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The Linvatec 3-CCD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

The Linvatec 3-CCD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head and cable is required before use. The camera heads may be sterilized using steam sterilization. The Linvatec 3-CCD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.

This document, K031098, for the "3-CCD Digital Camera System" does not contain information on acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, training set details, or how ground truth for the training set was established.

The document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on establishing substantial equivalence to legally marketed predicate devices. It describes the device, its intended use, and states that there are no significant differences that raise issues of safety or effectiveness compared to the predicates. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested information based on the provided text.

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The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.

This device is a 3-CCD Digital Camera System utilized for medical applications. The intended use for this device is identical to that of most contemporary surgical video camera systems and accessories. The 3-CCD Digital Camera System has been designed and manufactured to meet the UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 guidelines for electrical safety.

The provided text describes a 3-CCD Digital Camera System. However, it does not include information about acceptance criteria, device performance, or a study proving that the device meets specific criteria related to its diagnostic or surgical capabilities.

The document primarily focuses on:

• Regulatory clearance: FDA clearance (K970605) for the device as "substantially equivalent" to a predicate device (K941919).
• Safety standards: Mention of meeting UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 for electrical safety.
• Intended use: "providing medical professionals with video capabilities for diagnostic and surgical procedures."

Since the document does not contain the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications, I cannot populate the table or answer the specific questions.

The document is a regulatory clearance letter and a brief device description, not a performance study report.

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