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The ConMed Looking Glass System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, sinuscopic, plastic and as an accessory for microscopic surgery.

The Looking Glass™ 4K Integrated Visualization System (Looking Glass System, LG4K) is a combined system that provides image visualization to the user during minimally invasive surgical procedures. The system is comprised of a 4K monitor with a built-in camera control electronics and the Camera Head. The Camera Head is connected to the Looking Glass via Cable Connector Interface (CCI).

The Camera Head is a hand-held, sterilizable portion of the system which gets connected to the CCI via electrical cable. The Looking Glass System is designed to be used with Standard Eye-Cup Endoscopes. Additionally, the system can be used in conjunction with other light sources, e.g. Xenon or LED. The Camera Head is offered in non-sterile configuration and requires sterilization prior to use via Autoclave Method.

The provided text is a 510(k) summary for the ConMed Looking Glass™ 4K Integrated Visualization System. It describes the device, its intended use, and how it is substantially equivalent to a predicate device. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/ML-driven device.

This 510(k) is for an endoscopic visualization system, which is essentially an upgraded camera and monitor for surgical procedures. It's not an AI/ML device that performs diagnostic or prognostic tasks, nor does it involve human readers interpreting images with or without AI assistance. Therefore, many of your questions (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information provided in this document.

The "Performance Testing" section broadly states that tests were conducted to demonstrate the device performs as intended and meets specifications. It lists general categories like "System Testing" (Verification, Validation), "Standard Compliance" (EMC, Electrical Safety, Endoscopic Equipment Safety), and "Risk analysis." It also mentions software verification and validation activities per IEC 62304. However, it does not provide:

• Specific acceptance criteria values (e.g., minimum resolution, color accuracy, latency thresholds).
• Reported device performance values against those criteria.
• Details about the methodology of these tests, such as the sample size of tested units, data provenance, or the nature of "ground truth" (which would simply be engineering specifications for hardware performance, not clinical ground truth as with diagnostic AI).
• Information about human expert involvement in establishing ground truth for performance, as this is a hardware system, not an image interpretation system.
• Any mention of AI/ML components, training sets, or comparative effectiveness studies involving human readers.

In summary, based only on the provided text, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I answer questions related to AI/ML device validation. The document indicates the device is a hardware upgrade to an existing visualization system, not an AI/ML diagnostic tool.

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