(259 days)
To cleanse minor wounds, scrapes and minor burns
It may also be used to moisten dressings to ease removal from the wound area.
Saline Wound Wash is an isotonic sterile saline solution packaged in a bag-in-can (also known as bag-on-valve, BOV) aerosol system. Actuation of the valve device delivers a consistent flow of sterile isotonic saline solution at the wound site. The flow of isotonic saline solution at the wound or abrasion site aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudate and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 requirements [Sterilization of Health Care Products -Requirements for development, validation and routine control of a sterilization process for medical devices]. Saline Wound Wash passes the USP Sterility Test.
The provided text is a 510(k) Summary for a medical device called "Saline Wound Wash" (SteriCleanse™). It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence.
However, the document does NOT contain information related to a study proving the device meets acceptance criteria through a comparative effectiveness study involving human readers or AI, specifically in the context of diagnostic accuracy, image interpretation, or human-AI interaction.
The "studies" mentioned in this document are primarily bench testing and laboratory validations to confirm the physical and chemical properties, manufacturing processes, and sterility of the Saline Wound Wash. These are typical for medical devices like wound cleansers, which are not diagnostic tools or AI-powered systems.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies that involve:
- A table of acceptance criteria and reported device performance (in the context of AI/diagnostic accuracy).
- Sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details, because these types of studies were not conducted or described for this specific device.
The "study" that proves this device meets acceptance criteria primarily consists of:
- Manufacturing and Quality Control Testing:
- Validation of gamma irradiation sterilization according to ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 requirements.
- USP Sterility Test.
- Conformity to USP monograph, Sodium Chloride Irrigation (May 1, 2018).
- Testing against established manufacturing specifications.
- Bench Testing / Laboratory Analysis for Substantial Equivalence:
- Laboratory testing of componentry and formulation of the device and predicate device.
- Analysis of technological characteristics (can pressure, pH, saline concentration) to support technical equivalence.
In summary, this document describes the regulatory submission for a wound cleanser, not a diagnostic AI or image interpretation device. Consequently, the study design elements you asked about (MRMC, expert consensus, AI training, etc.) are irrelevant to this specific product and its regulatory approval process.
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