(139 days)
OxyBand ™ Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other would products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover at risk skin. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage For II pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
The Over-The-Counter OxyBand ™ Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor burns, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing.
OxyBand™ is a multilayer wound dressing that keeps out water, dirt and germs, and supplies oxygen to the wound. It is designed to be applied directly over clean skin or wounds for up to 5 days. A study has shown that upon attaching the dressing over a test plate, oxygen levels rise steadily over the device area for the first few hours and then maintain at elevated levels through 5 days as long as the dressing remains intact and secure around the perimeter.
The provided text is a 510(k) Summary of Safety and Effectiveness for the OxyBand™ Wound Dressing. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The statement "A study has shown that upon attaching the dressing over a test plate, oxygen levels rise steadily over the device area for the first few hours and then maintain at elevated levels through 5 days as long as the dressing remains intact and secure around the perimeter" is the only mention of a "study." However, this is a general statement about the device's function, not a detailed description of an efficacy study with acceptance criteria and results.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory equivalence with predicate devices rather than specific performance benchmarks met through testing.
- Sample size used for the test set and the data provenance: Not present. The "study" mentioned is a general observation about oxygen levels, not a clinical trial with a defined test set.
- 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, as there's no diagnostic study or expert-adjudicated test set described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as there is no training set for a wound dressing device.
- How the ground truth for the training set was established: Not applicable.
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