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Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue.

Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.

The electrosurgical instrument is used for grasping, dissection and cauterization in endoscopic general surgery. The distal instrument scissors or jaws are opened and closed using ring loop handles. The instrument shaft is insulated and designed for use with an appropriately sized trocar cannula; the shaft can be rotated 360° in either direction using a handle knob. Devices with electrocautery capability are supplied with a pin for connection to a compatible electrosurgical unit; use of the device for monopolar electrocautery requires use of a patient grounding pad. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.
Vanguard receives previously used electrosurgical instruments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility.

No acceptance criteria or study information for a medical device's performance against specific metrics is provided in the document.

The document is a 510(k) summary for Vanguard Reprocessed Electrosurgical Instruments, establishing substantial equivalence to predicate devices. It focuses on the regulatory process and general statements about the device's characteristics and safety, rather than detailed performance study results.

Here's a breakdown of why the requested information cannot be extracted:

• No Acceptance Criteria Table: The document does not present a table of acceptance criteria or reported device performance against such criteria.
• No Specific Performance Study: The "Test Data" section states, "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." This is a general statement and does not describe a detailed study with sample sizes, data provenance, ground truth establishment, or specific performance metrics (like accuracy, sensitivity, specificity, etc.) that would be associated with AI or diagnostic devices. This type of testing is typical for reprocessed physical medical instruments to ensure they function safely after reprocessing, not for evaluating an algorithm's performance.
• No AI or Algorithm Component: The device described is reprocessed electrosurgical instruments (physical tools). There is no mention of an AI component, an algorithm, or any software that would require performance measurements like those typically described in AI/ML medical device submissions (e.g., standalone performance, MRMC studies, training/test sets). Therefore, questions related to AI performance, ground truth, and reader studies are not applicable.
• Focus on Substantial Equivalence: The primary purpose of this 510(k) summary is to demonstrate that the reprocessed instruments are "substantially equivalent" to existing, legally marketed predicate devices in terms of materials, specifications, and technological characteristics, and that they perform as intended and are safe and effective. This typically involves comparing design specifications and general function, along with validation of the reprocessing methods, rather than a clinical performance study with detailed statistical outcomes for acceptance criteria.

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