(252 days)
The Hygia Health Services Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services Reprocessed SCD™ Sleeve is a compression limb device that, when attached to an approved controller, provides intermittent, sequentially graduated pressure. As the sleeves compress the legs, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the controller, which inflates first the ankle section, then the calf section, and finally the thigh section (on larger models). The pressure of compression is determined by the controller and is adjusted by varying the ankle pressure.
I am sorry, but the provided text does not contain the specific information required to complete your request for a detailed description of acceptance criteria and a study proving device performance for the Hygia Health Services Reprocessed Kendall SCD™ Sleeves.
The document is a 510(k) Summary for a reprocessed medical device. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance study results against specific acceptance criteria.
Here's what the document does state regarding performance, and why it doesn't fulfill your request:
- Nonclinical Tests: "Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Service Reprocessed Kendall SCD™ Sleeves and the original Kendall SCD™ Sleeve. All tests found that functional and operational performance characteristics including compression, pressure control, timing sequence, sleeve compatibility, safety and operational parameters used when connected to a controller where substantially equivalent."
- Missing from your request: Specific acceptance criteria values, reported performance numbers against those criteria, sample sizes, data provenance, ground truth details, etc. "Substantially equivalent" is a regulatory conclusion, not a detailed performance metric.
- Clinical Tests: "Clinical test results were summarized in support of the premarket notification submission."
- Missing from your request: No details provided about these clinical tests, such as their design, sample size, methodology, acceptance criteria, or actual results.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies for this device based on the given text. The document's purpose is to establish "substantial equivalence," which often relies on demonstrating that reprocessing does not alter the original device's performance, rather than conducting new, detailed performance studies against novel acceptance criteria.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).