Search Results

The ARROWtip™ Single-Use monopolar electrosurgical instrument for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The ARROWtip™ Single-Use monopolar electrode is not intended for use in the central nervous system or in the central circulatory system.

Sutter ARROW tip™ Monopolar Electrodes are electrosurgical instruments. The electrodes are provided with different angled electrode front parts and in different lengths. They are to be connected through an appropriate monopolar handpiece with the monopolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

The provided text describes the 510(k) submission for the Sutter ARROWtip™ Monopolar Electrodes. It is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies or establishing complex acceptance criteria for AI/ML-driven performance.

Therefore, the information required to populate the fields regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven device's performance, as outlined in your request, is not present in the provided document.

The document discusses:

• Bench Testing: Performance testing in line with FDA guidance for electrosurgical devices, including Electromagnetic Compatibility and Electrical Safety, Mechanical strength and functionality, and Thermal effects on tissue.
• Sterilization and Shelf Life Testing: Validation of the sterilization cycle and shelf-life.
• Biocompatibility Testing: Evaluation according to ISO standards.
• Comparison to Predicate: A table comparing technological characteristics with the predicate device (Stryker Leibinger Colorado MicroDissection Needles® (K033232)).

It explicitly states:

• No animal studies have been performed.
• No clinical studies have been performed.

The "Acceptance Criteria" in this context are related to meeting these engineering and biological safety standards, and demonstrating substantial equivalence to the predicate device, not statistical performance metrics for an AI/ML algorithm.

Therefore, I cannot provide the requested table and details for an AI/ML-driven device's performance, as the provided text pertains to a traditional electrosurgical instrument without AI/ML components.

Ask a specific question about this device