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Rx

Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.

OTC

Management of minor wounds including minor cuts, abrasions, lacerations and burns.

The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.

The provided document describes the KeriCure Inc.'s Field Shield Wound Dressing, an unclassified device. The information focuses on demonstrating its substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the Field Shield Wound Dressing. Instead, the document focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices, particularly through various types of testing. The reported device performance is outlined in the "Summary of Performance Testing" table.

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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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