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The WinForth is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The WinForth massage device is intended to provide a temporary reduction in the appearance of cellulite.

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I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the WinForth (LM-E470KA) device does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria.

The document primarily focuses on:

• The FDA's decision of substantial equivalence to predicate devices.
• General regulatory requirements for the device (e.g., quality system, labeling, adverse event reporting, UDI).
• The intended indications for use of the device.

There is no mention of:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, or technical performance parameters)
• A trial or study design.
• Sample sizes for test or training sets.
• Number or qualifications of experts.
• Ground truth establishment or type.
• MRMC studies or effect sizes.
• Standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This type of detailed study information is typically found in the applicant's 510(k) submission summary or a separate clinical/performance study report, not in the FDA clearance letter itself.

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The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Zionic Pro Max with Radiofrequency is a non-invasive topical heating device that produces RF energy to warm subcutaneous tissue the therapeutic temperature of 40-45°C. The device includes two different type of RF handpieces, resistive and capacitive, which are connected to a console and software-powered user interface. The Zionic Pro Max adds a new capacitive handpiece and user interface to a previously cleared generation of the device.

The provided FDA 510(k) clearance letter for the Zionic Pro Max (Radiofrequency) device primarily concerns the safety and effectiveness of a medical device intended for topical heating and reduction of cellulite. It is not an AI/ML device that deals with image analysis, diagnosis, or prediction, and therefore, many of the typical acceptance criteria and study details associated with AI/ML medical devices (like MRMC studies, ground truth establishment by experts, sample sizes for training/test sets in the context of machine learning, etc.) are not applicable to this document.

The document discusses performance testing in the context of electrical safety, electromagnetic compatibility, and the device's ability to achieve and maintain a specific tissue temperature. It does not involve any AI/ML components requiring complex ground truth adjudication or studies for human-in-the-loop performance improvement.

Therefore, I will extract relevant information that is present in the document pertaining to the device's performance criteria and how it was shown to meet them.

Acceptance Criteria and Reported Device Performance

The core performance criterion for the Zionic Pro Max device, as established through non-clinical testing, is its ability to heat tissue to a specific therapeutic temperature.

Study Details (Based on available information in the 510(k) Summary)

Since this is not an AI/ML device, the standard questions regarding AI/ML study design (such as data provenance, expert ground truth establishment for diagnostic performance, MRMC studies, training set details) are not directly addressed in this type of 510(k) summary. The "study" here refers to non-clinical, benchtop performance testing to ensure the device meets its physical and electrical specifications and performs its intended function (heating tissue) effectively and safely.

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

   • The document mentions "Tissue thermal testing" and "Bench testing" but does not specify the sample size (e.g., number of test repetitions, number of ex-vivo tissue samples, or number of devices tested).
   • Data Provenance: Not specified, but generally, bench testing data would be generated in a lab setting, likely by the manufacturer (TermoSalud S.L.) or a contracted testing facility. No indication of patient data or country of origin for such data.

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

   • Not applicable. The "ground truth" for this device's performance is determined by physical measurements (temperature, power, frequency, voltage) using calibrated equipment, not by expert interpretation of complex visuals or medical conditions. Therefore, no human experts are mentioned for establishing ground truth in this context.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are interpreting complex data (e.g., medical images) and their decisions need to be reconciled. This device's testing involves objective physical measurements.

4. 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 hardware for topical heating and cellulite reduction, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

   • Not applicable. This device does not have a standalone algorithm in the sense of an AI/ML component performing diagnostic tasks. Its "performance" is based on the physical output and safety of the radiofrequency energy. The "software" mentioned (IEC 62304) relates to the control unit's functionality, not an AI/ML diagnostic algorithm.

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

   • The "ground truth" for the non-clinical testing appears to be measured physical parameters (e.g., temperature attained, electrical output values) against predefined specifications (40-45°C, accurate power/frequency/voltage).

7. The sample size for the training set:

   • Not applicable. There is no indication of a machine learning model being trained with a dataset mentioned in this 510(k) document. The "training" here refers to manufacturing and operational parameters, not data for an AI algorithm.

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

   • Not applicable. As there is no mention of an ML training set, there's no ground truth establishment method for it.

In summary, the provided document details the regulatory clearance for a physical medical device (radiofrequency equipment) based on its direct electrical and thermal performance characteristics, not on the performance of a software algorithm leveraging a dataset of medical cases.

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HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation.

