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The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves (Product Code "JOW"). They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered by an external IEC 60601-1 Power Supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.

The provided text describes a 510(k) premarket notification for the NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 devices. It focuses on demonstrating substantial equivalence to existing predicate devices (NormaTec PCD-B and NormaTec PCD-T K161346) rather than proving de novo acceptance criteria for an AI/ML medical device through a performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.

The provided text concerns a device that applies pressure to extremities for therapeutic purposes, which falls under physical therapy or rehabilitation, not an AI/ML imaging or diagnostic device. The "AI" mentioned is simply a mobile application that mimics the physical device's user interface via Bluetooth, not an artificial intelligence algorithm that performs analysis or makes decisions.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. AI/ML Device Context: The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are compressible limb sleeves. Their core function is mechanical (applying pressure). The "Bluetooth capability" and "NormaTec app" are described as solely mimicking the device's physical interface ("does not provide or unlock any additional features or alter the therapy provided by the device"). This indicates the device does not employ AI/ML for analysis, diagnosis, or treatment planning that would require performance criteria as typically assessed for AI/ML medical devices.

2. Regulatory Pathway: The document is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device. This pathway typically relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons and non-clinical testing (e.g., electrical safety, EMC, performance verification), not necessarily extensive clinical performance studies comparing diagnostic accuracy or AI algorithm performance.

Therefore, the specific information requested in the prompt (acceptance criteria for AI/ML performance, ground truth, expert opinions, MRMC studies, etc.) is not applicable to or present in this 510(k) submission, as it pertains to a different type of medical device and regulatory evidence.

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