(113 days)
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.
Ascent Healthcare Solutions' Reprocessed Compression Sleeves were tested against several acceptance criteria through bench and laboratory testing. The study proved that the reprocessed sleeves perform as originally intended, demonstrating safety and effectiveness compared to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
| Validation of Reprocessing | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
| Function Test(s) | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly states that "Bench and laboratory testing was conducted," implying a controlled experimental environment rather than patient data.
3. Number of Experts and Qualifications for Ground Truth:
This information is not provided in the document. Given that the testing involved "bench and laboratory testing" rather than clinical assessment or diagnostic evaluations, the concept of "ground truth established by experts" as typically understood in AI/medical imaging studies may not directly apply. The evaluation would likely have been based on established engineering and materials science standards.
4. Adjudication Method:
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The device is a reprocessed physical medical device, not a diagnostic algorithm or AI system intended to assist human readers.
6. Standalone Performance (Algorithm Only):
Not applicable. The device is a physical medical device (compression sleeve), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing was based on established engineering and safety standards for medical device function and material properties, as evidenced by the mention of "Biocompatibility," "Validation of reprocessing," and "Function test(s)." It was not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or predictive device. The goal was to show that the reprocessed device met the performance characteristics of its original, non-reprocessed counterparts.
8. Sample Size for the Training Set:
Not applicable. The device is a reprocessed physical medical device, not an AI model requiring a training set. The "reprocessing" itself involves a set of procedures that are validated, rather than an algorithm that is "trained."
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device. The reprocessing process itself would be validated against established standards to ensure the device performs as intended after reprocessing, which serves a similar role to "ground truth" for the manufacturing/reprocessing process.
§ 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).