not an algorithm or software-only device. Performance studies were conducted on the device's physical and electrical characteristics.
7. Type of Ground Truth Used:
- Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: The ground truth for these tests is based on adherence to established international and national standards (e.g., ISO, ASTM, IEC) and internal specifications. This is objective and measurable data compared against predefined thresholds.
- Simulated Use and Implantation Accuracy Study: The ground truth for implantation accuracy would be derived from objective measurements taken within the cadaver study, comparing the planned trajectory/placement with the actual placement, likely using imaging modalities.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable as this is a physical medical device, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set for this device.
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