(254 days)
Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
Prontosan Wound Irrigation Solution is a clear, colorless containing liauid undecylenamidopropyl betaine. polyaminopropyl biguanide, sodium hydroxide and purified water. The solution is aseptically filled using a blow fill seal process into low density polyethylene 40 mL ampoules and 350 mL squeeze bottles with screw caps. Prontosan Wound Irrigation Solution is used for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt and debris.
The provided text is a 510(k) summary for a medical device (Prontosan™ Wound Irrigation Solution). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or expert agreement that would typically be found in an AI/software as a medical device (SaMD) submission.
This document focuses on demonstrating substantial equivalence to an existing predicate device based on:
- Similar Indications for Use: The new device and the predicate device (Dermacyn® Wound Care solution) are both intended for cleaning and irrigating wounds and moistening wound dressings.
- Biocompatibility Testing: To ensure the materials used are safe for bodily contact.
- Functional Performance Testing: To verify the solution performs its intended physical functions.
- Shelf Life Testing: To ensure stability over time.
- Comparison Testing: Directly comparing the proposed device with the predicate device to show similarities and confirm no new safety/effectiveness issues.
Therefore, for the type of information requested (acceptance criteria and study details related to device performance metrics, human-in-the-loop, ground truth, etc., typically found in SaMD studies), the provided text does not contain this information.
Here's a breakdown of why each requested point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This document doesn't provide specific performance metrics or acceptance criteria in the way an AI/software device would (e.g., sensitivity, specificity thresholds). It only states that comparison testing "demonstrated that Prontosan Wound Irrigation Solution, the proposed device is similar to Dermacyn Wound Care solution, the predicate device."
- Sample sized used for the test set and the data provenance: Not applicable or provided. The "testing" mentioned is likely laboratory or chemical analysis, not clinical trials with sample sizes in the context of disease detection or diagnosis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound irrigation solution would relate to its chemical composition, sterility, physical properties, and safety, not expert interpretation of images or clinical data.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study demonstrates improved human performance with AI assistance, which is irrelevant for a wound irrigation solution.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable. This device is a solution, not an algorithm.
- Type of ground truth used: For this type of device, the "ground truth" would be established by rigorous chemical analysis, sterility testing, and biocompatibility standards, not expert consensus or pathology in a diagnostic sense.
- Sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical wound irrigation solution, not an AI/software medical device. As such, it relies on different types of evidence (biocompatibility, functional testing, comparison to predicate) to establish substantial equivalence, rather than the performance metrics and study designs typically associated with AI/SaMD devices.
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