(75 days)
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):
| Acceptance Criteria (Implied) | Reported Device Performance and Support |
|---|---|
| Safety: Device is safe for intended use. | Safety test data found in predicate device 510(K) files K952565 and K864084. "All safety data is summarized in those files and indicates product is safe for use." |
| Effectiveness/Equivalency: Equivalent to predicate devices for odor absorption and wound dressing function. | Lyofoam® Extra "C" combines features of Lyofoam® Extra and Lyofoam® "C." Both use the same activated carbon layer for odor absorption. |
| Performance (Absorbency): Improved fluid handling for moderately to heavily exuding wounds. | "Inner absorbent layer...holds more excess wound fluid than Lyofoam® "C"." "Performance date for the Lyofoam® Extra dressing segment of this product an be found in the Lyofoam® Extra 510(K) file K952565." (Direct performance data for Lyofoam® Extra "C" in this document is qualitative/comparative, not quantitative). |
| Sterility: Must be sterile. | Sterilized using gamma radiation with a SAL 10-6. |
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.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.