Search Results

The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist wound healing environment and manage exudate.

The dressing is indicated for the local management of the following types of wounds:

1. Partial and full thickness wounds, moderate to heavily exudating wounds such as;
   a. venous stasis ulcers.
   b. pressure sores.
   c. post operative incisions.
   d. diabetic ulcers.
2. Partial thickness wounds such as;
   a. abrasions.
   b. lacerations.
   c. donor sites.
   d. superficial burns.
3. Other indications include;
   a. drainage dressing for tracheostomy and gastrostomy tubs.

Bioderm Foam Wound Dressing

This document is a 510(k) clearance letter from the FDA for a wound dressing, not a study describing the acceptance criteria and performance of a device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text.

The document primarily states that the Bioderm Foam Wound Dressing is substantially equivalent to legally marketed predicate devices and outlines its approved indications for use and certain labeling limitations. It does not contain any performance data or study results demonstrating the device meets specific acceptance criteria.

Ask a specific question about this device

• 1. Venous stasis ulcers.
• 2. Pressure sores Stages 1, 2, 3, & 4.
• 3. Ulcers triggered by trauma.
• 4. Drainage dressing for tracheostomy and gastrostomy tubes.
• 5. Post operative incisions.

Bioderm Foam wound Dressing

The provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document only states that the device, "Bioderm Foam Wound Dressing," is "substantially equivalent" to legally marketed predicate devices for the following indications for use:

• Venous stasis ulcers.
• Pressure sores Stages 1, 2, 3, & 4.
• Ulcers triggered by trauma.
• Drainage dressing for tracheostomy and gastrostomy tubes.
• Post operative incisions.

It also lists limitations on labeling claims, such as not being labeled for use on third-degree burns, or as having an accelerating effect on wound healing.

To provide the requested information, a different type of document, such as a clinical study report or a detailed summary of the premarket submission, would be necessary.

Ask a specific question about this device