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The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications:

• i-Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

· WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.

· BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:

· Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.

· Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62m.J/pin, use of the applicator is limited to skin types I-IV

· Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

The InMode RF Pro System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Pro System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.

The InMode RF Pro System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.

The provided text describes the FDA 510(k) clearance for the InMode RF Pro System, demonstrating substantial equivalence to a predicate device (InMode RF Multi System, K201150). The study focuses on safety and performance rather than diagnostic accuracy or human reader improvement with AI. Therefore, many standard acceptance criteria for AI-powered diagnostic devices (e.g., sensitivity, specificity, F1 score, MRMC studies) are not applicable here.

Below is an adaptation of your requested table and information based on the available data, focusing on the device's substantial equivalence through performance and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes several non-clinical studies and tests performed to demonstrate the device's safety and effectiveness, primarily through comparison to a predicate device for the purpose of 510(k) clearance.

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

• Electrical Safety & EMC Testing: Sample size not specified, but typically involves testing a representative number of units or a single unit for regulatory compliance. Data provenance is internal testing performed by the manufacturer or accredited labs based on international standards.
• Software Verification & Validation: Sample size for testing not specified, but covers the entire software system. Data provenance is internal software development and testing.
• Bench Testing (i-Forma Applicator):
  • Ex-vivo tissue study: Sample size not specified for the ex-vivo model (e.g., number of tissue samples). Data provenance is internal lab testing.
  • Comparative test on human volunteers: The document states "human volunteers," but does not specify the number of volunteers. Data provenance would be a clinical study, likely conducted by the manufacturer. This would be considered prospective data collection.

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

• This is not applicable as the studies were focused on device performance and safety (e.g., electrical, thermal, software verification) against established engineering and medical device standards, rather than diagnostic accuracy requiring expert consensus on "ground truth." The "ground truth" for these tests would be the measured physical parameters, the functionality of the software, and the physiological response (temperature elevation) in tissue/volunteers, compared against predetermined specifications and the predicate device.

4. Adjudication Method for the Test Set

• Not applicable in the context of device safety and performance testing against objective standards or direct comparison to a predicate. Results are typically quantitative measurements and observations, not subjective interpretations requiring adjudication.

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. This device is not an AI-powered diagnostic system aimed at improving human reader performance. It is an RF energy delivery system for aesthetic and medical treatments.

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

• No. This is an RF energy delivery system, not a standalone AI algorithm. The performance studies evaluate the physical device's operation, safety, and functionality.

7. The Type of Ground Truth Used

• For Electrical Safety, EMC, Usability, High-Frequency Surgical Equipment Safety: Compliance with specific international consensus standards (IEC 60601-1, -1-2, -1-6, -2-2). The "ground truth" is adherence to the technical requirements and limits defined by these standards.
• For Software Verification and Validation: Adherence to FDA guidance for software in medical devices and the software's specified functional requirements.
• For Bench Testing (i-Forma Applicator):
  • Accuracy of RF output parameters & temperature sensor accuracy: Measured values against calibration standards and design specifications.
  • Temperature build-up in ex-vivo model & ex-vivo tissue study: Measured temperature and tissue penetration against expected physiological effects and comparison to the predicate device.
  • Comparative test on human volunteers: Measured thermal effect (e.g., temperature elevation) against the thermal effect of the predicate device and safety thresholds.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML-driven diagnostic or analytical tool that requires a "training set" in the conventional sense. The software is likely deterministic control software, validated against specifications rather than trained on data.

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

• Not applicable, as there is no "training set."

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The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 ml/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-V.

The InMode System with the Morpheus8 (Fractora) Applicators is a computerized, programmed, RF technology-based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.

The device platform is basically constituted on the same system platform as FDA cleared for the proposed predicate device; The InMode System with the Fractora3D/3D-90 Applicators (K180189). The device applicators employ fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morphues8 (Fractora) Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins.

The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 (Fractora) Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 (Fractora) Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The subject device applicator comprises a disposable, single use, fractional RF electrode pins tip head.

The InMode System with the Morpheus8 (Fractora) Applicators comprises the following applicator tip heads:

• Morpheus8 24 Pin Applicator (Fractora3D) tip (FDA Cleared in K180189)
• Morpheus8 40 Pin treatment tip (New tip) .
• . Morpheus8 12 Pin treatment tip (New tip)
• . Morpheus8 T Pin treatment tip (New tip)

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "InMode System with the Morpheus8 (Fractora) Applicators." It establishes the substantial equivalence of this new device to a previously cleared predicate device.

Crucially, this document is for an electrosurgical cutting and coagulation device, not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance, such as ground truth, multi-reader multi-case studies, training sets, and expert consensus, are not applicable to the information contained in this document.

