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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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The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types

The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types. The mechanism of action of the Subject Device involves the delivery of thermal energy to the subcutaneous tissue and the deep dermis. The Device utilizes the electromagnetic waves originated from two poles: a single electrode on the handpiece that contacts the skin and a grounding reference plate (monopolar RF), or two electrodes of the handpiece placed over the treatment area (bipolar RF). Medical RF is equipped with three types of handpieces: Two monopolar handpieces (small and medium) and one bipolar handpiece; all of them contain a sensor temperature used by the DTC (Derma Temperature Control) technology. The DTC is an innovative system that instantly detects the temperature of the skin and regulates the power emissions to maintain (at the same value) the transferred temperature of RF during the treatment. The DTC system allows the operator to know the real-time temperature of the skin surface, there is no further need to manually regulate the power according to the temperature changes during the treatment session. DTC technology ensures the safety and effective functioning of the Subject Device. The user always knows the real-time temperature on the skin during the treatment and does not have to manually change the power emissions in relation to the patient's perception of heat, thereby improving the efficacy of the treatment. The Subject Device is recommended to be used by trained and qualified personnel only and includes a dedicated software (interface RS-232), installed by the manufacturer in the device's memory.

I am unable to provide a comprehensive answer to your request because the provided text describes a 510(k) premarket notification for a medical device (Medical RF) and states that "Results of the clinical testing demonstrated that the Subject Device is safe and effective for its intended use." However, the document does NOT contain a table of acceptance criteria, nor does it explicitly detail the study that proves the device meets specific acceptance criteria in the format you've requested.

Here's what I can extract from the provided text and why I cannot complete the table or provide all the requested details of a study that proves device meets criteria:

Device: Medical RF

Intended Use: Non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.

What the document does describe related to performance (but not as formal acceptance criteria table):

• Clinical Evaluation: A clinical study was conducted.
• Success Metric: "Any wrinkle score improvement (downgrade score >1) following the last treatment and at the follow-up visit, relative to pre-treatment wrinkle (baseline) score, was considered a success."
• Result: "Analysis of photographic results reveals improvements in facial wrinkles (downgrade of at least 1 score, according to the Fitzpatrick scale) in all (100%) patients according to the clinical assessment."
• Statistical Significance: "Score differences were found to be statistically significant while comparing baseline scores to the scores obtained at the end of treatment (p1 from baseline) | 100% of patients showed improvement (downgrade of at least 1 score on Fitzpatrick scale) |
  | Statistical significance of improvement (p

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