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O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to protect light to moderate wounds including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, and minor burns, chafed or irritated skin.

OxyBand™ Wound Dressings are intended to provide a moist, oxygen rich environment to facilitate the normal wound healing process. OxyBand™ Wound Dressings can be used to cover and protect wounds and cather sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debritement facilitators, or a protective cover over at risk skin. Common applications include: clean dosed surgical incisions, sin graft donor sites, Slage I or II pressure ulcers, pressure sores, superficial wounds such as abrasigns, skirtes, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.

The OxyBand™ Wound Dressing is made up of a thin polyurethane film commonly used in other wound dressings, with adhesive that seals around the wound at the perimeter of the dressing. An occlusive oxygen barrier film is sealed over the polyurethane film to hold a layer of oxygen over the high oxygen permeability polyurethan

The provided 510(k) summary for the O2S, LLC OxyBand™ Wound Dressing (K121407) does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K04063) based on device description and intended use. The core of the submission is that the O2S OxyBand™ Wound Dressing is the "exact same device" as the previously approved one, but manufactured and sold by a new entity (O2S, LLC) for governmental customers.

Therefore, I cannot populate the table or answer the specific questions about device performance studies, as this information is not present in the provided text.

The document states: "This device is the exact same device previously approved for our partner OxyBand Technologies, Inc. This device has previously been cleared for marketing under the OxyBand Technologies, Inc. 510(k), number K04063." This indicates that the regulatory pathway relies on the prior clearance of the predicate device, rather than new performance studies for this specific submission.

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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:

1. 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.
2. 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.
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, as there's no diagnostic study or expert-adjudicated test set described.
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-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as there is no training set for a wound dressing device.
9. How the ground truth for the training set was established: Not applicable.

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