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IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns.

IRRIGO Wound Wash Jet System is a sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water for Irrigation and packaged in a food grade compressible translucent LDPE 2oz (60mL) bottle with a LPDE luer-lock type tip spray insert and an HPDE colored cap.

The provided text describes a 510(k) premarket notification for the IRRIGO Wound Wash Jet System. This document is a submission to the FDA seeking to demonstrate substantial equivalence to existing legally marketed devices, not a study proving the device meets specific acceptance criteria through clinical or AI-based performance metrics.

The document discusses bench testing conducted to ensure the device meets established specifications and standards related to its composition, sterility, pressure generation (up to 15 psi), biocompatibility, and packaging integrity. However, it does not present a study with the kind of acceptance criteria, test set, ground truth establishment, or human-in-the-loop performance evaluation that would be relevant for an AI/ML medical device.

Therefore, I cannot provide the requested information for acceptance criteria and study proving device performance, as the document pertains to a medical device for wound irrigation and does not describe an AI/ML-based device or a clinical study with the specified types of performance measures.

Here's why the specific points cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: The document lists standards and tests (e.g., USP standards for sodium chloride irrigation, sterility, endotoxins, biocompatibility tests). It states that the device "is tested against established specifications and meets Biocompatibility requirements" and "IRRIGO Wound Wash Jet System is tested against established specifications and meets Biocompatibility requirements." It also mentions "IRRIGO PSI Testing/Internal Pressure Curves" and that the device "can generate upto 15 psi of stream pressure." However, these are general statements of compliance with technical standards, not a specific table of acceptance criteria with corresponding performance values that would typically be presented for an AI/ML or a complex clinical effectiveness study. There are no performance metrics like sensitivity, specificity, accuracy, or reader improvement.

2. Sample size, data provenance: Not applicable. This is not a study involving patient data or an AI model. The "testing" refers to manufacturing and device-specific technical compliance.

3. Number of experts, qualifications: Not applicable. No ground truth established by experts is mentioned, as this is not a diagnostic device or a study requiring human adjudication of performance.

4. Adjudication method: Not applicable.

5. MRMC comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.

6. Standalone performance (algorithm only): Not applicable. This is not an algorithm.

7. Type of ground truth: Not applicable.

8. Sample size for training set: Not applicable. There is no AI model.

9. How ground truth for training set was established: Not applicable.

In summary, the provided text describes the regulatory filing for a physical medical device (wound wash system) and its bench testing for safety and functional specifications, not a study evaluating an AI/ML device or its clinical performance in the way implied by the request.

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