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To assist in the management of venous stasis ulcers by applying pressure.

The device includes a Leg Compressor and a Pre-Filled Air Bladder (PFAB).

The PFAB does not apply pressure, but when it is used in conjunction with a compression bandage, it will exert local pressure (because of the air pocket). Compression bandages exert pressure, therefore the pre-filled air bladder will redistribute the pressure that the bandage would already by supplying.

Overall the device is meant to redistribute and apply pressure to the venous ulcer. It has been found over the years that compression bandages or stockings healed more venous leg ulcers than no compression.

If the venous ulcer is kept covered and clean with applied pressure the healing process is more effective. The concept behind this device is to keep the wound covered and apply pressure on the wound.

PFAB (Pre-Filled Air Bladder)

The PFAB is an oval shaped polyurethane pre-filled air bladder with four flanges. The tips of the flanges have medical adhesive, which adheres to the skin. The bottom of the PFAB has medical grade hydrophilic foam, which will cover the ulcer and is used to absorb the exudates.

The PFAB will be offered in three sizes (Small, Medium, and Large).

Leg Compressor

The leg compressor is used to hold the PBAB in place and apply additional pressure. The leg compressor contains an air chamber that is made of 2 layers of urethane film. The outer black fabric is Nylon. The leg compressor also has a self adjusting manometer attached to the outside to measure the pressure within the air bladder, which will be situated along the Great Saphenous Vein.

The manometer is used for reference only and is not meant to be used for accurate measurements of pressure.

The Leg Compressor includes a safety release valve to deflate the compressor. In addition, the manometer is color coded. As a precaution the user should not inflate the compressor in the red zone.

The pressure at the beginning of the red zone is approximately 30 mm Hg, which is similar to the pressure from a typical Umma Boot or compression bandage.

The provided document K070457 describes the submission of a 510(k) for the "Leg Compressor & PFAB" device. However, it explicitly states that performance data consists solely of biocompatibility testing. The submission concludes that the device is "as safe and effective as the predicate device" based on minor changes and material identity to a predicate.

Therefore, the document does not contain any information regarding a study demonstrating the device's clinical performance, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The device was classified as "Unclassified" and later as "Elastic Bandage" (Product Code FRO N.HW / MHW), which typically implies a lower regulatory burden and often does not require extensive clinical performance studies for 510(k) clearance if substantial equivalence to existing devices can be proven through other means (e.g., material equivalence, intended use equivalence).

Here's a breakdown of why many of your requested items cannot be fulfilled from this document:

1. Table of acceptance criteria and reported device performance: Not available. The document does not define specific performance metrics or acceptance criteria for clinical effectiveness.
2. Sample size for test set and data provenance: No clinical test set or study is mentioned beyond biocompatibility.
3. Number of experts and qualifications for ground truth: Not applicable, as no clinical ground truth was established for performance.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not done.
6. Standalone performance study: No standalone clinical performance study is described. The "Performance Data" section only mentions biocompatibility.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device, and no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The only "performance data" mentioned is:
"The materials that make contact with the patient are biocompatible and are identical to the materials used in one of the predicate devices."

And the conclusion:
"We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device."

This indicates that the clearance was based on demonstrating substantial equivalence through material safety and comparison to existing predicate devices, rather than a new clinical performance study.

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