The primary acceptance criteria for this type of device, as per the document, revolve around substantial equivalence to a predicate device in terms of:

1. Intended Use/Indications for Use
2. Technological Characteristics
3. Safety and Effectiveness (demonstrated through performance testing and compliance with recognized standards).

Here's a breakdown of the relevant information provided in the document concerning the device's acceptance criteria and the study proving it meets those criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (InMode System with the Fractora3D/3D-90 Applicators, 510(k) No. K180189). The 'studies' are non-clinical bench performance tests.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or image-based AI/ML test set. The 'test set' here consists of the subject device (InMode System with new Morpheus8 applicators) comparing its performance and characteristics against the predicate device.
• Data Provenance: The tests are non-clinical bench performance tests. Data is proprietary to the manufacturer (InMode MD Ltd.) and was collected as part of their device development and regulatory submission process. There is no mention of country of origin for data related to patients or clinical studies, as none were required or performed. The tests are "retrospective" in the sense that they were performed after the device was manufactured to verify its specifications.

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

• This is not applicable as there is no "ground truth" established by experts in the context of an AI/ML device for diagnostic purposes. The ground truth for performance here is the physical output of the device and its compliance with engineering specifications and recognized safety standards, measured by calibrated equipment.

4. Adjudication Method for the Test Set

• Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or labelers, typically in image interpretation for AI/ML ground truth generation. Here, the "test" is largely a comparison of engineering specifications and performance with those of a predicate device and relevant standards.

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

• No. This type of study is for evaluating human performance, often with and without AI assistance, especially in diagnostic imaging. It is not relevant for an electrosurgical device like the InMode System.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. There is no "algorithm" in the sense of an AI/ML model being assessed independently. The performance assessed is the device's physical output and adherence to safety standards.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for this device's performance evaluation comprises:
  • Engineering Specifications: The design parameters and operational capabilities of the device as per its intended function (e.g., RF output power, frequency, energy per pin, dimensions).
  • Recognized Consensus Standards: Compliance with international standards for medical electrical equipment (IEC 60601 series, AAMI/ANSI standards) and sterilization (ISO 11137-1).
  • Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (K180189) serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As no training set is involved, no ground truth needed to be established for it.

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The EmFace Device with 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 EmFace Device with the Cheek and Chin Applicators is a hands-free, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 43℃. The hands-free applicators multiple RF units are sequentially activated over the treatment area. This ensures homogenous and safe heating distribution over the entire treatment area. The EmFace Device consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF non-invasive 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. The System operates while connected to any of the following applicators: - . Chin Applicator (with three sequentially activated units) or; - . Cheek Applicator (with eight sequentially activated units) The applicator is connected to the main console via a designated cable and a connection port. The applicators' units are adjusted to the patient using an adjustable designated belt set.

The provided text describes the EmFace Device and its submission for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device (InMode PLUS System). The text focuses on safety and performance, rather than specific diagnostic accuracy or classification of medical conditions, which would typically involve detailed acceptance criteria for an AI-powered diagnostic device.

Therefore, many of the requested categories for AI device evaluation are not directly applicable or explicitly stated in the provided documentation, as the device is an electrosurgical cutting and coagulation device.

Here's an attempt to extract relevant information and note where the requested information is not available or applicable based on the provided text:

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

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific clinical outcomes or diagnostic accuracy metrics. Instead, the "acceptance" is based on demonstrating safety and comparable performance to a predicate device, primarily through thermal effects.

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

• Test Set Sample Size (Clinical Study): Thirty (30) eligible human subject participants.
• Data Provenance (Clinical Study): Prospective, conducted on human subjects (no specific country of origin mentioned, but the manufacturer is InMode MD Ltd. from Israel).

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

This information is not provided in the document. For aesthetic devices like this, "ground truth" related to diagnostic accuracy is not typically established by expert consensus in the same way it would be for an imaging-based AI diagnostic device. The "ground truth" here revolves around safety (e.g., absence of adverse events, temperature readings) and the observation of the device's intended physiological effects, likely performed by the study investigators.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of the device (electrosurgical for muscle relief, not a diagnostic tool), a formal adjudication process for "truth" in the context of diagnostic agreement (like 2+1 or 3+1) is not typically applicable. Safety observations and temperature measurements would likely be recorded directly by study staff.

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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging interpretation where human readers (e.g., radiologists) use AI assistance to improve their performance. This device is not an AI diagnostic tool and does not involve "human readers" in this context.
• Effect Size: Not applicable as no such study was performed.

