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The STERIS® 5085 SRT is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. The STERIS® 5085 SRT accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients.

The STERIS® 5085 SRT enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).

The STERIS® 5085 SRT Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures including cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmology and orthopedics with the addition of STERIS table accessories. The STERIS® 5085 SRT Surgical Table features powered lateral tilt, Trendelenburg / reverse Trendelenburg, Zip-Slide™ movable tabletop, and adjustable height functions. The STERIS® 5085 SRT has a patient transport feature that allows the user to transport patients to and from the surgical suite on hard level surfaces.

The provided text is a 510(k) summary for the STERIS® 5085 SRT Surgical Table, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards.

There is no study described in the provided text that defines acceptance criteria for a device's performance based on diagnostic metrics (like sensitivity, specificity, or accuracy) and then reports on how the device meets those criteria using clinical data or an AI-driven analysis.

Instead, the document primarily discusses:

• Device Name, Classification, and Predicate Devices: Identifies the device and its regulatory context.
• Description of Device and Intended Use: Explains what the device does and for whom it is intended.
• Safety and Substantial Equivalence: States that the device is substantially equivalent to predicate devices and complies with various voluntary safety standards (UL, IEC, EN/IEC, CAN/CSA). These standards relate to electrical safety, electromagnetic compatibility, usability, and specific requirements for operating tables.

The "acceptance criteria" presented are in the form of compliance with these safety and performance standards, and the "study that proves the device meets the acceptance criteria" refers to testing conducted to ensure this compliance. However, this is not a study in the context of evaluating a diagnostic or AI-powered medical device's performance against clinical ground truth.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the format of diagnostic metrics because this type of study is not presented in the provided text. The document describes compliance with engineering and safety standards, not a clinical performance study using ground truth and diagnostic metrics.

None of the specific subsections (1-9) of your request can be directly addressed from this document, as they pertain to clinical performance studies, ground truth establishment, expert adjudication, or AI performance, which are not detailed here.

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