(84 days)
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd wound dressings may be used Over-The-Counter for:
- Minor Abrasions
- Lacerations
- Minor Cuts
- Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKAhd wound dressings may be used for:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns (Superficial and Partial Thickness)
- Diabetic Foot Ulcers
- Surgical Wounds
- Traumatic Wounds
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings for use in moist wound management. The primary device is a super absorbent polymer (SAP) fibre material impregnated with medical grade Manuka honey and coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum medical grade Manuka honey that is harvested and processed under controlled conditions. One version of the product (MANUKAhd Border) has the honey-impregnated pad retained in a central position on an adhesive backing. Another version of the device (MANUKAhd Rope) is identical to the primary device, but spiral cut to provide the care provider flexibility in packing a wound bed.
The provided document describes the ManukaMed MANUKAhd wound dressings, a medical device. The information details nonclinical testing performed to establish biocompatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cytotoxicity | Met acceptance criteria |
| Intracutaneous Reactivity | Met acceptance criteria |
| Systemic Toxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Wound Healing Studies | Met acceptance criteria |
| Overall Conclusion | Considered biocompatible under the conditions tested. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Standard biocompatibility tests were performed," including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. However, the exact sample size used for each of these tests is not specified in the provided text.
Regarding data provenance:
- Country of origin of the data: Not explicitly stated for each test, but the testing organization, North American Science Associates, Inc. (NAMSA), is implied to be conducting tests in accordance with US FDA guidelines and ISO standards. NAMSA is a global company, but the submission is to the US FDA, suggesting the results would be presented in a US format.
- Retrospective or prospective: Biocompatibility tests are typically prospective studies designed specifically to evaluate the device's interaction with biological systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Biocompatibility testing often relies on standardized protocols and laboratory analysis performed by trained technicians and overseen by scientific experts (e.g., toxicologists, pathologists), but these details are not present in this summary.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Biocompatibility test results are generally interpreted based on predefined criteria within the test protocol and ISO standards, rather than requiring an adjudication process in the way clinical studies or image interpretations might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes nonclinical biocompatibility testing, not clinical studies involving human readers or comparative effectiveness with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a wound dressing, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the biocompatibility tests, the "ground truth" would be established by:
- Standardized biological responses/observations: For cytotoxicity, it would be cell viability; for sensitization, it would be skin irritation scores; for systemic toxicity, it would be physiological parameters and organ histopathology; for wound healing, it would be observations of tissue repair and inflammation.
- Adherence to ISO standards: The tests were performed "in accordance with US FDA General Program Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices)." These standards define the methods and criteria for evaluating biological responses.
8. The Sample Size for the Training Set
Not applicable. This device is a physical wound dressing, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is irrelevant.
N/A