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

• The device functions as a standalone electrosurgical device. Its performance is evaluated on its direct physical effects (temperature, tissue response), not as an algorithm making a decision. The clinical study described evaluates the device in its intended operational mode, which is "standalone" in the sense that it directly applies energy without an AI interpretation layer.

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

The "ground truth" for the device's performance relies on several objective and observational measures:

• Bench Testing: Direct physical measurements (temperature build-up at different power levels).
• Pre-Clinical (Animal) Study: Histopathological examination (tissue vitality, absence of necrosis) and direct temperature profiling.
• Clinical Study: Direct thermal measurements on human skin, skin observation for adverse events, and subject reports of discomfort (absence of adverse events and maintenance of target temperature profiles being the positive "ground truth").

8. The sample size for the training set

This information is not applicable/not provided as the EmFace Device is an electrosurgical device, not an AI/machine learning model that requires a training set. The device is hardware-based with software controls; it learns nothing from data.

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

This information is not applicable as there is no training set for an AI/machine learning model.

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The InMode EmBody System with its designated hand pieces is intended for the treatment of the following medical conditions;

The EmBodyPLUS hand piece 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 EmBodyFX Hand piece is intended for the treatment of the following medical conditions using RF combined with massage:

· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

· Temporary reduction in the appearance of cellulite.

The EmBody System with the EmBodyFX and EmBodyPlus Applicators is a free hand, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The EmBodyFX Applicator also incorporates a mechanical vacuum skin massaging mechanism.

The EmBody System is employing RF technology for various aesthetic applications.

The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The design of the device applicators allows efficient treatment of large tissue surfaces.

The EmBody System consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF noninvasive applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button located on the LCD screen.

The EmBody System operates while connected to any of the following Applicators:

• . EmBodyFX (Up to Six units connected simultaneously) or;
• . EmBodyPlus (Up to Eight units connected simultaneously)

Each applicator unit is connected to the main console via a designated cable and a connection port. The applicator units are adjusted to the patient body using a designated belt set.

The provided text describes the EmBody System, which is intended for temporary relief of minor muscle aches and pain, muscle spasms, local blood circulation improvement, and temporary reduction in the appearance of cellulite. The device uses non-thermal RF energy and, in the case of the EmBodyFX applicator, a mechanical vacuum skin massaging mechanism.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through various tests.

However, based on the non-clinical and clinical studies, the implied performance outcomes and safety parameters could be considered acceptance criteria and reported performance:

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

• Sample Size for Test Set:
  • Bench Test (Thermal Effect Comparison): The text mentions "human volunteers" but does not specify the sample size for this comparative bench test.
  • Ex-vivo Animal Study: Not specified, but involved "porcine tissue."
  • Human Clinical Study: Thirty (30) eligible human subject participants.
• Data Provenance:
  • Bench Test (Thermal Effect Comparison): Conducted in-house by the manufacturer (InMode MD Ltd.) comparing their own devices. Specific country of origin not explicitly stated, but the manufacturer is based in Israel.
  • Ex-vivo Animal Study: Conducted in-house by the manufacturer. Specific country of origin not explicitly stated, but the manufacturer is based in Israel.
  • Human Clinical Study: Conducted in-house by the manufacturer. Specific country of origin not explicitly stated, but the manufacturer is based in Israel. This was a prospective study.

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

The provided text does not mention using experts to establish ground truth for the test set. The evaluation was based on:

• Thermal measurements.
• Skin observation.
• Tissue vitality evaluation (in the animal study).
• Adverse event reporting.
• Subject discomfort levels.

Therefore, no information on the number or qualifications of experts for ground truth establishment is available.

4. Adjudication method for the test set

The provided text does not mention any adjudication method for the test set. The safety and performance assessments were directly observed (e.g., thermal measurements, skin observation, adverse event reporting) rather than requiring independent review or consensus.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is an electrosurgical device for aesthetic and therapeutic applications, not an AI-powered diagnostic imaging tool that would typically involve human readers or AI assistance in interpretation.

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

This refers to a physical medical device, not an algorithm or AI. Performance was assessed through direct physical interaction with tissue (bench, animal, and human studies), not through an algorithm operating independently. Therefore, this question is not applicable.

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

The ground truth for evaluating the device's safety and performance was primarily based on:

• Physiological measurements: Thermal measurements (temperature around 43°C).
• Direct observation: Skin observation for transient responses, absence of tissue necrosis, and absence of adverse events.
• Subjective reporting: Discomfort levels reported by human subjects.
• Comparison to predicate devices: Demonstration of "similar thermal effect" and "same thermal outcomes" as the legally marketed predicate devices.

