Search Results
Found 1 results
510(k) Data Aggregation
(280 days)
The Triosyn T40™ Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. The Triosyn T40™ Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.
The Triosyn T40'''' Antimicrobial Wound Dressing is a sterile, primary wound dressing. It is a multi-layer composite dressing consisting of an absorbent polycster non-woven pad, a permeable adhesive, a single layer of Triosyn iodinated resin beads, and a non-adherent high-density polyethylene mesh (HDPE). This non-adhesive composite dressing is designed to be used as a barrier against microbial penetrations and as a method to reduce the microbial load in partial and full thickness wounds'.
The provided text describes the Triosyn T40™ Antimicrobial Wound Dressing and its substantial equivalence to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics in the format requested. The document focuses on the device description, intended use, technological characteristics, and biocompatibility, stating that the device "functioned as intended" based on "laboratory tests."
Therefore, I cannot populate most of the requested fields directly from the provided text. I will indicate where information is missing or inferred.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Antimicrobial Effectiveness (In Vitro) | Effective against a broad spectrum of clinically relevant microorganisms, including gram-positive bacteria, gram-negative bacteria, and fungal organisms. This includes multi-drug resistant organisms Staphylococcus aureus MRSA (ATCC 33591) and Enterococcus faecalis VRE (ATCC 51575). | "The Triosyn T40™ Antimicrobial Wound Dressing was found in laboratory tests to be effective against a broad spectrum of clinically relevant microorganisms including gram-positive bacteria, gram-negative bacteria, and fungal organisms. This list includes multi-drug resistant organisms Staphylococcus aureus MRSA (ATCC 33591) and Enterococcus faecalis VRE (ATCC 51575). In all instances, the Triosyn T40™ Antimicrobial Wound Dressing functioned as intended." |
| Iodine Release | Consistently release less iodine in simulated wound exudates than a similarly sized Iodoflex dressing. | "The Triosyn T40™ Antimicrobial Wound Dressing was found in laboratory tests to consistently release less iodine in simulated wound exudates than a similarly sized Iodoflex dressing." |
| Biocompatibility | In accordance with ISO 10993 requirements for ISO 10993 tests: Cytotoxicity, Primary Skin Irritation, Closed Patch Sensitization. | "This product was tested in accordance with ISO 10993 requirements for biocompatibility using the following tests: Cytotoxicity, Primary Skin Irritation, Closed Patch Sensitization." (The document states it was tested in accordance with, implying successful completion, but does not provide specific results like pass/fail.) |
| Overall Intended Function (Substantial Equivalence) | Functions in a substantially equivalent manner to the predicate devices (Acticoat 7 Composite Wound Dressing and Iodoflex Paste). | "The test results demonstrated that the Triosyn T40™ Antimicrobial Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." (This is a conclusion statement; specific comparative data points are not provided in the summary.) The FDA's 510(k) clearance letter also confirms substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the "laboratory tests."
- Data Provenance: The document states "Data on file" for in vitro testing. No country of origin is specified, but the applicant is based in Vermont, USA. The nature of the tests (laboratory/in vitro) suggests they were conducted in a controlled environment as opposed to clinical trials. The data would be considered prospective in the sense that the tests were carried out specifically to evaluate the device for this submission, rather than retrospective analysis of existing data.
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)
- Number of Experts: Not applicable/not specified. The "effectiveness" claims are based on in vitro laboratory test results against defined microbial strains and simulated exudates, and biocompatibility testing according to ISO standards, not on expert interpretations of clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. The assessments are based on laboratory measurements and standards, which typically do not involve human adjudication in the way clinical studies or image interpretation tasks do.
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
- MRMC Study: No. This device is a wound dressing, not an AI-assisted diagnostic tool or imaging device that would typically undergo an MRMC study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a medical device (wound dressing), not an algorithm or AI system. The performance evaluated is the direct physical/chemical action of the dressing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth:
- Antimicrobial Effectiveness: Defined microbial strains (e.g., ATCC 33591 for MRSA, ATCC 51575 for VRE) and standardized laboratory methods for evaluating microbial reduction.
- Iodine Release: Simulated wound exudates and analytical methods for measuring iodine concentration.
- Biocompatibility: ISO 10993 standards and specified toxicity, irritation, and sensitization tests.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning model that requires a training set. The "laboratory tests" described are for performance evaluation, not model training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device type.
Ask a specific question about this device
Page 1 of 1