(218 days)
To prevent the pooling of blood and deep vein thrombosis in the legs. For patients at risk of developing compromised or inadequate venous return from the legs as a result of both medical and non-medical circumstances. The HeelSafe DVT Hose are designed to aid and prevent deep vein thrombosis in the recumbent patient with limited mobility. Progressive compression from foot to knee aids in improving venous return and avoiding clot formation.
The HeelSafe DVT Hose open heel aids in preventing pressure on the heel that could be caused by the additional 15-18 mm Hg of pressure of other compression stockings. The HeelSafe DVT Hose open heel allows for easy visualization and palpation of the heel at all times.
I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "HeelSafe™ DVT Hose" (K101614). It discusses the regulatory classification, general controls, and indications for use, but it does not detail any specific studies that were conducted to establish performance or acceptance criteria.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.