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The Amputee Garment for use with Lympha Press Optimal Plus is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: · Primary Ivmphedema · Secondary Ivmphedema - - · Venous insufficiency - Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reduction of wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema

Amputee Garment for use with Lympha Press Optimal Plus

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "Amputee Garment for use with Lympha Press Optimal Plus." This document describes the device's regulatory clearance and its intended uses, but it does not contain any information about acceptance criteria, a specific study proving device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies (like MRMC or standalone AI performance studies).

Therefore, I cannot provide the requested information based on the input text.

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The device 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
• · Reduction of pain and swelling after injury and surgery
• · The device may also be beneficial in the management of Lipoedema

The device is intended for hospital, home, and clinic use.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the "Lympha Press Optimal Plus" device, which is a compressible limb sleeve.

The document discusses the regulatory classification, indications for use, and general controls provisions of the Act that the device must comply with. However, it does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a study proving the device meets acceptance criteria. It also does not mention any multi-reader multi-case studies or standalone algorithm performance.

Ask a specific question about this device

The device 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
• · Reduction of wound healing time
• · Reduction of pain and swelling after injury and surgery
• · The device may also be beneficial in the management of Lipoedema

The device is intended for hospital, home, and clinic use.

Lympha Press Optimal Plus Model 912

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Lympha Press Optimal Plus." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way you've requested.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and lists the indications for use. It's a regulatory approval document, not a scientific study report.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study information as they are not present in the provided text.

Ask a specific question about this device