(121 days)
Sterile, single-use dressings for management of pressure ulcers, 1st and 2nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.
The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.
The provided text describes the AbsoClear® wound dressing. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | |
| Absorption Capacity | Met all acceptance criteria in GLP testing of each lot. |
| Sterility | Met all acceptance criteria in GLP testing of each lot. |
| Package Seal Strength | Met all acceptance criteria in GLP testing of each lot. |
| Seal Integrity | Met all acceptance criteria in GLP testing of each lot. |
| For products with adhesive borders: | |
| Coat Weight | Met all acceptance criteria in routine acceptance testing. |
| Peel Adhesion | Met all acceptance criteria in routine acceptance testing. |
| MVTR (Moisture Vapor Transmission Rate) | Met all acceptance criteria in routine acceptance testing. |
| Sterilization | |
| Sterility Assurance Level (SAL) | Validated to 10e-6 per ISO 11137. |
| Bioburden | Met all acceptance criteria. |
| Pyrogenicity | Met all acceptance criteria. |
| Shelf-life | |
| Peel Adhesion (after storage) | Met all specifications after storage at 40°C for 12 months and real-time stability at 25°C for 3 years. |
| Moisture Vapor Transmission Rate (after storage) | Met all specifications after storage at 40°C for 12 months and real-time stability at 25°C for 3 years. |
| Absorption Capacity (after storage) | Met all specifications after storage at 40°C for 12 months and real-time stability at 25°C for 3 years. |
| Sterility (after storage) | Met all specifications after storage at 40°C for 12 months and real-time stability at 25°C for 3 years. |
| Packaging Seal Strength (after storage) | Met all specifications after storage at 40°C for 12 months and real-time stability at 25°C for 3 years. |
| Packaging Seal Integrity (after storage) | Met all specifications after storage at 40°C for 12 months and real-time stability at 25°C for 3 years. |
| Biocompatibility | |
| Cytotoxicity | Product met all acceptance criteria per ISO 10993-5. |
| Sensitization | Product met all acceptance criteria per ISO 10993-10. |
| Intracutaneous Reactivity | Product met all acceptance criteria per ISO 10993-10. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data for the AbsoClear device. Instead, the performance evaluations are based on:
- Bench Testing: Performed on "each lot" of AbsoClear product. The exact sample size per lot is not specified.
- Sterilization Validation: No specific sample size for a "test set" is mentioned, rather the process was validated per ISO 11137.
- Shelf-life Testing: No specific sample size for a "test set" is mentioned. Testing was done on product and packaging after specific storage conditions.
- Biocompatibility Testing: No specific sample size of devices is mentioned, but tests were performed on "the finished packaged, sterilized product."
The data provenance is not described as being from a specific country or retrospective/prospective in a clinical sense, as the studies are primarily lab-based (bench, sterilization, shelf-life, biocompatibility).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The studies described are not clinical studies that would involve experts establishing ground truth for a test set. The acceptance criteria are based on pre-defined technical specifications and international standards (e.g., ISO 11137, ISO 10993).
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set described that would require an adjudication method.
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: "Additional clinical testing was not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is a physical wound dressing, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Technical Specifications: Pre-defined performance parameters for the wound dressing (e.g., absorption capacity, seal strength, MVTR).
- International Standards: Compliance with standards such as ISO 11137 for sterilization and ISO 10993 for biocompatibility. These standards define the methods and acceptance limits for various tests.
- Comparison to Predicate Device: The claim of substantial equivalence is based on the new device having "similar technological characteristics and materials as a previously cleared device." This implies the predicate device's established safety and effectiveness serve as the benchmark.
8. The Sample Size for the Training Set
Not applicable. The device is a physical wound dressing and does not involve a training set as would be found in machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.
N/A