(37 days)
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Bydrogel Dressing is indicated for: First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. This is a disposable, short term (less than 72 hours between changes) device for single patient use
This is a medical device approval letter from the FDA for the Ad-Heal™ Hydrogel Dressing. The letter states that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on regulatory approval, labeling limitations, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
Therefore, I cannot provide the requested information based on the provided text. The document does not contain details regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 878.4022 Hydrogel wound dressing and burn dressing.
(a)
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.