(213 days)
The exSALT ™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
The exSALT™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. The dressing is available in various sizes and can be cut to size. Silver in the exSALT™ SD7 Wound Dressing kills bacteria which are in direct contact with the dressing.
This document describes Exciton Technologies Inc.'s 510(k) submission for the exSALT™ SD7 Wound Dressing, seeking substantial equivalence to the Acticoat® 7 Dressing. The study focuses on comparing the technological characteristics and performance data between the two devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was measured) | Reported Device Performance (exSALT™ SD7 vs. Predicate) |
|---|---|
| Physical Properties | |
| Absorptive Capacity | Substantially equivalent |
| Moisture Content | Substantially equivalent |
| Drop Penetration | Not explicitly stated as equivalent, but included in tests for performance |
| Adhesion | Substantially equivalent |
| Abrasion | Not explicitly stated as equivalent, but included in tests for performance |
| Silver Content | Less silver ion release than predicate over similar time periods |
| Antimicrobial Efficacy | |
| Anti-microbial (Bacterial) Effectiveness | Same as predicate |
| Bactericidal Effectiveness (against Pseudomonas aeruginosa and Staphylococcus aureus) | Same as predicate (under similar conditions) |
| Biocompatibility | |
| Biocompatibility | Non-toxic, non-irritant, no sensitization response (no new safety concerns relative to predicate) |
| Biological Reactivity | Non-toxic, non-irritant, no sensitization response (no new safety concerns relative to predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for each test conducted. It states that "the results of physical, efficacy, and biocompatibility testing" were used for comparison. The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be retrospective in the sense that they are laboratory tests performed to compare the new device against an existing predicate, rather than new clinical trials as part of a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention the use of experts or a ground truth established by experts for the test set. The "ground truth" for this type of device comparison is based on standardized laboratory testing methods for physical, efficacy, and biocompatibility properties, with the predicate device serving as the benchmark.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the data are laboratory measurements and comparisons to a predicate device's established performance, rather than human expert assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and an AI's impact on their performance is being evaluated. This document concerns a wound dressing, and the evaluation is based on laboratory performance metrics.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The entire evaluation is effectively a "standalone" performance assessment of the device's physical, chemical, and biological properties in a laboratory setting, without human-in-the-loop interaction in its performance evaluation. The device itself is not an algorithm, but a physical product.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is implicitly based on established benchmark performance of the predicate device (Acticoat® 7 Dressing) and internationally recognized standards for testing physical properties, antimicrobial efficacy, and biocompatibility. For instance:
- Physical properties: Measured parameters like absorptive capacity, moisture content, etc., are inherent properties of the material.
- Antimicrobial efficacy: Laboratory tests against specific bacteria (e.g., Pseudomonas aeruginosa, Staphylococcus aureus) providing quantitative kill rates.
- Biocompatibility: Standardized in vitro and in vivo tests for toxicity, irritation, and sensitization.
8. The Sample Size for the Training Set:
This question is not applicable. Wound dressings are physical medical devices, not AI/ML algorithms that require training sets of data.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set for this device.
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