(14 days)
Ronclave® packaging is indicated for use by health care facilities for the packaging, sterilization (by steam, chemical vapor or dry heat) and maintenance of sterility during storage of various medical items. The chemical indicator imprint is intended to allow the user to distinguish packages that have been processed from those that have not by changing its color from green to blue-gray.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a sterilization wrap, not a device that would typically have acceptance criteria and a study to prove performance in the way machine learning or diagnostic devices do.
The content mainly focuses on the regulatory approval process (510(k)) and states that the device is "substantially equivalent" to legally marketed predicate devices. It does not contain information about specific performance acceptance criteria, a standalone study evaluating the device's diagnostic or predictive capabilities, or details like sample sizes, expert qualifications, or ground truth establishment for such a study.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Reported Performance: The document does not specify quantitative acceptance criteria for device performance nor does it report performance metrics (e.g., sensitivity, specificity, accuracy) that would be derived from a clinical or technical study. The approval is based on "substantial equivalence" to existing predicate devices for its intended use (sterilization wrap for packaging, sterilization, and maintaining sterility).
- No Clinical/Performance Study Details: The document does not describe a study design, sample sizes, data provenance, expert involvement, or ground truth establishment. This type of information is typically found in submissions for diagnostic or AI-powered devices, not for a sterilization wrap where the primary concern is its physical properties and ability to maintain sterility.
- No AI Component: The Ronclave® is a sterilization wrap, a physical product, and does not involve AI, machine learning, or software with human-in-the-loop performance measurement. Therefore, questions about MRMC studies, standalone algorithm performance, or human reader improvement with AI assistance are not applicable.
- Ground Truth for Manufacturing: While there would undoubtedly be quality control and testing for the physical properties of the wrap (e.g., microbial barrier, tear strength), the document does not detail these, nor does it refer to a "ground truth" in the diagnostic sense (e.g., pathology vs. AI interpretation). The ground truth for a sterilization wrap would be its ability to maintain sterility through physical and chemical testing, which is assumed to be part of the manufacturing process and regulatory submission, but not detailed here.
In summary, the provided text is a regulatory clearance letter for a medical device (sterilization wrap) based on substantial equivalence, not a technical report detailing the performance of a diagnostic or AI-powered device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).