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510(k) Data Aggregation
(88 days)
Hartmann USA, Inc.
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical wounds, and abrasions.
Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.
The provided document is an FDA 510(k) clearance letter for a medical device (Atrauman® Ag antimicrobial wound dressing) and its associated 510(k) summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not typically include information about sophisticated AI/ML driven diagnostic devices, multi-reader multi-case (MRMC) studies, or ground truth establishment in the context of diagnostic performance.
Therefore, many of the requested items related to AI/ML performance, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria and performance in a direct "criteria vs. reported data" table format as one might find for a diagnostic device. Instead, it states that the device was evaluated and met standards. The "performance" is implicitly the successful demonstration of meeting these standards.
| Test Category | Acceptance Criteria (Implied by meeting standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1, 5, 10, 11, 23 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Material mediated pyrogenicity, Acute/subacute/subchronic systemic toxicity, Implantation effects) | All tested endpoints (Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Acute/subacute/subchronic systemic toxicity, Implantation effects) were met. |
| Antimicrobial Effectiveness | Effective for up to 7 days against 6 clinically relevant microorganisms under simulated use conditions. | Demonstrated effectiveness for up to 7 days throughout the labeled shelf-life. |
| Sterilization | Achieves a Sterility Assurance Level (SAL) of 10^-6 via gamma irradiation and adheres to relevant ISO and EN standards. | Terminally sterilized via gamma irradiation with an SAL of 10^-6; process performed and monitored according to specified standards. |
| Shelf-life | Maintains full product performance after 3 years aging. | Labeled with a 3-year shelf-life based on real-time testing demonstrating full product performance. |
| Packaging | Meets acceptance criteria for transport testing. | Met acceptance criteria per ASTM D4169. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a medical device (wound dressing) and the evaluation involves non-clinical laboratory testing, not a "test set" of patient data for diagnostic performance. The testing was conducted on samples of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., expert consensus on medical images) is not relevant for this type of non-clinical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human reader interpretation or adjudication.
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. This document pertains to a wound dressing, not an AI-driven diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" here is the defined performance and safety standards for medical devices (e.g., ISO, EN, ASTM standards) and the results of laboratory tests conducted to demonstrate compliance with these standards. For example:
- Biocompatibility: In vitro and in vivo test results against established toxicology profiles.
- Antimicrobial Effectiveness: Laboratory culture results demonstrating bacterial growth inhibition.
- Sterilization: Microbiological testing (e.g., bioburden, sterility testing) results.
- Shelf-life: Real-time aging studies and performance testing after aging.
8. The sample size for the training set:
Not applicable. This is not a machine learning device, so there is no training set. The tests were performed on representative samples of the manufactured device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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