(157 days)
To secure devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin. For use as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, sites, davice incention its cond degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donors sites.
The new product is sterile single use silver antimicrobial adherent transparent film. Sterility assurance will conform to AAMI/ANSI/ISO 11137-1994.
The provided text is a 510(k) summary for the AcryDerm Silver Antimicrobial Thin Film. It describes the device, its intended use, and pre-clinical testing for antimicrobial effectiveness and biocompatibility. However, it does not contain information about specific acceptance criteria or performance studies as typically understood for AI/ML-driven medical devices.
Instead, the document details a regulatory submission process to demonstrate "substantial equivalence" to legally marketed predicate devices, which is a different type of assessment than proving a device meets specific performance criteria through clinical or analytical studies with defined metrics.
Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed device performance metrics in the way one would for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC, recall). The primary performance criteria mentioned relate to antimicrobial effectiveness and biocompatibility, which are qualitative or based on standard test methods rather than statistical thresholds from a clinical study.
| Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Antimicrobial Efficacy | Zone of Inhibition Studies against clinical isolates | Effective against: |
- Coagulase negative Staphylococcus sp.
- E. coli
- Pseudomonas aeruginosa
- Staphylococcus aureus (MRSA)
- Candida albicans
- Enterococcus sp.
- Klebsiella pneumoniae (3 strains)
- Candida parapsilosis
- Candida galbrata
- Bacillus subtilis
- Enterobacter cloacae (2 strains)
- Enterococcus faecalis (2 strains)
- Aspergillus niger
- Serratia marcescens
- Citrobacter diversus
- Citrobacter kasseri
- Staphylococcus saprophyticus |
| Antimicrobial Duration | In vitro serial transfer testing | Active for in excess of 7 days |
| Safety & Biocompatibility | ISO 10993 (Biological Evaluation of Medical Devices) Part-1 | Established in accordance with the standard |
| Sterility | Sterility Assurance | Will conform to AAMI/ANSI/ISO 11137-1994 |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The document refers to "pre-clinical testing" which typically involves laboratory-based studies (e.g., microbiology cultures, biocompatibility assays) rather than human subject test sets for performance evaluation.
- Data Provenance: The pre-clinical testing describes in vitro studies ("zone of inhibition studies against clinical isolates," "in vitro serial transfer testing"). This data would be generated in a laboratory setting rather than being retrospective or prospective patient data from a specific country.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. Ground truth, in this context, would be determined by laboratory assays (e.g., presence/absence of microbial growth, measurement of zone of inhibition) rather than expert consensus on complex medical images or clinical outcomes.
- Qualifications of Experts: N/A. The "experts" would be laboratory technicians or scientists performing standard microbiological and biocompatibility tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., radiology reads) to establish consensus ground truth when individual expert opinions might differ. This document describes laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done, as this is a device for antimicrobial properties and wound dressing, not an AI-assisted diagnostic or decision support system intended to improve human reader performance.
6. Standalone Performance Study
- Standalone Performance Study: The "Pre-Clinical Testing" section describes a form of standalone performance evaluation for the device's antimicrobial properties. This involves direct testing of the film against various microorganisms and for its duration of activity. However, it's not a "standalone algorithm performance" study as would be conducted for AI/ML.
7. Type of Ground Truth Used
- Type of Ground Truth: For antimicrobial efficacy, the ground truth is based on microbiological assays (e.g., inhibition of microbial growth, measured zone of inhibition). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993 Part-1 standards. For sterility, compliance with AAMI/ANSI/ISO 11137-1994 ensures sterility.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML model that requires a training set. The "training" in manufacturing refers to quality systems and production processes, not data for machine learning.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned for an AI/ML model.
N/A