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PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.

PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue. After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc. This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.

The provided text is an FDA 510(k) clearance letter and an associated 510(k) summary for the PLAXPOT™ MULTI PLASMA device. This documentation primarily focuses on establishing "substantial equivalence" of the device to legally marketed predicate devices, rather than a detailed study proving the device's clinical performance against specific acceptance criteria for a novel AI/ML device.

Therefore, the document does not contain information regarding acceptance criteria for an AI/ML device, nor does it describe a study that proves the device meets such criteria. The device in question, an electrosurgical device, is not an AI/ML product.

The 510(k) summary (specifically sections 5.8 and Table 2) outlines performance bench tests designed to demonstrate the device's functional requirements and safety as an electrosurgical device, but these are not the type of studies (e.g., MRMC, standalone AI performance) you've inquired about for AI/ML device validation.

Here's an explanation of why the requested information is not present based on the provided text:

• Acceptance Criteria for AI/ML Performance: The document does not mention any AI/ML components. The device operates on the principle of generating plasma through high-frequency current to remove/destroy skin lesions and coagulate tissue. Its "Performance Testing" relates to electrical safety, EMC, and thermal effects, which are standard for electrosurgical devices, not AI/ML performance metrics like sensitivity, specificity, AUC, or F1-score.
• Study Proving Device Meets Acceptance Criteria: No study in the document describes the formal validation of an AI/ML algorithm against specified performance thresholds. The "Performance Testing" section mentions "bench tests" and "functional requirements," which are engineering and electrical safety checks, not clinical performance studies for an AI/ML diagnostic or therapeutic aid.
• Table of Acceptance Criteria and Reported Performance: No such table exists for AI/ML performance. The table (Table 2) lists "Performance Testing Summary" for bench tests with "Pass" results, indicating compliance with electrical safety and other engineering standards.
• Sample Size for Test Set and Data Provenance: Not applicable as there's no AI/ML test set defined.
• Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no AI/ML ground truth generation process described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, as it's not an AI/ML device requiring human-in-the-loop performance evaluation.
• Standalone (Algorithm Only) Performance: Not applicable, as there's no standalone algorithm.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document details the FDA clearance process for an electrosurgical device (PLAXPOT™ MULTI PLASMA) based on substantial equivalence to existing predicate devices. It covers safety, electrical standards, and intended use as an electrosurgical device, but it does not contain any information about an AI/ML component or studies related to AI/ML device performance.

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