(469 days)
The TT-102 Wound Dressing is indicated for the management of: Diabetic ulcers, Venous ulcers, Pressure ulcers, Ulcers caused by mixed vascular etiologies, Full thickness and partial thickness wounds, Traumatic wound healing by secondary intention, Dehisced surgical wounds, Abrasions, Donor sites and other bleeding wounds
TT-102 Wound Care Dressing is a highly absorbent, sterile, single-use primary dressing comprised of phosphorylated cellulose with ionically bound silver. The dressing prevents microbial colonization in the dressing.
The TT-102 Wound Dressing is a medical device. The provided text describes the acceptance criteria and a study demonstrating the device's performance, but it primarily focuses on antimicrobial activity and biocompatibility as part of its substantial equivalence claim, rather than a clinical effectiveness study.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing, and non-cytotoxic. |
| Antimicrobial Activity | Effective against: Staphylococcus aureus ATCC 6538Staphylococcus aureus, methicillin resistant (MRSA) ATCC 33591Escherichia coli ATCC 8739Pseudomonas aeruginosa ATCC 9027Enterococcus faecalis, vancomycin-resistant enterococci (VRE) ATCC 51575Candida albicans ATCC 10231 |
| Absorbency | High capacity to absorb and retain wound exudate (comparable to AQUACEL® Ag). |
| Silver Binding | Silver is highly bound to the matrix of the dressing, preventing colonization by microbes (comparable to AQUACEL® Ag). |
Study Details
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Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified, but standard tests typically involve in vitro and in vivo models using specific cell lines or animal subjects. The data provenance is not mentioned, but these are typically laboratory-based studies.
- Antimicrobial Activity: Not specified in terms of the number of unique samples of the dressing or replicates. The organisms used (listed above) are standard laboratory strains. Data provenance is laboratory testing.
- Absorbency/Silver Binding: These are described as technical characteristics and compared to a predicate device (AQUACEL® Ag), suggesting internal testing for these properties. Sample size and provenance are not explicitly stated for these comparative evaluations.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are laboratory-based performance tests (biocompatibility and antimicrobial) or technical characteristic comparisons, not studies requiring expert interpretation of clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is typically used in studies involving human interpretation of images or clinical outcomes, which is not the case here.
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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 device is a wound dressing, not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical wound dressing and does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Ground truth is established through standardized toxicological, irritation, sensitization, and cytotoxicity assays.
- Antimicrobial Activity: Ground truth is established by measuring the reduction in microbial counts according to the specified standard (ASTM E2149-01). The "ground truth" is a quantifiable reduction in colony-forming units (CFUs) or similar microbial load indicators.
- Absorbency/Silver Binding: Ground truth would be the measurement of these physical/chemical properties and their comparison to the predicate device.
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The sample size for the training set: Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set.
Overall Study Summary
The submission for the TT-102 Wound Dressing relies on laboratory performance testing to demonstrate its substantial equivalence to a legally marketed predicate device (AQUACEL® Ag with Hydrofiber). The key studies cited are:
- Biocompatibility studies: These tests demonstrated the device to be "non-toxic, non-irritating, non-sensitizing and non-cytotoxic," establishing its safety for contact with tissue.
- Antimicrobial activity testing: Conducted according to ASTM E2149-01, this study showed the dressing was effective against a panel of common wound-related pathogens, including Staphylococcus aureus, MRSA, Escherichia coli, Pseudomonas aeruginosa, VRE, and Candida albicans.
- Technical Characteristics comparison: The device's absorbency and silver binding mechanism are described as similar to its predicate, highlighting its capacity to absorb exudate and prevent microbial colonization.
"No clinical evaluation has been done on this device." This statement indicates that the regulatory submission for TT-102 Wound Dressing did not include human clinical trials to demonstrate effectiveness in a patient population. Instead, its substantial equivalence was based on its material composition, technical characteristics, and in vitro performance relative to a predicate device.
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