(140 days)
The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDerm™ Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
The device is intended for one-time use.
FortaDerm™ Antimicrobial PHMB Wound Dressing consists of two layers, crosslinked sheet of fenestrated sheet of porcine intestinal collagen coated with 0.1 % Polyhexamethylene Biguanide hydrochloride (PHMB). FortaDerm Wound Dressing is supplied dry in sheet form in sizes ranging from 4 x 4 cm to 12 x 36 cm. The device is packaged in sterile, sealed single pouches.
This 510(k) summary (K051647) describes the FortaDerm™ Antimicrobial PHMB Wound Dressing. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, much of the requested information regarding a formal study with detailed acceptance criteria, sample sizes, expert involvement, and statistical analysis is not provided in this document.
However, based on the available text, here's what can be extracted:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Passed the requirements |
| Performance | Passed the requirements |
| Specific quantitative criteria (e.g., microbial reduction percentage, barrier effectiveness) | Not specified in this document. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely from in-vitro and/or in-vivo laboratory tests given the nature of the device and testing categories (biocompatibility, performance). It is not stated if this was retrospective or prospective data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The testing described (biocompatibility, performance) implies laboratory assessments against predetermined standards or methods rather than expert consensus on a 'ground truth' in a clinical diagnostic sense.
- Qualifications of Experts: Not applicable/not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This type of adjudication is typically used in clinical studies involving interpretation of data by multiple readers, which is not described here.
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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:
- MRMC Study: No. This device is a wound dressing, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical wound dressing, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For "biocompatibility" and "performance" tests, the "ground truth" would be the predefined pass/fail criteria or standards for those specific tests (e.g., ISO standards for biocompatibility, or specific laboratory protocols for antimicrobial efficacy or barrier properties). The document does not detail these specific standards.
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The sample size for the training set:
- Sample Size: Not applicable. This is not a machine learning device that requires a training set. The "testing" likely refers to validation against established physical and biological performance characteristics.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
Summary based on the provided text:
The 510(k) submission for the FortaDerm™ Antimicrobial PHMB Wound Dressing primarily relies on demonstrating substantial equivalence to existing predicate devices (FortaDerm™ Wound Dressing K011026 and Xcell Antimicrobial Cellulose Wound Dressing K024054) in terms of intended use, technological characteristics, materials, and physical construction.
The only "performance data" mentioned is that the device underwent "a number of tests to assess biocompatibility and performance" and "passed the requirements of all tests." However, specific acceptance criteria for these tests, the methodology, sample sizes, or detailed results are not provided in this summary. This is typical for a 510(k) where detailed study reports are usually referenced but not fully included in the public-facing summary. The evaluation focuses on meeting general safety and performance standards for wound dressings, rather than specific quantitative metrics against a defined "ground truth" involving expert interpretation (as would be the case for a diagnostic AI).
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