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510(k) Data Aggregation
(77 days)
For the dressing and management of chronic/open wounds.
The AllDress® Multi Layered Wound Dressing is a sterile wound dressing composed of an absorbent layer with a non-adherent wound contact surface. The absorbent layer is bonded to an adhesive backing layer which secures the dressing to the skin around the wound. Dressings are supplied in sizes of 2 ¼ "x 2 ¼ (1"x 1" wound contact surface); 6"x 6" (4"x 4" wound contact surface); 4"x 4" (2"x 2" wound contact surface); and 6"x 8" (4"x 6" wound contact surface). The wound contact side of the dressing is covered with scored siliconized release paper to permit aseptic application.
The AllDress® Multi Layered Wound Dressing represents a modified version of the currently marketed AllDress® Multi Layered Wound Dressing (K945206) and is identical to the predicate device with respect to function and intended use. to the Comfeel® Plus Ulcer Dressing (K941263). The composition of the backing layer of the modified product has been changed to improve the wound barrier properties of the dressing.
Biocompatibility of the modified device has been established by intracutaneous toxicity test (rabbit), systemic toxicity test (mice), muscle implantation test (rabbit), primary skin irritation test (rabbit), hemolysis test (In Vitro), cytotoxicity test (In Vitro), and delayed hypersensitivity test (guinea pig). In addition, bacterial penetration (strike-through) studies with S. aureus and P. aeruginosa and ASTM viral penetration test with фХ174 bacteriophage were conducted to demonstrate the effective performance of the dressing as a bacterial and viral barrier.
The provided text describes a 510(k) summary for a wound dressing, not an AI/ML medical device. Therefore, most of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.
However, I can extract information related to the performance testing of this wound dressing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Standard (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Intracutaneous toxicity test (rabbit) | (Implicitly passed) | Established biocompatibility |
| Systemic toxicity test (mice) | (Implicitly passed) | Established biocompatibility | |
| Muscle implantation test (rabbit) | (Implicitly passed) | Established biocompatibility | |
| Primary skin irritation test (rabbit) | (Implicitly passed) | Established biocompatibility | |
| Hemolysis test (In Vitro) | (Implicitly passed) | Established biocompatibility | |
| Cytotoxicity test (In Vitro) | (Implicitly passed) | Established biocompatibility | |
| Delayed hypersensitivity test (guinea pig) | (Implicitly passed) | Established biocompatibility | |
| Barrier Properties | Bacterial penetration (strike-through) | Effective barrier | Demonstrated effective performance as a bacterial barrier |
| Viral penetration test (with фХ174 bacteriophage) | Effective barrier | Demonstrated effective performance as a viral barrier |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for each test, but various animal models (rabbit, mice, guinea pig) and in vitro tests were used.
- Data Provenance: The tests conducted appear to be laboratory-based and conducted specifically for this device modification. No indication of retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical wound dressing, not an AI/ML algorithm requiring expert interpretation of results. The "ground truth" here is the scientific measurement of biological and physical properties.
4. Adjudication method for the test set:
- Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human-interpreted results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is relevant for diagnostic performance, not for a physical wound dressing's barrier properties or biocompatibility.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- For biocompatibility: The "ground truth" is established through standardized laboratory tests (e.g., observing for toxic reactions, irritation, hemolysis) against established biological safety criteria.
- For barrier properties: The "ground truth" is established by direct measurement of microbial penetration (e.g., presence or absence of bacteria/viruses on the other side of the dressing) using specified challenge organisms and methods.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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