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The Hygia Health Services Reprocessed NuTech® Foot Wrap is designed to enhance the circulation of blood in the venules and artise therapeutic method 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 .
• Decrease compartmental pressures

The Hygia Health Services Reprocessed NuTech® Foot Wrap Garment is a compressible limb device that is placed around the patient's foot and when attached to an approved controller, provides intermittent pneumatic compression. The garment is constructed out of brushed nylon with polyester foam backing. The single bladder is constructed out of poly vinyl chloride (PVC), which is RF welded at the seams. The inflation/deflation tube is also composed of PVC. The hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The garments are placed around the foot at the area of the plantar arch and secured with a hook and loop fastener. As the garment compresses the plantar plexus, veins collapse longitudinally, increasing the venous pressure thus ejecting the blood upward. After compression, the devices deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.

The provided text describes a 510(k) summary for a reprocessed medical device, specifically the Hygia Health Services Reprocessed NuTech® Foot Wrap. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic AI or complex therapeutic device.

Here's an analysis based on the provided text, addressing your points where possible:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria. Instead, the "acceptance criteria" are implicitly defined by the demonstration of "substantial equivalence" to the predicate device, the NuTech® PlexiPulse Foot Wrap Garment.

Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Detailed Responses to Specific Questions:

1. A table of acceptance criteria and the reported device performance:

   • See the table above. The acceptance criteria are "substantial equivalence" across various functional, safety, operational, material, and efficacy domains compared to the predicate device. The reported device performance is that nonclinical (bench) and clinical tests "indicated substantial equivalence in all aspects" to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify the sample size for nonclinical (bench) tests nor for the "clinical tests."
   • The document does not specify the data provenance (country of origin, retrospective/prospective). It simply states nonclinical and clinical test results were "summarized." Given the context of a 510(k) for a reprocessed device, these tests would likely be focused on verifying the reprocessing method's impact and the device's maintained functionality rather than extensive de novo clinical trials.

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):

   • This information is not provided as the submission focuses on substantial equivalence based on physical and functional characteristics, not on diagnostic accuracy requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided and is not applicable to this type of device submission.

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 relevant for AI-powered diagnostic devices, which this reprocessed foot wrap is not.

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

   • A standalone performance study of an algorithm was not done. This device is a mechanical medical device, not an AI or software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The concept of "ground truth" in the diagnostic sense is not directly applicable here. For the nonclinical tests, the "ground truth" was likely defined by established engineering parameters and performance specifications of the predicate device. For the "clinical tests," the "ground truth" would implicitly be the clinical outcomes or functional measures compared to known performance of the predicate device, although specific details are not provided.

8. The sample size for the training set:

   • This device does not involve a "training set" in the context of machine learning or AI.

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

   • This question is not applicable as there is no training set for this type of medical device.

In summary: The provided 510(k) summary is for a reprocessed intermittent pneumatic compression foot wrap. The regulatory pathway is based on demonstrating "substantial equivalence" to a legally marketed predicate device. The supporting evidence provided consists of nonclinical (bench) tests and summarized clinical test results, all asserting that the reprocessed device performs identically and safely compared to the original. The details regarding specific sample sizes, expert involvement, or AI-related metrics (like MRMC studies, training sets, or ground truth establishment for AI) are not included because they are not relevant to this type of medical device submission.

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