(154 days)
Over-The Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Prescription Indications:
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
Silverlon Wound Contact, Burn Contact Dressings are sterile, porous, non-adherent, knitted nylon plated with 99% elemental silver oxide. Silver oxide. Silverlon Wound Contact, Burn Contact Dressings delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed.
Silverlon Wound Contact, Burn Contact Dressings are used as the primary wound contact layer and is placed under reticulated foam, gauze, or other wound dressings. Silverlon Wound Contact, Burn Contact Dressings are non-adherent, wound care dressings designed to be used up to seven (7) days.
The provided document is a 510(k) summary for the Silverlon® Wound Contact, Burn Contact Dressings. It describes the device, its indications for use, and a nonclinical (animal) study conducted to support an expanded indication.
Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance
The document describes a non-inferiority study performed on Gottingen minipigs. The acceptance criteria are based on a "non-inferiority margin" for a "histopathology composite score."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Inferiority Margin: 1.5 points (or 10% of maximum possible score of 15) for the total histopathology composite score. The subject device is considered non-inferior if its score is not substantially worse than the standard of care. | Moderate Partial Thickness (DD) Injuries: Mean composite histopathology score for the subject device was 0.36 points higher than standard of care. |
| Superficial Partial Thickness (SD) Injuries: Mean composite histopathology score for the subject device was 0.01 points higher than standard of care. | |
| Conclusion: | The study demonstrated that the Silverlon Wound Contact, Burn Contact Dressing is non-inferior to standard of care for both moderate and superficial partial thickness mustard-induced vesicant injuries. For DD injuries, this was demonstrated when changed every 7 days, and for SD injuries, when changed every 4 days. |
Explanation of Performance:
Since a higher histopathology score is implicitly better (as the device score was higher than the standard of care and still met non-inferiority), the device performed as well as or slightly better than the standard of care, falling within the pre-defined non-inferiority margin.
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 165 Gottingen minipigs.
- Data Provenance: Nonclinical study, animal data (Gottingen minipigs). The study was a GLP (Good Laboratory Practice) nonclinical study.
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):
The document does not specify the number or qualifications of experts used to establish the ground truth (histopathology scores). It only mentions that the primary endpoint was the "histopathology composite score." Typically, a pathologist would be responsible for such assessments, but no details are provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any expert adjudication method for the histopathology scores. It only refers to a "histopathology composite score," which implies a single score derived from the histological examination.
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. This was a nonclinical (animal) study comparing the wound dressing to standard of care. It was not an MRMC study and did not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This was a nonclinical study of a physical wound dressing device. It does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The primary endpoint (ground truth) was a histopathology composite score of dermal wounds. This suggests a pathology-based assessment.
8. The sample size for the training set:
Not applicable. This was a nonclinical study of a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there was no training set.
N/A