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The Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds, while Lycfoam®"C" would be used to treat lightly to moderately exuding wounds.

Lyofoam® Extra "C" Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with activated carbon for odor absorption.

This document describes a medical device, Lyofoam® Extra "C" Odor Absorbing Wound Dressing, and its comparison to predicate devices for 510(K) clearance. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the way a modern AI/ML medical device submission would.

Based on the provided text, here's an analysis of what is available and what is missing based on your specific questions:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the Lyofoam® Extra "C" device itself. The acceptance criteria for this type of device (a wound dressing) are implicitly related to its safety and equivalency to previously cleared predicate devices.
• Reported Device Performance:
  • "The inner absorbent layer of Lyofoam® Extra "C" Odor Absorbing Wound Dressing holds more excess wound fluid than Lyofoam® "C"." (Quantitative metric or reported value not provided, only a comparative statement).
  • "This would allow the Lyofoam® Extra "C" to be left on the wound without changing for a longer period of time." (A claim of improved performance based on the above, but no specific data or studies are presented in this excerpt to support this claim directly for Lyofoam® Extra "C". It refers to data in K952565 for the Lyofoam® Extra segment).
  • "Lyofoam® Extra "C" Odor Absorbing dressing is intended for the treatment of moderately to heavily exuding wounds, while Lyofoam® "C" would be used to treat lightly to moderately exuding wounds." (This is an intended use distinction, not a direct performance metric).
  • Safety data is referenced as being in files K952565 and K864084, and "indicates product is safe for use." (No specific safety metrics are provided here).

Summary Table (Best Effort given limited information):

Regarding AI/ML Medical Device Specific Questions (2-9):

The provided text describes a traditional wound dressing device, not an AI/ML medical device. Therefore, the following AI/ML-specific questions are not applicable to this document and the information is not present.

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

• Not Applicable. This is not an AI/ML device, and no test set in this context is discussed.

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)

• Not Applicable. This is not an AI/ML device. Ground truth establishment as described would not be relevant for a wound dressing's 510(K) summary.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device. For a wound dressing, "ground truth" would relate to laboratory testing (e.g., absorbency, bacterial barrier, cytotoxicity) and clinical observations/outcomes if actual clinical trials were performed (which are typically not extensive for 510(k) devices compared to PMAs). The text refers to "Safety test data" and "Performance date" in predicate device files.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so no training set exists.

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

• Not Applicable. This is not an AI/ML device.

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The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds.

Lyofoam® Extra "A", Extra Absorbent, Non-Adherent Polyurethane Foam Dressing with adhesive boarder.

This 510(k) summary does not contain the level of detail necessary to answer all sections of your request. It describes a wound dressing (Lyofoam® Extra "A" Sterile Adhesive Wound Dressing) and claims equivalence to predicate devices (Modified Lyofoam® Wound Dressing and Lyofoam® Extra Absorbent Wound Dressing), rather than presenting a study with specific acceptance criteria and performance metrics typically associated with AI/medical device software.

Here's what can be extracted and what cannot:

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

This document does not define specific quantitative "acceptance criteria" or provide "reported device performance" in the way one would for a software algorithm (e.g., sensitivity, specificity, AUC). Instead, it relies on claiming equivalence to existing devices and referring to safety data from previous 510(k) filings.

The "performance data" mentioned refers to the physical properties and functionality of the wound dressing (e.g., absorbency, waterproof barrier, moisture vapor permeability) as established for the predicate devices, rather than a quantifiable performance metric for a specific study.

• Modified Lyofoam® Wound Dressing
• Lyofoam® Extra Absorbent Wound Dressing | Lyofoam® Extra "A" is a combination of Lyofoam® Extra and Modified Lyofoam® ("A"), improving upon them by using Lyofoam® Extra foam dressing for the wound pad and extending the third layer with an adhesive coating. |
  | Absorbency: Ability to hold excess wound fluid. | Inner absorbent layer of Lyofoam® Extra holds more excess wound fluid than Modified Lyofoam®'s regular Lyofoam®. Intended for moderately to heavily exuding wounds. (Modified Lyofoam® for lightly to moderately exuding wounds). |
  | Barrier Properties: Waterproof, moisture vapor permeable. | Provides a waterproof barrier for the wound, which is moisture vapor permeable. |
  | Bacterial Contamination Prevention: Ability to help prevent bacterial contamination. | Helps to prevent bacterial contamination of the wound. |
  | Safety: Device is safe for use. | Safety data is summarized in Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file K895764, indicating product is safe for use. |
  | Sterility: Sterilized to a specified sterility assurance level (SAL). | Sterilized using gamma radiation with a SAL 10-6. |

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

This information is not provided in the 510(k) summary. The document refers to "Performance data for this product can be found in the Lyofoam@ Extra 510(K) File K952565" and safety data in K952565 and K895764. The details of any studies, including sample sizes, would be in those referenced files, not in this summary.

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 as the device is a physical wound dressing, not an AI/software device requiring ground truth established by experts for performance evaluation.

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

Not applicable for this type of device.

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

Not applicable as this is not an AI-assisted diagnostic or interpretation device.

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

Not applicable as this is not an algorithm.

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

For a physical medical device like a wound dressing, "ground truth" would relate to its physical and biological performance characteristics, verified through laboratory testing (e.g., absorbency tests, permeability tests, biocompatibility tests) and potentially clinical trials (though not detailed here). The summary points to existing safety data and performance data in previous 510(k) files, suggesting reliance on established testing methods for wound dressings.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a software algorithm requiring a training set.

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

Not applicable.

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