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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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SMOOTHKIT+ is intended for laser assisted lipolysis.

SMOOTHKIT+ is a medical laser accessory. It includes a cannula crimped on an optical fiber and a handpiece. The extremity of the cannula is sharp edges rounded. The extremities of the cannula and of the optical fiber are in the same plan and there is some adhesive between the cannula and the fiber at the distal end.

The provided text is a 510(k) summary for a medical device called SMOOTHKIT+ and the FDA's clearance letter. This document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered device, which is what your request implies with "AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "ground truth," "training set," and "test set."

The SMOOTHKIT+ is described as a "medical laser accessory" intended for "laser assisted lipolysis." The "Performance data" section explicitly states: "Performance data demonstrate the safety and effectiveness (mainly biocompatibility) of SMOOTHKIT+ for its intended use." This indicates that the performance data for this device primarily focuses on its physical and biological safety, as is typical for a medical accessory of this nature.

Therefore, I cannot fulfill your request for the following reasons:

1. AI/ML Performance Data: The device does not appear to be an AI/ML powered device, and thus, the concepts of acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, F1-score), ground truth, training sets, test sets, or human-in-the-loop performance are not applicable or discussed in this document.
2. Specific Acceptance Criteria: While the document mentions "safety and effectiveness (mainly biocompatibility)," it does not provide a table of specific, quantifiable acceptance criteria (e.g., "biocompatibility must meet ISO 10993 standards") followed by reported performance against those criteria.
3. Study Details: There are no details about specific studies (sample size, data provenance, number of experts, adjudication methods) related to performance metrics that would typically apply to an AI/ML device.

In summary, the provided text does not contain the type of information required to populate the table and answer the study-related questions for an AI/ML device. The device described is a physical medical accessory, and its "performance data" refers to its safety and effectiveness in a traditional sense, not algorithmic performance.

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PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs.

The medical device PHARAON 980 is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. PHARAON 980 includes the whole of the supplies necessary to supply the laser and to ensure its thermalisation using a Peltier element built on a ventilated radiator.

PHARAON 980 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 TFT screen and a tactile flagstone.

PHARAON 980 is available for ENDO application (endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux) and EXO application (photocoagulation of teleangectasia of the legs).

PHARAON 980 EXO is supplied with CONTROL4+ HANDPIECE a dedicated handpiece including an auto-requlated cooling system and video allowing optimal mapping of the treatment area and screen display of the vessel on PHARAON 980.

The provided text is a 510(k) summary for the PHARAON 980 ENDO & EXO laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the PHARAON 980 itself.

Therefore, the requested information for acceptance criteria and a study proving device conformance cannot be fully extracted from the provided document. The document states that the device "conform[s] to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)" and "conform[s] to 21 CFR part 1040.10 and 1040.11," indicating compliance with regulatory standards, not performance against specific clinical acceptance criteria.

The 510(k) summary explicitly states: "Performance data demonstrate the safety and effectiveness of PHARAON ENDO /EXO for its intended use." However, it does not provide this performance data, acceptance criteria, or details of the study in the document itself. The basis for substantial equivalence is primarily the similarity in intended use, design, and function to the predicate device, CERALAS D 980 LASER SYSTEM.

Here's what can be stated based on the provided text, and what cannot be:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document does not list specific acceptance criteria (e.g., success rate, complication rate, accuracy, sensitivity, specificity) for the PHARAON 980 device's clinical performance. It also does not report specific device performance metrics against such criteria. The document states that "Performance data demonstrate the safety and effectiveness," but does not present the data itself.

2. Sample size used for the test set and data provenance:

• Cannot be provided. The document does not describe any specific clinical "test set" for the PHARAON 980 device. The performance claims are based on substantial equivalence to the predicate device, not on a new clinical study with a specified sample size or data provenance for the PHARAON 980.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Cannot be provided. Since no specific clinical test set is described for the PHARAON 980 device, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set:

• Cannot be provided. No test set is described.

5. Multi-reader multi-case (MRMC) comparative effectiveness study information:

• No, an MRMC comparative effectiveness study was not done according to the provided text. This device is a laser surgical instrument, and MRMC studies are typically for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. This document does not mention any human-in-the-loop performance or AI assistance.

