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The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal.

The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.

The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation

The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor.

The system is compatible with the following applicators:

• DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL)
• LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA)
• VASCULAZE 1064 (previously cleared as Vasculaze)
• FORMA (previously cleared as Forma (Plus))
• PLUS (previously cleared as Plus/Plus)
• MORPHEUS8
• MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)

The provided text describes the FDA 510(k) clearance for the Optimas MAX System, comparing it to predicate devices. However, it does not contain information about acceptance criteria or specific study details proving the device meets those criteria, particularly regarding an AI component or machine learning performance.

The document focuses on the substantial equivalence of the hardware and general system functionality, including:

• Indications for Use: Listing the intended applications of the system's various applicators (hair removal, vascular lesions, pigmented lesions, muscle aches/pains, soft tissue coagulation/hemostasis).
• Technological Characteristics: Describing the system as a computerized device generating Laser, IPL, and RF energies, with a new industrial design and an upgraded operating system (Linux from Windows CE). It explicitly states that "The specifications for the critical components of the system remain unchanged," and "The system components, handpiece connectors, and the operating parameters of each handpiece remains unchanged."
• Non-Clinical and/or Clinical Tests Summary: Mentions "software validation testing to demonstrate that the system's new Burst and Scale Modes for the Morpheus8 handpieces function as expected" and new electrical testing against various IEC standards.

Therefore, based solely on the provided text, I cannot describe acceptance criteria and a study proving the device meets them in the context of AI or machine learning performance, as that information is not present. The clearance process described is typical for a hardware device with minor software updates and cosmetic changes, relying on substantial equivalence to previously cleared devices.

To answer your request, if an AI/ML component was implicitly part of "software validation testing" or "Burst and Scale Modes," the document does not provide the specifics you're asking for.

If this were an AI/ML device, the FDA clearance would typically include sections detailing:

• Performance Metrics: Sensitivity, specificity, AUC, etc.
• Dataset Details: Size, provenance, diversity.
• Ground Truth: How it was established (e.g., expert consensus, pathology).
• Reader Study: If human-in-the-loop performance was evaluated.

Since none of that information is in the provided text, I must state that the document does not contain the details to fulfill your request.

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The DEFINE System with the non-invasive applicators employs RF energy for various applications:

The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain. relief of muscle spasm. and for the temporary improvement of local blood circulation.

The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite.

The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed.

At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The DEFINE device is designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF energy is transmitted to the Applicators and delivered to the treatment area throughout the set of RF electrodes positioned on the treatment units. The invested RF energy is transformed into local heating of the treatment area. Local heating of the skin and underlying tissue layers temporarily ease the symptoms of muscle aches, pain & spasm. It also contributes to the temporary improvement of local blood circulation.

The DEFINE device platform comprises a AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen. The system platform contains four designated connectors for the following applicators:

• Cheek Applicator (hands-free) ●
• Chin Applicator (hands-free) ●
• FORMA Applicator ●
• MiniFX ●
• MORPHEUS8 Applicator with the resurfacing, 12 and 24 pin tip heads ●

The DEFINE device RF Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a "Start"/"Stop" button on the LCD screen or by a foot pedal. The DEFINE device incorporates a treatment deactivation button. Pressing the deactivation button by either the patient or caregiver would immediately halt the treatment and switch the device into a Pause mode until the operator re-enables it.

The provided text is a 510(k) summary for the InMode Ltd. DEFINE System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this type of regulatory submission.

The 510(k) process primarily relies on showing that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through:

• Comparison of technological characteristics: Demonstrating that the new device has the same fundamental technology, intended use, and similar design as the predicate.
• Non-clinical performance data (bench testing): Verifying that the device meets safety and performance standards (e.g., electrical safety, electromagnetic compatibility, RF energy output).
• Absence of clinical performance data for substantial equivalence: In many cases, if technological characteristics are sufficiently similar and non-clinical testing confirms equivalence, new clinical data is not required.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of specific "acceptance criteria" and "reported device performance" as typically seen in a clinical trial or performance study (e.g., sensitivity, specificity, accuracy for a diagnostic device) is not applicable or stated in this 510(k) summary for the DEFINE System.

Instead, the submission demonstrates compliance with:

• Safety standards: IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-2 (for RF surgical equipment), IEC 60601-1-6 (usability), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), IEC 62304 (software life cycle), ISO 14971 (risk management).
• Equivalence in intended use and technological characteristics to predicate devices.

