(100 days)
The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Hygia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
Here's a breakdown of the acceptance criteria and study information for K090074, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional performance as intended (similar to OEM devices) | Functional Testing demonstrates the reprocessed sleeves/foot cuffs perform as intended. |
| Cleaning validation (safe for reuse) | Cleaning validation demonstrates the reprocessed sleeves/foot cuffs are safe and effective. |
| Biocompatibility (safe for patient contact) | Biocompatibility testing demonstrates the reprocessed sleeves/foot cuffs are safe and effective. |
| Technological characteristics identical to original OEM devices. | "The overall designs, materials, energy sources, modes of operation, and performance characteristics are no different than the original devices." |
| Substantial equivalence to predicate devices | Conclusion states the device is substantially equivalent based on the functional, cleaning, and biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size. The performance data refers to "Functional Testing, cleaning validation, and biocompatibility testing," which are typically laboratory or bench tests. Therefore:
- Sample Size for Test Set: Not explicitly stated as a clinical sample size. It would refer to the number of reprocessed devices subjected to bench testing for functional, cleaning, and biocompatibility assessments.
- Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective. Given the nature of the tests (functional, cleaning, biocompatibility), they are almost certainly conducted in a laboratory setting, likely at Hygia Health Services, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the type of testing described. Ground truth established by experts is relevant for studies involving diagnosis, image interpretation, or clinical outcomes. The studies cited are laboratory-based assessments of device integrity and performance.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for subjective assessments or when there's disagreement among independent evaluators (e.g., radiologists interpreting images). The "functional testing, cleaning validation, and biocompatibility testing" are objective, measurable laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for this mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a reprocessed medical sleeve/foot cuff, not an AI algorithm.
7. The Type of Ground Truth Used
For the functional, cleaning validation, and biocompatibility testing, the "ground truth" would be established by:
- Functional Testing: Established engineering specifications and performance benchmarks for the original OEM devices (e.g., pressure output, inflation/deflation cycles, material integrity).
- Cleaning Validation: Established standards and protocols for sterilization and removal of biological contaminants.
- Biocompatibility Testing: Established international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
Essentially, the "ground truth" is adherence to predefined technical and safety standards relevant to the device's original design and intended use, as well as standards for reprocessing.
8. The Sample Size for the Training Set
This is not applicable. The device is a reprocessed medical sleeve/foot cuff and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set mentioned or implied for this device.
§ 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).