(36 days)
CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:
- Pressure ulcers
- Venous ulcers
- Vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, skin tears)
- First and second degree burns
- Surgical wounds
CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises insoluble fibrous collagen derived from porcine with white to off-white appearance, which forms a layer of thin film by maintaining a moist environment at the wound site.
This document is a 510(k) summary for the CollaWound™ dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial for a novel AI/software device would.
Based on the provided text, the device is a medical dressing and not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable to this submission.
Here's a breakdown of the available information relevant to your request, adapting the structure to fit the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The 510(k) summary for a wound dressing primarily focuses on demonstrating safety and substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and performance metrics in the same way an AI/software device would. The "acceptance criteria" here are implicitly the requirements for biocompatibility and substantial equivalence to existing devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Meet biocompatibility requirements. | Biocompatibility tests have confirmed that CollaWound™ dressing meets the requirements stated in ISO 10993/G95-1. |
| Substantial Equivalence: Similar material, function, technological characteristics, and intended use to predicate collagen-based devices. | CollaWound™ dressing is substantially equivalent in material, function, technological characteristics and intended use to predicate collagen-based devices that are previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (K011026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device (wound dressing) submission, not an AI/software device with a "test set" in the computational sense. The "testing" referred to is biocompatibility testing and characterization studies, not performance evaluation on a dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth establishment with experts is a concept relevant to AI/software performance evaluation. For this device, regulatory experts at the FDA review the submission for compliance and equivalence.
4. Adjudication Method for the Test Set
Not applicable. Adjudication is relevant for AI/software performance evaluation.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is not an AI/software device. Comparative effectiveness for a wound dressing would typically involve clinical trials comparing wound healing outcomes, which are not detailed in this 510(k) summary (a 510(k) focuses on substantial equivalence, not necessarily extensive clinical efficacy trials).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
Not applicable in the context of AI/software. The "ground truth" for this submission is regulatory compliance (e.g., biocompatibility standards, established equivalence to predicate devices).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device with a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/software device with a "training set."
Summary of what the document does provide regarding the "study" (biocompatibility and characterization):
- Study Type: Product characterization studies and biocompatibility studies.
- Purpose: To demonstrate safety and substantial equivalence to predicate devices.
- Key Findings:
- Biocompatibility tests confirmed compliance with ISO 10993/G95-1.
- The device is substantially equivalent in material, function, technological characteristics, and intended use to several named predicate collagen-based wound dressings.
- Nature of "Acceptance": The FDA's acceptance of the 510(k) submission, based on the demonstrated substantial equivalence to predicate devices and adherence to safety standards.
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