The "performance" is primarily demonstrated through bench testing for electrical safety, EMD safety, RF output (IEC 60601-2-2), and software validation. These are conformity assessments to established standards rather than performance against a clinical acceptance threshold for diagnostic or therapeutic efficacy outcomes.

Note: The submission explicitly states "Clinical Performance Data: Not Applicable" (page 7 of 14). This signifies that the decision for substantial equivalence was based solely on non-clinical (bench) testing and comparison to predicate devices, without new human clinical studies for performance metrics.

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

• Sample Size for Test Set: Not applicable. No clinical test set data is provided or referenced, as the submission states "Clinical Performance Data: Not Applicable." The "test set" for non-clinical performance refers to the device and its components undergoing bench testing according to various standards. The document does not specify the number of units tested.
• Data Provenance: Not applicable for clinical data. For non-clinical data, it's typically performed by the manufacturer or a certified testing lab. The country of origin of the data is implied to be within controlled engineering/testing environments, likely at the manufacturer's location (Israel) or a contracted lab. The data is implicitly "prospective" in the sense that the tests were conducted specifically for this submission.

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

• Not applicable. There was no clinical test set for which ground truth needed to be established by experts.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. No clinical studies were conducted or referenced for this 510(k) submission. Therefore, no MRMC study, human reader improvement effect size, or AI assistance claims are present.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI or algorithm-only device in the context of diagnostic or interpretive performance. Its performance is tied to its physical mechanisms and safety parameters validated through bench testing, not an algorithm's standalone accuracy. Software validation (IEC 62304) ensures the software functions as intended and is safe, not that it performs a diagnostic or prescriptive task independently.

7. Type of Ground Truth Used

• For non-clinical testing: The "ground truth" is adherence to established engineering standards (e.g., IEC, ANSI, ISO). For example, electrical safety is "ground true" if the device passes the specified tests in IEC 60601-1.
• For clinical performance claims: Not applicable, as no clinical performance data was provided.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set in the typical sense (e.g., for image classification). The "software validation" mentioned relates to the software controlling the device's operation, not to a learned model.

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

• Not applicable, for the same reasons as point 8.

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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 System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coaqulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 90 Applicator is limited to Skin Types I-IV.

The InMode System with the Morpheus8 90 Applicator is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Fractora3D 90 Applicator (K180189), inclusive of minor software modifications. The InMode System with the Morpheus8 90 Applicator employs fractional RF multi-electrode technology for procedures requiring electrocoaqulation and hemostasis. The Morpheus8 90 Applicator is deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 90 Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 90 Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus a handle and a detachable, sterilized, disposable, singleuse 24 pin tip head accessory.

The provided text is a 510(k) summary for the InMode System with the Morpheus8 90 Applicator. It describes a device that is substantially equivalent to a previously cleared device. Therefore, the information provided focuses on demonstrating this substantial equivalence rather than presenting an independent acceptance criteria study for a novel device or AI algorithm.

Here's a breakdown based on your request, filling in where possible from the provided text and noting when the information is not available due to the nature of a 510(k) submission for an already cleared device's modification:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification (clearing the Fractora 3D 90 for a treatment depth of up to 7mm via software change) and claiming substantial equivalence to predicate devices, explicit "acceptance criteria" and "reported device performance" in the sense of a new clinical study with specific metrics are not detailed for the subject device in the provided document. Instead, the document relies on previously established performance of predicate devices and comparative testing.

The "acceptance criteria" can be inferred as meeting the safety and performance characteristics of the predicate devices. The "reported device performance" is implicitly that the subject device performs equivalently.

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for patients or clinical cases. The testing was primarily ex-vivo tissue testing and bench testing.
• Data Provenance: The testing for the current submission was conducted to compare the subject device to the predicate devices. The original predicate device (K180189) performance testing is referenced, and further ex-vivo testing was performed with the secondary predicate device (K200947). The exact location or nature (retrospective/prospective) of these non-clinical tests is not specified beyond "ex-vivo tissue testing."

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

• This information is not provided in the document. Given that the testing detailed is primarily ex-vivo and bench testing, rather than a clinical trial requiring human interpretation of results against a gold standard, this type of expert review is typically not part of these types of 510(k) submissions.