HEBE is a device indicated for radiofrequency (RF) treatments at 448kHz. This frequency is associated with pain reduction and improved functionality in patients with musculoskeletal disorders. This wavelength promotes ion mobilization between the intracellular and extracellular matrix and restores cell membrane permeability. The energy generated at 448 kHz improves cell membrane permeability, enhancing intracellular and extracellular exchange and tissue regeneration. Furthermore, high-intensity radiofrequency treatment at 448 kHz can induce significant hyperthermia, which can lead to a considerable increase in cell metabolism and accelerated recovery. These hyperthermal adaptations to radiofrequency treatment are based on vasodilatation, causing a targeted local increase of blood perfusion and decreases in muscle tension and spasm, increased oxygen and nutrient supply, and healing acceleration.
RF treatment can be applied through either capacitive or resistive electrodes that pass radiofrequency to the human body.
HEBE has 3 different technologies:

• Monopolar Capacitive Radiofrequency
• Monopolar Resistive Radiofrequency
• Bipolar Resistive Radiofrequency

The provided FDA 510(k) clearance letter and summary for the HEBE device primarily focus on substantial equivalence to predicate devices through comparisons of features and performance specifications. It does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on clinical outcomes or a rigorous statistical evaluation of its effectiveness.

The document highlights bench testing and compliance with safety and electrical standards (IEC 60601 series, IEC 62304) and biocompatibility standards (ISO 10993 series). This indicates the device's safety and fundamental operational aspects were verified, but not its clinical efficacy against pre-defined performance metrics in a clinical setting.

Therefore, many of the specific questions about acceptance criteria and clinical study details cannot be answered from the provided text, as the application relies on substantial equivalence and non-clinical performance data, rather than a direct clinical performance study with acceptance criteria for clinical outcomes.

Here's an attempt to answer the questions based only on the provided information, noting where information is absent:

Acceptance Criteria and Device Performance (Based on Provided Data)

The concept of "acceptance criteria" for clinical performance is not explicitly defined or measured in this document. Instead, the "performance specifications" are a comparison to predicate devices, indicating similarity rather than a proven threshold for efficacy.

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

Based on the provided information, there are no clinically-defined acceptance criteria with corresponding device performance data for efficacy. The "performance specifications" listed are comparative to the predicate and reference devices regarding technical parameters.

Note on "Acceptance Criteria" for Performance Features: For a 510(k) submission based on substantial equivalence, the "acceptance criteria" for these technical performance specifications is typically that they are "the Same" or "Equivalent" to the predicate device(s) without raising new questions of safety or effectiveness. The document asserts that the HEBE device meets this implicitly by stating "Same" or providing values within a comparable range.

Study Details (Based on Provided Data)

The document does not describe a clinical study that proves the device meets specific acceptance criteria for clinical outcomes (e.g., pain relief, muscle spasm reduction). The performance data cited are related to bench testing for safety, electrical, and biocompatibility standards, and a comparison of technical specifications to predicate devices.

Therefore, for most of the following questions, the answer will be that the information is not provided in the clearance letter.

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

• Not provided. The document describes "Verification and validation were performed on the device using the established methods by using the predicate device" and lists standards for safety and electrical performance. This refers to bench testing, not a clinical human test set.

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. No clinical test set with human data requiring expert ground truth establishment is described. The "experts" would be engineers and testers performing bench tests.

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

• Not applicable. No clinical test set requiring adjudication is 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

• Not applicable. This device is an electrosurgical cutting and coagulation device for topical heating, not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study.

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

• Not applicable. This is a physical medical device (radiofrequency treatment), not an algorithm with standalone performance. Its "performance" relates to its physical output and safety.

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

• For the bench testing: The "ground truth" would be the specifications and requirements defined by the IEC and ISO standards (e.g., electrical safety limits, biocompatibility thresholds, specified temperature output).
• For clinical efficacy: This information is not provided. The 510(k) relies on substantial equivalence and the known mechanism of action of similar devices for its intended use, rather than presenting new clinical outcomes data.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would have a "training set" in the conventional sense. The "training" for such devices is their design and manufacturing to meet the specified performance and safety standards.

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

• Not applicable. (See point 8.)

Summary of what the document does provide:

The 510(k) summary focuses heavily on:

• Substantial Equivalence: Comparing the HEBE device's features, indications for use, principle of action, and technical specifications (frequency, power) to a primary predicate device (NuEra Tight RF Family) and a reference device (Deep Care). The conclusion is that it is "safe and effective and are substantially equivalent."
• Bench Testing & Standard Compliance: The device underwent verification and validation tests in accordance with a range of established international standards for medical electrical equipment (IEC 60601 series, IEC 62304) and biocompatibility (ISO 10993 series). These tests verify the device's electrical safety, usability, electromagnetic compatibility, and material safety.

This type of submission is common for Class II devices where a new device is similar enough to existing legally marketed devices that extensive new clinical trials demonstrating efficacy are not required, provided new questions of safety or effectiveness are not raised.

