(181 days)
The ZEISS CONVIVO is a surgical endomicroscope intended for viewing intra-operative blood flow in the cerebral vascular area, including microvasculature and capillaries.
The CONVIVO's fiber optic scanner probe is placed in direct contact with tissue during cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, to create in-vivo confocal laser scanning images of the internal microstructure of tissues.
The CONVIVO is a Confocal Laser Endomicroscopy (CEM) system intended to create in vivo confocal laser scanning images of the microvasculature and microstructures of the tissue. The system can be applied during surgical procedures and is to be used in direct contact with the tissue.
The system is comprised of a confocal processor, handheld scanner probe, computer, touchscreen monitor, cart and foot control panel.
The Sterile Sheath for CONVIVO is a mandatory single use accessory to the system, intended to provide a sterile barrier between the scanner and the patient's tissue. Before the scanner is used on the patient, the Sterile Sheath is fitted to the scanner using sterile techniques.
Sodium fluorescein is used as a fluorescence contrast agent to visualize intraoperative cerebral vascular area, including microvasculature/capillaries. Sodium fluorescein can be used as contrast agent with CONVIVO without changes to the formulation, mode of action, approved dose or route of administration; it is systemically administered and its delivery is independent of CONVIVO.
The provided text is a 510(k) summary for the CONVIVO device. While it details various aspects of device testing, it does not contain a specific table of acceptance criteria and reported device performance in the way typically seen for a study proving a device meets acceptance criteria related to a diagnostic or AI-assisted system's performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Cellvizio 100 Series System) and a reference device (YELLOW 560) through engineering and safety testing, rather than a clinical performance study with specific quantitative acceptance criteria for diagnostic efficacy.
Therefore, many of the requested details cannot be extracted directly from this document. However, I can infer some information based on the provided text.
Here's what can be gathered and what is explicitly not available from the provided text, in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
A specific table with quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values is not provided in this document. The document describes various types of testing but not in a format that directly addresses a clinical performance study's acceptance metrics. The performance data mentioned are primarily related to safety and functionality.
| Acceptance Criteria Category | Specific Criteria (not explicitly quantitative performance for clinical efficacy) | Reported Device Performance (not explicitly quantitative performance for clinical efficacy) |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 | Validated according to ISO 11135:2014; Microbiological barrier function, seal strength, dye penetration tested. |
| Biocompatibility | Compliance with ISO 10993 for patient-contacting components. | Materials tested for Cytotoxicity, Irritation, Sensitization, Material mediated pyrogenicity, acute systemic toxicity, Chemical information/characterization. |
| Design Verification | Compliance with established system requirements | Demonstrated compliance. |
| Laser Safety | Conformity with IEC 60825-1 | Assessed for conformity. |
| Thermal Safety | Maximum temperature limits established in IEC 60601-1 not exceeded. | Maximum temperature did not exceed limits when operated in intermittent mode. |
| In Vivo Testing | Ability to view microstructure of tissues and blood flow intraoperatively. | "The ability to view microstructure of tissues and blood flow intraoperatively was confirmed." (Qualitative statement, no quantitative metrics provided) |
| Software Documentation | Sufficiency for a MAJOR Level of Concern device. | Provided. |
| Electrical Safety | Conformance with ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-2-18:2009. | Demonstrated conformance. |
| Electromagnetic Compatibility | Conformance with IEC 60601-1-2 (4th Edition). | Demonstrated conformance. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document mentions "In vivo Testing" was conducted but does not specify the sample size (e.g., number of patients or images) used for this testing.
- Data Provenance: Not explicitly stated. The in-vivo testing likely occurred in a controlled environment as part of the device development, but details regarding country of origin or whether it was retrospective/prospective are not detailed. It's presented as part of design verification, suggesting internal company testing rather than a large-scale clinical trial.
3. Number of Experts and Qualifications for Ground Truth:
- The document mentions "In vivo Testing" confirming the ability to view microstructures. However, it does not specify the number or qualifications of experts used to establish ground truth for this testing. Given it's a device for direct visualization, the "ground truth" is likely the direct observation by the device itself, validated by experts, but the process is not elaborated.
4. Adjudication Method:
- Since a formal clinical performance study with expert reads/assessments is not described in detail, an adjudication method (2+1, 3+1, etc.) for a test set is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC study comparing human readers with and without AI assistance was not conducted or described in this document. This device is a direct imaging tool, not an AI-diagnostic aid in the typical sense that would necessitate an MRMC study to show improvement in human reader performance.
6. Standalone (Algorithm Only) Performance:
- This device is an endomicroscopy system for direct visualization, not an AI algorithm. Therefore, a "standalone algorithm performance" study is not applicable and was not conducted or described. The device's performance is inherently tied to its operation as an imaging system.
7. Type of Ground Truth Used:
- For the "In vivo testing" that "confirmed the ability to view microstructure of tissues and blood flow intraoperatively," the "ground truth" would implicitly be the direct visualization capability of the device itself during the procedure, likely assessed by qualified personnel. However, the document does not specify if this was through pathology confirmation, other imaging modalities, or a consensus of experts retrospectively labeling images.
8. Sample Size for the Training Set:
- This document describes a medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" for machine learning is not applicable, and no sample size for such a set is provided.
9. How Ground Truth for the Training Set was Established:
- As above, the concept of a training set is not applicable here.
In summary, this 510(k) submission primarily focuses on demonstrating substantial equivalence through engineering, safety, and functionality testing. It does not present a clinical performance study with quantitative diagnostic metrics and associated acceptance criteria that would involve detailed information on ground truth establishment, expert reader studies, or AI algorithm training/testing. The "In vivo Testing" mentioned is a high-level confirmation of the device's basic function.
§ 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).