(263 days)
WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.
Core Scientific Creations WoundClot Hemostatic Gauze device is made from regenerated cellulose, chemically treated to become water-soluble. When the regenerated cellulose contacts blood and exudates, it expands and forms into gel, adheres and creates pressure to seal wound.
The provided FDA 510(k) summary for the WoundClot Hemostatic Gauze does not present formal acceptance criteria in a quantitative table format with corresponding reported device performance, which is typical for AI device studies. Instead, it demonstrates substantial equivalence to a predicate device through various non-clinical and animal studies.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided document for some points:
1. Table of Acceptance Criteria and Reported Device Performance
As a medical device demonstrating substantial equivalence to a predicate, the "acceptance criteria" are implied to be that the device performs as safely and effectively as the predicate device. Quantitative thresholds for acceptance, like specific sensitivity/specificity targets for an AI device, are not specified because this is a hemostatic gauze. The "reported device performance" is a demonstration of similarity in various tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO standards for biocompatibility. | Cytotoxicity: Compliant with ISO 10993-5:2009 |
| Irritation/Intracutaneous: Compliant with ISO 10993-10:2010 | |
| Sensitization: Compliant with ISO 10993-10:2010 | |
| Acute Systemic Toxicity: Compliant with ISO 10993-11:2006 | |
| Non-Clinical (Bench) Equivalence: Similar physical and chemical properties to predicate. | Physical Appearance, Weight, Density, Conductivity, pH, Solubility, Dissolution Profile, FTIR Analysis, Degree of Substitution: Shown to be similar to predicate (BenaCel Hemostatic Gauze). |
| Animal Study Equivalence: Achieve hemostasis as effectively as predicate in a severe bleeding model. | Primary Endpoints (Mean Arterial Pressure (MAP), Survival Time, Percentage Survival, Bleeding/Hemostasis Time, Post-Treatment Blood Loss): Demonstrated equivalence to BenaCel Hemostatic Gauze in achieving hemostasis in a femoral arteriotomy swine model. |
| Secondary Endpoints (Hemoglobin, Hematocrit, Platelet Counts, pH, Base Deficit, Coagulation Values (PT, aPTT, fibrinogen, TEG parameters)): Measured and compared. | |
| Histology Analysis: Conducted and showed similarities in pathological findings between WoundClot and the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Animal Study (Test Set): 10 swine (5 tested with WoundClot, 5 with BenaCel).
- Data Provenance: The animal study was conducted using "Large white Landrace cross-bred (male) swine" with "normal coagulation functions." The country of origin for the animal study data is not explicitly stated in the document. The study appears to be prospective as it involves specifically testing the device on animals.
- Sample Size for Bench Testing: Not specified, but involved comparisons between WoundClot and the predicate device.
- Sample Size for Biocompatibility Testing: Not specified, but standard tests performed in compliance with ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not directly applicable in the context of this device and study. The "ground truth" in this case is objective physiological measurements (e.g., bleeding time, blood loss, pathological findings) observed in the animal model, not expert consensus on image interpretation or diagnosis. Therefore, there are no "experts" establishing ground truth in the sense of human readers for an AI study.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI device, and the ground truth in the animal study is based on physiological measurements and histological analysis, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI devices where human readers' performance with and without AI assistance is evaluated. The WoundClot Hemostatic Gauze is a physical medical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The WoundClot Hemostatic Gauze is a physical medical device. It does not have an "algorithm-only" or "standalone" mode as understood for AI devices because it is not an AI algorithm. Its performance is inherent to its physical properties and interaction with blood.
7. The Type of Ground Truth Used
- Biocompatibility: Compliance with established ISO standards, verified through laboratory tests.
- Non-Clinical (Bench) Testing: Direct comparison of chemical and physical properties against the predicate device, using analytical methods (e.g., FTIR analysis).
- Animal Study:
- Physiological Measurements: Objective measurements of blood pressure, survival, bleeding time, blood loss, and blood parameters (hemoglobin, hematocrit, etc.). This acts as objective outcomes data.
- Histology Analysis: Microscopic examination of tissue, presumably performed by trained pathologists, to compare tissue responses and pathological findings between the device and the predicate. This could be considered a form of "pathology" ground truth, established by expert interpretation of tissue slides.
8. The Sample Size for the Training Set
Not applicable. The WoundClot Hemostatic Gauze is a physical device, not an AI algorithm that requires a training set. The development of the device would involve materials science and engineering rather than data-driven machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this physical device.
N/A