(197 days)
For over-the-counter use, Exufiber Ag+ may be used for:
- · Abrasions
- · Lacerations
- Minor cuts
- · Minor scalds and burns
Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:
- · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers
- · Pressure ulcers (partial and full thickness)
- Partial thickness burns
- · Donor sites and other wounds that are prone to bleeding, such as debrided wounds
- Traumatic wounds
- Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
- · Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.
Indicated wear time: up to seven (7) days.
Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.
The provided document is a 510(k) Summary for the "Exufiber Ag+ Antimicrobial Gelling Fibre Dressing" and mainly focuses on demonstrating substantial equivalence to a predicate device ("Aquacel Ag Extra Hydrofiber Dressing with Silver and Strengthening Fiber"). It does not include detailed information about specific acceptance criteria and a study proving the device meets those criteria, as one would expect for a performance study with detailed metrics.
Instead, the document states: "In vitro and in vivo methods have been used to demonstrate the safety and effectiveness of the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing with regards to the following parameters: Cytotoxicity, Irritation, Sensitization, Wound healing model, Antimicrobial efficacy against 11 strains, Silver release kinetics, Minimum effective concentration." It also explicitly states: "No clinical data was required to support substantial equivalence."
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance based on the input text. The information is not present in this regulatory submission.
However, I can extract the general categories of performance data mentioned:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., "cytotoxicity level must be below X") or detailed quantitative reported device performance for these criteria. It only lists the types of tests performed to demonstrate safety and effectiveness.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Cytotoxicity | Demonstrated safety |
| Irritation | Demonstrated safety |
| Sensitization | Demonstrated safety |
| Wound healing model | Demonstrated effectiveness |
| Antimicrobial efficacy (against 11 strains) | Demonstrated effectiveness |
| Silver release kinetics | Performed and evaluated |
| Minimum effective concentration | Performed and evaluated |
2. Sample sized 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 studies mentioned are described as "in vitro and in vivo methods," which typically refer to laboratory and animal studies, not human clinical trials in this context.
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 provided in the document. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant for the types of in vitro and in vivo safety/effectiveness studies mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as it's not applicable to the types of studies described (laboratory and animal studies for safety and effectiveness).
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to an antimicrobial gelling fibre dressing. The document explicitly states "No clinical data was required to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a medical device like a wound dressing. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mentioned studies:
- Cytotoxicity, Irritation, Sensitization: Likely based on standardized biological assay results (e.g., cell viability, skin reactions) compared against established safety thresholds.
- Wound healing model: Likely based on observable physiological changes and measurements in an animal model, compared to controls.
- Antimicrobial efficacy: Likely based on laboratory measurements of bacterial count reduction (e.g., colony-forming units) after exposure to the dressing, compared to specified acceptance criteria.
- Silver release kinetics: Likely based on analytical chemistry measurements of silver concentration over time.
- Minimum effective concentration: Likely based on microbiology experiments to determine the lowest concentration of silver needed to inhibit microbial growth.
8. The sample size for the training set
This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.
N/A