4. Adjudication Method for the Test Set

• This information is not provided. As above, for non-clinical, ex-vivo, and bench testing, a formal adjudication process using multiple experts is generally not applicable in the same way it would be for clinical image interpretation or diagnosis.

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

• No, a MRMC comparative effectiveness study was not done. The document states, "No clinical data was submitted." The submission relies on non-clinical performance data and substantial equivalence to legally marketed predicate devices.

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

• This device is not an AI algorithm. It is a physical medical device (radiofrequency technology for dermatological applications). Therefore, the concept of "standalone algorithm performance" is not applicable here. The "performance" refers to the device's physical and functional capabilities.

7. The Type of Ground Truth Used

• For the ex-vivo tissue testing, the "ground truth" would be the physical measurement and visual assessment of the fractional coagulation necrosis pattern in the tissue. This is a direct physical effect, not an expert consensus or pathology report in the traditional sense for diagnostic AI. For electrical, mechanical, and EMC testing, the "ground truth" would be the defined standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no training set for this 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 Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.

The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The Transform Applicator in EMS mode is intended for:

• . Relaxation of muscle spasms
• . Prevention or retardation of disuse atrophy
• . Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion ●
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●

The Transform Applicator in TENS mode is intended for:

• Symptomatic relief and management of chronic, intractable pain
• . Post-surgical acute pain
• . Post-trauma acute pain

Additionally the Transform Applicator in sequential RF/EMS mode is intended for:

• . Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen ●

The Evolve System with the Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-cleared Evolve System platform (K210877).

The Evolve System includes the following components:

• LCD display touch screen, ●
• Audio loudspeaker,
• 48V AC/DC power supply, ●
• Real time controller, distributor card and 2 RF generators, .
• . Fans

The System operates while connected to the Transform Applicator.

The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.

The provided text describes the regulatory clearance of "The Evolve System with the Transform Applicator" and includes information about its performance data to demonstrate safety and efficacy. However, it does not present acceptance criteria in a formal table or describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it explicitly define "acceptance criteria" for the clinical study results.

Based on the information provided, here's an attempt to answer your questions, interpreting some elements from the clinical study summary:

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

The document doesn't explicitly define "acceptance criteria" with numerical thresholds for performance. Instead, it states that "The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%" for the photographic assessment. For the primary outcome (circumference measurement), it broadly states "Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other."

Without explicit pass/fail criteria from the submission, we can infer the "reported device performance" based on the study outcomes:

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

• Sample Size for Test Set: 44 subjects.
• Data Provenance: Prospective, multi-site, single-arm clinical study. The country of origin of the data is not specified in the provided text.

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

• Number of Experts: Three blinded evaluators were used to assess the "before and after 3 months photographs."
• Qualifications of Experts: The qualifications of these experts are not explicitly stated (e.g., radiologist with 10 years of experience). They are only referred to as "blinded evaluators."

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

The document states that "Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other." It also mentions that "Before and after 3 months photographs were assessed by three blinded evaluators."

The method for reconciling differences between the three evaluators for the photographic assessment, or if simple majority or consensus was used, is not specified. Therefore, the adjudication method is unclear from the provided text.

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

The provided text describes a single-arm clinical study evaluating the Evolve System with the Transform Applicator. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses solely on the device's performance in achieving non-invasive lipolysis and circumference reduction.

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

This device is not an AI algorithm but a physical device that delivers RF and EMS energy. Therefore, the concept of "standalone (algorithm only)" performance does not directly apply here in the way it would for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The study assesses the device's effect on patients.

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

The ground truth for the efficacy evaluation was based on clinical measurement and observation data:

• Circumference measurement by measurement tape (primary endpoint)
• Fat thickness caliper measurement
• Fat layer ultrasound measurement
• Assessment of before and after photographs by three blinded evaluators.
• Patient-reported comfort and satisfaction.

8. The sample size for the training set

The provided text describes a clinical study validating the device's effectiveness. It does DNOT refer to a "training set" in the context of an AI/ML model. The 44 subjects are part of the performance data or test set for demonstrating the device's clinical efficacy.

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

As there is no training set discussed in the context of an AI/ML model, this question is not applicable based on the provided document. The study is a clinical validation of a physical medical device.

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The InMode System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-V.

The InMode System with the Morpheus8 Applicators is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Morpheus8 Applicators (K200947), inclusive of minor software modifications, cleared in K210492 and K221571. The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The device has two Applicators which can be connected to the platform, one at the time. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use 12, 24, and T tip head accessories. The Morpheus8 Body Applicator is identical except that the compatible tip head is a 40 pin tip head.

