(71 days)
Dermaphylyx Hydrocolloid Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds.
The following Indications are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers Diabetic ulcers Pressure sores Blisters
Superficial burns Abrasions and laccrations Donor sites
The following Indications are for Over-the-Counter Use:
Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters
Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive.
The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous water and dirt while maintaining breathability.
This 510(k) submission for the Dermaphylyx Hydrocolloid Wound Dressing describes its intended use and claims substantial equivalence to an existing device (SpyroColloid® Wound Dressings). However, it does not provide any specific acceptance criteria or details of a study that proves the device meets such criteria.
The provided document is a 510(k) summary and the FDA's response letter. A 510(k) summary typically includes:
- A description of the device.
- Intended use.
- Comparison to a predicate device to establish substantial equivalence.
- A brief summary of any performance data if available, but it's not always required to be extensive for substantial equivalence claims.
In this specific document, the focus is on establishing equivalence to the predicate wound dressing based on material composition and intended use, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text.
Here's how I would address your request based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| Implied Acceptance Criterion for 510(k): | |
| Substantial Equivalence to Predicate Device (SpyroColloid® Wound Dressings) in terms of: |
- Self-adhesive, semi-occlusive, absorptive hydrocolloid wound dressing.
- Provides a barrier to exogenous water/dirt while maintaining breathability.
- Intended for management of partial and full thickness wounds (venous stasis ulcers, diabetic ulcers, pressure sores, blisters, superficial burns, abrasions, lacerations, donor sites).
- Over-the-counter use for abrasions, minor cuts, minor lacerations, minor burns, and blisters. | The device, Dermaphylyx Hydrocolloid Wound Dressing, is described as meeting these characteristics, aligning with the predicate device. The FDA's letter states: "We have reviewed your Section 510(k) notification... It is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. The document does not describe a clinical performance study with a test set.
- Data provenance: Not applicable.
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. The document does not describe a study involving expert assessment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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-assisted diagnostic tool.
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)
- Not applicable, as a performance study generating ground truth data is not described in this document. The "ground truth" for a 510(k) for a simple device like this is typically the established performance and safety profile of the predicate device.
8. The sample size for the training set
- Not applicable. There is no training set described as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
N/A