(242 days)
The Hygia Health Services Reprocessed NuTech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order to:
- Prevent deep vein thrombosis .
- Reduce wound healing time .
- Treat and assist healing of venous leg ulcers .
- Reduce edema caused by venous insufficiency in the lower extremities .
The Hygia Health Services Reprocessed NuTech® Calf Wrap is a compressible limb device for the lower limb, that when attached to an approved controller, provides intermittent pneumatic compression of the gastrocnemius muscle. The garment is constructed out of brushed nylon with an elastic lining. The single inflation chamber is constructed from the garment itself. The device has an internal coating of a latex free polymer that creates an airtight seal. The inner lining is elastic, which allows for the inflation. The inflation tube is constructed of poly vinyl chloride (PVC), which terminates in a snap-lock connector. The hook fasteners are made of polyethylene. The garments are placed around the gastrocnemius muscle of the calf and secured with a hook and loop fastener. As the garment compress the muscle, venous pressure is increased, ejecting the blood upward toward the heart. After a rapid compression, the garment deflates allowing the veins to refill and bring oxygenated blood to the lower limbs. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
The provide text is a 510(k) summary for the Hygia Health Services Reprocessed NuTech® Calf Wrap, a device intended to prevent deep vein thrombosis (DVT) and treat edema. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the requested table and answer all questions regarding acceptance criteria and a study proving device performance.
The document states:
- Performance Data: "Nonclinical Tests- Comparative bench testing was utilized to assess and prove similarity of function between the Hygia Health Services Reprocessed NuTech® Calf Wrap and the predicate device, the NuTech® Universal Calf Wrap. All tests found that functional and operational performance characteristics including compression, pressure control, and timing sequence were substantially equivalent. Safety and operational parameters regarding controller connections were also found to be equivalent. Clinical Tests- Clinical tests were summarized in support of the premarket notification submission. Test Conclusions- Clinical and nonclinical test results of the Hygia Health Services Reprocessed NuTech® Calf Wrap indicated substantial equivalence in all aspects to the predicate device, the NuTech® Universal Calf Wrap."
This indicates that studies were performed, but the document lacks the detailed quantitative acceptance criteria and specific results for device performance, sample sizes, ground truth establishment, expert involvement, and comparative effect sizes that you requested.
Therefore, I cannot populate the table or answer most of your questions based on the provided text.
Based on the available information, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated with numeric values in the document. The general criteria seem to be "substantial equivalence" in functional and operational performance characteristics to the predicate device.
- Reported Device Performance: "All tests found that functional and operational performance characteristics including compression, pressure control, and timing sequence were substantially equivalent. Safety and operational parameters regarding controller connections were also found to be equivalent." No specific quantitative performance metrics are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document refers to "bench testing" and "clinical tests" but does not detail the methodology for establishing ground truth or expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not specified. This device is a physical medical device (calf wrap), not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not specified, as this is a physical device and not an algorithm. Bench tests would represent standalone performance of the device without a human in the loop, but detailed results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "nonclinical tests," the ground truth was likely established by comparing the reprocessed device's physical and operational characteristics (compression, pressure control, timing sequence, safety, controller connections) against the known/expected characteristics of the original predicate device.
- For "clinical tests," the ground truth or endpoints evaluated are not detailed, but generally for DVT prevention and edema reduction, these would involve clinical outcomes, physiological measurements, or imaging.
8. The sample size for the training set
- Not applicable for this type of device (physical reprocessed device, not a machine learning algorithm).
9. How the ground truth for the training set was established
- Not applicable for this type of 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).