(297 days)
Prescription Use:
"Polyver Silver Alginate Dressing" is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC Use:
First aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns
"Polyver Silver Alginate Dressing (Prescription and OTC)" is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which releases silver ions within the dressing and absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment.
The dressing may be used for periods up to 7 days, and can be removed intact during dressing changes
The alginate material consists of silver that controls bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis.
Based on in vitro testing, the silver effectively reduces bacterial growth within the dressing for up to seven days. Use of this device should be discontinued completely after 7 days.
No clinical benefit has been demonstrated regarding the effectiveness of silver in the subject dressing.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
The provided text is a 510(k) summary for a medical device called "Polyver Silver Alginate Dressing." It details the device's description, indications for use, and comparison to predicate devices to establish substantial equivalence.
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a silver alginate wound dressing, which is a physical medical device, not a software-based or AI/ML product.
Therefore, I cannot extract the requested information regarding:
- Table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size and data provenance for an AI/ML test set.
- Number of experts and qualifications for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study for AI/ML.
- Standalone (algorithm only) performance for AI/ML.
- Type of ground truth used for AI/ML (expert consensus, pathology, etc.).
- Training set sample size for AI/ML.
- How ground truth for the training set was established for AI/ML.
The document does mention:
- Performance: "Antibacterial activity was measured following AATCC 100-2004 for total of six clinical relevant bacteria to evaluate antibacterial preservative effectiveness. 'Polyver Silver Alginate Dressing (Prescription and OTC)' is effective (>99.99% reduction) for seven days for all six bacteria..." This is a performance claim for the physical dressing's antibacterial properties, not for an AI/ML algorithm.
- Testing Method: Antibacterial activity was measured following AATCC 100-2004, and Biocompatibility was evaluated per ISO 10993-1: 2009. These are standard tests for material properties and an antibacterial agent, not AI/ML validation.
In summary, the provided text is relevant to a traditional medical device's 510(k) submission, not an AI/ML device.
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