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510(k) Data Aggregation
(505 days)
The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.
The Recording and stimulating for Central Nervous System electrodes are used for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci. The electrodes are multipole arrays of electrodes that are positioned on the surface of the brain. The electrode must be designed to follow the complex anatomy and they can assume different conformations in relation to the requests of clinical needs. The neurosurgeon is the person recommended for electrode placement. The electrodes have to be used under the direction of the neurosurgeon and other skilled physicians to support their clinical needs.
The provided text describes the acceptance criteria and the results of various performance tests for the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (hereinafter referred to as "the device").
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Cytotoxicity | Reactivity grade of 0 (none reactivity) | Test sample results to have a reactivity grade of 0 (=none reactivity) | NON-CYTOTOXIC. No test extract does not show any reactivity. |
| Skin Irritation | Final test sample score of 1.0 or less | The final test sample score is 1.0. Very slight erythema (barely perceptible). | NON-IRRITATING. The test item satisfied the requirements of the test. |
| Skin Sensitization | % sensitising treated guinea pigs equal to 0% (no visible change) | The results show a % sensitising treated guinea pigs equal to 0% (=no visible change). | NON-SENSITIZING. The tested item is considered not sensitizing. |
| Systemic Toxicity | No weight loss, mortality, or toxic signs/symptoms in treated and control animals | Weight increase: no weight loss was recorded in any treated and control animals. Mortality: in none of the treated and control animals mortality was observed. Clinical symptoms: in none of the treated and control animals toxic signs or symptoms were observed. | DO NOT CAUSE TOXIC SYMPTOMS. The tested item doesn't cause toxic symptoms and satisfies the requirements of the test. |
| Pyrogenicity Test | Sum of individual temperature rises < 3.3°C, with no more than two rabbits showing individual rise of temperature ≥ 0.5°C. | Two of the eight rabbits showed individual rise of temperature ≥ 0.5°C and the sum of the eight individual rises is 2.0°C (<3.3°C). | ABSENCE OF PYROGENS. The tested item meets the requirement for absence of pyrogens. |
| Hemolysis Test (indirect contact) | Final hemolytic index between 0-2 (non-hemolytic grade) | The final hemolytic index for all three experimental replicates result to be between the range 0-2, which means: non hemolytic grade. | NOT HEMOLYTIC for indirect contact. The tested item is not hemolytic for indirect contact. |
| Packaging Validation (3 years shelf-life) | Sterility, sterile barrier characteristics, seals integrity and strength, visual inspection, peeling, seals width, absence of pinholes, impermeability to microorganisms must be compliant after accelerated aging. | - Visual inspection: compliant- Seals integrity: compliant- Peeling: compliant- Seals width: compliant- Pinholes absence: compliant- Microorganisms impermeability: compliant- Seals strength: compliant. Average strength internal pouch at T0: 2,22 N/1,5mm. Average strength outer pouch at T0: 2,32 N/1,5mm. Average strength internal pouch at T3: 2,15 N/1,5mm. Average strength outer pouch at T0: 2,42 N/1,5mm.- Sterility tests: compliant, Sterile. | The sterile barrier system maintains integrity (efficacy) for the foreseen 3-year shelf-life, with no damage or alterations to pouches, and products remaining morphologically and visually intact and sterile after accelerated aging. |
| Cable Tensile Testing | Tensile strength during pull-out > 30N | All the tensile strength evaluates results to be greater than 30N (average 41.35 N). | The device demonstrates very high strength during pull-out tests, ensuring manufacturing process safety and strength of use. |
| Impedance Test and Dielectric Strength | Impedance < 5kOhm both pre and post stimulation | All the impedance evaluates results to be less than 5kOhm both pre and post simulation. | Stimulation doesn't affect or worsen the electrode performance. |
| Electrical Safety - Insulation | All different parts of the electrode (connector, case, dielectric) must be insulated at 250V, 500V, and 1000V. | All the different parts of the electrode (connector, case, dielectric) results to be insulated. | The electrodes are isolated and comply with electrical safety requirements. |
| Climatic Tests | No damage to the product due to changes in temperature and relative humidity. | Refrigerated storage test, extreme cold test, and tropical test showed positive results. The test samples were then subjected to vibration tests. | No damage to the product has been observed. |
| Shipment Tests | No impact/damage on packaging and materials from handling, stacking, vibration, and impact tests. | The results of handling test, vehicle stacking test, loose load vibration test, vehicle vibration test, and concentrated impact test are found to be in compliance with the pass/fail criteria of the tests. | No damage to the product has been observed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each test in terms of the number of devices or specific units. However, it does refer to "test sample results," "test item," and "test articles" for various tests. For the pyrogenicity test, it explicitly mentions "eight rabbits." The packaging validation for shelf-life refers to "pouches samples" and "medical devices sterile barrier system samples."
The data provenance is from Spes Medica S.r.l., Italy, and the studies are prospective performance tests conducted to demonstrate the device's safety and effectiveness.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The studies described are performance and biological evaluations, not clinical studies involving expert interpretation for ground truth.
4. Adjudication Method:
This information is not applicable as the studies are technical performance and biocompatibility tests, not studies requiring adjudication of disagreements among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. The document focuses on the technical and biological performance of the device itself, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The device is an electrode for recording and stimulating the central nervous system, and not an algorithm or AI-powered diagnostic tool.
7. Type of Ground Truth Used:
The ground truth for these studies is based on established scientific and regulatory standards for biocompatibility, electrical safety, mechanical durability, and packaging integrity. The results are compared against predefined acceptance criteria for these tests. For instance:
- Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization, Systemic Toxicity, Hemolysis): Based on the biological response of cells/animals to the device materials according to standardized test methods (e.g., ASTM F 756-17 mentioned for Hemolysis).
- Pyrogenicity: Based on the temperature response of rabbits.
- Packaging and Shelf Life: Based on the physical properties and sterility of the packaging after accelerated aging.
- Electrical and Mechanical Performance: Based on measured values against engineering specifications.
8. Sample Size for the Training Set:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The studies are for product performance and safety validation.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for an AI/ML algorithm.
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