(45 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Equivalence to Predicate Devices: - 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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Acme United Corporation
510(K) SUMMARY
MAY 3 | 1996
Page 12
941452
| Submitter's Name: | Acme United Corporation75 Kings Highway CutoffFairfield, CT 06430 |
|---|---|
| Contact Person: | Thomas E. Flynn, Director of RegulatoryAffairs and Quality Assurance |
| Telephone Number: | 203-332-7330 |
| Fax Number: | 203-576-0007 |
| Date of Submission: |
"This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92." . . . .
The assigned 510(K) number is:
| Proprietary Name of Device: | Lyofoam® Extra "A" Sterile AdhesiveWound Dressing |
|---|---|
| Common/Usual Name: | Extra absorbent, polyurethane foamisland dressing. |
| Classification Name: | Dressing, Class I |
| Product ClaimingEquivalence To: | Modified Lyofoam® Wound Dressing andLyofoam® Extra Absorbent WoundDressing |
| Description of Device: | Lyofoam® Extra "A", Extra Absorbent,Non-Adherent Polyurethane FoamDressing with adhesive boarder. |
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Image /page/1/Picture/0 description: The image shows the logo for Acme United Corporation. The logo consists of a black circle with a white design inside, resembling a pair of scissors or shears. To the right of the logo is the text "Acme United Corporation" in a simple, sans-serif font. The text is aligned horizontally with the logo.
Paqe 13 K961452 Page 2 of 3
Intended Use, Comparison To Predicate Device:
The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is a combination of the Lyofoam® Extra product and the Modified Lyofoam® Dressing Product (Lyofoam® "A"). The main difference between them is . that Lyofoam® Extra Foam Dressing is used in place of the regular Lyofoam® for the wound dressing pad segment of this product. The third layer of thin foam is extended beyond the wound pad and has a adhesive coating which is used to hold the product in place over the wound.
The inner absorbent layer of Lyofoam® Extra Wound Dressing Pad holds more excess wound fluid than the Modified Lyofoam® Wound Dressing Pad which is made from regular Lyofoam®. The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding wounds while the Modified Lyofoam® Wound Dressing would be used to treat lightly to moderately exuding, wounds. Lyofoam® Extra "A" provides a waterproof barrier for the wound which is moisture vapor permeable and helps to prevent bacterial contaminiation of the wound.
Medical Products Division • 75 Kings Highway Cutoff, Fairlield, Connecticut 06430 • Phone (203) 332-7330
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Image /page/2/Picture/0 description: The image shows the logo for Acme United Corporation. The logo consists of a black circle with a white stylized image of scissors inside. To the right of the logo is the text "Acme United Corporation" in a simple, sans-serif font.
Safety:
Page 14
Page 3 of 3
Performance data for this product can be found in the Lyofoam@ Extra 510(K) File K952565.
Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K895764. All safety data is summarized in those files and indicates product is safe for use.
Sterility and Packaging:
Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is packaged in a paper/foil peel pouch and is sterilized using gamma radiation and has a SAL 10-6.
§ 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.