(340 days)
The intended use of the HydroCision General Surgery FluidJet System is for the tangential cutting, resection and removal of soft tissue or fluid from the body. HydroCision General Surgery FluidJet System is not intended for use in suction lipoplasty procedures.
The HydroCision General Surgery FluidJet System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.
This 510(k) premarket notification for the HydroCision General Surgery FluidJet System does not contain the level of detail required to answer your questions about acceptance criteria and study design for Artificial Intelligence (AI) / Machine Learning (ML) enabled devices.
Here's why and what information is missing:
The document describes a medical device called the "HydroCision General Surgery FluidJet System" which is a surgical instrument using a pressurized stream of sterile saline. This is a mechanical device, not an AI/ML powered device. The "performance testing" mentioned refers to traditional engineering and biological tests, not AI model evaluation.
Therefore, for this specific document, I cannot provide the requested information about acceptance criteria and study details for an AI-powered device.
To answer your questions for an AI/ML device, the input document would need to include information such as:
- Quantitative performance metrics: Specific thresholds for sensitivity, specificity, AUC, F1-score, accuracy, etc.
- A "study" section detailing the evaluation of an AI algorithm. This would typically involve:
- Descriptions of training and test datasets.
- Ground truth establishment methods.
- Expert involvement in ground truth and/or reading studies.
- Details of any comparative effectiveness studies (e.g., MRMC).
- Reporting of standalone performance.
Without an AI component in the described device, the concept of "acceptance criteria" as you've framed it (referring to AI performance) and an AI-specific study is not applicable to this document.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.