(155 days)
The reprocessed cordless ultrasonic dissection devices are intended to be used for cutting soft tissue when control of bleeding and minimal thermal injury is desired. The devices can be used to coagulate isolated vessels up to 5 mm.
The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
The cordless ultrasonic dissection devices are intended to be used to position, grasp, seal and dissect soft tissues, as well as providing control for functions such as selecting power levels, and blade placement and position. The instruments are used with a reusable generator, reusable battery pack and include a torque wrench as an accessory piece (the torque wrench is designed to ensure that the generator is properly secured to the device). The instruments have a 5 mm shaft diameter, 14.5 mm active blade, dual-mode energy button and are available in a variety of lengths. They can be used to coagulate vessels up to 5 mm and are designed to be inserted and extracted through a compatible 5mm trocar when used endoscopically.
I am sorry, but the provided text is a 510(k) premarket notification for a reprocessed medical device, specifically a "Reprocessed Cordless Ultrasonic Dissection Device." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed clinical study with acceptance criteria for an AI/algorithm-based diagnostic device.
Therefore, the input text does not contain the information necessary to answer your request regarding acceptance criteria and a study proving a device meets those criteria for an AI/algorithm. Specifically, the document does not describe:
- Acceptance criteria for an AI/algorithm's performance.
- A study proving an AI/algorithm meets acceptance criteria.
- Sample size and data provenance for a test set of an AI/algorithm.
- Number and qualifications of experts for ground truth establishment for an AI/algorithm.
- Adjudication method for an AI/algorithm's test set.
- MRMC comparative effectiveness study for an AI/algorithm.
- Standalone performance study for an AI/algorithm.
- Type of ground truth used for an AI/algorithm.
- Sample size and ground truth establishment for the training set of an AI/algorithm.
The document describes non-clinical testing performed on the reprocessed physical device to ensure its functional performance, cleaning, sterilization, and biocompatibility are equivalent to new devices. This is a different type of evaluation altogether.
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