(51 days)
MANUKA IG wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA IG 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, MANUKA IG 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
MANUKA IG wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand impregnated into acetate gauze. MANUKA IG is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium Manuka honey that is harvested and processed under controlled conditions.
This submission describes the "MANUKA IG wound dressings" and its substantial equivalence to the predicate device "MANUKAtex Wound Dressing". The acceptance criteria and the study performed are focused on demonstrating the safety and performance of the new device relative to its predicate, rather than an AI-powered diagnostic device. Therefore, some of the requested information regarding AI-specific criteria (like AI vs. human reader improvement, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable to this document.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | 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) for cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing. | "The MANUKA IG wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested." |
| Sterilization | Not explicitly stated, but implied to meet performance requirements for sterility. | "All acceptance criteria were met for all tests conducted," including sterilization validation. "MANUKA IG... meet performance requirements for sterility." |
| Shelf-Life | Not explicitly stated, but implied to meet performance requirements for shelf-life under accelerated and real-time conditions. | "All acceptance criteria were met for all tests conducted," including shelf-life under accelerated and real-time conditions. "MANUKA IG... meet performance requirements for... shelf-life." |
| Packaging Validity | Not explicitly stated, but implied to meet performance requirements for packaging. | "All acceptance criteria were met for all tests conducted," including packaging validation. "MANUKA IG... meet performance requirements for... packaging." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of evaluating an AI or diagnostic algorithm on patient data. The nonclinical testing performed (biocompatibility, sterilization, shelf-life, packaging) would involve samples of the device and biological models for biocompatibility, but the specific sample sizes for these lab tests are not detailed in this summary. There is no information about data provenance (e.g., country of origin, retrospective/prospective) as this is not a clinical study involving patient data in the typical sense for a diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring an adjudication method for a diagnostic test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a wound dressing, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility studies, the "ground truth" would be established by the biological responses observed in the tests (e.g., cell viability for cytotoxicity, skin reaction for intracutaneous reactivity, etc.). For sterilization, shelf-life, and packaging, the ground truth would be based on validated scientific methods and measurements to confirm sterility, stability over time, and package integrity, respectively. These are standard laboratory measures, not clinical outcomes or expert consensus.
8. The sample size for the training set
Not applicable. This device is a wound dressing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a wound dressing, not an AI algorithm.
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