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The Antlia III™ Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluid, including wound exudates, irrigation fluids, body fluids and infectious materials.

The Antlia III™ Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the ITI Dressing to remove fluid and infectious materials from the wound as it may promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.

The Antlia III™ Wound Treatment System consists of the same powered suction pump components and functions the same as the Antlia II Suction Pump device, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the ITI 300cc and 500cc collection canisters, and optional pressure settings of -50mmHg, -75mmHg, -100mmHg, - 125mmHg, and -150mmHg.

Based on the provided text, the document describes a 510(k) submission for the Antlia III™ Wound Treatment System, a medical device. The information provided heavily pertains to substantial equivalence and safety and electrical testing, rather than a clinical performance study of an AI/algorithm-based device.

Therefore, I cannot fulfill most of your request as the provided text does not contain the information related to an AI/algorithm-based device's validation study including:

• Acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets (beyond general product testing)
• Data provenance for clinical images/data
• Number of experts for ground truth establishment or their qualifications
• Adjudication methods
• MRMC studies or effect sizes for AI assistance
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data) for clinical performance
• Training set details (sample size, ground truth establishment)

The document focuses on demonstrating that the Antlia III is substantially equivalent to a predicate device (Antlia II) based on:

• Similar technological characteristics and function: It's described as having the same powered suction pump components and functions, just in a smaller, lighter enclosure with optional pressure settings.
• Non-clinical tests: IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility were conducted.
• Verification and Validation activities: These were performed based on risk analyses for the device modifications, and it's stated that "predetermined acceptance criteria were met." However, the specific criteria and performance results are not detailed in the summary provided. They refer to the full V&V documentation which is not included here.

In summary, the provided text describes a submission for a physical medical device (negative pressure wound therapy system), not an AI/algorithm-based device. Hence, the requested parameters for an AI device's validation study are not applicable or present in this document.

If you were expecting information on an AI device, please provide the relevant documents for such a device.

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