(162 days)
For the management of: Diabetic Ulcers, Foot Ulcers, 1st and 2nd Degree Burns, Pressure Ulcers Stages I-IV, Cuts, and Abrasions.
phytacare™ Alginate Hydrogel Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide a moist environment for the management of moderately exuding, partial to full thickness wounds. There are 2 components of the phytacare™ Alginate Hydrogel Wound Dressing: a standard 12-ply cotton gauze pad and the phytacare™ Alginate Hydrogel. The primary function of the alginate component of the phytacare™ Alginate Hydrogel Wound Dressing is to absorb excess wound exudate, providing a moist wound environment to encourage healing. The phytacare™ Alginate Hydrogel also contains common humectants and moisturizers, thickeners and stabilizers, anti-oxidants, preservatives, and a fragrance. The dressing is packaged in a foil laminate pouch.
This document describes a 510(k) submission for the phytacare™ Alginate Hydrogel Wound Dressing. The submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than detailed performance studies with acceptance criteria in the context of clinical efficacy. As such, information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment methods as typically understood for medical device validation studies (e.g., in AI/ML performance) are not present in the provided text.
The closest information provided pertains to safety and comparison to predicate devices, which forms the basis for the FDA's substantial equivalence determination.
Here's the breakdown of what is and is not available in the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance and Evidence Provided |
|---|---|
| Safety: Biocompatibility (cytotoxicity, irritation, sensitization, etc.) | "Standard biocompatibility tests were performed on the phytacare™ Alginate Hydrogel to establish device safety. All the test and assay results were negative..." |
| Substantial Equivalence: Similar function, composition, and intended use as predicate devices. | "phytacare™ Alginate Hydrogel Wound Dressing is similar in function, composition, and intended use to the predicate devices..." |
| Intended Use: Management of specific wound types (diabetic ulcers, foot ulcers, 1st & 2nd degree burns, pressure ulcers stages I-IV, cuts, abrasions). | The device's stated indications match those shared by predicate devices. The FDA clearance letter also lists limitations related to claims the device cannot make (e.g., for 3rd-degree burns). |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document does not describe a clinical study with a specific "test set" for performance evaluation in the way a diagnostic algorithm or device would. The "performance data" section primarily refers to biocompatibility testing, which generally uses laboratory samples or animal models, not human "test sets" with clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No adjudication method is mentioned as there is no described test set of clinical data requiring expert review.
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
- No. This is a medical device (wound dressing), not an AI/ML diagnostic or assistive device. Therefore, an MRMC study is not relevant or applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the biocompatibility tests, the "ground truth" would be the established safety standards and laboratory testing results being within acceptable ranges. For the substantial equivalence argument, the "ground truth" is the established safety and efficacy profiles of the predicate devices. There is no mention of clinical outcomes data in the context of a study for this device.
8. The sample size for the training set
- Not Applicable / Not Provided. This document does not describe an AI/ML training set. Biocompatibility testing typically involves a set number of samples for each test (e.g., cytotoxicity on specific cell lines, irritation on a certain number of animal subjects), but these are not considered "training sets" in the AI/ML context.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. See point 8.
N/A