(214 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.
Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven needled polyester coated with gray Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (2.5% w/w). The exsalt™ SD7 Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis when they are in direct contact with the dressing. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonos aeruginosa and Staphylococcus aureus.
Here's a breakdown of the acceptance criteria and study information for the exsalt™ SD7 Wound Dressing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Absorptive Capacity | Same as predicate device (K083870) |
| Moisture Content | Same as predicate device (K083870) | |
| Drop Penetration | Not explicitly stated as "same as predicate," but implied as acceptable | |
| Adhesion | Same as predicate device (K083870) | |
| Abrasion | Same as predicate device (K083870) | |
| Silver Content | Specific amount: 0.4 mg/cm² (2.5% w/w) (implied as acceptance criteria met) | |
| Biocompatibility | Biocompatibility (toxicity, irritation, sensitization) | No new safety concerns relative to biocompatibility; predicate was non-toxic, non-irritant, non-sensitizing |
| Antimicrobial Efficacy | Anti-microbial (Bacterial) Effectiveness (in vitro) | Effective against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Enterococcus faecalis (in direct contact) |
| Bactericidal Effectiveness (in vitro, 7-day claim) | Maintains antibacterial activity for up to 7 days against Pseudomonas aeruginosa and Staphylococcus aureus | |
| Manufacturing Process | Manufacturing changes do not affect safety or efficacy | Final product specifications remain unchanged, no concerns related to safety or effectiveness from manufacturing process change |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each in-vitro test (e.g., how many dressings tested per bacterial strain, or how many iterations for physical tests). It only states that "in vitro data have demonstrated..."
- Data Provenance: The studies were in vitro (laboratory-based) and conducted by the manufacturer, Exciton Technologies Inc., based in Canada. Given the context of a premarket notification, these are prospective studies conducted to support the device's claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For in-vitro studies, ground truth is typically established by the scientific methodology itself (e.g., bacterial count reduction based on established laboratory protocols), rather than by expert consensus on individual "cases."
4. Adjudication Method for the Test Set
- This information is not applicable as the studies described are in-vitro efficacy and physical performance tests, not human-reader-based assessments requiring 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
- No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, and the studies described are primarily in-vitro performance and biocompatibility assessments, not studies involving AI-assisted human readers.
6. 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 or AI.
7. The Type of Ground Truth Used
- The ground truth for the performance tests (e.g., antimicrobial activity, physical properties) was established through laboratory-based, scientific measurement and observation using validated protocols (e.g., bacterial culture methods for antimicrobial efficacy, standardized tests for absorptive capacity). For biocompatibility, it was based on standardized biological reactivity tests.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI models, therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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