(182 days)
The Ultec Pro Ag+ Hydrocolloid Dressings are indicated for use on venous stasis ulcers, pressure ulcers, arterial ulcers, diabetic ulcers, donor sites, lacerations, post surgical incisions, and other dry to lightly exudating symptoms.
The proposed Kendall ULTEC PRO Ag+ Hydrocolloid Dressing is a sterile, single use, highly flexible wound dressing designed for use on dry to lightly exudating wounds. ULTEC PRO Ag+ Hydrocolloid Dressing was designed to create and maintain a moist wound environment that is optimal for wound healing. The alginate formulation of ULTEC PRO Ag+ releases anti-microbial silver and absorbs wound exudates. The release of anti-microbial silver enhances the barrier properties of the hydrocolloid by reducing bacterial growth on the dressing. The proposed wound dressing consists of 65 % acrylic hot melt pressure sensitive adhesive, 25 % sodium alginate, and 10 % inorganic polymer containing silver.
The provided text is a 510(k) summary for the Kendall ULTEC PRO Ag+ Hydrocolloid Dressing. It describes the device, its intended use, and a comparison to legally marketed predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about device performance metrics, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies.
The "Nonclinical Testing" section mentions: "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." This indicates that biocompatibility was evaluated against a standard, but it doesn't provide specific performance numbers, acceptance criteria, or a detailed study description as requested in your prompt.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.
Here's what I can extract and state based on the given information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1 and FDA modified matrix (G95-1) | Demonstrated to meet the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. |
| Other performance criteria (e.g., wound healing efficacy, antimicrobial effectiveness, exudate absorption rates, wear time, etc.) | Not provided in the document. |
2. Sample size used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. The information relates to a medical device's regulatory submission, not an AI or diagnostic study requiring expert ground truth for image analysis.
4. Adjudication method for the test set: Not applicable/provided.
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 document describes a hydrocolloid wound dressing, not an AI-assisted diagnostic tool or system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For biocompatibility, the ground truth is adherence to the specified ISO standard and FDA guidance. For other performance aspects (e.g., wound healing), no specific ground truth or study details are provided.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device; there is no mention of a "training set."
9. How the ground truth for the training set was established: Not applicable.
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