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The Préime DermaFacial with Collagen+ Applicator is intended to relieve minor muscle aches and pain, relieve muscle spasms, temporarily improve local blood circulation, temporarily improve the appearance of cellulite.

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I apologize, but the provided FDA 510(k) Clearance Letter for the "Préime DermaFacial Collagen+" device does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter is a formal notification of substantial equivalence for a medical device (an electrosurgical cutting and coagulation device) based on its intended use to relieve minor muscle aches and pain, muscle spasms, improve local blood circulation, and temporarily improve the appearance of cellulite.

It details:

• The device name and regulation information.
• The legal basis for its clearance (substantial equivalence to predicate devices).
• Applicable regulations and requirements (e.g., general controls, Quality System regulation, UDI Rule).
• Contact information for FDA.
• The specific Indications for Use.

It does NOT include:

• Any performance specifications or acceptance criteria (e.g., sensitivity, specificity, accuracy, or any performance metrics related to its stated indications).
• Details of any clinical or non-clinical studies conducted to demonstrate its performance against such criteria.
• Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or any aspects of a statistical study design.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text, as this information is not present. This type of detail is typically found in a separate study report or a more comprehensive FDA submission document, not within the clearance letter itself.

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The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also is intended to provide a temporary reduction in the appearance of cellulite.

The XOD diathermia radiofrequency device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed, and RF therapy can be provided. The device can be operated in a resistive monopolar mode.

The product consists of a portable power console with a color touchscreen, and accessories including resistive threaded electrodes, and a silicon return plate. The unit can be adjusted to provide various levels of treatment frequency ranging from 442kHz to 454MHz.

The provided text describes the 510(k) submission for the XOD Diathermia Radiofrequency Device and its substantial equivalence to a predicate device. However, it does not contain information about a clinical study involving human readers, AI assistance, or the creation of a ground truth for a test set or training set.

The document primarily focuses on:

• Device Description and Intended Use: The XOD device provides topical heating using radiofrequency for pain relief, muscle spasms, increased local circulation, and temporary reduction of cellulite.
• Substantial Equivalence Comparison: It compares the XOD device to a predicate device (Indiba Diathermia Radiofrequency Device K161458) based on product code, indications for use, device description, principle of operation, frequency range, input voltage/power, treatment time, intensity, maximum tissue temperature, and regulatory testing standards (EMC, Electrical Safety, Biocompatibility).
• Regulatory Compliance: It highlights that the XOD device meets various electrical safety, EMC, and biocompatibility standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, ISO 10993-1).

Therefore, based on the provided text, I cannot answer most of your questions as the requested information is not present. I can only provide details on the performance testing that was mentioned.

Here's what can be extracted from the text:

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

The document primarily focuses on meeting regulatory and design specifications rather than specific clinical performance criteria from a human-AI study. The "performance criteria" here refer to compliance with technical standards and design specifications.

The following information is NOT available in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as there is no mention of a test set for AI performance or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the document refers to a physical radiofrequency device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Indiba Diathermia Radiofrequency Deep Care/Activ devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.

The device models consist of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes, stainless steel conductive resistive electrodes (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.

The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.

The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.

The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.

The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.

Improvements were performed in both device models in the console design and in the graphical user interface (GUI).

New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.

The provided text describes a 510(k) premarket notification for two medical devices: the Indiba Diathermia Radiofrequency Deep Care Device and the Indiba Diathermia Radiofrequency Activ Device. This submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing performance against specific, quantifiable clinical acceptance criteria for effectiveness.

Therefore, the information typically found in a study proving device meets acceptance criteria for a novel device (e.g., diagnostic accuracy metrics, sensitivity, specificity, statistically significant improvement over a comparator) is not present in this document. This is common for 510(k) submissions, especially for devices undergoing modifications or being introduced as substantially equivalent to existing ones.

Instead, the acceptance criteria revolve around safety, electrical performance, and substantial equivalence to a predicate device. The study proving the device meets these "acceptance criteria" consists of non-clinical (bench) performance data, demonstrating adherence to recognized standards and consistency with the predicate device.

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

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

Since this is a substantial equivalence submission, the "acceptance criteria" are compliance with recognized standards and demonstration that the changes do not raise new safety or effectiveness concerns compared to the predicate devices. The "reported device performance" is successful completion of these non-clinical tests and the maintenance of the predicate device's technological characteristics.

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

• Sample Size for Test Set: Not applicable for clinical data. The "test set" here refers to the physical devices themselves and their components undergoing bench testing. The document implies that the "subject device models" (Activ CT9 and EVONY) were tested. The specific number of individual units tested is not provided, but it's understood that representative units were used for the non-clinical tests.
• Data Provenance: The data is described as "Non-Clinical (Bench) Performance Data." It would have been generated in a controlled laboratory or testing facility environment, presumably by the manufacturer (INDIBA S.A.U.) or a contracted testing lab. Country of origin not explicitly stated, but the manufacturer is based in Spain. The data is prospective in the sense that tests were conducted on the newly designed devices per predefined protocols.

