(365 days)
Dermacyn™ Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.
The subject device is an 8 ounce polyethylene bottle containing Dermacyn™ Wound Care Dressing intended for multi-use.
This document describes the 510(k) summary for the Dermacyn™ Wound Dressing (K041161). It is a medical device application that establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.
Here's an analysis based on the provided text, addressing the requested points where applicable:
1. A table of acceptance criteria and the reported device performance
This 510(k) summary does not present specific quantitative acceptance criteria or performance metrics in the way a clinical study for a novel device would. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Intended Use Equivalence: The device should have the same intended use as the predicate device. | Dermacyn™ Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions, and minor burns, which is similar to the predicate device. |
| Technological Characteristics Equivalence: The device should have similar technological characteristics or demonstrate that different characteristics do not raise new questions of safety and effectiveness. | The summary states "The product is similar in function and intended use to Saljet Single Dose Sterile Saline Topical Solution...". The non-clinical testing further aimed to confirm "safe and effective performance... as compared to 0.9% sterile saline" and "demonstrated the biocompatibility of the subject device." The core formulation (hypochlorous acid) and its safety and efficacy profile in wound care are not explicitly detailed here, but the equivalence is asserted based on "similar in function." |
| Safety and Effectiveness Equivalence: The device should be as safe and effective as the predicate device. | Non-clinical testing was conducted to confirm the safe and effective performance of Dermacyn™ Wound Care Dressing as compared to 0.9% sterile saline. Preclinical testing also demonstrated the biocompatibility of the subject device. The conclusion states "The Dermacyn™ Wound Care Dressing is substantially equivalent to the currently cleared and marketed Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This document refers to "non-clinical testing" and "preclinical testing" but does not detail the sample sizes for these tests. There's no mention of a human "test set" in the context of a clinical performance study.
- Data Provenance: Not specified, but given the nature of non-clinical and preclinical testing, it would typically be laboratory-based rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study that involves expert review or ground truth establishment in the context of diagnostic accuracy or equivalent performance. The evaluation is based on scientific testing related to the product's formulation and biocompatibility, as compared to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human "test set" or adjudication process described.
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 not an AI-powered diagnostic or assistive tool, nor does the document describe a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a topical solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the traditional sterile saline wound dressing, to which the new device is compared in terms of its properties and intended use. The non-clinical and preclinical tests would have generated data on properties like sterility, pH, antimicrobial activity (if applicable, though not explicitly stated as a primary function here), and biocompatibility, using established laboratory methods.
8. The sample size for the training set
Not applicable. There is no machine learning or AI component that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
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