(28 days)
Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.
The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing. The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").
This document is a 510(k) summary for the Alldress® Absorbent Film Dressing. As such, it is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the manner of a clinical trial for a new drug or a novel AI diagnostic device.
Therefore, many of the requested categories related to device performance studies, such as sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable or not provided in this type of regulatory submission. The "acceptance criteria" here refer more to the biocompatibility and functional characteristics typically tested in laboratory settings for wound dressings, rather than diagnostic accuracy metrics.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxicity | Shown to be nontoxic through laboratory tests. |
| Non-irritation | Found to be non-toxic and non-irritating when tested in accordance with ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). | |
| Functional Characteristics | Moisture Vapor Permeability | Described as a "sterile moisture vapor permeable selfadhesive absorbent dressing." (Implicitly meets functional requirements for this type of dressing). |
| Absorbency | "Intended to absorb..." (Implicitly meets functional requirements for absorbency). | |
| Adhesion | "Selfadhesive" (Implicitly meets functional requirements for adhesion). | |
| Material/Sterility | Sterile | "Individually sealed in medical grade paper pouches" and described as "sterile." (Meets sterility requirements). |
Note: The document does not provide specific quantitative thresholds for "nontoxic" or "non-irritating," but rather refers to compliance with a recognized standard (ISO 10993 Part I).
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This submission describes laboratory tests for biocompatibility and functional performance of a wound dressing, not a diagnostic algorithm. There isn't a "test set" of patient data in the context of an AI device. The tests mentioned (e.g., ISO 10993) involve material testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable/Not provided. As above, this pertains to material testing based on established standards, not interpretation of patient data by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided.
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
Not applicable/Not provided. This device is a wound dressing, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For biocompatibility, the "ground truth" is defined by the established criteria and methodology outlined in ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix. These standards define what constitutes "nontoxic" and "non-irritating" through specific biological test procedures.
8. The sample size for the training set
Not applicable/Not provided. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. This is not an AI device that requires a training set.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.