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The Hygia West Reprocessed Compression Garments operate in the identical manner as the predicate devices. They are designed for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insulficiency. The devices are used in both the home and institutional settings.

The Hygia West Reprocessed Huntleigh DVT Sleeve is to be used by patients in both the home and institutional settings used as a non-invasive therapeutic method to:

• Prevent deep vein thrombosis and resulting pulmonary embolism .
• Intra-operative compression therapy

The Llygia West Reprocessed Compression Garments are intermittent compressible limb devices that are placed around cither the patient's foot (with the compression chamber placed under the plantar arch), calf (gastrocnemius muscle), thigh, or a combination there of. The garments are constructed from materials that are common to the medical device industry. Depending on the type of device, the method of fastening to the patient may vary from a hook and loop closure system to a uni-body style that is slipped over the limb. In foot compression devices, as the garment compresses the plantar plexus, the veins collapse longitudinally; this action causes an increase in the venous pressure thus eiceting the blood upward. After compression, the devices deflate allowing the veins to refill bringing oxygenared blood to the lower limbs. In devices used on the calf or thigh the compression to the area causes the blood to be ejected upwards to the heart, as the compression relaxes the valves in the veins close allowing them to refill. This cyclical method removes deoxygenated or stale blood from the region allowing fresh blood to be received. On all devices the controller predetermines the inflation and deflation sequence. The operational characteristics such as the pressure of compression, hold time, and inflation time are determined by the controller. It is the responsibility of the end user to ensure that the device is connected to an approved controller and to ensure that the controller settings are accurate. Hygia West does not repair, refurhish, or reprocess the controlling unit. Hygia West guarantees 100% of our devices ONLY if it has heen connected to an approved, functional, and correctly adjusted controller.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hygia West Reprocessed Compression Garments:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the acceptance criteria implicitly through the concept of "substantial equivalence" to predicate devices. The study aims to demonstrate that the reprocessed devices perform identically to the original devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document mentions "Comparative bench testing was utilized" and "a NTH level combination irritation/sensitization human skin patch test was conducted." However, no specific numerical sample sizes are provided for either the bench testing or the human skin patch test. The "NTH level" for the skin patch test is unclear without further context.
• Data Provenance: The data is generated by Hygia West, Inc. as part of their 510(k) submission. It represents prospective testing conducted by the manufacturer to demonstrate substantial equivalence for their reprocessed devices. The country of origin for the data is implicitly the USA, where Hygia West, Inc. is based and where the regulatory submission is made to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: The document does not specify the number of experts used for establishing ground truth, nor does it detail any expert involvement in the testing process beyond the general statement of "testing was utilized."
• Qualifications of Experts: Not provided.

4. Adjudication Method for the Test Set:

• The document does not describe any adjudication method for the test set. The tests mentioned appear to be objective performance and biocompatibility tests rather than assessments requiring human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No, an MRMC comparative effectiveness study was not done. The device in question is a reprocessed compression garment, and the studies performed are bench tests and a human skin patch test, not studies involving human readers interpreting medical cases. Therefore, there is no mention of "human readers" or "AI assistance."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable to the device described. The Hygia West Reprocessed Compression Garments are physical medical devices (compressible limb sleeves), not an AI algorithm or software. The "performance" refers to the physical function of the garment, not an algorithm's output.

7. The Type of Ground Truth Used:

• For functional performance, the ground truth appears to be the performance characteristics of the original, new predicate devices. The reprocessed devices are compared against these known, established performance metrics.
• For biocompatibility, the ground truth is established based on accepted standards for human skin irritation and sensitization, as evaluated by the "NTH level combination irritation/sensitization human skin patch test."
• For intended use and technological characteristics, the ground truth is the stated and established properties of the predicate devices.

8. The Sample Size for the Training Set:

• This question is not applicable, as the device is a reprocessed physical medical device, not an AI algorithm or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable for the same reason as point 8.

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