(194 days)
Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.
Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.
The document describes the Prontosan® Wound Gel X, a wound dressing, and its substantial equivalence to predicate devices. It mentions that performance testing was conducted to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1 | Test results met the acceptance criteria. |
| USP | Not explicitly stated, implied to be passed | Test results met the acceptance criteria. |
| Strike Through Barrier Test | Not explicitly stated, implied to be passed | Test results met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on the sample sizes used for the biocompatibility, USP , or Strike Through Barrier tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The testing described appears to be laboratory-based performance and biocompatibility testing, not studies requiring expert interpretation of results to establish ground truth in the context of medical imaging or diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing described does not involve adjudication as it's not a study where human readers or algorithms interpret data against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through biocompatibility and performance testing, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as Prontosan® Wound Gel X is a wound dressing, not an algorithm or AI device. The studies mentioned are traditional medical device performance tests.
7. Type of Ground Truth Used
The ground truth for the performance tests (Biocompatibility, USP , Strike Through Barrier Test) would be established by the defined standards and protocols of these specific tests. For example, for biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1. For USP , it likely refers to antimicrobial effectiveness testing against predefined microorganisms and reduction criteria.
8. Sample Size for the Training Set
This is not applicable and not provided. Prontosan® Wound Gel X is a medical device (wound dressing), not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set for this type of medical device.
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