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Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.

The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.

The provided text describes an antibacterial bandage, not an AI device. Therefore, it does not contain information about acceptance criteria or studies related to AI device performance. The document focuses on regulatory approval (510(k)) for the antibacterial bandage based on substantial equivalence to a predicate device.

The document discusses the following for the Antibacterial bandage:

• Acceptance Criteria (as demonstrated by testing):

  • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic Toxicity, Material-mediated Pyrogenicity, Endotoxin testing)
  • Sterilization (EO sterilization, complying with ISO 11135:2014)
  • Shelf Life (Accelerated Aging per ASTM F1980-16, Real-time ageing study)
  • Storage and Transport (ASTM 4169-16)
  • Antibacterial Finishes (AATCC 100: 2019)
  • Wound Healing Performance (comparable to predicate device in porcine study)

• Study Proving Acceptance Criteria:

  • Non-clinical tests: Conducted to verify the proposed device met design specifications and was safe and effective.
    • Biocompatibility tests
    • Sterilization testing
    • Shelf life testing (accelerated aging and real-time ageing)
    • Storage and transport testing
    • AATCC 100: 2019 for antibacterial finishes.
  • Animal studies: A porcine wound healing study was carried out to evaluate the cytotoxicity and wound healing performance, demonstrating no significant difference from the predicate device.

The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device, as this information is not present in the provided text.

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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and study results for the Allmed Medical Products Co., Ltd. Surgical Mask.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

This document describes the non-clinical testing performed to demonstrate that the Allmed Medical Products Co., Ltd. Surgical Mask is substantially equivalent to a predicate device (K153496). The acceptance criteria and performance data are based on standard test methods for surgical masks.

1. Table of Acceptance Criteria and Reported Device Performance

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