(13 days)
The exsalt™ T7 Wound Dressing is indicated for use in 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™ T7 Wound Dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing for up to 7 days.
Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven polyester with gray Delnet® HDPE mesh layers thermally bonded on both sides. Silver in the exsalt™ T7 Wound Dressing inhibits bacterial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (4.5% w/w). The exsalt™ T7 Wound Dressing is known to be effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days. The exsalt™ T7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of polyester which are all silver-coated. The skin-contacting materials in both the exsalt™ T7 Wound Dressing and the predicate are the same. The exsalt™ T7 Wound Dressing is sterilized by gamma irradiation.
The provided document is a 510(k) summary for a medical device (exsalt™ T7 Wound Dressing). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a standalone clinical study or multi-reader multi-case (MRMC) study for an AI algorithm.
Therefore, many of the requested categories related to AI algorithm evaluation, such as acceptance criteria in terms of diagnostic performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC study details, are not applicable to this type of device and submission.
However, I can extract the relevant information regarding performance testing that was conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Silver Content | Equivalent to predicate (exsalt™ SD7 Wound Dressing) | Performed on exsalt™ SD7, implied equivalence for exsalt™ T7. |
| Moisture Content | Equivalent to predicate | Performed on exsalt™ SD7, implied equivalence for exsalt™ T7. |
| pH | Equivalent to predicate | Performed on exsalt™ SD7, implied equivalence for exsalt™ T7. |
| Absorbency | Equivalent to predicate | Performed on exsalt™ SD7, implied equivalence for exsalt™ T7. |
| Anti-bacterial Effectiveness | Effective against specified bacteria for up to 7 days, equivalent to predicate | Effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days (for exsalt™ T7 and implied for predicate). |
| Bactericidal Effectiveness | Equivalent to predicate | Performed on exsalt™ SD7, implied equivalence for exsalt™ T7. |
| Biocompatibility | Non-toxic, non-irritant, non-sensitizing | Testing on exsalt™ SD7 (K083870) showed it was non-toxic, non-irritant, and did not elicit a sensitization response. Exsalt™ T7 raised no new safety concerns relative to biocompatibility. |
| Biological Reactivity | Equivalent to predicate | Performed on exsalt™ SD7, implied equivalence for exsalt™ T7. |
| Substrate Configuration Change | No new safety or effectiveness concerns compared to predicate | The change in substrate configuration does not raise any concerns related to safety or effectiveness. |
Study Proving Device Meets Acceptance Criteria:
The device's performance is not proven through a single, comprehensive study with explicit acceptance criteria for diagnostic metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (exsalt™ SD7 Wound Dressing, K103067 and K083870) through a series of performance tests and by asserting that differences in design (specifically the substrate configuration) do not raise new issues of safety or effectiveness.
The document states: "All performance characteristics of the exsalt™ T7 Wound Dressing are the same as the predicate(s)." and "The exsalt™ T7 Wound Dressing raised no new safety concerns relative to biocompatibility. Testing performed on the exsalt™ SD7 Wound Dressing (K083870) showed that it was nontoxic, non-irritant, and did not elicit a sensitization response."
The antibacterial effectiveness for exsalt™ T7 is specifically mentioned as being effective in vitro against the listed bacteria for up to 7 days, which is consistent with the intended function.
Details Not Applicable for this 510(k) Submission:
The following information types are typically relevant for AI/software as a medical device (SaMD) submissions involving diagnostic or screening performance, but are not provided or applicable in this 510(k) for a wound dressing, which focuses on material properties, safety, and functionality claims based on in vitro testing and equivalence to an existing product:
- Sample size used for the test set and the data provenance: Not applicable. Performance tests were likely conducted on laboratory samples of the dressing, not a patient test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the clinical diagnostic sense was established.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" was likely defined by standardized laboratory test results for material and antimicrobial properties.
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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