(220 days)
The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.
Allevyn Ag has a trilaminate structure composed of a polyurethane top film, polyurethane central Silver Sulfadiazine (SSD) containing foam pad and polyurethane perforated wound contact film. This design allows Allevyn Ag to provide continual exudate absorption and barrier protection for up to seven days, while creating and maintaining a moist wound-healing environment in a presentation that is comfortable for the patient and easy to use, apply and remove for the user.
This document is a 510(k) premarket notification for the Allevyn Ag Dressings. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or a specific study designed to prove the device meets such criteria in the way typically found for diagnostic or software-based medical devices. The performance information provided is related to "in-vitro testing studies" demonstrating antibacterial barrier characteristics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Antibacterial Barrier Characteristics (Implied acceptance criteria: device demonstrates barrier to common bacterial strains to support its function as an antibacterial barrier dressing) | In-vitro testing studies showed that Allevyn Ag dressing has demonstrated to have barrier characteristics to bacterial strains: |
- P. aerunginosa
- S. aureus
- E. coli
- K. pneumoniae
- A. calcoaceticus
- S. pyogenes
- E. faecalis
- MRSA
- C. perfringens
- B. fragilis
- P. melaninogenica |
| Biocompatibility (Implied acceptance criteria: device is biocompatible and does not introduce additional safety risk) | Biocompatibility of Allevyn Ag has been demonstrated through appropriate in vivo and in vitro tests on the foam as well as a literature review for the use of SSD. - Assessed in accordance with ANSI/AAMI/ISO 10993.
- Does not introduce any additional safety risk over the predicate devices (Acticoat Moisture Control K050030 or Allevyn Foam K963096). |
| Performance (Exudate absorption, barrier protection, moist wound-healing) and User Comfort (Implied acceptance based on design and comparison to predicate devices) | Design allows Allevyn Ag to provide: - Continual exudate absorption
- Barrier protection for up to seven days
- Creation and maintenance of a moist wound-healing environment
- Comfortable for the patient
- Easy to use, apply and remove for the user |
2. Sample size used for the test set and the data provenance
The document mentions "in-vitro testing studies" for antibacterial barrier characteristics and "in vivo and in vitro tests" for biocompatibility. However, it does not specify the sample sizes used for these tests. There's no mention of specific data provenance (country of origin, retrospective/prospective clinical study) as these appear to be laboratory-based performance and safety studies rather than clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the provided document. The studies mentioned are laboratory-based performance and safety evaluations (e.g., antibacterial activity, biocompatibility), which typically do not involve human experts establishing ground truth in the context of diagnostic output or subjective assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable to the provided document. Adjudication methods are typically used in clinical studies or expert review processes, which are not detailed here for these specific performance tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a wound dressing, not a diagnostic or AI-assisted device, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The Allevyn Ag Dressing is a physical medical device (a wound dressing) and does not involve algorithms or AI for standalone performance evaluation in the way a software device would.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the antibacterial barrier characteristics, the "ground truth" would likely be based on standard microbiological assays and laboratory techniques to determine bacterial viability and growth in the presence of the dressing.
For biocompatibility, the ground truth would be established by standardized laboratory tests (e.g., cytotoxicity, sensitization, irritation studies) as per ANSI/AAMI/ISO 10993 guidelines, which define acceptable biological responses.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific performance claims in this document.
8. The sample size for the training set
This section is not applicable. This is a physical medical device and does not involve machine learning algorithms that require a "training set" in the computational sense.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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