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The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

The InMode RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.

The provided FDA 510(k) summary (K240780) is for an InMode RF System and describes its substantial equivalence to a predicate device (K233642).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing indications for use, technological characteristics, and safety and efficacy data. The acceptance criteria appear to be met by showing that the new handpieces (HP1022B6A and HP2539B6A) perform similarly to the cleared handpieces and predicate device.

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

• Sample size for test set: Not explicitly stated. The document mentions "Comparative ex vivo tissue study results demonstrate the safety and efficacy of thermal effects of the new handpieces on three different tissue types, muscle, liver, and fat." The type of tissue (muscle, liver, fat) is mentioned, but not the number of samples or specimens used for each.
• Data provenance: "ex vivo tissue study." This suggests the data was obtained from tissues outside of a living organism, likely from animal or cadaveric sources in a laboratory setting. The country of origin is not specified. It is a retrospective study in the sense that the data was collected for the purpose of demonstrating equivalence for this submission.

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

The document does not provide any information about the number or qualifications of experts involved in establishing ground truth for the ex vivo tissue study.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set.

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

No MRMC comparative effectiveness study was done. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or interpretative system that would typically involve human readers.

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

This is not applicable, as the device is a medical instrument (RF System) and not an algorithm or software-only device. Its performance is inherent to its physical operation.

7. The type of ground truth used

The ground truth for the "ex vivo tissue study" would likely be based on:

• Direct observation/measurement: Of the thermal effects (e.g., coagulation depth, tissue contraction, hemostasis) on the tissue samples after RF energy application.
• Histopathological analysis: Microscopic examination of the treated tissues to assess cellular changes and thermal damage.

The "ground truth" for electrical and mechanical safety and electromagnetic compatibility would be adherence to the specified IEC standards.

8. The sample size for the training set

This is not applicable. This is a medical device (hardware) submission, not a machine learning or AI model that requires a training set. The "training" of its performance is through its design and engineering, and then validated through testing.

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

This is not applicable as there is no training set for this type of device.

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The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The handpiece is comprised of a disposable, single use plastic handle with internal and external electrodes.

The provided text is a 510(k) summary for the InMode RF System, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182325) rather than providing detailed acceptance criteria and a study proving those criteria for a novel device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the given document.

Here's an attempt to answer what can be extracted or inferred, and explicitly state what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state specific numerical acceptance criteria for performance. Instead, it relies on demonstrating that the InMode RF System's performance is "as predicted" or "virtually identical" to the predicate device.

Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "three different tissue types, muscle, liver, and fat" for the ex vivo study. The number of samples within each tissue type is not provided.
• Data Provenance: The studies are described as "ex vivo tissue study" and "nonclinical performance test," indicating that the data is from laboratory (bench) testing, not from human patients or a specific country. This implies it's a retrospective analysis of experimental data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable / Not provided. The studies described are non-clinical (ex vivo tissue and bench testing), not involving human diagnostic interpretation where expert ground truth would typically be established. The "ground truth" for the device's performance is based on direct measurements and physical principles (e.g., RF specifications, thermal response).

4. Adjudication Method for the Test Set

Not Applicable / Not provided. Since there's no human diagnostic interpretation of cases, an adjudication method for a test set is not relevant in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document describes a medical device generating RF energy, not an AI or imaging diagnostic tool that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is a treatment system (electrosurgical) and not an AI algorithm performing a diagnostic task. The "standalone performance" is its ability to generate RF energy and achieve the stated effects.

7. The Type of Ground Truth Used

For the non-clinical studies:

• For RF frequency and output: Engineering specifications and direct measurements against those specifications (e.g., "waveform, amplitude, frequency, crest factor").
• For RF power density: Measurements of tissue thermal response.
• For safety and effects on tissues: Direct observation and measurement of effects on ex vivo muscle, liver, and fat tissues.
• For software, electrical/mechanical safety, EMC: Compliance with international standards (IEC 60601-1, IEC 60601-2-2) and internal system requirements.

8. The Sample Size for the Training Set

Not applicable / Not provided. This document does not describe the development of an AI algorithm that would typically have a "training set." The system's design and operation are based on engineering principles and existing technology.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not provided. As there's no mention of an AI algorithm or a training set, the establishment of ground truth for such a set is irrelevant to this document.

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The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis

The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.

The InMode RF System is compatible with the following hand pieces:

• . HP060909A (Non-sterilized)
• HP101306A (Non-sterilized/Sterilized) ●
• HP172206A (Non-sterilized/Sterilized) .
• . HP172246A (Non-sterilized/Sterilized)
• HP172248A (Sterilized )

This document is a 510(k) summary for the InMode RF System, seeking substantial equivalence to a previously cleared InMode RF System (K171593). It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a numeric or specific performance metric table format as one might expect for a clinical trial endpoint. Instead, the acceptance criteria are implicitly tied to demonstrating the device's ability to perform "electrocoagulation and hemostasis" safely and effectively, and showing substantial equivalence to the predicate device.

The reported device performance is described through various tests rather than numerical outcomes against pre-defined thresholds.

