(294 days)
The Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of 1st and 2nd degree burns, minor cuts and abrasions. Under the care of a healthcare professional the Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of diabetic ulcers, foot ulcers, 1st and 2nd degree burns, pressure ulcers (stages I-IV), cuts and abrasions.
There are 2 components of the device. Phytacare® Alginate Hydrogel and the airless pump container. Phytacare® Alginate Hydrogel Wound Dressing contains sodium alginate, whose primary function is to absorb excess wound exudate, providing a moist wound environment to encourage natural healing. Phytacare Alginate hydrogel also contains moisturizers, thickeners and stabilizers, preservatives, and a fragrance. The Phytacare Alginate Hydrogel is packaged in 30 or 50 ml polypropylene airless pump containers.
The provided information is for K053538 Phytacare Alginate Hydrogel Wound Dressing, and it explicitly states that the device is a wound dressing. While the request asks about acceptance criteria and studies proving the device meets them, the provided text describes biocompatibility tests for safety rather than performance acceptance criteria as might be expected for an AI/CADe device.
Therefore, the following information is based on what is available in the text, highlighting that the "acceptance criteria" and "device performance" in this context refer to safety rather than diagnostic accuracy or efficiency for an AI system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 10993) | Reported Device Performance (Safety) |
|---|---|
| Cytotoxicity (absence of toxic effects on cells) | Indicated as safe |
| Sensitization (absence of allergic/sensitizing reactions) | Indicated as safe |
| Acute Systemic Toxicity (absence of toxic effects after single exposure) | Indicated as safe |
| Intracutaneous Reactivity (absence of local irritation after intracutaneous injection) | Indicated as safe |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Standard biocompatibility tests... were performed," but does not provide details on the number of samples or subjects used in these tests.
- Data Provenance: The tests were performed in accordance with ISO 10993 by North America Science Associates, Inc. (NAMSA). The country of origin of the data is not explicitly stated, but NAMSA is a US-based company with global operations. The tests are retrospective in the sense that they were conducted for the purpose of demonstrating the device's safety prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of biocompatibility testing. The "ground truth" for these tests would be established through laboratory analyses and observations according to standardized protocols and expert interpretation of those results (e.g., cell viability, animal reactions), rather than consensus among medical experts on images or clinical data.
4. Adjudication Method for the Test Set
This question is not applicable to biocompatibility testing. The results of the tests (e.g., cell viability, observed animal responses) are interpreted against established criteria outlined in ISO 10993, rather than through an adjudication process like 2+1 or 3+1 used for clinical diagnostic studies.
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
This question is not applicable as the device is a wound dressing, not an AI/CADe system. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a wound dressing, not an AI/CADe system.
7. The Type of Ground Truth Used
The ground truth used for these tests was based on biological responses and observations (e.g., cell death, inflammatory reactions, systemic toxicity) evaluated against predefined criteria outlined in the ISO 10993 standard. This is a form of laboratory/biological data rather than expert consensus, pathology reports, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This question is not applicable. Biocompatibility testing does not involve training sets in the way AI/Machine Learning models do.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons stated above.
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