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truFlex is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of arms, buttocks, thighs, and calves
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
• To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions

truFlex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use.

truFlex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.

The fundamental scientific technology has not changed in the modified device. Changes are solely considered for addition of indication for use. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use.

The clinician can increase or decrease the intensity as per the desired stimulation. While modified device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.

The modified device, as described in this submission, have only addition of the indication for use and name the device

The device has two treatment types:

• Classic - In Classic mode, the treatment duration is 45 minutes.
• flex+ - In flex+ mode, the treatment duration is 15 minutes.

For ease of use and operation for the clinicians, we have 3 modes (suggestive):

• PREP mode creates a twisting motion to warm up and stretch the muscles and to slowly build a tolerance to muscle contractions. PREP mode is available for Classic treatments only.
• TONE mode contracts the muscles, holds it, and then relaxes to increase strength and muscle endurance. TONE mode is available for Classic and flex+ treatments.
• SCULPT mode uses fast, sequential contractions of the muscles which lead to toning and firming. SCULPT mode is available for Classic and flex+ treatments

Based on the provided FDA 510(k) Clearance Letter for the truFlex Muscle Stimulator, it's important to clarify that this document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy or performance through a traditional clinical study with defined acceptance criteria for de novo AI/ML devices.

The truFlex device is a Powered Muscle Stimulator, classified as Class II, and uses electrical muscle stimulation (EMS). Its clearance is based on the premise that its safety and effectiveness are "demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device," as stated on Page 4 and Page 9. This means the acceptance criteria are largely met by showing the device performs similarly to or within the established safety and performance parameters of already cleared, similar devices (predicates).

Therefore, the requested information points (1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, etc., typically apply to the rigorous clinical validation studies for novel medical devices, especially AI-driven ones where performance metrics like sensitivity, specificity, or AUC are critical. For a 510(k) based on substantial equivalence to predicate muscle stimulators, the "study" is often a combination of non-clinical bench testing, electrical safety testing, electromagnetic compatibility (EMC) testing, and comparison of technical specifications to demonstrate that the new device is as safe and effective as the predicate.

Given this context, I will address your points as best as possible based on the provided document, acknowledging where the information is not directly applicable or explicitly stated as it would be for a typical AI/ML clinical validation study.

Acceptance Criteria and Study for truFlex Muscle Stimulator

The acceptance criteria for the truFlex Muscle Stimulator, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by showing that the truFlex device has the same intended use, similar technological characteristics, and meets recognized safety and performance standards as its predicates, without raising new questions of safety or effectiveness.

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

Since this is a substantial equivalence submission for a traditional medical device (not an AI/ML diagnostic/therapeutic device), the "acceptance criteria" are generally that the device performs within the established safety and effectiveness profiles of the predicates. The "reported device performance" is demonstrated through compliance with voluntary standards and direct comparison of specifications.

• Normal Condition: Less than 100µA (Predicate 1,2:

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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

Not Found

The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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CoolTone is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs.

The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm abdomen, buttocks and thighs.

The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels.

Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. The CoolTone is equipped with the securement system which is designed to maintain applicator position throughout treatment.

A large color touch screen facilitates the use of the device. The on-screen information guides the user step-by-step through the entire treatment process. The treatment is operated through parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.

The provided FDA 510(k) clearance letter pertains to the CoolTone device (K251378). It states that this device is substantially equivalent to a previously cleared CoolTone device (K220601).

Crucially, the document explicitly states: "No clinical testing was required for this change." This means that for the K251378 submission, no new studies were performed to prove the device meets acceptance criteria. Instead, the clearance relies on its substantial equivalence to the predicate device, which presumably had clinical data supporting its initial clearance.

Therefore, many of the requested information points regarding acceptance criteria and study details cannot be directly extracted from this specific 510(k) clearance letter. The information below reflects what can be inferred or directly cited from the provided text about K251378, with an acknowledgement that the core "proof" resides within the documentation for the predicate device (K220601).

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no new clinical study was conducted for this specific 510(k) submission (K251378). Therefore, there are no new acceptance criteria or reported device performance for this updated device. The clearance is based on the identical technological characteristics and indications for use to the predicate device (K220601). The "acceptance criteria" for K251378 are implicitly met by demonstrating substantial equivalence to the predicate device, meaning it performs as safely and effectively for the stated indications.

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

Not applicable for K251378 as no new clinical testing was performed for this submission. The substantial equivalence argument relies on prior data for the predicate device (K220601).

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

Not applicable for K251378 as no new clinical testing was performed for this submission.

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

Not applicable for K251378 as no new clinical testing was performed for this submission.

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 for K251378. The CoolTone device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable for K251378. The CoolTone is a physical device for muscle stimulation.

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

Not applicable for K251378 as no new clinical testing was performed. For the predicate device (K220601), clinical trials would likely have used objective measurements (e.g., imaging to assess muscle thickness, physical measurements for circumference changes, or patient/physician reported outcomes on tone/firmness) to establish the ground truth for muscle strengthening, toning, and firming.

