(517 days)
Stimulen™ Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including:
- ·full and partial thickness wounds
- ·pressure ulcers (stages I-IV)
- •venous stasis ulcers
- ·diabetic ulcers
- ·partial thickness burns
- ·acute wounds
- ·abrasions
- •traumatic wounds healing by secondary intention
- •donor sites and other surface wounds
Stimulen™ Collagen is a sterile primary single use dressing comprised of soluble modified bovine collagen base. The Stimulen™ collagen is soluble in the wound fluid and supplied as a powder or gel or sheet.
The provided text describes a 510(k) summary for the Stimulen™ Collagen wound dressing, which establishes substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or a study showing the device meets acceptance criteria in the format requested.
Here's why and what information is missing:
- Acceptance Criteria & Reported Performance: The document lists "Indications For Use" and compares the Stimulen™ Collagen to predicate devices based on characteristics like material, collagen source, biodegradability, biocompatibility, and sterility. However, it does not provide specific quantitative acceptance criteria (e.g., "device must achieve 90% wound closure by 4 weeks") or reported performance metrics against such criteria. The "Safety" section mentions biocompatibility tests (Primary Skin Irritation Test, Acute Systemic Injection Test, Intracutaneous Test) demonstrated Stimulen collagen to be "non-toxic and non-irritating," but these are general safety findings, not performance metrics against acceptance criteria for efficacy.
- Study Details: There is no description of a study designed to prove the device meets acceptance criteria. The 510(k) process for this device relies on demonstrating "substantial equivalence" to legally marketed predicate devices, not on presenting novel clinical study data for efficacy against predefined acceptance criteria.
Therefore, I cannot populate the requested table or provide the detailed study information regarding sample size, data provenance, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.
The closest I can come to fulfilling your request, based solely on the provided text, is to list the claims made about the device and its characteristics as compared to predicate devices, but these are not "acceptance criteria" for a clinical performance study.
Summary of what cannot be provided from the text:
- Table of Acceptance Criteria and Reported Device Performance: Not present. The document focuses on demonstrating equivalence in design, function, material, and intended use, not clinical performance metrics.
- Sample size used for the test set and the data provenance: No performance study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study is detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a wound dressing, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a 510(k) summary focused on regulatory clearance through substantial equivalence, which typically does not involve the detailed clinical efficacy studies and performance criteria evaluation you are asking about for a novel device.
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