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extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

extriCARE® Negative Pressure Wound Therapy 100cc canister extriCARE® Negative Pressure Wound Therapy 250cc canister extriCARE® Negative Pressure Wound Therapy 400cc canister

I apologize, but the provided text from the FDA 510(k) summary (K132252) for the ExtriCARE® Negative Pressure Wound Therapy system does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or details of a device performance study.

The document is a letter of substantial equivalence from the FDA, confirming that the ExtriCARE® device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory classification, general controls, and labeling requirements.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance: This information is not present.
• Sample size and data provenance for the test set: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• MRMC comparative effectiveness study details: Not mentioned.
• Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not applicable, as this is a physical medical device.
• How ground truth for the training set was established: Not applicable.

The document states the device's Indications for Use, which is: "extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing." This describes the intended function but does not provide performance metrics or studies to support specific claims.

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