8. The sample size for the training set

Not applicable for K251378 as no new clinical testing or algorithm training was performed for this submission.

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

Not applicable for K251378 as no new clinical testing or algorithm training was performed for this submission.

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Pure Impact is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
• The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.

Pure Impact device provides both training and physical therapy using Electrical Muscle Stimulation (EMS). The EMS is provided through electrodes that are controlled by the Touch Control Module.

The system includes:

• Touch Control Module
• Pure Impact™ Wireless Stimulation Modules
• Pure Impact™ Electrode Pads
• Pure Impact™ Charging Station

The Touch Control Module runs the Pure Impact™ program and displays the user interface, which provides the full range of controls to identify the patient and the required treatment. The Pure Impact™ Wireless Stimulation Modules provide EMS to selected body locations on the patient and communicate to the Touch Control Module through Bluetooth Low Energy (BLE). Each Stimulation Module contains a main stimulation unit and several stimulation subunits, each of which is attached to a Pure Impact™ Electrode Pad placed on the patient. The Pure Impact™ Electrode Pads are disposable and intended for single patient, single use only. They contain a hydrogel adhesive to attach to the selected body locations on the patient and magnetic connectors to attach to the Stimulation Modules. The Pure Impact™ Charging Station charges the Stimulation Modules.

This FDA 510(k) clearance letter pertains to the Pure Impact device, a powered muscle stimulator. The clearance is based on demonstrating substantial equivalence to a predicate device, the Pure Impact Module of the SofWave System (K250146).

The document states that the Pure Impact device is a modification of the predicate, with the only changes being related to the standalone PC, GUI, and software updates. It explicitly states that no changes were made to the Pure Impact Charging Station Unit, Pure Impact Wireless Stimulation Modules, or Pure Impact Electrode Pads. Furthermore, the change does not affect the treatment protocols, stimulation parameters, or energy delivery.

Therefore, the performance data and acceptance criteria for electrical muscle stimulators (EMS) typically revolve around safety and technical specifications, rather than clinical efficacy or diagnostic accuracy, which would involve more complex studies like MRMC or ground truth assessment from expert consensus or pathology. This is because EMS devices, particularly those for muscle conditioning, are often cleared based on demonstrating that their technical characteristics (e.g., waveform, output, safety features) are equivalent to a legally marketed predicate device, and that these characteristics do not raise new questions of safety or effectiveness.

Given the information provided, which heavily emphasizes direct technical comparison and safety testing (electrical safety, EMC, software V&V), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily framed around these technical and safety aspects, and the device's functional equivalence to its predicate. There is no mention of a clinical study assessing improvement in muscle tone or firmness with quantified metrics from human subjects, or any study involving human readers/experts for performance evaluation, as would be common for diagnostic AI/ML devices.

Here's a breakdown of the requested information based solely on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are predominantly framed as mirroring the technical specifications and safety standards met by the predicate device, and ensuring the modified device continues to meet these.

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The XBODY Go USA and XBODY Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used only for healthy muscles and clients, not for rehabilitation purposes.

Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Neither model is intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA or XBODY Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.

For both models, electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. Both models may therefore be considered a technique of muscle training.

The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on electrical muscle stimulation (EMS) technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.

Based on the provided FDA 510(k) Clearance Letter and Submission Summary, here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) submission summary, primarily focused on establishing substantial equivalence to a predicate device. It details the similarities and minor differences between the new device and the predicate. For devices like the XBody Go USA and XBody Pro USA, which are "Powered Muscle Stimulators," the primary "performance" and "acceptance criteria" revolve around demonstrating equivalence in electrical safety, electromagnetic compatibility, and fundamental stimulation characteristics, rather than a clinical study measuring a specific physiological outcome (like muscle strength improvement). The document explicitly states, "Any differences that exist between the subject and predicate devices do not affect safety or performance." This implies that the acceptance criteria are largely met by demonstrating adherence to recognized safety and performance standards and showing that any changes do not negatively impact these.

Therefore, the "proof" described is not a typical clinical trial demonstrating superiority or non-inferiority in effectiveness, but rather a demonstration of continued safety and equivalent performance to a device already deemed safe and effective.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the XBody Go USA and XBody Pro USA, as implied by the 510(k) submission, are primarily centered around demonstrating essential safety and equivalent performance to their predicate devices, particularly regarding electrical muscle stimulation parameters and the introduction of new accessories (the XBody DrySuit and DryWear). Since this is a 510(k) for a powered muscle stimulator, the "performance" proved is not a clinical outcome like muscle strength gain, but rather the device's ability to safely and effectively deliver electrical impulses as intended, consistent with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (substantial equivalence for a powered muscle stimulator), the "acceptance criteria" are predominantly related to compliance with recognized standards and maintaining equivalent technical specifications and safety profiles. The "device performance" is therefore demonstrated by meeting these standards and showing that the subject device's operation is not adversely affected by the minor changes.