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. For non-clinical bench testing and safety standards compliance, "ground truth" is established by the specifications in the recognized standards and validated engineering principles, not by expert medical opinion in the clinical sense.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers review and resolve discrepancies in interpretations (e.g., medical images). This submission pertains to device engineering and safety performance, not clinical interpretation.

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 a radiofrequency therapy device, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device does not feature an algorithm for standalone performance evaluation in the usual sense (e.g., an AI algorithm for diagnosis). Its functionality is a therapeutic radiofrequency delivery system, where the "performance" is its ability to generate specific RF fields and temperatures, and the "human-in-the-loop" is the medical professional operating the device.

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

For the non-clinical performance data, the "ground truth" is defined by:

• Recognized Standards: e.g., AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-2 for electrical safety, EMC, and specific RF surgical equipment requirements.
• Device Specifications: The manufacturer's defined technical specifications for power output, frequency, temperature ranges, etc.
• Biocompatibility Standards: Standards for materials that contact the patient's skin.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of algorithm development.

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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FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.

FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are active and therapeutic medical devices that perform their function by releasing energy to the human body.

The provided text is a 510(k) summary for the medical device Fisiowarm 7.0. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device performance study (e.g., diagnostic accuracy, reader performance).

The performance testing mentioned in the document is for electrical safety, electromagnetic compatibility, and a comparative thermal test on human skin to verify energy transfer, not related to an AI/ML device's diagnostic or analytical performance.

Therefore, I cannot provide the requested information from the given text as it does not pertain to an AI/ML-driven medical device and its associated performance study.

The document covers:

• Device Name: Fisiowarm 7.0
• Regulation Number: 21 CFR 878.4400 (Electrosurgical Cutting And Coagulation Device And Accessories)
• Product Code: PBX
• Intended Use: Topical heating to elevate tissue temperature for the treatment of pain, muscle spasms, increased local circulation, and temporary reduction in cellulite appearance.
• Predicate Device: Winback Back 3SE (K162828)
• Performance Testing: Electrical compliance (EN 60601-1, EN 60601-1-2) and tissue testing to compare thermal spread. This is essentially showing the device performs its physical function (heating) comparably to the predicate.
• No mention of AI/ML components or studies measuring diagnostic/analytical performance.

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MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation.

The Mirari Cold Plasma System is a portable, hand-held device that emits RF energy at 80kHz. The system is comprised of a battery-operated RF generator, a rechargeable power supply powered by a pair of lithium batteries and a plasma array which is placed in fleece pouch. The plasma array is then placed in a fleece pouch which is then placed on the RF energy is emitted through the array..

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance. Instead, it is an FDA 510(k) summary for a medical device called the "MIRARI® Cold Plasma System," which is an electrosurgical cutting and coagulation device.

The document focuses on demonstrating substantial equivalence to a predicate device (TempSure FlexSure Applicator) for the purpose of market clearance, not on evaluating the performance of an AI/ML algorithm against specific acceptance criteria.

Therefore, I cannot extract the requested information (such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it describes a different type of medical device submission that does not involve AI/ML performance evaluation.

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INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain. muscle spasms and increase in local circulation.

The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.

The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable.

In resistive mode the system delivers a high- frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current at 448 kHz to pass. Current returns through the neutral return electrode.

INDIBA Compact devices are provided with an electroconductive media which is applied to the patients' skin prior to each treatment session. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. In Compact Lite, the temperature on the skin is measured using a separate IR (Infra-red) thermometer and in Compact Plus and Compact Pro temperature is measured through the smart electrodes and smart handle, which inform of the surface skin temperature trough a color scale. There are also other accessories available as massage electrodes with different shapes that can be used to massage the skin during cellulite treatment.

The provided text is a 510(k) summary for the INDIBA COMPACT devices. It asserts that the device is substantially equivalent to a predicate device (INDIBA Diathermia Radiofrequency Device, K161458) based on non-clinical data.

Key Findings:

• No Clinical Studies Submitted: The document explicitly states, "No clinical studies are submitted."
• Basis of Substantial Equivalence: Substantial equivalence is supported by non-clinical performance tests, including electrical safety, electromagnetic compatibility, and software verification to IEC 62304. Biocompatibility of patient-contacting materials was also evaluated per ISO 10993-1.

Given these findings, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria, as no clinical studies with acceptance criteria or performance metrics were provided for the INDIBA COMPACT devices in this document.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Multi reader multi case (MRMC) comparative effectiveness study results or effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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