(108 days)
AQUACEL® Ag Surgical SP may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
Under the supervision of a healthcare professional, AQUACEL™ Ag Surgical SP cover dressing may be used for the management of:
Wounds healing by primary intent (e.g. traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
AQUACEL™ Ag Surgical SP dressing is a sterile post-operative dressing comprising of an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and ionic silver which is stitch bonded with nylon and elastane yarns. The pad is held in place between a top layer of hydrocolloid adhesive which is bound to an outer polyurethane film and a windowed skin contact layer consisting of polyurethane film sandwiched between one layer of acrylic and one layer of Hydrocolloid contacting the skin.
The outer layer of polyurethane film of AQUACEL™ Ag Surgical SP dressing provides a bacterial and viral barrier to reduce the risk of infection provided the dressing remains intact and there is no leakage.
The highly absorbent central Hydrofiber™ pad absorbs and retains serosanguinous leakage and transforms into a soft gel which maintains a moist environment to support the body's healing process.
The hydrocolloid component of the dressing provides secure, skin friendly adhesion and supports non traumatic removal of the dressing while minimizing damage to the intact surrounding skin.
AQUACEL™ Ag Surgical SP dressing is a waterproof, bacterial and viral barrier dressing which is designed to conform to changes in the wound/incision geometry during body movement and post-operative edema.
The dressing is intended for single use and is provided sterile (via a gamma irradiation process).
This Special 510(k) details the modifications of the predicate device, AQUACEL™ Ag Surgical dressing, which form the AQUACEL™ Ag Surgical SP dressing. These modifications do not alter the intended use or indications for use.
This document is a 510(k) Summary for the AQUACEL™ Ag Surgical SP Dressing, demonstrating its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a diagnostic AI device would. Instead, it focuses on non-clinical testing to show performance comparability and safety.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document in the typical sense for a diagnostic device. However, I will answer the questions based on the information provided, explicitly stating where the information is not available or not applicable.
Here's an interpretation of the request in the context of this document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds in the way a diagnostic AI would have for sensitivity, specificity, etc. Instead, the acceptance criterion for this submission is substantial equivalence to the predicate device based on comparable functional and structural design parameters and biological safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Design Parameters: (e.g., fluid handling) | Found to be comparable to the predicate device. |
| Structural Design Parameters: (e.g., adhesive properties) | Found to be comparable to the predicate device. |
| Biological Evaluation: Non-toxic, biocompatible. | Found safe for its intended use, in accordance with ISO-10993. |
| Intended Use & Indications for Use: Identical to predicate device. | The modifications do not alter the intended use or indications for use. Indications are identical to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical testing" but does not specify sample sizes or data provenance.
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)
This information is not applicable as this is not a diagnostic device involving expert interpretation or ground truth establishment in that manner. The evaluation is based on laboratory/bench testing and biological assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
This information is not applicable. This is not an AI/diagnostic device; no human reader studies or MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is based on established testing methodologies and standards for medical device performance (e.g., fluid handling, adhesion strength, biocompatibility testing) for which the predicate device's performance already set a benchmark. It is not expert consensus, pathology, or outcomes data in the diagnostic sense.
8. The sample size for the training set
This information is not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set.
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