(245 days)
For adjunctive therapy of the following conditions:
- Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
- Decubitus ulcers
- Amputations/infected stumps
- Skin grafts
- Burns
- Frostbite
Numobag™
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Numobag™ device, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use.
The letter does not include details about:
- A table of acceptance criteria or reported device performance.
- Sample sizes, data provenance, or ground truth establishment for any test or training sets.
- Information about expert involvement, adjudication methods, or MRMC studies.
- Results from standalone algorithm performance studies.
The document's purpose is regulatory clearance based on substantial equivalence, not a detailed scientific study report.
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.