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For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.
For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design. In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.

The provided 510(k) summaries for Procellera™ (both professional and over-the-counter use) do not describe specific acceptance criteria in terms of quantitative performance metrics, nor do they detail a study designed to prove the device meets such criteria.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (CMB Antimicrobial Dressing - K060237) based on technological characteristics and general performance data relevant to safety and biocompatibility.

Here's an analysis based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Data Categories:
Antimicrobial testing
Animal testing
Bench testing
Biocompatibility testing (cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, 28-day subcutaneous implantation) |

Detailed Breakdown of Study Information (Based on Available Text):

The provided text describes the type of performance data gathered, but does not detail the specifics of studies that would allow for the reconstruction of a typical acceptance criteria table and performance comparison as requested for a diagnostic or AI device.

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

   • Not specified. The document mentions "antimicrobial, animal, bench and biocompatibility testing" but does not provide sample sizes, study designs (prospective/retrospective), or data provenance for these tests.

2. 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):

   • Not applicable. The tests described are laboratory and animal-based performance tests (e.g., biocompatibility, antimicrobial activity), not studies requiring expert interpretation of diagnostic data to establish ground truth in the way a clinical study for a diagnostic algorithm would.

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

   • Not applicable. This concept typically applies to clinical studies involving human observers and their interpretations, not to the types of performance tests described (e.g., in vitro antimicrobial assays, biocompatibility tests).

4. 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. This device is a wound dressing, not a diagnostic algorithm or an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant to its clearance.

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

   • Not applicable. As stated above, this is a wound dressing, not an algorithm.

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

   • The "ground truth" for the performance data mentioned would be established by the standard scientific and regulatory protocols for the specific tests performed:
     • Antimicrobial testing: Likely based on standardized microbiological assays (e.g., bacterial reduction, zone of inhibition) with objective measurements.
     • Animal testing: Likely based on objective physiological responses and observations in animal models.
     • Bench testing: Objective measurements against predefined physical or chemical properties.
     • Biocompatibility testing: Compliance with ISO 10993 standards, using objective measurements of cellular response, systemic effects, and local tissue reactions. The "ground truth" here is the adherence to these accepted standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI/ML algorithm is involved.

Summary of Device Acceptance:

The acceptance of Procellera™ for marketing was based on demonstrating substantial equivalence to a predicate device (CMB Antimicrobial Dressing, K060237) under the 510(k) pathway. This means the FDA concluded that Procellera™ is as safe and effective as the predicate device. The evidence provided for this conclusion consisted of:

• Identical Technological Characteristics: The Procellera™ is explicitly stated to be "the same device as the predicate CMB™."
• Performance Data: General categories of testing were conducted (antimicrobial, animal, bench, and various biocompatibility tests following established guidelines). These tests are aimed at supporting the safety and effectiveness claim by demonstrating the device performs as expected for a wound dressing and does not pose undue risks.

The 510(k) summaries do not present quantitative acceptance criteria or detailed results from specific studies in a format typically seen for devices that require complex performance metrics (e.g., sensitivity, specificity for diagnostic devices). Instead, the regulatory pathway relies on the direct comparison to an already cleared device and general safety assessments.

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The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.

The CMB Antimicrobial dressing is a single layer dressing consisting of a woven adsorbent polyester containing elemental silver and zinc. In the presence of exudate, the dressing can be used with an appropriate secondary barrier to help maintain a moist wound healing environment.

The provided text describes the CMB Antimicrobial Dressing, a device primarily for wound care. There is very limited information about specific acceptance criteria or details of a study that proves the device meets particular criteria. The document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a novel device.

However, based on the limited 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 explicitly state numerical acceptance criteria with corresponding performance results. It only mentions types of tests performed.

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 does not specify sample sizes for any of the in vitro or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 is not applicable to the information provided. The studies mentioned (antimicrobial performance, biocompatibility) are laboratory tests, not clinical studies requiring expert interpretation of results to establish a "ground truth" in the way it's described for image analysis or diagnoses.

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

Not applicable. Laboratory tests typically involve established protocols and readouts, not adjudications of subjective interpretations.

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 such study was mentioned. The device is a wound dressing, not an AI-powered diagnostic tool that human readers would use.

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

This question is not applicable as the device is a physical wound dressing, not an algorithm. The "antimicrobial performance" was tested in vitro, which can be considered a standalone test for the device's inherent property.

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

For the in vitro antimicrobial performance, the ground truth would be established by standard microbiological methods, such as colony counts or zone of inhibition measurements, which quantify bacterial reduction or inhibition. For biocompatibility tests, the ground truth is established by standard toxicology and biological evaluation methods (e.g., cell viability assays for cytotoxicity, skin reaction scores for irritation/sensitization). These are objective measurements against established scientific standards, not expert consensus or pathology in the clinical sense.

8. The sample size for the training set

Not applicable. The CMB Antimicrobial Dressing is a physical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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