Search Results

The MediPlus-Foam™ AG, MediPlus-ComfortFoam™ AG, and MediPlus-SuperFoam™ AG Dressings are indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:

• Ulcers (venous, arterial, diabetic) .
• Pressure Sores ●
• . Donor Sites
• Surgical Incisions .
• Surgical Excisions .
• . Burns (1st and 2nd degree)

The MediPlus-Foam™ AG Dressings product line is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film and a silver net layer acting as an ... antimicrobial barrier. The product line is available in different sizes. The MediPlus-SuperFoam™ AG Dressings product line has slightly thicker PU foam and is easier to bend for covering wound areas such as elbows or heels.

The MediPlus-ComfortFoam™ AG Dressings is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film coated with acrylic adhesive and extends to act as a border adhesive film to allow application without need for secondary dressing or fixation bandage. The silver net layer acts as an antimicrobial barrier. MediPlus-ComfortFoam AG is useful for body sites where applying a secondary dressing or fixation bandage is not practicable or not desired by the user.

MediPlus-Foam AG, MediPlus-ComfortFoamAG, andMediPlus-SuperEoam AG Dressingsare used as an antimicrobial barrier for partial and full-thickness wounds such as builts, donor sites and graft recipient sites that are judged to be at risk from infection. The product features include: managing moisture level in the wound environment, controlled silver release, and the product mesh facilitates the passage of fluids/exudates through the dressing into the PU foam for adsorption. The dressings can remain on the wound for five to seven (5-7) days dependent on the amount of wound exudates.

The provided text describes a 510(k) premarket notification for "MediPlus-Foam™ AG Dressings," a type of silver-containing wound dressing. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria for AI or diagnostic purposes.

Therefore, the provided text does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria, especially in the context of AI/diagnostic device performance. The document is for a traditional medical device (wound dressing) and its approval is based on equivalence to existing products, supported by biocompatibility and antimicrobial effectiveness testing, not a comparative effectiveness study involving human readers or standalone AI performance.

To directly address your numbered points based only on the provided text, the answer is that this information is Not Applicable or Not Provided for an AI/diagnostic device.

However, I can extract information relevant to the type of device and the regulatory process described:

Device Type: Medical Device (Wound Dressing), specifically Silver Containing Wound Dressing. Product Code: FRO.

Regulatory Pathway: Traditional 510(k), seeking to demonstrate Substantial Equivalence to a predicate device (Smith & Nephew Inc., Allevyn Ag Dressings, 510(k) # K063835).

Here's a breakdown of why each of your requested points cannot be answered from the provided text in the context of AI/diagnostic device performance:

1. A table of acceptance criteria and the reported device performance: Not Applicable/Provided. This document does not establish performance criteria in terms of sensitivity, specificity, accuracy, or similar metrics for an AI or diagnostic device. Performance is framed as demonstrating comparable attributes (technology, materials, intended use) and passing standard tests for biocompatibility and antimicrobial effectiveness for a physical wound dressing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Applicable/Provided. The document refers to "testing requirements of the recognized biocompatibility standard" and "antimicrobial effectiveness" but does not detail the specific sample sizes, data provenance, or study design typical for an AI performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable/Provided. Ground truth establishment by experts is not relevant for the type of testing (biocompatibility, antimicrobial effectiveness) described for this physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable/Provided. Adjudication methods are not relevant for the testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not Applicable/Provided. This is a physical wound dressing; it does not involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Applicable/Provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not Applicable/Provided. Ground truth as defined for AI/diagnostic studies is not relevant. The "truth" for this device relates to meeting established safety and performance standards for wound dressings (e.g., non-toxic, effectively manages exudate, releases silver as intended).
8. The sample size for the training set: Not Applicable/Provided. There is no AI training set for this device.
9. How the ground truth for the training set was established: Not Applicable/Provided. There is no AI training set for this device.

Ask a specific question about this device