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The ProAct with Gel is a prescriptive device indicated for:

• Lymphedema - primary and secondary
• Prevention of venous stasis
• Prevention of Deep Vein Thrombosis (DVT)
• Edema following trauma and sports injuries
• Post immobilization edema

The ProAct 1 or ProAct with gel device is a gradient sequential compression device used in the treat ment of lymphedema. The ProAct with gel is a modification to the ProAct 1 device that received FDA marketing clearance under 510(k) K003909. The ProAct with gel uses the same powered control device that delivers gradient sequential compression pressure to the chambered compressible limb sleeves. The device is composed of three components:

• Lightweight, portable control unit .
• Compressible limb sleeves with gel in 3 sizes for arms and legs (Brookwood 70 denier MD Nylon . and DAF Breathable 270 Nylon)
• . Pneumatic connecting tubes
  The subject device includes sleeves with Nosocryl D60 gel in the chambers. The gel was added to address market requests.

The provided text is a 510(k) summary for the ProAct with gel / ProAct 1 device, which is a gradient sequential compression device used in the treatment of lymphedema, prevention of venous stasis, DVT, and edema. The submission seeks to establish substantial equivalence to a predicate device, ProAct 1 (K003909).

However, the provided document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document primarily focuses on:

• Contact information of the submitter and applicant.
• Device classification and description.
• The modification made to the predicate device (addition of Nosocryl D60 gel to the sleeves).
• Safety characteristics of the gel material.
• Intended use of the device.
• Technological characteristics comparison, highlighting that only the gel addition is new.
• A conclusion of substantial equivalence.
• The FDA's decision letter confirming substantial equivalence.
• The Indications for Use statement for the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is typically found in a clinical study report or a more detailed section of a 510(k) submission, especially for devices claiming new clinical performance or requiring clinical data for substantial equivalence. In this case, the modification (adding gel) was deemed minor, and the submission likely relied on non-clinical data (e.g., material safety, physical characteristics) to establish equivalence without extensive clinical studies proving new performance metrics.

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