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Prescription use indications (Rx-only):

• · Partial and full thickness wounds,
• · Pressure ulcers (stage I-IV),
• · Diabetic ulcers,
• · Venous stasis ulcers,
• · Arterial ulcers.
• · 1st and partial thickness burns,
• · Surgical wounds,
• · Vascular access or peripheral IV sites,
• · Orthopedic external pin sites, and
• · Acute wounds such as lacerations, abrasions, and skin tears.

Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).

"Copper Foam Dressing (Prescription and OTC)" is a sterile, single-use dressing composed of polyurethane and copper oxide particles, which absorbs wound exudate and releases copper ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

Based on in vitro laboratory testing, the copper has been shown to inhibit bacterial growth within the dressing for up to 7 days.

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.

This is a medical device submission, specifically a 510(k) summary for a Copper Foam Dressing. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel AI/software device. As such, the information typically found in an AI/software device submission regarding acceptance criteria, study design, and performance metrics for an algorithm is not present in this document.

The provided text describes a traditional medical device (Copper Foam Dressing) and its physical and chemical properties, indications for use, and a comparison to a predicate device. It evaluates attributes such as material, design, antibacterial agents, and sterilization.

Therefore, I cannot provide the requested information, which is specific to AI/software device studies. The document does not contain:

1. A table of acceptance criteria and reported device performance for an AI/software.
2. Sample size used for a test set or data provenance for an algorithm.
3. Number and qualifications of experts for establishing ground truth for an AI/software.
4. Adjudication method for a test set for an AI/software.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance data.
7. Type of ground truth used for an AI/software (expert consensus, pathology, outcomes data).
8. Sample size for a training set for an AI/software.
9. How ground truth for a training set was established for an AI/software.

The closest information related to "acceptance criteria" for this device exists in the "Antibacterial Effectiveness" and "Absorbency" rows in Table 5.1 (Comparison of Intended Use, Design, and Material) and the "Antibacterial activity was measured following AATCC 100-2004" statement, but these are for the physical dressing, not an AI/software component.

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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:

1. Table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size and data provenance for an AI/ML test set.
3. Number of experts and qualifications for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study for AI/ML.
6. Standalone (algorithm only) performance for AI/ML.
7. Type of ground truth used for AI/ML (expert consensus, pathology, etc.).
8. Training set sample size for AI/ML.
9. 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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Roosin Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.

Roosin Xeroform Petrolatum Dressing is a type of wound dressing and has ingredients of finely woven mesh gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate. It is a sterile, single use dressing. This is a combination product. Roosin Xeroform Petrolatum Dressing is used as a primary contact layer in dressing for wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. The dressing has a yellow appearance and is available in the form of pad and in four different sizes (2" x 2", 1" x 8", 4" x 4", 5" x 9"), packaged in pouches. All dressings are sterilized by gamma radiation using conditions validated following ISO 11137-2: 2013.

The provided document describes a 510(k) premarket notification for a medical device called "Roosin Xeroform Petrolatum Dressing." This document does not contain information about acceptance criteria or a study proving that a device meets such criteria, especially not in the context of an AI/algorithm-based medical device.

The document details the device's intended use, materials, manufacturing, and a comparison to a predicate device (K152970: "Dynarex Xeroform Petrolatum Dressing") to establish substantial equivalence. The "performance tests" mentioned are likely related to general medical device standards (e.g., sterilization, biocompatibility, material properties) rather than specific clinical performance metrics that would involve complex data analysis, ground truth establishment, or human reader studies typically associated with AI/ML-driven devices.

Therefore, I cannot provide the requested information for the following reasons:

• No AI/Algorithm Component: The device described is a wound dressing, which is a physical product, not an AI or algorithm.
• No Performance Study as Described: The document mentions "Performance tests were conducted following in house procedures, and results for Roosin Xeroform Petrolatum Dressing met all relevant requirements, and are comparable to the predicate devices." However, these are general performance tests, not a clinical study involving a test set, ground truth, experts, or MRMC studies as outlined in your request.
• No Acceptance Criteria for AI Performance: Since it's not an AI device, there are no acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC, human reader improvement, etc.).

In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and a study proving an AI/algorithm device meets those criteria.

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