(212 days)
AWBAT-S Plus: is intended for clean Superficial burn wounds.
AWBAT-D Plus: are intended for Donor sites after hemostasis has been established.
AWBAT-M Plus: are intended to be used as a protective covering for Meshed autografts.
A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT Plus is composed of a single or multiple filesned knitted nylon fabric, bonded to a thin porous silicone membrane (enproximately 0.01 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen. peptides, chondroitin-4-sulfate, chondroitin-6-sulfate, Immuno-10 (Aloe polysiaconarides), vitamin C, vitamin E, and polysorbate 20.
AWBAT Plus is manufactured in 12"x12" sheets that are cut to sizes of 6"x6", 6"x12" and 12"x12" and ink stamped AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus accordingly.
AWBAT-S Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S Plus pore is 0.0036 square inch each.
AWBAT-D Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D Plus pore is 0.0073 square inch each.
AWBAT-M Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M Plus pore is 0.0070 square inch each.
The provided text is a 510(k) summary for the AWBAT Plus Wound Dressings. It describes the device, its intended use, and its substantial equivalence to a predicate device (AWBAT).
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices. This is a traditional wound dressing, and the assessment here focuses on biocompatibility and comparison to a predicate device, rather than performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI system.
Therefore, many of the requested fields cannot be filled from the provided text.
Here is an attempt to answer based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Compliant with ISO 10993-1:2003 for: | Biocompatibility: Testing "is being conducted" and Aubrey Inc. certifies it will not distribute until testing demonstrates compliance with ISO 10993-1:2003. This implies performance will meet these criteria, but specific results are not reported in this summary. |
| - Cytotoxicity | (Results not reported in this summary, but expected to be compliant) |
| - Sensitization | (Results not reported in this summary, but expected to be compliant) |
| - Irritation or intracutaneous reactivity | (Results not reported in this summary, but expected to be compliant) |
| Substantial Equivalence: To predicate device AWBAT (K082869) in terms of intended use, materials, design, function, and operating characteristics. | Substantially Equivalent: The submission "demonstrates that AWBAT Plus... is substantially equivalent to the AWBAT wound dressing (K082869) in terms of intended use, materials, design, function and operating characteristics." |
| Manufacturing Process: Compliance with US FDA and European Standards for medical device manufacturing. | Manufacturing Process: The manufacturing process "complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided 510(k) summary. The submission focuses on biocompatibility testing (which is not typically "test set" based in the AI/ML sense) and demonstrating substantial equivalence to a predicate device, rather than a clinical performance study with a test set of cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available. The device is a wound dressing, not an AI/ML diagnostic tool, so the concept of "ground truth" and expert adjudication in this context does not apply. The assessment is based on material properties, biocompatibility, and intended use comparison.
4. Adjudication Method for the Test Set
This information is not available. Not applicable for this type of device and submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted image analysis or diagnostic tools and is not applicable to a wound dressing. The device does not use software (as stated in Table 1, "Does the device use software? No").
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This device is a physical wound dressing and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML devices (e.g., pathology, outcomes data) is not applicable here. The assessment for this device relies on:
- Biocompatibility testing against a recognized standard (ISO 10993-1:2003). The 'truth' here is compliance with the assays defined by the standard (cytotoxicity, sensitization, irritation).
- Comparison of device characteristics to a legally marketed predicate device. The 'truth' of substantial equivalence is established by comparing features like intended use, materials, design, function, and operating characteristics.
8. The Sample Size for the Training Set
This information is not available. Not applicable as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not available. Not applicable as this is not an AI/ML device requiring a training set.
N/A