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For Over-The Counter Use, DuoDERM Hydroactive Gel Wound Dressing may be used for abrasions, lacerations, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a healthcare professional, DuoDERM Hydroactive Gel may be used for the hydration and management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers and skin conditions resulting from radiation dermatitis.

DuoDERM Hydroactive Gel Wound Dressing is substantially equivalent to Carrasyn Hydrogel Wound Dressing. The products are equivalent in intended use and function. Both products provide a moist wound healing environment. DuoDERM Hydroactive Gel Wound Dressing is also capable of absorbing exudate.

The provided text is related to a 510(k) Premarket Notification for a wound dressing and does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the DuoDERM® Hydroactive® Gel Wound Dressing to a predicate device (Carrasyn® Hydrogel Wound Dressing) for regulatory approval. This is a common pathway for medical devices where a new device is compared to an already legally marketed device, demonstrating that it is as safe and effective.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe performance metrics, statistical analysis, sample sizes for test or training sets, expert qualifications, or details of a study designed to prove specific acceptance criteria.

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DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue.

The concept of DuoDERM Hydroactive Gel is not significantly different from other commercially available dressings intended for use in the management of wounds. DuoDERM Hydroactive Gel is indicated for use on partial and full thickness wounds such as pressure ulcers and diabetic ulcers. The gel is used for the management of wounds requiring hydration.

The provided document is a 510(k) Premarket Notification for DuoDERM® Hydroactive® Gel from 1997. This type of submission is for medical devices, specifically wound dressings, and does not involve AI or algorithms that would have acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the requested information regarding acceptance criteria for a device's performance, sample sizes for test and training sets, expert consensus, MRMC studies, or standalone algorithm performance, is not applicable to this document.

However, I can extract information relevant to the substantial equivalence claim and indications for use.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is not applicable:

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

• Not Applicable in the traditional sense of AI/algorithm performance. The acceptance criteria for this type of device are primarily related to safety, equivalence to a predicate device, and the validity of stated indications for use. Performance is typically assessed through demonstrating substantial equivalence to a legally marketed predicate device (SignaDRESS Hydrocolloid Dressing) based on intended use and function, as well as safety data.
• Implied Acceptance Criteria for Claims: The FDA's limitations on labeling indicate the types of claims that were not accepted without further premarket notification:
  • Not labeled for use on third-degree burns.
  • Not labeled as having any accelerating effect on the rate of wound healing or epithelization.
  • Not labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
  • Not labeled as a treatment or a cure for any type of wound.

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 a medical device (wound dressing) submission. The concept of "test sets" in the context of an algorithm's performance data does not apply here. The submission refers to "Data/information supporting the safety of DuoDERM Hydroactive Gel was presented in Premarket Notification K931618." This implies previous testing for safety, but specific sample sizes or study designs are not detailed in this document.

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. Ground truth in the context of expert consensus for algorithm evaluation is not relevant to this device submission.

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

• Not Applicable. Adjudication methods are for resolving discrepancies in expert labeling or model outputs, not for wound dressings.

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. There is no AI or software involved with "human readers" in this submission.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable in the context of algorithm performance. The "ground truth" for this device relates to its safety and effectiveness for its intended use, which would have been established through preclinical testing and potentially clinical data (though not detailed here beyond referring to a previous submission, K931618). For a wound dressing, this would typically involve biocompatibility testing, sterility, and possibly wound healing assessments in animal or human studies to support claims.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical device like a wound dressing.

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

• Not Applicable.

Summary of Relevant Information from the Document:

• Device Name: DuoDERM® Hydroactive® Gel
• Predicate Device: SignaDRESS Hydrocolloid Dressing
• Statement of Equivalence: DuoDERM Hydroactive Gel is substantially equivalent to SignaDRESS Hydrocolloid Dressing in intended use and function.
• Intended Use/Indications for Use: Hydration and management of partial and full-thickness wounds such as pressure sores, leg ulcers, and diabetic ulcers. Provides a moist wound environment supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing.
• Contraindications: Individuals with a known sensitivity to the gel or its components.
• Safety Data Reference: Data/information supporting the safety was presented in Premarket Notification K931618. All testing was performed in accordance with Good Laboratory Practice Regulations.
• FDA Limitations/Non-Accepted Claims:
  • Not for use on third-degree burns.
  • No accelerating effect on the rate of wound healing or epithelization.
  • Not a long-term, permanent, or no-change dressing, or artificial skin.
  • Not a treatment or cure for any type of wound.

The provided text describes a traditional medical device premarket notification, not a submission for an AI or software algorithm. Therefore, the specific criteria and study details requested in the prompt related to AI performance metrics are not present and do not apply.

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