(450 days)
CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use
CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.
This document describes the 510(k) submission for the CollaFirm Collagen Wound Dressing. As such, it is not a study proving device performance against acceptance criteria in the manner of an AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and shared technological characteristics and intended use.
Here's an breakdown of the information based on the provided text, addressing your questions where applicable to a non-AI/ML device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of medical device (collagen wound dressing), the "acceptance criteria" are typically the standards and tests performed to demonstrate safety, effectiveness, and substantial equivalence to existing predicate devices.
| Acceptance Criterion (Standard Test) | Reported Device Performance (CollaFirm Collagen Wound Dressing) |
|---|---|
| Material/Composition Equivalence | Amino Acid Analysis performed by HPLC compared to Medfil II collagen particles. |
| amino acid composition (18 amino acids each) of CollaFirm collagen and predicate device Medfil II is quite similar on comparison. | |
| Biocompatibility - Cytotoxicity | Agar Overlay (direct contact) Cytotoxicity testing. |
| Indicated a grade 0. (non-cytotoxic) | |
| Biocompatibility - Irritation | ISO Intracutaneous reactivity (Irritation) testing. |
| Indicates a non-irritant. | |
| Biocompatibility - Sensitization | ISO Guinea Pig Maximization Sensitization Test Report. |
| Indicates the product is a non-sensitizer. | |
| Stability | Stability has been demonstrated over a three (3) month period at Room Temperature and accelerated conditions. |
| Was found to maintain the product's attributes and characteristics. | |
| Sterility | USP Sterility testing. |
| Has indicated that the product is sterile. | |
| Pyrogenicity | LAL Chromogenicity testing. |
| Indicates the product is non-pyrogenic. | |
| Technological Characteristics | Device is highly purified porcine collagen which absorbs wound fluid, maintains a moist wound environment. |
| Equivalent to predicate products currently in commercial distribution. This particular formulation does not affect the intended use or alter the fundamental scientific technology. | |
| Intended Use | CollaFirm Collagen Wound Dressing has the same intended uses as the aforementioned predicate devices. |
| Safety and Effectiveness | CollaFirm Collagen Wound Dressing is as safe and effective as the predicate devices referenced herein and raises no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify "sample sizes" in the context of a "test set" as would be relevant for an AI/ML device. The "testing" here refers to non-clinical laboratory tests performed on the device material itself. The provenance of this data is from controlled laboratory experiments, not patient data in the sense of a clinical trial or AI model evaluation.
- Sample Size for Test Set: Not applicable in the context of typical AI/ML device evaluation. The "sample" is the manufactured device material used for the specified laboratory tests (e.g., cytotoxicity, irritation, sensitization, sterility, pyrogenicity, stability). The specific number of samples tested for each assay is not detailed in this summary but would be part of the full test reports.
- Data Provenance: The tests were conducted in accordance with ISO standards and USP (United States Pharmacopeia) for sterility. This indicates the testing was performed in a laboratory setting. Country of origin for data is not explicitly stated but would typically be from accredited testing facilities. The data is non-clinical/pre-clinical.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For this type of device submission, there is no "ground truth" in the sense of medical image interpretation or disease diagnosis established by experts. Substantial equivalence relies on comparing the device's characteristics and performance to established standards and predicate devices.
4. Adjudication Method
Not applicable. There is no adjudication method needed for establishing ground truth, as the ground truth concept (expert consensus in diagnostic tasks) does not apply here. The evaluation relies on standardized laboratory tests and comparison to predicate devices, which are objective measurements or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "CollaFirm Collagen Wound Dressing has not been studied in a clinical setting." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is typically for AI-assisted diagnostic or prognostic tools.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone performance study (algorithm only) was not done. This is not an AI/ML device, so concepts like "algorithm only" or "human-in-the-loop" are not relevant. The device is a physical wound dressing.
7. The Type of Ground Truth Used
Not applicable in the context of AI/ML. For this submission, "ground truth" is established through:
- Standardized laboratory tests: E.g., ISO standards for biocompatibility (cytotoxicity, irritation, sensitization), USP for sterility, LAL for pyrogenicity. The results of these tests, against predetermined pass/fail criteria, serve as empirical evidence.
- Comparison to predicate devices: The "ground truth" for substantial equivalence often involves demonstrating that the new device's properties and performance are comparable to (or within acceptable limits of) legally marketed predicate devices that have already been deemed safe and effective by the FDA. The amino acid analysis is an example of this.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device, so there is no "training set" or "ground truth for the training set."
N/A