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LIPOCONTROL is indicated for: Laser assisted lipolysis. LIPOCONTROL should be used to melt small amount of fat from small areas only such as chins or upper arms. LIPOCONTROL should not be used to melt larger volumes or areas of fat and on areas such as thighs, buttocks, or abdomen.

The medical device LIPOCONTROL is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ±10nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fibre of 200um or more. The optical fibre is screwed onto the SMA 905 connector of the laser module. LipoControl contains a localisation system. This localisation system is based on a magnetic sensor (LipoBird), positioned on the handpiece and a field transmitter. With this localization system, an informative function and a safety function are built-in: The informative function is a 2D map (display on the device screen) which indicates the area where the energy is deposited and the total amount of energy delivered. The safety function is on the delivered power. Maximum output power and output fiber speed displacement are chosen by physician and delivered when footswitch is pressed and the output fiber speed displacement is over the pre-defined limit. If it the output fiber speed displacement is below the pre-defined limit then the delivered power is diminished. The 2D map can be displayed only if the treatment surfaces are inclined less than 35 decree relative to the observation plane defined by the user. The user can divide the treated area in adiacent areas with an andle less than 35 degree or use the device without these optional functions. The LipoControl includes the power supplies necessary to supply the laser and to ensure its temperature control using Peltier elements built on a ventilated radiator. In addition, the LIPOCONTROL includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a LCD (Liquid Crystal Display) screen and a touch screen controlled by a PC.

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_and_performance": {
      "table": [
        {
          "criteria": "Accuracy of the localization system in normal and worst-case situations (electrical noise, magnetic distortion)",
          "reported_performance": "In good agreement with theoretical accuracy claimed by the supplier of the localization module."
        },
        {
          "criteria": "Accuracy of the energy mapping display",
          "reported_performance": "Complies with the mathematical model of projection in 2D plan of 3D data and to the energy pattern defined by OSYRIS MEDICAL."
        },
        {
          "criteria": "Power regulation according to speed displacement (power diminished if speed below pre-defined limit, full power if speed above)",
          "reported_performance": "When the speed is below the set value, the power is regulated linearly depending on the speed. When the speed is above the set value, the power set is delivered."
        },
        {
          "criteria": "Stop of power delivery if the probe is outside the screen monitoring area",
          "reported_performance": "Checked and confirmed."
        },
        {
          "criteria": "Feasibility of defining Region of Interest (ROI) using Lipocontrol",
          "reported_performance": "Investigator was able to define the ROI using the Lipocontrol, and the ROI recorded by the system matched the one plotted on transparencies."
        },
        {
          "criteria": "Safety and efficacy (subject recovery time, pain/heat sensation, adverse events, subject satisfaction)",
          "reported_performance": "Recovery time less than 1 week. Minor and transitional pain or heat sensation observed. No serious adverse event occurred. Minor and transitional side effects occurred. On average, subjects very satisfied with both the procedure and clinical result."
        }
      ]
    },
    "2_sample_size_and_data_provenance": {
      "sample_size_test_set": "4 subjects (2 treated on the chin, 2 treated on the upper arms).",
      "data_provenance": "Prospective clinical feasibility study."
    },
    "3_number_and_qualifications_of_experts_for_ground_truth": {
      "number_of_experts": "Not explicitly stated. The study involved an 'investigator' who defined the ROI and assessed feasibility. It does not mention multiple experts for ground truth establishment for the device's technical functions but does refer to clinical assessment by 'investigator' and subject questionnaires.",
      "qualifications_of_experts": "Not specified beyond 'investigator'."
    },
    "4_adjudication_method": "Not explicitly stated. The document mentions the 'investigator' defining ROI and assessing feasibility. It does not describe an adjudication process for conflicting interpretations, implying a single assessment method or the details are not provided.",
    "5_mrmc_comparative_effectiveness_study": "No. This study was a feasibility study for a medical device (laser lipolysis system) itself, not an AI-assisted diagnostic device, and thus no MRMC study or human reader improvement effect size is relevant or reported.",
    "6_standalone_performance": "The performance data described for the localization system, energy mapping display, and power regulation are for the algorithm/device's standalone function (bench tests). The clinical feasibility study also assesses the device's function and safety in human use but doesn't compare it directly to unaided human performance in an 'AI vs. human' context.",
    "7_type_of_ground_truth": {
      "technical_functions": "Internal specifications, mathematical models, and supplier claims for the localization module for bench tests.",
      "clinical_feasibility": "Investigator-defined Region of Interest (ROI), comparison of recorded ROI to plotted transparencies, video review, subject questionnaires, and assessment of side effects for clinical tests."
    },
    "8_sample_size_training_set": "Not applicable for this device. This is a medical device (laser system) with a localization and energy regulation system, not an AI/ML model that requires a 'training set' in the traditional sense.",
    "9_ground_truth_for_training_set_establishment": "Not applicable as there is no traditional 'training set' for an AI/ML model for this device."
  }
}

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