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510(k) Data Aggregation
(165 days)
The QEVO System with KINEVO 900 is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
The subject device is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:
. QEVO System - QEVO Endoscope Control Unit (ECU) + QEVO endoscope
KINEVO 900 surgical microscope .
The KINEVO 900 can be operated by the surgeon and surgical assistant as a standard optical surgical microscope, using tubes and evepieces to view the surgical anatomy. When used with the QEVO System, the KINEVO 900 provides the additional capability to view images from the hand-held QEVO endoscope during neurological and spinal procedures.
The KINEVO 900 is physically connected (via power cable, HDMI/DVI cable, and Ethernet cable) to the QEVO Endoscope Control Unit (ECU). The QEVO endoscope plugs into the QEVO ECU outlet provided on the KINEVO 900.
This document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with defined endpoints for diagnostic accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (QEVO System with KINEVO 900), focusing on demonstrating substantial equivalence to a predicate device.
The "studies" mentioned are primarily non-clinical performance tests designed to show the device's compliance with established safety, electrical, and physical standards, rather than evaluating its clinical effectiveness or diagnostic accuracy against a ground truth.
Here's an analysis based on the provided text, addressing the points you requested where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes. Instead, the "performance" is reported as compliance with various standards and safety requirements.
| Category | Acceptance Criteria (Implied by Standards/Testing) | Reported Device Performance |
|---|---|---|
| Sterilization | Achieve a sterility assurance level (SAL) of 10^-6^ for steam sterilization. | "The steam sterilization process was validated to achieve a sterility assurance level (SAL) of 10^-6^." |
| Biocompatibility | Compliance with ISO 10993 for Tissue/Bone/Dentin Communicating, < 24 hours contact. (Specific tests: Cytotoxicity, Irritation, Skin Sensitization, Systemic Toxicity) | "The materials were testing in accordance with ISO 10993." |
| Design Verification | The system complies with established system requirements. (Specific requirements not detailed in this summary) | "The purpose of the design verification is to demonstrate that the system complies with the established system requirements." |
| Optical Safety | Conformity with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). | "The QEVO Endoscope and ECU were assessed for conformity with the relevant requirements of IEC 62471:2006... and were found to comply." |
| Thermal Safety | Maximum temperature of the QEVO endoscope does not exceed established limits in IEC 60601-1 when operated in intermittent mode. | "When operated in intermittent mode, the maximum temperature of the QEVO endoscope did not exceed the limits established in IEC 60601-1." |
| Software | Documentation for a MODERATE Level of Concern device is provided. (Implied acceptance criteria are that the documentation meets FDA's guidance for moderate concern software). | "Software documentation for a MODERATE Level of Concern device is provided in support of the subject device." |
| Electrical Safety | Conformity with IEC 60601-1:2005 (Edition 3.1, including US deviations) and IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment). | "The QEVO endoscope, ECU, and cables were assessed for conformity with the relevant requirements of IEC 60601-1... and IEC 60601-2-18... and were found to comply." |
| EMC Testing | Conformity with IEC 60601-1-2 (4th Edition). | "The QEVO endoscope, ECU, and cables were assessed for conformity with the relevant requirements of IEC 60601-1-2... and was found to comply." |
| Image Resolution | 2 Mega Pixel (Full HD imager) and 642 TV lines (optical resolution at 15% MTF). (These are specifications rather than acceptance criteria per se, but serve as performance metrics.) | Reported: "2 Mega Pixel (Full HD imager)" and "642 TV lines (optical resolution at 15% MTF)". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document for any of the non-clinical tests. The number of devices or components tested, or the origin of any data, is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical engineering and safety tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical engineering and safety tests, not clinical evaluations requiring adjudication.
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 was not done. The document explicitly states: "Clinical Testing: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This device is an endoscope/microscope visualization system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The device is a visualization system and does not appear to incorporate an AI algorithm for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" is typically defined by the standards themselves (e.g., sterilization efficacy requirements, electrical safety limits, biocompatibility criteria). Chemical, physical, and biological analyses are performed against these predetermined thresholds or methods, rather than against clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device (visualization system), not an AI algorithm requiring a training set in the machine learning sense.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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