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The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Negative pressure wound therapy system

The provided document is a 510(k) premarket notification for a medical device (Prevena Incision Management System). It does not describe a study involving an AI/Machine Learning device or outline particular acceptance criteria usually associated with such devices (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the device to a predicate device, focusing on functional and safety aspects for a medical device.

Therefore, I cannot extract the acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, or ground truth information relevant to an AI/ML device from the provided text.

The document primarily focuses on:

• Device Description and Indications for Use: The Prevena Incision Management System manages surgical incisions by maintaining a closed environment and removing exudate via negative pressure wound therapy.
• Comparison to Predicate Device: The current device is substantially equivalent to a previously cleared Prevena Incision Management System (K121883). The core technology (negative pressure wound therapy) and primary components are the same.
• Technological Differences: Minor changes were made to the software to reduce "nuisance alerts" related to the Leak Alert and Low Battery Alert mute times and a slight increase in the air leak threshold.
• Non-Clinical Testing: Bench tests were conducted to confirm the therapy unit delivers negative pressure within specifications, software verification and validation, and battery life testing.
• Clinical Testing: No clinical tests were deemed necessary for substantial equivalence. However, usability testing was conducted with patient users to assess the impact of labeling changes due to software modifications, and all usability goals were met.

In summary, this document is for a traditional medical device demonstrating substantial equivalence, not an AI/ML device.

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