(344 days)
Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds which are: Moderately and heavily exuding, Superficial or Deep, Such as: Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds.
Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are soft, conformable wound covers with a high mannuronic acid content. The silver-impregnated calcium alginate fibres, when in contact with wound exudate or blood, form a gel which creates a moist wound healing environment. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days in the in vitro challenge test. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are sterilized by irradiation and must not be re-sterilized. The products are sterile unless the package is opened or damaged. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are for single use only.
The provided 510(k) summary for K071442, "Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver," describes a new device and its substantial equivalence to predicate devices, but does not contain details of a clinical study or acceptance criteria in the typical sense for algorithm performance. Instead, it focuses on demonstrating comparable performance to existing, legally marketed devices through in vitro testing and biocompatibility assessments.
Therefore, the requested tables and specific study details in several sections cannot be fully completed as the document does not describe the types of studies pertinent to algorithm performance, expert ground truth, or MRMC studies.
Below is an attempt to structure the available information provided in the format requested, with specific notes where information is not present in the document.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Assessment Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Equivalence to predicate devices (Aquacel Ag K013814, Maxorb Extra Ag K041316) per ISO 10993-1 and FDA Blue Book memorandum #G95-1 | Results were equivalent to those for the predicate devices. |
| Silver Content | Similar results to predicate devices | Gave similar results to the predicates. |
| Silver Release | Similar results to predicate devices | Gave similar results to the predicates. |
| Absorbency | Similar results to predicate devices | Gave similar results to the predicates. |
| Antibacterial Effect | Demonstrated antibacterial effect against Staphylococcus aureus and Escherichia Coli. Protection from a broad spectrum of bacterial contamination over a period of up to 3 days in in vitro challenge test. | Has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. Silver ions protect the dressing from bacterial contamination for up to 3 days in vitro. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The studies mentioned are in vitro tests and biocompatibility assessments, not a test set for an algorithm. No "data provenance" in the sense of patient data is relevant for these types of tests.
- Data Provenance: The biocompatibility tests were conducted in accordance with ISO 10993-1 and FDA Blue Book memorandum #G95-1. The in vitro tests for silver content, release, and absorbency, and antibacterial effect were also conducted. The country of origin for the device manufacturer is the U.K.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a medical dressing and its performance evaluation does not involve ground truth established by experts in the context of diagnostic algorithms or imaging. The "ground truth" for the performance characteristics (e.g., silver release, absorbency) would be determined by established laboratory measurement techniques, not expert consensus on medical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no test set in the context of expert review or algorithm output adjudication is mentioned.
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
- Not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing with antibacterial properties, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance characteristics (biocompatibility, silver content, silver release, absorbency, antibacterial effect) was established through laboratory testing and standardized in vitro methods according to relevant international standards (ISO 10993-1) and FDA guidance, and comparison to the performance of predicate devices. This does not involve expert consensus on clinical cases, pathology, or outcomes data in the context of diagnostic interpretation.
8. The sample size for the training set
- Not applicable. This device is a physical medical dressing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an algorithm.
N/A