(243 days)
Excellagen is indicated for the management of wounds including 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, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for one-time use.
Excellagen is a wound care device composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal collagen (Type I) that is topically applied directly to the wound surface. Excellagen is packaged as single-use units to ensure safety and provide for easy topical application. The device is tested for sterility in accordance with USP. Excellagen is supplied in one of two kit configurations. One kit configuration consists of four single-use 1.0 cc syringes, each containing 0.5 cc of 2.6% (26 mg/mL) formulated collagen, and four singleuse sterile flexible applicators. This kit can be used for smaller wounds. The second kit configuration consists of one single-use 10.0 cc syringe containing 4.0 cc of 2.6% (26 mg/mL) formulated collagen, and one single-use sterile flexible applicator. This kit can be used for larger or tunneling/undermined wounds. Excellagen is stored at standard refrigeration temperature (2-8°C).
During manufacture, the collagen component of Excellagen is purified using a specialized process that eliminates impurities (including endotoxins), and removes denatured molecules and collagen fragments. Excellagen consists almost exclusively of high molecular weight, intact, fibrillar collagen and is formulated at a concentration of 2.6% (26 mg/mL) in an isotonic buffer with protein stabilizing agents.
The provided 510(k) summary for Excellagen Collagen Wound Dressing describes the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about a clinical study with acceptance criteria, reported device performance, or performance metrics typically associated with AI/software devices.
Instead, this document focuses on demonstrating substantial equivalence based on material composition, intended use, and safety through non-clinical biocompatibility testing.
Here's a breakdown of why many of your requested items cannot be answered from the provided text:
- Acceptance Criteria & Reported Device Performance (Table): This document does not present acceptance criteria or reported performance data in the way you've outlined for a clinical study comparing a device's effectiveness against a threshold. The "performance" discussed relates to material properties and safety.
- Sample Size (Test Set) & Data Provenance: Not applicable as no clinical test set is described. The "sample" referenced is the device material itself for biocompatibility testing.
- Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic task requiring expert ground truth.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not performed or mentioned.
- Standalone Performance: Not performed or mentioned in the context of an algorithm.
- Type of Ground Truth: Not applicable for a clinical performance evaluation. The "ground truth" here is the standard for biocompatibility.
- Sample Size (Training Set): Not applicable, as this is not a machine learning/AI device that requires a training set.
- How Ground Truth for Training Set was Established: Not applicable.
However, I can extract information related to the device's "acceptance" based on the FDA 510(k) process:
The "acceptance" in this context refers to the FDA's determination of Substantial Equivalence (SE) to legally marketed predicate devices. The study proving this "acceptance" is the biocompatibility testing and the comparative analysis of technological characteristics.
Here's the closest I can get to your requested format based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device Performance (Excellagen) |
|---|---|
| Safety: | |
| * Biocompatibility (in vitro) | In vitro (cytotoxicity) testing in accordance with ISO 10993-1: Found to be biocompatible. |
| * Biocompatibility (in vivo) | In vivo (sensitization and intracutaneous reactivity) biocompatibility testing in accordance with ISO 10993-1: Found to be biocompatible. |
| * Sterility | Tested for sterility in accordance with USP: Passed sterility testing. |
| Functional Equivalence: | |
| * Intended Use Match | Intended use: "management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds... trauma wounds... and draining wounds." This matches the indication of the predicate devices for wound management. |
| * Material Composition Match | Material: Composed of 2.6% fibrillar bovine dermal collagen (Type I). This is substantially equivalent to predicate devices which also use Type I bovine collagen (e.g., Integra Flowable, Stimulen, Medifil Gel, HyCure, Collatek, HeliDerm - all listed as Type I collagen, bovine source, although Integra includes x-linked + GAGs and Stimulen is soluble modified collagen, the core material is still bovine Type I collagen). |
| * Application Method Match | Topically applied directly to the wound surface: Consistent with predicate devices. |
| * Physical Form (Fibrillar Gel) | While predicate devices vary in form (hydrated granules, gel, suspension, powder, microfibrils), Excellagen's fibrillar gel form is considered functionally equivalent for wound dressing. |
| * Biodegradability | Yes, stated to be biodegradable, matching predicates. |
Additional Breakdown based on provided document:
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Sample size used for the test set and the data provenance:
- Test Set: For biocompatibility testing, the "sample size" refers to the tested material of Excellagen. Specific quantitative sample sizes (e.g., number of test specimens or animals) are not provided in this summary, but the testing was conducted in vitro (e.g., cytotoxicity assays) and in vivo (e.g., animal models for sensitization and intracutaneous reactivity).
- Data Provenance: The standard cited for biocompatibility testing is ISO 10993-1. The origin of specific test data (e.g., country) is not mentioned, but it would have been generated in a lab setting adhering to these international standards. This testing is prospective for the device's regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for biocompatibility is established by the test standards themselves (ISO 10993-1) and the objective results (e.g., cell viability, observed reactions). There are no experts establishing a "ground truth" in a diagnostic sense.
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Adjudication method for the test set: Not applicable. Biocompatibility testing results are typically objectively measured and interpreted against pre-defined criteria in the standard, not through an adjudication process.
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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: Not applicable. This device is not an AI/software device, nor does it involve human readers interpreting data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- For biocompatibility: Adherence to ISO 10993-1 standards and objective laboratory measurements (e.g., cytotoxicity levels, immune responses).
- For substantial equivalence comparison: Categorical attributes of the device (material, intended use, form, biodegradability, sterility etc.) compared directly to the published characteristics of the predicate devices.
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The sample size for the training set: Not applicable. This is not a machine learning/AI device.
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How the ground truth for the training set was established: Not applicable.
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