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PCD 737A is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:

• Primary lymphedema
• Secondary lymphedema
• Venous insufficiency
• Venous stasis ulcers
• Dysfunction of the muscle pump
• Post mastectomy edema
• Edema following trauma and sports issues
• Post immobilization edema
• Reducing wound healing time
• Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
• Reduction of pain and swelling after injury and surgery
• Enhancement of venous circulation
• Prevention of venous stasis
• Assistance in healing of cutaneous ulcers
• Reduction of compartmental pressures
  The device is intended for hospital, home, and clinic use.

Not Found

I am sorry, but after reviewing the provided document, I was unable to find the acceptance criteria for a medical device and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the PCD 737A device, which is a compressible limb sleeve. It mainly details the regulatory approval process, lists the indications for use, and includes standard FDA disclaimers and contact information.

There is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details of a study.
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case comparative effectiveness study or any effect sizes.
• Results of a standalone algorithm performance study.
• Type of ground truth used.
• Sample size for a training set or how its ground truth was established.

This document confirms the device's substantial equivalence to a predicate device, which is a regulatory assessment, not a detailed technical performance study with acceptance criteria.

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