(316 days)
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility.
Help prevent edema and arm discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility.
Not Found
The provided document is a 510(k) premarket notification acceptance letter for a medical support stocking (anti-embolism stocking/arm sleeve). This type of document does not contain the details of acceptance criteria or the study data as typically found for devices like AI algorithms or diagnostic tools.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. This determination is based on the information provided in the 510(k) submission, which would include performance data, but that specific data and the acceptance criteria are not present in this public letter.
Therefore, I cannot provide the requested information from the given text. The text only mentions the device name, regulation number, regulatory class, product code, and the FDA's decision on substantial equivalence. It does not detail any performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
If you have a document that contains the study report or the 510(k) submission summary, I would be able to extract the requested information.
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.