• AAMI/ANSI 60601-1 (2012) (General Requirements For Basic Safety And Essential Performance)
• IEC 60601-1-2 (Edition 3.0, 2007) (Electromagnetic Compatibility)
• IEC 60601-2-2 Edition 5.0 2009-02 (High-Frequency Surgical Equipment)
• IEC 60601-1-6:2013-10 (Usability)
• IEC 62366-1:2015 (Usability Engineering)

Non-Clinical (Bench) Performance Data: The modified InMode RF System was evaluated for its system performance specifications. "The results of the bench tests demonstrate that the modified InMode RF System performed as expected and in a similar fashion to the predicate device." The modified device software/firmware was retested to verify system configuration and integration with all ancillary hand pieces. |
| II. Effectiveness in Electrocoagulation and Hemostasis (Tissue Interaction) | Animal Performance Data / Histology Data (Ex-vivo study): The thermal effects of the modified InMode RF System on target tissue were evaluated. "The ex-vivo study results show that the modified InMode RF System is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." |
| III. Substantial Equivalence to Predicate Device | "Based on the comparison to the predicate device and on the performance testing, the modified InMode RF System is substantially equivalent to the predicate InMode RF System for the mentioned indication for use."
The subject device is composed of the same main device components as the predicate (K171593), except for the addition of two new hand piece versions. It uses the same underlying technology for the same intended use (delivery of monopolar RF energy, monitored and controlled by the ESU). It introduces similar safety features and complies with the same relevant consensus standards as the predicate. Performance bench, ex-vivo, and software validation test results show the modified system produced and delivered desired RF energy according to design requirements, comparable to the predicate. |

2. Sample Size Used for the Test Set and the Data Provenance:

• Bench Performance Data: Not explicitly stated, but it involved system performance specifications and retesting of software/firmware with all ancillary hand pieces. No specific "test set" in terms of biological samples or patients is mentioned. This is likely an engineering validation with a variety of operational scenarios.
• Animal Performance Data / Histology Data: "The study was conducted on three different porcine tissue models (muscle, liver & fat)." This is an ex-vivo study (meaning performed on tissue outside a living organism).
  • Data Provenance: Porcine tissue models (ex-vivo). Specific country of origin is not mentioned. Retrospective/prospective doesn't apply to ex-vivo models in the same way as human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Animal Performance Data / Histology Data: The document mentions "TTC staining analysis" was used to evaluate thermal effects. It does not specify the number of experts, their qualifications, or if any experts were used to establish a "ground truth" for this specific analysis. It's implied that standard histological analysis protocols were followed.

4. Adjudication Method for the Test Set:

• Not applicable as no human-read test set requiring adjudication (e.g., image interpretation) is described for the primary performance evaluations for substantial equivalence.

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:

• Not applicable. This device is an electrosurgical system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant here.

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

• Not applicable. This is not an algorithm, but a physical medical device (RF system). Its performance is inherently "standalone" in its function of generating RF energy.

7. The Type of Ground Truth Used:

• Bench Performance Data: Engineering specifications, design requirements, and comparisons to the performance of the predicate device (K171593) served as the "ground truth" or reference for expected performance.
• Animal Performance Data / Histology Data: The "ground truth" for effectiveness in achieving thermal effects for electrocoagulation and hemostasis was established through TTC staining analysis on the porcine tissue models. This is a direct biological measure of tissue viability/damage.

8. The Sample Size for the Training Set:

• Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for this type of device.

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The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.

The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.

The InMode RF System is compatible with the following hand pieces:

• HP101306A (optional sterile/non-sterile)
• HP172206A (optional sterile/non-sterile ●
• HP172246A (non-sterile) ●

The provided text describes the 510(k) premarket notification for the InMode RF System, which is a device for electrocoagulation and hemostasis in dermatological and general surgical procedures. The notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (InMode RF System, K160193), particularly with the addition of a modified hand piece, HP172246A.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in a table for each criterion. Instead, it describes performance through compliance with standards and comparative testing for substantial equivalence.

However, based on the context, we can infer some implied "acceptance criteria" related to functionality, safety, and equivalence, and align them with the reported test results.

2. Sample Size Used for the Test Set and Data Provenance

• Non-Clinical (Bench) Performance Data:

  • Sample Size: Not explicitly stated as a number. The text mentions "a side by side comparison tests were performed utilizing the HP172246A and the HP172206A hand pieces." This implies at least one of each handpiece was used, but the number of tests or repetitions is not specified.
  • Data Provenance: This is bench testing, not human or animal data from a specific country. It's presumably conducted by the manufacturer, InMode MD Ltd., at their facilities. It's retrospective in the sense that it's testing a completed device design, but it's not retrospective patient data.

• Animal Performance Data / Histology Data:

  • Sample Size: The study was conducted on "three different porcine tissue models (muscle, liver & fat)." It does not specify the number of samples within each tissue type or the number of animals used.
  • Data Provenance: Not explicitly stated, but it's an ex-vivo study using porcine tissue. The location of the study (e.g., country) is not mentioned. This can be considered prospective data gathered for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Non-Clinical (Bench) Performance Data: No external experts are mentioned for establishing ground truth for bench tests. The "ground truth" here is the physical measurement of electrical parameters against engineering specifications and comparison to the predicate device's measured output.
• Animal Performance Data / Histology Data:
  • Number of Experts: Not specified.
  • Qualifications of Experts: Not specified. The "ground truth" was established by "TTC staining analysis," which is a standard histological technique, implying interpretation by trained personnel, likely a pathologist or equivalent, but specific expert qualifications are not provided.

