(87 days)
Rx:
The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for management of:
- Pressure sores
- Diabetic ulcers
- Leg ulcers
- Donor sites and graft sites
- Surgical wounds
- Skin abrasions and lacerations
- 1st and 2nd degree burns
- Trauma wounds
OTC:
The KA01 Chitosan Wound Dressing may be used for the management of:
- Minor cuts
- Minor scalds and 1st degree burns
- Abrasions
- Lacerations
The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal.
The KA01 Chitosan Wound Dressing is intended for use as a primary dressing on a variety of chronic and acute wounds. It is intended to be secured with a semi permeable adhesive secondary dressing and to remain in place up to 7 days depending on the level of exudate. Dressings are individually packed in paper/poly pouches and terminally sterilized to achieve a SAL 106. A range of dressing sizes between 25cm2 and 220cm2 is available.
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, particularly with regards to the specific subsections you outlined (e.g., sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set).
This document is a 510(k) premarket notification letter from the FDA to Foshan United Medical Technologies LTD regarding their KA01 Chitosan Wound Dressing. It primarily focuses on the FDA's determination of substantial equivalence to predicate devices. While it mentions "Functional and Safety Testing" including "bench testing (absorbency, gel absorbency retention, moisture content, pH), viral inactivation testing, biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity), packaging testing (pouch seal and transportation), sterilization validation testing, and shelf life stability testing (accelerated aged and real time)," it does not provide any specific acceptance criteria, performance metrics, or details of the studies conducted to demonstrate these, nor does it refer to any clinical studies involving human readers or AI.
The document states that the manufacturer "considers the KA01 Chitosan Wound Dressing to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in intended use, design, mechanisms of action, technology and materials." This suggests the approval is based on substantial equivalence to existing devices rather than a direct demonstration of meeting new, quantifiable acceptance criteria through detailed clinical performance studies that you are asking for.
N/A