8. The sample size for the training set

The provided context describes performance testing for device clearance, not the development or training of an AI model. Therefore, there is no "training set" in the context of this document.

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

As there is no training set for an AI model, this question is not applicable.

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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 Diolaze XL System with the Diolaze XL 810mm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

The InMode Diolaze XL multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system was already FDA cleared in K170738 along with its designated Diolaze 810nm hand piece. The InMode Diolaze XL System is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The handpiece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser 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 comprises the InMode Diolaze XL System with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power. The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces: Diolaze 810nm Hand piece (FDA cleared in K17078), Diolaze 755/810nm Hand piece, Diolaze 810/1064nm Hand piece.

This document describes the FDA 510(k) summary for the InMode Diolaze XL System, a laser device for hair removal. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed study results as might be found in a clinical trial report.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for device performance based on hair reduction percentages. Instead, it relies on demonstrating "significant reduction in hair count" to show efficacy, aligning with the "permanent hair reduction" indication. The performance is compared to the effects observed with predicate devices.

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

• Sample Size for Test Set: 31 female subjects.
• Data Provenance: The study was "multicenter" but the specific country of origin is not explicitly stated. Given that InMode MD Ltd. is based in Israel, it is plausible the study was conducted there or in another country. The study was prospective, described as a "proscription, open labelled, multicenter, single arm Clinical study."

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

• Number of Experts: Three independent, blinded evaluators.
• Qualifications of Experts: Not specified. The document only mentions "three independent, blinded evaluators" performed photography hair counts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated, but implies a consensus or averaging approach: "Photography hair counts were performed by three independent, blinded evaluators and a statistical comparison was conducted..." It does not specify if disagreements were resolved through additional review (like 2+1 or 3+1) or if an average or majority vote was used.

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

• Not Applicable. The described study is a single-arm clinical study evaluating the device's efficacy, not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a laser hair removal system, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is a hardware medical device (laser system), not a software algorithm. The "performance" being evaluated is hair reduction on human subjects.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for hair reduction efficacy was established using photography hair counts performed by independent evaluators, compared to baseline. This can be considered a form of expert consensus/objective measurement based on photographic evidence.

8. Sample Size for the Training Set

• Not Applicable. The device is a laser system and does not involve AI or machine learning algorithms that would typically require a "training set" for model development. The software validation mentioned (IEC 62304) pertains to the safety and functionality of the device's operating software, not to an AI model trained on data.

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

• Not Applicable. As there is no AI/ML algorithm requiring a training set, this question is not relevant to the provided information.

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The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.

The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis. The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.

Based on the provided text, the device in question is the "InMode System with Fractora3D/3D-90 Applicators," which is an electrosurgical cutting and coagulation device. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device rather than proving efficacy through clinical trials with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" for performance, "ground truth establishment," "expert adjudication," and "multi-reader multi-case studies" is not applicable or explicitly stated in the context of this traditional medical device submission.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

• AAMI/ANSI 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
• IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
• IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories. |
  | Accuracy and Consistency of RF Output Parameters (Bench Test) | Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters. Results demonstrated that the InMode System complies with design requirements and consists of similar RF output specifications as the predicate device. |
  | Safety and Efficacy for Indicated Use (Animal Study) | A preclinical study on a porcine model evaluated thermal effects and tissue healing. "The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." |
  | Biocompatibility of Patient Contact Materials | All device materials which come in direct contact with the patient skin are biocompatible. Reference made to predicate devices: K102461, K082451, K142438, K151019 and K081365 for biocompatibility determination. |
  | Substantial Equivalence to Predicate Device (Performance Specs)| The performance specifications (including RF frequency, pulse duration, and RF energy per pin) of the InMode System were shown to be similar and yielded similar RF energy per pin values to those of the predicate EndyMed Intensif Applicator (K130501). |

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

• Test Set Sample Size:
  • Bench Test: Not explicitly stated how many tests were run, but it refers to "performance bench tests."
  • Animal Study: The study was conducted on a "porcine model." The exact number of animals is not specified, but it refers to a "single RF treatment" per animal at various follow-up times (immediately, 7, 14, and 21 days post-treatment).
  • Clinical Data: "Not Applicable" for this 510(k) submission.
• Data Provenance: The device manufacturer (InMode MD Ltd.) is located in Israel. The studies are described as pre-clinical (animal model) and bench tests. The location where these specific tests were performed is not detailed. The data is retrospective in the sense that it's reported for a 510(k) submission, but the tests themselves would have been performed prospectively as part of validation.