4. Adjudication Method for the Test Set

• Non-Clinical (Bench) Performance Data: No adjudication method is mentioned. Bench tests typically involve objective measurements against predefined specifications.
• Animal Performance Data / Histology Data: No adjudication method is mentioned. The "TTC staining analysis" would be interpreted by a single or multiple histologists/pathologists, but a formal adjudication process (e.g., 2+1, 3+1) is not described.

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

• No MRMC study was done. This device is a surgical energy-based device, not an AI-powered diagnostic or assistive tool for human readers. Clinical performance data was "Not Applicable" for this 510(k) submission, meaning no human clinical trials were performed for this specific modification to demonstrate substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical RF energy system, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

• Non-Clinical (Bench) Performance Data: The ground truth for these tests was the engineering specifications of the device and the measured output of the predicate device.
• Animal Performance Data / Histology Data: The ground truth was based on histological staining (TTC staining analysis) to evaluate thermal effects on tissue.

8. The Sample Size for the Training Set

• Not applicable. As this is a medical device for energy delivery rather than an AI/ML algorithm, there is no "training set" in the machine learning sense. The device's operation is based on predefined electrical and physical principles, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See point 8).

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The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.

The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.

The provided text describes the 510(k) premarket notification for the InMode RF System, focusing on its substantial equivalence to a previously cleared device. The document does not contain information about explicit acceptance criteria with numerical thresholds for performance metrics and a study directly demonstrating the device meets these specific criteria. Instead, it details that the device complies with recognized consensus standards and underwent non-clinical (bench) and ex-vivo animal performance testing to support its substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or corresponding reported device performance values. It states that the device "complies with the following FDA recognized consensus standards" and that "The results of the bench tests demonstrate that the InMode RF System with the HP172206A hand piece performed in a similar way to the predicate device."

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

• Test Set Sample Size:
  • Bench Performance Data: Not explicitly stated as a number of devices or tests. It mentions "The InMode RF System with the HP172206A hand piece was utilized in bench performance tests."
  • Animal Performance Data: The ex-vivo study "was conducted on three different porcine tissue models (muscle, liver & fat)." The number of tests or specific tissue samples within each model is not provided.
• Data Provenance: The studies were conducted by InMode MD Ltd., an Israeli company. The text doesn't explicitly state the country where the studies were performed, but it's reasonable to infer they were likely conducted under the company's purview, possibly in Israel. The studies appear to be prospective in nature, as they involve testing the device (bench and ex-vivo).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The studies described are non-clinical (bench and ex-vivo animal studies) and do not involve human subjects or expert assessment of clinical outcomes in the way a diagnostic AI device would. The ground truth for the animal study was established through TTC staining analysis, which is a laboratory technique, not expert consensus.

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

Not applicable. As noted above, this study does not involve human expert assessment of a test set that would require an adjudication method.

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

No. An MRMC comparative effectiveness study was not done. The device is not an AI diagnostic tool and does not involve human readers for interpretation.

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

Yes, in a sense. The "performance data" presented (bench and animal studies) describes the standalone performance of the device (InMode RF System with the HP172206A hand piece) in achieving electrocoagulation and hemostasis. This is an algorithm-only (or device-only) performance without human-in-the-loop as it's an electrosurgical device, not a diagnostic AI.

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

• Bench Performance Data: Ground truth would be based on engineering specifications and measurements to confirm output power, frequency, safety parameters, etc.
• Animal Performance Data: The ground truth for evaluating thermal effects was established via TTC staining analysis.

8. The sample size for the training set

Not applicable. This device is an electrosurgical system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its operation is based on pre-programmed parameters and real-time feedback mechanisms, not learned from a dataset.

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

Not applicable. As mentioned, there is no "training set" in the machine learning sense for this device. Its development would involve engineering design, testing against physical properties, and safety standards.

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The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.

The InMode RF System including the InMode RF Hand piece (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF Hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.

Following are the InMode RF System specifications: RF Max Output Power: 20 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 35cm W x 46cm D x 100cm H (14.2'' W x 18.2'' D x 40'' H) Weight: 15 Kg (33 lbs) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC

The provided document is a 510(k) Premarket Notification from the FDA for the InMode RF System. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device (ThermiGen Symphony RF System, K130689).

However, this document does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. Instead, it focuses on the performance of a radiofrequency medical device for electrocoagulation and hemostasis through bench testing and ex-vivo studies, comparing it to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for an AI/ML powered device, ground truth establishment, or multi-reader multi-case studies from this document. The document describes a traditional medical device clearance process, not one for an AI/ML based diagnostic or treatment device.

To answer your request, if this were an AI/ML powered device, the information would typically be found in detailed clinical study reports or regulatory submissions specifically addressing the performance of the AI algorithm.

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