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The Exsudex™ Wound Drainage Device is indicated for patients who would benefit from the application of negative pressure to the area of a wound to promote wound healing by drainage of fluids and infected materials from the wound and wound bed.

The Exsudex™ Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient's bedside particularly as the device may promote wound healing.

The Exsudex™ unit is a compact portable suction device that can be powered by either an internal battery pack or wall current and is compatible with U.S. electrical standards. The pump will be used in combination with accessory kits to create localized topical negative pressure and promote wound healing by drainage of fluids and infected materials from the wound and wound bed into a disposable canister.

The Exsudex™ consists of a medium sized housing that contains a vacuum pump and control system with a location for a fluid canister system. There is also a bacterial filter which is plugged directly into a housing in the pump and replaced as necessary. Accessories include a bed clamp, infusion pole clamp and carry bag. For the expanded indication of use for wound healing the unit is used in conjunction with accessory kits conforming to the guidelines for dressings developed by Chariker et al already available in the U.S. market. This kit consists of individually reviewed medical components that have added instructions for use. The kits are considered "Convenience Kits", falling under the General Surgical classification (see 21 CFR 878.4800.)

To use the pump, the suction tube must be connected to the canister and to the drain.

After checking the set up and confirming connection between the drain, the Exsudex™ is activated by pressing the start/stop button.

To ensure the maintenance of the desired level pressure, Exsudex™ monitors and controls:

• . The buildup of pressure
• . pressure loss
• . pressure tolerance

The Exsudex™ is intended for acute, institutional, and long-term care use and only when prescribed by a physician. Product may be indicated for patient home-care, when carefully monitored by licensed home health-care providers, and only when prescribed by a physician.

The provided text is a 510(k) Summary for the Exsudex™ Wound Drainage Pump. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical study with structured acceptance criteria and device performance metrics in the way a clinical trial report would.

Therefore, many of the requested sections about specific acceptance criteria and detailed study results cannot be fully populated from this document. The document describes technological characteristics, functional performance and electrical leakage testing, and states "extensive clinical use in Europe." It doesn't present a randomized controlled trial or a standalone performance study with quantifiable acceptance criteria.

However, I can extract the information that is present and highlight what is not available.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantifiable acceptance criteria with corresponding reported device performance in a table format. The primary "performance" is stated as having "the same intended uses as the predicate devices, with similar technological characteristics" and that "The system performs as intended and raises no new safety or effectiveness issues."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Verification and validation testing of the Exsudex™ device, including functional performance testing and electrical leakage testing." It does not provide:

• A specific sample size for a test set (e.g., number of patients, number of cases).
• Data provenance beyond "extensive clinical use in Europe." It does not specify whether this was retrospective or prospective data.

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 establishment, expert review, or qualifications are not detailed for any testing related to clinical performance. The document refers to "established design control procedures" for functional and electrical testing, which typically do not involve expert ground truth in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

No MRMC study is mentioned. This device is a powered suction pump, not an AI-assisted diagnostic or therapeutic device for which "human readers improve with AI" would be applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document describes functional performance testing and electrical leakage testing. While these are standalone tests of the device itself, they are not a "standalone algorithm" performance study in the context of AI/ML devices. The device is a physical pump, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Verification and validation testing of the Exsudex™ device, including functional performance testing and electrical leakage testing," the ground truth would likely be established engineering specifications and regulatory standards (e.g., electrical safety standards, vacuum pressure targets). The document does not specify these explicitly but implies adherence to them. For the "extensive clinical use in Europe," no specific ground truth methodology for clinical outcomes is described.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML algorithm that would typically have a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not provided, as it's not relevant to this type of device.

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