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

• This concept of "ground truth established by experts" is not explicitly applicable or discussed in the context of this traditional device submission for electrocoagulation and hemostasis. The "ground truth" for the animal study would be the histological findings and clinical observations of tissue effect and healing. The expert interpreting these would likely be a veterinary pathologist, but their number and qualifications are not specified in this summary.

4. Adjudication method for the test set

• Not applicable/mentioned. This is typically relevant for diagnostic AI studies where multiple readers might review cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The document states "Clinical Performance Data: Not Applicable."

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

• This is not an AI/algorithm-driven device. It is a physical electrosurgical device. Therefore, the concept of "standalone performance" of an algorithm is not applicable. The device's performance stands alone in its ability to deliver RF energy as specified.

7. The type of ground truth used

• For the non-clinical studies:
  • Bench Tests: The ground truth is the designed specifications and physical measurements of RF output parameters.
  • Animal Study: The ground truth is histological analysis (tissue changes and healing process) and observation of the gross thermal effects in the porcine model.

8. The sample size for the training set

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

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

• Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment method for one.

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The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, telangiestasia, port wine stains, leg veins and other benign vascular lesions.

The InMode VLaze device is designed to deliver diode laser energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode VLaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser 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 comprises the InMode VLaze device laser with linear scanning system, cooled sapphire output window (3 x 4mm2), and electronic shutter. The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 7°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence is delivered within the limits of 40 to 300J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.

The provided text describes the InMode VLaze laser surgical instrument and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance.

Instead, the document focuses on:

1. Regulatory Compliance: Demonstrating that the device adheres to recognized voluntary performance standards for medical electrical equipment and laser product safety (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
2. Substantial Equivalence: Arguing that the InMode VLaze device is substantially equivalent to previously cleared predicate devices (Lumenis Ltd. ET Lightsheer 1060, Quanta System SPA EVO Platform, and InMode MD Ltd. InMode Diolaze XL) based on its intended use, design, components, performance specifications (wavelength, fluence, pulse width, cooling), and safety features.

The document explicitly states under "Clinical Performance Data": "Not Applicable". This means no clinical study with human subjects was conducted to evaluate the device's efficacy or performance in terms of treatment outcomes for vascular lesions for this 510(k) submission. Therefore, it's not possible to extract the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these pertain to clinical or AI/algorithm performance evaluation, which was not part of this specific submission.

Summary of what can be extracted from the provided text:

• Device Performance (as per non-clinical testing): The device was tested for compliance with electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). The "Non-Clinical Performance Data" section states, "The test results show that the device performance specifications meet the system requirements."
• No Clinical Study Details: The document explicitly states "Clinical Performance Data: Not Applicable." This means no clinical study measuring treatment effectiveness or outcomes was submitted or is detailed.

Therefore, based on the provided text, the following information cannot be provided:

1. A table of acceptance criteria and reported device performance related to clinical efficacy or diagnostic accuracy.
2. Sample sizes used for a test set for clinical performance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect size of human readers with/without AI assistance.
6. If a standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
8. Sample size for a training set (as no AI/algorithm is detailed).
9. How ground truth for a training set was established.

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The InMode PLUS System with the PLUS/PLUS90/PLUS-PLUS Hand pieces 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 InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 42°C. The hand pieces are operated while in continuous movement over the treatment area. This ensures uniform and safe heating of the entire treatment area.

Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System.

Three InMode PLUS hand pieces are available:

• . InMode PLUS hand piece
• InMode PLUS90 hand piece
• InMode PLUS-PLUS hand piece (

The provided text does not describe the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML-based medical device. Instead, it is a 510(k) premarket notification summary for the InMode PLUS System, an electrosurgical cutting and coagulation device. This document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions.

Therefore, I cannot provide the requested information regarding acceptance criteria, performance studies (like MRMC or standalone AI performance), sample sizes for AI training/testing sets, expert ground truth establishment, or any information typical for an AI/ML device submission.

The document states:

• "Clinical Performance Data: Not Applicable" (Page 5)
• "Software & Cybersecurity: The InMode PLUS System software is based on the software modules of the predicate device... The device software was adjusted to support the integration and operation of the PLUS-PLUS hand piece. The software is designed in accordance with ISO 62304 standard - Medical device software- Software life cycle processes. The InMode PLUS System is a closed, standalone system and as such it is not effected by cybersecurity related issues." (Page 6)

This clearly indicates:

• No clinical trials were performed or were necessary for this submission.
• The software is for basic device operation and control, not for diagnostic or predictive AI functions. It's an update to existing software for a new handpiece, following standard software lifecycle processes.

To answer your request based only on the provided text, I can only state that the document does not contain the information you are asking for, as it pertains to a different type of medical device submission and a different type of technology.

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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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