6. Standalone (algorithm only without human-in-the-loop performance) study information:

• Not applicable in the context of this device. The PHARAON 980 is a laser surgical instrument; its "performance" is about its physical operation, safety, and effectiveness in delivering laser energy as intended, not about an algorithm's standalone diagnostic performance. The document mentions conformity to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)," which suggests software is involved, but not in a diagnostic or interpretive capacity that would typically warrant a "standalone" algorithm performance study as understood in AI/imaging contexts.

7. Type of ground truth used:

• Cannot be provided as no specific clinical study data for the PHARAON 980 is presented. For a laser device, "ground truth" (if a study were conducted) would likely relate to clinical outcomes (e.g., successful coagulation, absence of reflux, teleangectasia reduction, complication rates) rather than expert consensus on an image or pathology.

8. Sample size for the training set:

• Cannot be provided. This is not an AI/ML device in the sense of requiring a "training set" of data to learn from. Its safety and effectiveness are established through engineering design, adherence to standards, and substantial equivalence to a predicate device.

9. How the ground truth for the training set was established:

• Cannot be provided. Not applicable.

In summary: The provided 510(k) summary is typical for a medical device seeking clearance through substantial equivalence. It confirms compliance with relevant regulations and guidance documents and asserts that performance data exists to demonstrate safety and effectiveness. However, it does not present the detailed studies, acceptance criteria, or performance results that would answer the specific questions posed, as these details are usually contained within the full 510(k) submission and not summarized in this public document to the same level of granularity.

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PHARAON LIPO is intended for laser assisted lipolysis

The medical device PHARAON LIPO is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm 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 fiber of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.

In addition PHARAON LIPO 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 TFT screen and a tactile flagstone.

The provided 510(k) K073617 for the PHARAON LIPO device is for a laser surgical instrument, not an AI/algorithm-driven device. Therefore, the information requested about acceptance criteria, study details, ground truth, and expert involvement (which are typically relevant for AI/algorithm performance evaluation) is not explicitly available in this type of submission.

510(k) submissions for devices like PHARAON LIPO primarily focus on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, safety and performance testing against recognized standards, and functional comparison. They do not involve clinical studies with human readers, AI assistance, or the generation of ground truth in the same way an AI diagnostic or prognostic device would.

Based on the provided text, here’s what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that "Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use." However, it does not provide a table of specific quantitative acceptance criteria (e.g., power output tolerance, wavelength stability, thermal management metrics) nor detailed performance data against those criteria. It broadly states conformance to regulatory guidelines and standards.

• Acceptance Criteria (Implicit/General):
  • Conformance to Guidance on the content and organization of a premarket notification for a medical laser (June 1995).
  • Conformance to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
  • Conformance to 21CFR part 1040.10 and 1040.11 (Performance Standards for Laser Products).
  • Demonstration of safety and effectiveness for laser-assisted lipolysis.
  • Substantial equivalence to the predicate device SMARTLIPO (K062321) in terms of intended use, material design, and function.
• Reported Device Performance: The document only makes a general statement: "Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use." No specific quantitative performance metrics are provided in the summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not applicable/not provided in this 510(k) summary for a laser device. There is no "test set" in the context of an algorithm's performance on patient data. Performance evaluation for this type of device typically involves engineering tests, electrical safety tests, electromagnetic compatibility (EMC) tests, and biocompatibility tests, rather than clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable/not provided. Ground truth in the context of clinical images or patient data is not established for a laser device's mechanical or energy delivery performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, typically in AI performance studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/not provided. An MRMC study is designed for evaluating the impact of AI on human reader performance, which is not relevant for a standalone laser surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable/not provided. There is no "algorithm only" performance study relevant to this laser device in the context of AI. The device itself is the "standalone" entity whose physical and electrical performance is being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not applicable/not provided. "Ground truth" as understood in AI studies (e.g., pathology reports for image analysis) is not generated for evaluating the technical performance of a laser device. The "truth" for device performance lies in its adherence to engineering specifications and safety standards.

8. The sample size for the training set:

This information is not applicable/not provided. There is no "training set" for a laser surgical instrument in the context of machine learning.

9. How the ground truth for the training set was established:

This information is not applicable/not provided. As there is no training set, there is no ground truth established for it in this context.

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