(98 days)
The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.
The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.
The provided text describes the Penumbra Artemis™ Neuro Evacuation Device and its substantial equivalence to a predicate device, the Apollo System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a comparative effectiveness study with human readers or a standalone algorithm performance study.
Therefore, the information required to answer the following points is not available in the provided text:
- A table of acceptance criteria and the reported device performance: While some tests are listed with "100% Pass" or descriptions like "Non-toxic," specific numerical acceptance criteria (e.g., minimum aspiration rates, maximum force tolerances) and their corresponding performance values are not detailed. The provided information summarizes categories of tests and their overall success.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The text mentions "Design Verification (Bench-Top Testing)" and "Simulated Use" but does not specify the sample sizes (number of devices or simulated clots) used for these tests. Data provenance is also not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant to the non-clinical, bench-top testing described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to the non-clinical testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This study type is not mentioned or implied, as the device is a mechanical neuro evacuation device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a mechanical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and successful execution of the test methods (e.g., passing a specific force test, achieving a certain vacuum level, being non-toxic per ISO standards).
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
However, based on the provided text, here is a summary of the acceptance criteria and study information that is mentioned:
Acceptance Criteria and Reported Device Performance (Based on available summary data):
| Test Category | Test Method Summary | Reported Performance (Conclusion) |
|---|---|---|
| Biocompatibility | ||
| In vitro Cytotoxicity | MEM Elution Test | Non-toxic |
| Sensitization | ISO Guinea Pig Maximization Sensitization Test | Non-sensitizing |
| Irritation | ISO Tests for Irritation and Skin Sensitization | Non-irritant |
| Systemic Toxicity | ISO Acute Systemic Injection Test | Non-toxic |
| Material Mediated Pyrogen | ISO Materials-Mediated Rabbit Pyrogen Test | Non-pyrogenic |
| Hemocompatibility | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic |
| Coagulation (PT) | Prothrombin Time (PT) Test | Non-hemolytic |
| Coagulation (PTT) | Partial Thromboplastin Time (PTT) Test | Non-hemolytic |
| Hematology (Hemolysis) - Direct Contact | ASTM Hemolysis (Direct Contact Method) | Non-hemolytic |
| Hematology (Hemolysis) - Indirect Contact | ASTM Hemolysis (Extract Method) | Non-hemolytic |
| Genotoxicity | Ames Test | Non-mutagenic |
| ISO In Vivo Mouse Micronucleus Assay | Non-mutagenic | |
| Design Verification (Bench-Top Testing) | ||
| Packaging Inspection | Confirm the packaging outputs meet all product specifications. | 100% Pass |
| Dimensional / Visual Inspection | Confirm the dimensions / visual outputs meet all product specifications. | 100% Pass |
| Dynamic Vacuum Testing | Wand can sustain maximum vacuum and transfer vacuum to distal tip of wand. | 100% Pass |
| Simulated Use | Evaluate the effectiveness of the device to generate rotational energy to remove simulated clot. | 100% Pass |
| Tensile/Torque | All components are tested to ensure connections/joints meet all product specifications. | 100% Pass |
| Electric Safety Testing | Compliant to requirements of IEC 60601-1 (3rd Ed.), IEC 60601-1-2, 60601-1-6, and IEC 62366. | 100% Pass |
| Sterilization | Gamma irradiation sterilization to a 6-log sterility assurance utilizing the VDmax25. | Validated (in accordance with ISO 11137 and ISO 11737) |
| Shelf-Life | 12-month Shelf-life |
Additional Information from the text:
- Study Types: The studies conducted are primarily non-clinical bench-top testing and biocompatibility testing. This is a type of standalone performance testing in the sense that it evaluates the device's physical and biological properties in a controlled environment, not its performance in humans or with human interaction for diagnostic purposes.
- Ground Truth for Non-clinical Tests: For biocompatibility, the ground truth is established by the specified international and FDA guidelines (EN ISO 10993-1, 21 CFR, Part 58 Good Laboratory Practices). For bench-top testing, the ground truth is against pre-defined product specifications and engineering requirements.
- No Multi-Reader Multi-Case (MRMC) Study or AI/ML Algorithm Performance: The Artemis™ Neuro Evacuation Device is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, studies involving human readers, AI algorithms, training sets, or expert consensus for image interpretation are not applicable and were not performed or reported in this document.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).