(130 days)
MANUKA FOAM HC wound dressings are sterile, single-use wound care dressings for use in moist wound management of:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns
- Diabetic Foot Ulcers
- Surgical Wounds
- Trauma Wounds
A moist wound environment allows autolytic debridement of necrotic tissue.
MANUKA FOAM HC wound dressings are sterile, single use wound care dressings that help maintain a moist wound environment. The primary device consists of 100% Leptospermum scoparium honey from New Zealand impregnated into an absorbent foam-fiber hybrid material. One version of the product includes a polyurethane border with a silicone adhesive. Another version of the product includes a polyurethane border with an acrylic adhesive.
The provided 510(k) summary for the MANUKA FOAM HC Wound Dressing describes nonclinical testing performed but does not outline specific numerical acceptance criteria or a comparative study against a predefined benchmark for device performance that would involve an AI or algorithmic component.
The summary focuses on demonstrating substantial equivalence to predicate devices (MANUKA IG Wound Dressing and BioAquaCare) based on:
- Biocompatibility tests: These are standard tests (cytotoxicity, primary skin irritation, skin sensitization) performed according to ISO 10993-1.
- Wound healing study: Conducted on swine to assess the impact of repeated application on full-thickness dermal wounds.
- Other standard testing: Sterilization validation, shelf-life (accelerated and real-time), and packaging validation.
The statement, "The MANUKA FOAM HC wound dressings met the acceptance criteria for all tests conducted," signifies that the product passed these specific nonclinical tests. However, the document does not present a table of acceptance criteria for performance metrics that can be numerically correlated with a "reported device performance" in the way one might expect for an AI or diagnostic device (e.g., sensitivity, specificity, accuracy thresholds).
Therefore, based on the provided text, the specific information requested about acceptance criteria and studies (especially those relating to AI/algorithmic performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance) is not present. This device is a wound dressing, a physical medical product, not an AI-driven diagnostic or treatment algorithm.
If this were a device where such criteria would be applicable (e.g., an imaging diagnosis AI), the expected table and study details would be as follows, but currently, they cannot be populated from the provided text.
Unavailable Information Based on Provided Text:
The document describes a physical wound dressing and its nonclinical testing to demonstrate safety and effectiveness for a 510(k) submission, primarily focusing on biocompatibility and general performance (sterilization, shelf-life, packaging, wound healing in an animal model). It does not involve any AI, algorithmic, or diagnostic performance evaluation that would require the specific details requested above (e.g., sensitivity/specificity acceptance criteria, expert ground truth, MRMC studies, or training/test set data).
Therefore, none of the requested points regarding acceptance criteria, reported device performance in the context of an algorithm, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types and establishment for training sets can be extracted from this document as they are not relevant to the type of device and testing described.
N/A