The provided text is a 510(k) summary for the InMode System with Morpheus8 Applicators. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K200947), rather than conducting a new study to prove a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, which would typically be found in an AI/Software as a Medical Device (SaMD) submission.

Therefore, the requested information about acceptance criteria, study details (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training set details for a new device's performance study cannot be extracted from this document. This submission leverages prior testing of the predicate device and argues that no new performance data or clinical data is needed because the current device is substantially equivalent and the changes are minor (e.g., expansion of indications based on energy levels).

Here's what can be inferred and a clear statement of what is missing:

What can be extracted/inferred:

• Device Type: The device is an electrosurgical cutting and coagulation device, specifically using Radiofrequency (RF) technology. It's intended for dermatologic procedures requiring coagulation/contraction of soft tissue or hemostasis. This is a hardware device, not an AI/SaMD.
• Purpose of current submission: This is a "Special 510(k) notice" for an expansion of indications for use based on higher energy levels (greater than 62 mJ/pin) and limiting use to Skin Types I-V for the Morpheus8 Applicator.
• Performance Data Submitted (Leveraged from Predicate):
  • Bench Testing: An ex-vivo tissue study was conducted on two different harvested porcine tissues (muscle and fat) to evaluate the performance and safety of the Morpheus8 Applicators. The study involved biopsy sampling and staining to visualize the tissue coagulation necrosis pattern.
  • Standards Compliance: The device complies with several voluntary recognized standards related to medical electrical equipment (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2).
  • Prior Testing (from K200947): Software validation testing, electrical and mechanical safety testing, comparative bench testing, and ex-vivo tissue testing to evaluate the fractional coagulation necrosis pattern.
• Ground Truth (for the ex-vivo study): The ground truth appears to be based on visualizing the "tissue coagulation necrosis pattern" through biopsy sampling and staining. This would be a direct physical observation of the tissue's response to the device.
• Clinical Performance Data: Explicitly stated as "Not Applicable" for this submission.
• Animal Performance Data / Histology Data: Explicitly stated as "No new animal performance data is submitted to support this submission."
• Training Set/Test Set (as it relates to AI/ML): Not applicable, as this is a hardware device submission, not an AI/ML algorithm.

Information NOT present in the document (and why):

1. Table of acceptance criteria and reported device performance: This document does not describe acceptance criteria for metrics like accuracy, sensitivity, specificity, or similar quantitative performance outcomes typical for diagnostic or AI/ML devices. Instead, the "acceptance" is demonstrated by substantial equivalence to a predicate device and compliance with safety and performance standards for an electrosurgical device. The ex-vivo study concludes that the applicators "perform as intended for the specified indications," but no specific numerical performance metrics are given.
2. Sample size used for the test set and data provenance: The ex-vivo study mentions "two different harvested porcine tissues," but does not specify the sample size (e.g., number of tissue samples, number of treatment applications). Data provenance is "ex-vivo tissue study" (animal tissue, not human patient data), origin not specified beyond "harvested."
3. Number of experts used to establish ground truth & qualifications: Not applicable to ex-vivo studies of this nature using physical staining and observation, unless a subjective assessment by experts was performed (not indicated here).
4. Adjudication method: Not applicable/not described.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted, as this is a hardware device, not an AI/assisted reading device. Therefore, no effect size of human readers improving with AI assistance is reported.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a device that requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the ex-vivo study, the ground truth was directly observed and visualized "tissue coagulation necrosis pattern" through biopsy and staining. This is akin to a pathological or direct physical outcome.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, this 510(k) submission is for a physical medical device (an RF electrosurgical system) and therefore does not contain the information typically required for an AI/Software as a Medical Device (SaMD) submission regarding AI model performance, training sets, and expert consensus-based ground truth for diagnostic accuracy. The "study" referenced is an ex-vivo tissue study to demonstrate the physical effect of the device on tissue, supporting its intended use.

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The InMode Multi System with the Diode laser Applicators is indicated for:

· Diolaze XL 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

· Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal.

· VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

The InMode Multi System with the IPL Applicator is indicated for:

• IPL Applicator with wavelengths (515-1200mm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.

The InMode Multi System with the non-invasive RF Applicators is indicated for:

· BodyFX (WMBody) and MiniFX Applicators are intended for the tollowing medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite.

· PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

· FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids.

The InMode Multi System with the Fractional RF Applicators is indicated for:

· FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

· FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

· Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-V.

The InMode Multi-System supports multiple technological applications and accessories intended for different clinical indications. The subject device is designed to exert finely controlled radiofrequency, laser or IPL energy utilizing different treatment applicators. The subject device comprises a system platform and compatible set of applicators. The system platform was originally FDA Cleared in K180719 and is manufactured by InMode Ltd.

The subject device platform sustains additional FDA Cleared applicators, all manufactured by InMode Ltd.

The below list comprises the set of applicators to be registered under the subject device:

• . Laser Applicators:
  • o Diolaze XL 810nm
  • Diolaze XL 755/810nm o
  • Diolaze XL 810/1064nm o
  • VLaze (Vasculaze) о
• IPL Applicator: ●
  • o SR IPL (Lumecca 580, Lumecca 515)
• Non-Invasive RF Applicators: ●
  • o Forma (Plus)
  • Plus (Plus Plus) о
  • Plus90 o
  • о i-Forma
  • BodyFX™ (WMBody) o
  • MiniFXTM o
  • WMFace o
• Fractional RF Applicators: ●
  • Fractora o
    • 24 pins tip (FRF) -
    • । 60 pins tip
  • 0 Morpheus8TM
    • 12 pins tip (Prime Tip) -
    • 24 pins tip (Fractora 3D) -
    • 40 pins tip (Body Tip) -
    • T tip -

The platform of the subject device has undergone some slight design modifications, mainly in software, to support the integration of the abovementioned applicators.

Slight modifications were also performed on platform hardware for the same purpose.

Additionally, the user interface screen was slightly enlarged from 10" to 12".

This document describes an FDA 510(k) premarket notification for the InMode Multi-system, a medical device with various applicators for dermatological and general surgical procedures. The submission claims substantial equivalence to previously cleared predicate devices.

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, or metrics for effectiveness. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that does not require premarket approval.

The reported device performance is broadly stated as maintaining the same safety and effectiveness as the predicate devices:

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

The document explicitly states:

• Non-Clinical (Bench) Performance Data: Not Applicable
• Animal Performance Data / Histology Data: Not Applicable
• Clinical Performance Data: Not Applicable

Therefore, there is no mention of a test set, sample size, or data provenance from clinical studies for this 510(k) submission. The device's substantial equivalence is based on engineering comparisons and compliance with recognized standards.

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, as no clinical performance data or test set was used for this submission.

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

Not applicable, as no clinical performance data or test set was used.

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 not an AI-assisted diagnostic or interpretation tool; it is a physical device (laser, IPL, RF system) for treatments. No MRMC study was mentioned or performed.

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

Not applicable. This is not an algorithm-only device.

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

Not applicable, as no clinical performance data was used for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established safety and effectiveness of the predicate devices and the technical comparison performed.

8. The sample size for the training set

Not applicable, as no AI/machine learning model is being described or used in a way that requires a training set for this 510(k) submission.

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

Not applicable, as no AI/machine learning model is being described.

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The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.

The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The T3 Applicator in EMS mode is intended for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

The T3 Applicator in TENS mode is intended for:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285).

The Evolve System supports the placement of the following components:

• LCD display touch screen,
• Audio loudspeaker,
• 48V AC/DC power supply,
• Real time controller, distributor card and 2 RF generators,
• Fans

The System operates while connected to the T3 Applicator.

The Evolve System with the T3 Applicator is intended for temporary relief of minor muscle aches and pain, muscle spasm, and improved local blood circulation (RF mode), as well as relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (EMS mode), and symptomatic relief of chronic, intractable, post-surgical, and post-trauma acute pain (TENS mode).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that Non-Clinical (Bench) Performance Data was conducted to demonstrate the device performs as expected and meets design requirements. This included various bench tests (e.g., accuracy of RF output, electrode temperature sensors, thermal build-up, ex-vivo tissue thermal profile, safety and thermal profile testing, EMS/TENS output specifications).

However, the document explicitly states "Clinical Performance Data: Non-Applicable." This implies that there was no clinical test set using human subjects or patient data. The evaluation for substantial equivalence relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study with a test set of patient data. Therefore, questions regarding sample size, data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set are not applicable here.

