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Rx Indications for Use:

For professional use, MEBO Wound Dressing is indicated for management of the following types of wound:

-Skin graft recipient sites

-Newly sutured wounds

-Lacerations and abrasions

-Minor or superficial-partial thickness burns

OTC Indications for Use:

For over-the-counter use, MEBO Wound Dressing is indicated for:

-Minor cuts

-Minor abrasions

-Minor lacerations

-Minor burns

The MEBO Wound Dressing is a electron beam irradiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.

The provided text is related to an FDA 510(k) premarket notification for a medical device called "MEBO Wound Dressing". However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device (K193439 MEBO Wound Dressing) based on similarities in:

• Indications for Use: Both professional and over-the-counter uses are detailed, with the new device having additional OTC indications.
• Mechanism of Action: Providing a moist environment for wound healing.
• Material and Structure: Non-woven fabric immersed with sesame oil and beeswax.
• Applied Duration and Single Use.
• Biocompatibility: Established for both.

The "Performance Testing Summary" section describes bench testing to verify the subject device's performance characteristics are substantially equivalent to the predicate device. These tests relate to the physical and chemical properties of the wound dressing itself (not AI/ML model performance), such as:

• Appearance
• Size deviation
• Liquid absorbency
• Acid Value
• Paste content
• B-Sitosterol content
• Endotoxin level
• Biocompatibility (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity, pyrogen test, bacterial endotoxin test).

Therefore, I cannot fulfill the request as the provided text pertains to a traditional medical device (wound dressing) equivalency submission, not an AI/ML medical device performance study. The questions posed in your prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are relevant to AI/ML device evaluations, which are not detailed in this document.

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