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Rx Indications for Use: For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc. OTC Indications for Use: For over-the-counter use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.

Procellera Composite Antibacterial Wound Dressing is a three-layer dressing comprising a broadspectrum antibacterial contact layer (Procellera), a polyester-based absorbent layer, and a polyurethane semi-occlusive outer adhesive layer to keep the dressing in place and help maintain a moist wound environment. The dressing is offered in various shapes and elbow/shoulder dressings are prescription use only, while the square, rectangular and round shaped dressings are for both prescription and over-the-counter use. Embedded in the dressing are microcell batteries made of elemental zinc applied in a dot-matrix pattern to a polyester substrate. In the presence of a conductive medium such as wound exudate, water-based wound hydrogels, saline, or water, microcurrents are generated at the dressing surface due to its inherent design. Silver and zinc in the dressing help to preserve it and minimize or prevent the growth of bacteria within the dressing. Procellera Composite Antibacterial Wound Dressing may be used with other common wound treatment products such as sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to local clinical protocols.

The provided document is a 510(k) summary for a medical device (Procellera Composite Antibacterial Wound Dressing) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the way a clinical trial or a more extensive performance study might.

Based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and then report corresponding device performance against those targets (e.g., "Device must achieve X% sensitivity; device achieved Y% sensitivity").

Instead, the acceptance for this 510(k) submission is implicitly based on demonstrating that the new device is substantially equivalent to legally marketed predicate devices through a comparison of technological characteristics, intended use, and safety/performance data. The performance is assessed by showing compliance with relevant standards and established methods, implying that meeting these standards is the "acceptance criteria" for the device's characteristics.

Here's an interpretation of the implied acceptance criteria and reported performance:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size for a test set" in the context of clinical data. The studies conducted are primarily benchtop and in-vitro (biocompatibility, antibacterial effectiveness) rather than human clinical trials.

• Biocompatibility testing: This typically involves a range of in-vitro and in-vivo tests using animal models or cell cultures, adhering to ISO 10993 standards. Specific sample sizes for these tests are not provided but are assumed to follow standard regulatory guidelines for such testing.
• Antibacterial effectiveness testing (AATCC TM 100): This is an in-vitro laboratory test. The number of samples tested is not specified but would follow the methodology of the standard.

There is no mention of human subject data, and therefore no information on data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to the studies described. The ground truth for biocompatibility and antibacterial effectiveness is established by the standardized methods and accepted scientific principles of those tests, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This is not applicable. There is no mention of a human-read test set requiring adjudication in this 510(k) summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical characteristics and compliance with benchtop/in-vitro standards, not on human reader performance with or without AI assistance. This device is a wound dressing, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not a software/AI device, so this concept is not applicable.

7. The type of ground truth used

For the safety and performance data presented:

• Biocompatibility: Ground truth is established by adherence to ISO 10993 series standards and FDA guidance, meaning the biological response observed (e.g., lack of cytotoxicity, irritation) is the "ground truth" relative to the standard's criteria.
• Antibacterial effectiveness: Ground truth is established by the quantifiable reduction in bacterial growth as measured by the AATCC TM 100 method.

There is no clinical "ground truth" (pathology, expert consensus, outcomes data) derived from human subjects for this submission.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing, not an algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this device.

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For professional use. Procellera® antimicrobial wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.

For over-the-counter use, Procellera® antimicrobial wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, blisters, etc.

Procellera® is a single layer, broad-spectrum antimicrobial wound dressing: it consists of a polyester substrate containing elemental silver and elemental zinc bound to the surface by a biocompatible binder in a well-characterized dot matrix pattern.

In the presence of a conductive fluid, such as wound exudate or moisture, a small amount of current is produced at the surface of the device, due to its inherent design. The device is self-contained and has no accessories.

Procellera® contains Silver and Zinc as preservatives to the dressing, to minimize or prevent the growth of microorganisms within the dressing, not at the wound site, and to help preserve the dressing.

Procellera® is a primary contact layer dressing and it should be used under a secondary dressing or bandage, which keeps it in place and helps maintain a moist wound environment. Procellera® may be used with other common wound treatment products such as, sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to the local clinical protocols.

This document is a 510(k) premarket notification for the Procellera Antimicrobial Wound Dressing, primarily focusing on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs for performance, number of experts for ground truth, and training set details are not explicitly present in the provided text.

Based on the information provided, here's an attempt to answer your questions:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) typically seen for diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied by the demonstration of:

• Substantial Equivalence: The primary objective is to show the device is as safe and effective as legally marketed predicate devices.
• Biocompatibility: Meeting ISO 10993 standards.
• Antimicrobial Efficacy (in-vitro within the dressing): Previously cleared for prescription use.
• Voltage Potential: Generation of sustained, measurable voltage.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers to "in-vitro antimicrobial efficacy testing" and "voltage potential testing." These are laboratory/benchtop tests, not clinical studies involving human patient samples. Therefore, the concept of "sample size for a test set" in the context of human data is not applicable here. The "data provenance" would be laboratory data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The evaluations are based on laboratory testing (in-vitro efficacy, biocompatibility, voltage potential), not expert interpretation of clinical data where a ground truth would be established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies with expert reviewers, which is not the type of study described here.

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

No MRMC study was done, as this device is a wound dressing, not an AI-assisted diagnostic tool or an imaging device that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation in this context is based on:

• Laboratory measurements/standards: For biocompatibility (ISO 10993), in-vitro antimicrobial efficacy (presumably against standard microbial cultures), and electrical properties (voltage measurement).
• Predicate devices: The "ground truth" for substantial equivalence is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning model. The studies described are performance tests of the physical device.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device submission.

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