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

Since no clinical test set was conducted, the concept of "ground truth" derived from expert consensus on patient data (e.g., from radiologists, pathologists) is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the established engineering and safety standards and design specifications against which the device's performance was measured.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: Non-Applicable," making any evaluation of human reader improvement with or without AI assistance irrelevant in this context. The device is a physical therapeutic system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical therapeutic system, not an algorithm or AI. Its performance is tied directly to its hardware functionality and energy delivery.

7. Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" was based on:

• Engineering and Design Requirements: The device was tested to verify that its performance meets its own design requirements.
• Consensus Standards: The device's performance was evaluated against recognized consensus standards for medical electrical equipment, such as ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, and IEC 60601-2-2.
• Predicate Device Specifications: The device's technical specifications and performance characteristics were compared directly to those of legally marketed predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on established physical principles of RF and EMS/TENS technology.

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

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

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The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.

The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.

In EMS mode it is used for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode is intended for

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.

The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.

The System supports the following components:

• LCD display touch screen .
• Audio loudspeaker ●
• . 48V AC/DC power supply
• Controller
• . Fans

The System operates while connected to the Tone Applicator.

The provided document is a 510(k) summary for the InMode Ltd. EVOLVE System with the Tone Applicator. This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for the device's performance (especially related to clinical efficacy or AI model performance) is largely absent.

The "acceptance criteria" discussed in this document primarily refer to compliance with recognized consensus standards for safety and basic performance (bench testing) and demonstrating similar characteristics to a predicate device. There is no mention of an AI model within this submission, nor are there any clinical effectiveness studies, MRMC studies, or details on establishing ground truth for AI algorithms.

However, I can extract the information related to the device's performance based on the provided text, focusing on the available "acceptance criteria" (which are regulatory conformity and bench testing results) and the performance data for those criteria.

Based on the provided FDA 510(k) summary (K201285), here's an analysis of the "acceptance criteria" and the "study" proving the device meets them:

Crucial Caveat: This 510(k) summary does not describe an AI/ML model or its performance. The "acceptance criteria" and "study" described here pertain to the safety and basic functional performance of a medical device (an electro-muscle and transcutaneous nerve stimulator) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested points related to AI/ML model evaluation (e.g., sample sizes for training/test sets, expert adjudication of ground truth, MRMC studies) are not applicable and will not be found in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are framed as compliance with recognized consensus standards and meeting design requirements through bench testing. The "reported device performance" is the confirmation that these tests were passed and the design requirements were met. The table below summarizes the key performance specifications and their acceptance against the predicate device.

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

• Sample Size: This is a medical device safety and performance submission, not an AI/ML model evaluation. Therefore, there are no "test set" sample sizes in the sense of patient data for clinical performance evaluation. The "tests" performed are bench tests and compliance with recognized standards.
• Data Provenance: The "data" comes from mandated bench testing and compliance documentation. There is no mention of patient data, clinical studies, or data provenance (e.g., country of origin, retrospective/prospective) in the context of efficacy testing. The document explicitly states "Clinical Performance Data: Non-Applicable."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This submission does not involve an AI/ML model where "ground truth" adjudicated by experts is typically needed. The "ground truth" for this device's performance is established by direct physical measurements during bench testing and adherence to engineering and safety standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As there is no clinical or image-based "test set" requiring expert interpretation or labeling, no adjudication method (e.g., 2+1, 3+1) was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable. No MRMC study was done, as this is not an AI-assisted diagnostic device, nor is it reporting on human reader performance. The document states "Clinical Performance Data: Non-Applicable."

6. Standalone (Algorithm Only) Performance:

• Not Applicable. There is no AI algorithm being evaluated. The device functions as a physical muscle/nerve stimulator.

7. Type of Ground Truth Used:

• Technical Specifications and Compliance with Standards. The "ground truth" for this device's acceptance is its adherence to a specified design and its ability to pass established engineering, electrical safety, EMC, and specific performance standards for muscle/nerve stimulators (e.g., IEC 60601 series). This is verified through direct measurement and documentation from bench testing.

8. Sample Size for the Training Set:

• Not Applicable. There is no AI/ML model for which a "training set" would be used.

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

• Not Applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment process.

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It focuses on engineering specifications, safety compliance, and bench testing, not on the performance of a software algorithm or clinical efficacy requiring a test set, ground truth experts, or training data for AI.

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