(465 days)
Roosin Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.
Roosin Xeroform Petrolatum Dressing is a type of wound dressing and has ingredients of finely woven mesh gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate. It is a sterile, single use dressing. This is a combination product. Roosin Xeroform Petrolatum Dressing is used as a primary contact layer in dressing for wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. The dressing has a yellow appearance and is available in the form of pad and in four different sizes (2" x 2", 1" x 8", 4" x 4", 5" x 9"), packaged in pouches. All dressings are sterilized by gamma radiation using conditions validated following ISO 11137-2: 2013.
The provided document describes a 510(k) premarket notification for a medical device called "Roosin Xeroform Petrolatum Dressing." This document does not contain information about acceptance criteria or a study proving that a device meets such criteria, especially not in the context of an AI/algorithm-based medical device.
The document details the device's intended use, materials, manufacturing, and a comparison to a predicate device (K152970: "Dynarex Xeroform Petrolatum Dressing") to establish substantial equivalence. The "performance tests" mentioned are likely related to general medical device standards (e.g., sterilization, biocompatibility, material properties) rather than specific clinical performance metrics that would involve complex data analysis, ground truth establishment, or human reader studies typically associated with AI/ML-driven devices.
Therefore, I cannot provide the requested information for the following reasons:
- No AI/Algorithm Component: The device described is a wound dressing, which is a physical product, not an AI or algorithm.
- No Performance Study as Described: The document mentions "Performance tests were conducted following in house procedures, and results for Roosin Xeroform Petrolatum Dressing met all relevant requirements, and are comparable to the predicate devices." However, these are general performance tests, not a clinical study involving a test set, ground truth, experts, or MRMC studies as outlined in your request.
- No Acceptance Criteria for AI Performance: Since it's not an AI device, there are no acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC, human reader improvement, etc.).
In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and a study proving an AI/algorithm device meets those criteria.
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