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The Agelet system is an electrosurgical device and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The AgeJet system is an electro-surgical device intended for use in dermatological applications in hospital and clinics. The AgeJet system comprises of the following: AgeJet Generator, Footswitch, Handpiece/Cable Assembly, Handpiece holder, Procedure Pack, Nitrogen Gas Cylinder & Pressure regulator, and Cylinder Holder Plate Kit.

{"acceptance_criteria_table": [{"Acceptance Criteria": null, "Reported Device Performance": {"Characteristics": "Proposed device AgeJet Device K212472", "PlaDuo System K201735": "Degree of equivalence", "Frequency": "2.45Ghz", "Modulation": "Pulsed Carrier wave", "Max Power (w) overall": "260W (260-160 = 100W)", "Cooling compressor power (W)": "160W", "Maximum Magnetron output": "900W (AgeJet uses only 11% of total at all energy levels)", "Output Energy (joule)": "0.5-41", "Repetition rate": "1-3 Hz", "Pulse Width (single pulse)": "4 to 15ms", "Depth of Thermal effect": "Up to 350 microns", "Gas requirement": "Medical grade Nitrogen 99.9%", "Electrical supply Voltage": "AC 110 - 240 Volts 50/60 Hz", "Mains connection": "Detachable Power Cord to IEC type appliance inlet Mains Switch controlled ON/OFF Operation", "Device classification": "Class II", "Regulation number": "21 CFR 878.4400", "Rx/OTC": "RX", "Device classification name": "Electrosurgical cutting and coagulation device and accessories", "Device product code, classification name": "GEI"}}}], "sample_size_test_set": "Not applicable; non-clinical performance tests were conducted on tissue samples, not human subjects.", "data_provenance": "In vitro testing on four different types of tissue.", "number_of_experts_ground_truth": "Not applicable for non-clinical performance testing of thermal damage profiles.", "qualifications_of_experts": "Not applicable; histology samples were analyzed, suggesting pathologists or similar experts would interpret the results, but specific qualifications are not provided.", "adjudication_method": "Not applicable for non-clinical performance testing.", "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.", "effect_size_human_readers_improve": "Not applicable, as no MRMC study was performed.", "standalone_performance_done": "Yes, standalone performance testing was done to assess output power values and functionality. In vitro testing on tissue samples also evaluated the device's ability to achieve consistent thermal damage profiles.", "type_of_ground_truth_test_set": "Histological analysis of thermal damage profiles in tissue samples.", "sample_size_training_set": "Not applicable; this is not an AI/ML device that requires a training set.", "ground_truth_established_training_set": "Not applicable."}

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