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The Hygia Health Services Reprocessed NuTech® Combo is used as a non-invasive therapeutic method 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® Combo is a dual compressible limb device for the lower extremities; it is made up of both a foot wrap and a calf wrap. Each devices inflation tube is connected together at a "Y" junction with another single inflation tube exiting the "Y" connector and attaching to the controller. The action of the device occurs only when it is attached to an approved controller. The controller inflates the devices, which provide simultaneous intermittent pneumatic compression of the gastrocnemius muscle and the plantar plexus. Both garments are constructed out of brushed nylon with an elastic lining. The single inflation chambers are constructed from the garment itself. The devices both have an internal coating of a latex free polymer that creates an airtight seal. The inner lining is elastic, which allows for the inflation. The primary 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 the plantar arch of the foot. Both devices are secured with a hook and loop fastener. As the foot garment compresses the plantar plexus, the veins are stretched longitudinally simulating weight-bearing activities. This action causes the veins to empty upward. Then as the calf wrap compresses the gastrocnemius 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. Both devices inflate simultaneously with a 0.2 second delay between the foot wrap and calf wrap inflation sequence.

The provided text describes a 510(k) summary for a reprocessed medical device, specifically the Hygia Health Services Reprocessed NuTech® Combo, an intermittent pneumatic compressible limb sleeve. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, the NuTech® Combination Foot and Calf Wrap.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a numerical sample size for the test set used in the nonclinical (bench) tests. It generally refers to "All tests." The data provenance is not explicitly mentioned (e.g., country of origin), but the tests appear to be internal comparative bench testing against a predicate device. The nature of the study (retrospective or prospective) is not applicable to bench testing, which is generally a controlled, prospective evaluation.

For the "clinical tests," the document states "Clinical tests were summarized in support of the premarket notification submission," but provides no details on the sample size or provenance. This suggests the clinical tests might not have been primary studies conducted by Hygia Health Services for this specific reprocessed device, but rather a summary of existing clinical evidence that supports the predicate device's effectiveness, which by association would support the reprocessed device's effectiveness due to substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Given that the primary demonstration is for substantial equivalence through nonclinical bench testing, the "ground truth" would likely refer to established performance specifications or measurements of the predicate device. Experts would be involved in setting up and conducting the bench tests and interpreting the results, but the document does not elaborate on their number or qualifications as it would for, say, a diagnostic imaging study.

4. Adjudication method for the test set

This information is not provided nor is it applicable in the context of comparative bench testing for a physical medical device. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., reading medical images).

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

An MRMC study was not done. This type of study is specifically relevant to AI/diagnostic imaging devices where human interpretation is a key component, which is not the case for an intermittent pneumatic compression device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical device (compressible limb sleeve), not an algorithm or AI system. Its performance is inherent in its mechanical and hydraulic function, not in a standalone algorithm.

7. The type of ground truth used

For the nonclinical tests, the ground truth was the established functional and operational performance characteristics of the legally marketed predicate device, the NuTech® Combination Foot and Calf Wrap. The goal of the bench tests was to show that the reprocessed device's performance was "substantially equivalent" to this established benchmark.

For the "clinical tests," the document mentions they were "summarized in support of the premarket notification submission." This implies the ground truth for clinical efficacy and safety was established by prior clinical studies on the predicate device or similar devices, and not specifically for the reprocessed device in new clinical trials.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device.

In summary:

The provided document focuses on demonstrating the substantial equivalence of a reprocessed medical device to an original predicate device, primarily through nonclinical bench testing. The "acceptance criteria" are implicitly the performance specifications of the predicate device, and the "study" is comparative bench testing showing equivalence. Details typically required for evaluating AI or diagnostic imaging devices (like sample sizes for test/training sets, expert qualifications, MRMC studies) are not provided and are largely irrelevant to this type of medical device submission.

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