(486 days)
The Zuno Smart Sterilization Container is a reusable sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider with pre-vacuum, steam sterilization cycles, to maintain sterility after removal from the sterilizer until used, and to monitor and inform users of the status of the container's sterile barrier integrity.
The Zuno Smart Sterilization Container has been validated to allow for the sterilization of its contents in pre-vacuum steam sterilizers with the following parameters: 132 ℃ sterilization temperature. 4-minute sterilization. 30-minute dry time.
Do not use with instruments containing lumens with an inner diameter smaller than 1.2mm and an overall length longer than 500mm. Do not exceed a total container weight of 251bs.
The Zuno Smart Sterilization Container is a reusable, rigid sterilization container intended to enclose surgical instruments during steam sterilization, to allow for sterilization of the enclosed medical devices, maintain sterility of the container contents after removal from the sterilizer until intentionally opened in the surgical setting, and to inform the user of the status of the container's sterile barrier.
The Zuno Smart Sterilization Container has been validated for use in pre-vacuum steam sterilizers with the following parameters: 132°C sterilization temperature, 4-minute sterilization, 30-minute dry time.
It has been validated for use with instruments containing lumens with an inner diameter smaller than 1.2mm and an overall length longer than 500mm. Do not exceed a total container weight of 25lbs.
The Zuno Smart Sterilization Container is validated to show that its contents can achieve required sterility levels during typical use. When the user queries the system following a sterilization cycle and prior to opening the container to access its contents, they are checking the integrity of the sterile barrier. This barrier is qualified by three (3) primary factors:
- · The valves must have remained open for the entirety of the sterilization cycle,
- . The valves must have closed when control module triggers closure guided by data from the pressure sensor during drying phase of the sterilization cycle,
- Following sterilization, the real-time pressure within the container must be below a target . threshold to determine whether the sterile barrier has been compromised.
The sensors provide feedback to the microcontroller so that it may identify the stages of the sterilization cycle and close the valves at the appropriate time to achieve the internal sterile environment. The firmware and microcontroller also coordinate with the status button to query the internal state of the container and the indicator lights provide feedback to the user.
The device is composed of 3 primary components: the lid assembly (which includes the valves and has a space for attaching the control module), the base assembly (which houses the instruments to be sterilized), and the control module (which electronically controls valve actuation and monitors the low-pressure state of the container).
The provided text describes the Zuno Smart Sterilization Container, focusing on its regulatory information, indications for use, device description, and extensive performance testing. However, the document does not contain details about a study involving AI or a "human-in-the-loop" performance evaluation to establish acceptance criteria or demonstrate device performance in relation to AI assistance. The performance testing outlined here is for the physical device and its electronic monitoring capabilities, not for an AI system. Therefore, I cannot extract the specific information requested about acceptance criteria and a study proving an AI device meets those criteria from the provided text.
Specifically, the "performance testing" section details validation of mechanical, electrical, and sterilization efficacy aspects of the container (e.g., vent-to-volume, sterilization validation, battery performance, microbial barrier, electronic control module function). The "software" section mentions that the software interacts with sensors to identify sterilization cycle stages and coordinate valve closure, and it coordinates with a status button to query the internal state. While this involves "electronic monitoring" and "feedback," it does not describe an AI system making diagnostic or interpretive decisions in a way that would require an MRMC study or standalone AI performance evaluation as typically seen for AI/ML-based medical devices.
Therefore, since the provided text does not describe an AI-driven device or study, I must state that the requested information (table of acceptance criteria and reported device performance for an AI, sample sizes for AI test sets, expert ground truth establishment for AI, MRMC studies, standalone AI performance, etc.) cannot be extracted from this document.
N/A