(144 days)
An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
The provided text is a 510(k) summary for the OsmoCyte™ Ultra/PE Pillow Wound Dressing, a medical device for wound care. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information on performance criteria or a study demonstrating that the device meets specific acceptance criteria.
The "Assessment of Performance Data" section only mentions biocompatibility testing
per ISO 10993-1, which supports the safe use of the device. It does not provide any quantitative or qualitative performance criteria regarding the device's efficacy (e.g., absorption capacity, healing rates, or infection reduction) or a study to demonstrate these.
Therefore, I cannot populate the requested table or answer most of the other questions because the necessary information is not present in the provided text.
Here's what can be inferred or stated as missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in document) | The device passed "Biocompatibility testing... as recommended in the 'International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1.'" This supports the device's safe use as a temporary wound dressing in contact with breached or compromised skin. |
2. Sample size used for the test set and the data provenance:
- Not specified. The document does not mention a "test set" in the context of performance efficacy, only biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Ground truth establishment for a test set is not mentioned as such a study is not detailed.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication is not mentioned as such a study is not detailed.
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:
- No. This device is a wound dressing, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this medical device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a wound dressing, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not specified, as no formal performance study beyond biocompatibility is described. For biocompatibility, the "ground truth" would be the biological response observed in adherence to ISO 10993-1.
8. The sample size for the training set:
- Not applicable/Not specified. This device is a wound dressing, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. This device is a wound dressing, not an AI model.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.