(269 days)
Suprasorb® A +Ag "R" can be used for the management of wounds, in adult patients only, 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 "R" is a calcium alginate dressing with antibacterial silver. This device is a minor modification of the predicate device in which regenerated cellulose fibers (Tencel®) for strengthening purposes has been added. The dressings are also made in 2 variants namely 120 gsm and 200 gsm (in line with customer requirements for various options when choosing suitable size dressing for a wound) and are soft, conformable wound covers with a high mannuronic acid content. 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 5 days in the in vitro challenge test. The Suprasorb® A + Ag "R" Calcium Alginate Dressings with antibacterial silver (reinforced variant) are sterilized by irradiation and must not be re-sterilized. The product remains sterile unless the package is opened or damaged. Single use only should be applied and the product is for prescription use only.
The provided text describes a medical device, Suprasorb A + Ag "R", a calcium alginate dressing with antibacterial silver, and its substantial equivalence to a predicate device, Suprasorb A + Ag (K071442). The document focuses on demonstrating that the modified device, despite adding regenerated cellulose fibers for strengthening, maintains equivalent safety and performance.
However, the document does not describe a study that uses acceptance criteria in the context of a diagnostic or AI-driven device's performance metrics like sensitivity, specificity, or AUC, or human reader performance. Instead, the "acceptance criteria" discussed are related to the biological and physical properties of a wound dressing, which are verified through various physical and chemical tests.
Therefore, many of the specific points requested in the prompt related to acceptance criteria for device performance (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable or
available from this document.
Below, I will present the information that is present in the document, framed as closely as possible to your request, and explicitly state what information is not available.
Acceptance Criteria and Device Performance for Suprasorb A + Ag "R"
The acceptance criteria and reported device performance are based on the comparison of the subject device (Suprasorb A + Ag "R") to its predicate device (Suprasorb A + Ag, K071442). The "performance" in this context refers to the physical, chemical, and biological properties of the wound dressing, rather than diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Suprasorb A + Ag "R") | Comparison/Outcome |
|---|---|---|---|
| Intended Use | Same as predicate: Management of wounds in adult patients that are moderately/heavily exuding, superficial or deep (e.g., Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds). | Same as predicate. | Equivalent |
| Mode of Action | Releases silver ions into dressing, absorbs wound exudate, forms gel, traps debris/bacteria. | Same as predicate. | Equivalent |
| Silver Release | 22 ppm at 7 days (predicate) | 200 gsm: 22 ppm at 7 days; 120 gsm: 21.7 ppm at 7 days | Equivalent |
| Absorbency | 19 g/100cm² (predicate) | 200 gsm: 12 g/100cm²; 120 gsm: 22 g/100cm² | Similar |
| Tensile Wet Strength | MD 1.4 N/cm; CD 0.6 N/cm (predicate) | 200 gsm: MD 4.3 N/cm, CD 12.1 N/cm; 120 gsm: MD 2.4 N/cm, CD 5.5 N/cm | Equivalent (improved for subject device) |
| Antibacterial Activity | Log reduction for various bacteria > 4 | Log reduction for 4 gram positive and 3 gram negative bacteria > 4. | Meets requirement |
| Biocompatibility | Pass biocompatibility requirements of applicable standards (ISO 10993-1, etc.) | Comprehensive biocompatibility testing confirmed no safety concerns. | Meets requirements |
| Sterilization Validation | Meets predetermined acceptance criteria as per standards (ISO 11137-1, EN ISO 11137-2). | Successfully met predetermined acceptance criteria. | Met standards |
| Packaging Integrity | Meets predetermined acceptance criteria as per standards (ASTM F1886/F1886M, F1929, F88/F88M). | Successfully met predetermined acceptance criteria. | Met standards |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not provided in the document in terms of specific numbers of samples for each test (e.g., how many dressings were tested for silver release or tensile strength). The document generally refers to "testing" that was conducted.
- Data Provenance: The tests are conducted according to international standards (e.g., ISO, ASTM, British Pharmacopoeia, AATCC), implying laboratory-based testing rather than clinical study data from a specific country or retrospective/prospective design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable and not provided. The "ground truth" for the device's physical and biological properties is established by the results of standardized tests against defined criteria. There is no mention of human expert consensus or clinical adjudication for these types of performance evaluations.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Adjudication is typically associated with human interpretation of medical data, which is not what is being evaluated here. The device's performance is measured against objective laboratory test standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- This information is not applicable and not provided. This document describes a wound dressing, which is a medical device, not an AI or diagnostic tool that involves human readers interpreting medical images. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- This information is not applicable and not provided. This device is a wound dressing, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective measurements from laboratory tests conducted according to recognized international and pharmacopoeia standards (e.g., AATCC 100 for antibacterial activity, British Pharmacopoeia for absorbency and wet tensile strength, ISO 10993 for biocompatibility, ISO 11137 for sterilization, ASTM for packaging). These standards themselves define what constitutes acceptable performance for each characteristic.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. This product is a physical medical device (wound dressing), not a software algorithm that requires a training set. The "training" for such a device involves manufacturing processes and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided for the reasons mentioned in point 8.
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