(163 days)
The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.
The Artemis Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures. The System consists of two components:
- Artemis Eye a single-use neuro-endoscope consisting of a camera, two pathways for . irrigation and/or drain, and a working channel for a surgical tool.
- Artemis Eye Tablet a reusable component that connects to the Artemis Eye and . displays live imaging captured by the Artemis Eye camera.
This document is a 510(k) summary for the Penumbra Artemis Eye System, a neurological endoscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance.
Therefore, many of the requested details about acceptance criteria for device performance, especially those related to AI or algorithm performance, cannot be extracted directly from this document. The document primarily discusses non-clinical testing for manufacturing, safety, and physical performance of the neuro-endoscope itself.
Here's what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):
The document does not present a formal table of acceptance criteria with corresponding performance for the overall device's clinical efficacy or algorithm performance. Instead, it describes various non-clinical tests passed.
| Category | Test/Criterion | Reported Performance/Result |
|---|---|---|
| Sterilization | Be sterile in accordance with EN ISO 11135:2014 | Proved to be sterile |
| Biocompatibility | In Vitro Cytotoxicity (ISO Elution Test) | Non-Toxic |
| Sensitization (Magnusson-Kligman Method) | Non-Sensitizing | |
| Irritation (Intracutaneous Reactivity - ISO Intracutaneous (Intradermal) Injection Test) | Non-Irritant | |
| Systemic Toxicity (Acute - ISO Acute Systemic Injection Test) | Non-Toxic | |
| Material Mediated Pyrogen (USP Material-Mediated Rabbit Pyrogen Test) | Non-pyrogenic | |
| Hemo-compatibility (In-Vitro Hemolysis - ASTM Method) | Non-Hemolytic | |
| Coagulation (PT and PTT Test) | Non-Thrombogenic | |
| Bench-Top Performance (Design Verification) | Evaluate physical and mechanical properties; demonstrate substantial equivalence | All tests (Dimensional/visual inspection, Design Feature Testing, Simulated Use, Destructive Testing) passed successfully |
| Shelf-life | Maintain device performance for the duration of labeled shelf-life (12 months) | Test results confirm device stability for the proposed shelf-life |
| Software V&V | Comply with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Documentation provided as recommended; software considered a "major" level of concern |
| Electrical Safety/EMC | Comply with requirements of IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, and IEC/EN 62366 | System complies with the requirements |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The document describes non-clinical engineering and safety tests rather than performance evaluations on a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the document does not describe a clinical study or an AI/algorithm-based performance evaluation involving expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as there is no mention of a test set requiring adjudication in this document.
5. 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:
- No, an MRMC comparative effectiveness study is not mentioned in this document. This document is for a neurological endoscope, not an AI-assisted diagnostic tool in the typical sense that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This document is for a physical medical device (neuro-endoscope) with associated software for display. It does not describe a standalone algorithm performance in the context of diagnostic AI. The software is for displaying live imaging, not for autonomous analysis or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable in the context of this document, as it focuses on the substantial equivalence of device components and safety, not on diagnostic accuracy against a ground truth.
8. The sample size for the training set:
- This information is not provided as the document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established:
- This information is not applicable as the document does not describe the development or training of an AI algorithm.
§ 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).