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

The document does not specify a "sample size" in the context of a data-driven test set for complex performance metrics like accuracy or sensitivity/specificity for an AI/ML device. For this type of device, the "test set" is more conceptual, referring to the various configurations and conditions under which the device's electrical safety, EMC, and fundamental performance characteristics were validated through bench testing.

• Sample Size: Not applicable in the typical sense for a clinical data set. The validation is based on engineering tests performed on production units or prototypes.
• Data Provenance: The data comes from "independent testing" of the XBody Actiwear G2 main unit, the control unit, the XBody Training Suit 2.1, the XBody Training Suit 3.0, and the new XBody DrySuit. This implies lab-based testing. The country of origin of the data/testing is not specified, but the manufacturer is XBody Hungary Kft. The testing would be considered prospective in the sense that it's conducted to demonstrate compliance for the submission, rather than retrospective analysis of existing clinical data.

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

Not applicable. For a powered muscle stimulator's safety and performance testing, "ground truth" is established by calibrated instruments and adherence to engineering standards (e.g., peak voltage, current, waveform shape, and safety circuit functionality). There is no "expert consensus" on an image or clinical finding that requires adjudication.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment of data requiring adjudication.

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

Not applicable. This is not an AI/ML diagnostic or image-based device that would typically undergo an MRMC study to assess human reader improvement with AI assistance. The device's function is direct electrical muscle stimulation, not assisting in interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical electromedical device, not a standalone algorithm. Its performance is intrinsically linked to its hardware and software working together to deliver electrical impulses.

7. Type of Ground Truth Used

The "ground truth" is based on:

• Engineering specifications and standards: Adherence to output parameters (voltage, current, frequency, pulse width) as defined by electrical engineering principles and the device's design.
• Safety standards: Compliance with IEC 60601 series standards for electrical safety and electromagnetic compatibility.
• Predicate device characteristics: The predicate device itself effectively serves as a "ground truth" or benchmark for acceptable performance and safety, as the submission aims to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that learns from a "training set" of data in the typical sense of machine learning. The device's behavior is deterministic, based on its programmed logic and hardware design.

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

Not applicable, as there is no "training set" for this type of device. The ground truth for the device's design and functionality is rooted in established electrical engineering principles, medical device safety standards, and the performance characteristics of the legally marketed predicate device.

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The Muscle Stimulator Device is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks, thighs and calves.
• Improvement of muscle tone and firmness, for strengthening muscles in arms.

The Muscle Stimulator Device (model PZ-100) is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has four outputs, and two applicators perform simultaneous treatment.

The Muscle Stimulator Device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The Muscle Stimulator Device is composed of control display panel module, main control module, temperature module, treatment handle module, and fan cooling module.

The proposed device can simultaneously apply multiple treatment handles to patients, and the handles are held in place by bandages.

This document is a 510(k) clearance letter for the Muscle Stimulator Device (PZ-100). It focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of specifications.

Crucially, there is ABSOLUTELY NO MENTION of acceptance criteria related to a study proving performance, sample sizes, expert involvement, ground truth, or MRMC studies.

The document explicitly states:

• "No clinical study is included in this submission." This means there was no study to prove the device met acceptance criteria in a clinical setting with human subjects.
• The clearance is based on "non clinical tests" to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These typically involve engineering tests, electrical safety, EMC, and biocompatibility, as listed in the "Non-Clinical Test Conclusion" section.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for proving the device meets those criteria because this information is not present in the provided document.

The document describes regulatory compliance and equivalency based on technical specifications and non-clinical testing, not on a clinical performance study with human subjects, which would typically involve the criteria you asked about (sample size, expert ground truth, MRMC, etc.).

In summary, based on the provided text, the device was NOT proven to meet acceptance criteria through a clinical performance study. Its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical testing.

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The indications for the Limfa Therapy System are to temporarily increase blood circulation in healthy leg muscles and to stimulate healthy muscles in order to improve and facilitate muscle performance.

The Limfa® Therapy System is a medical device, intended for stimulation with extremely low frequencies (ELF), pulsed, and low frequency (ELF 3-300 Hz) magnetic fields, which generates pulsed, bipolar and variable electromagnetic fields, at very low and variable intensity and frequency using complex waveforms (sinusoidal, triangular and rectangular), thus obtaining multiple signals within a frequency spectrum composed of base waves from 2 to 80 Hz plus the harmonics that are produced by the hardware component.

The manufacturer presets base wave frequencies and the harmonics are generated by the DM hardware. The therapy is based on the generation of a pulsed magnetic field with a very low and variable frequency and variable intensity.

The provided FDA 510(k) clearance letter and summary for the Limfa Therapy System (K243165) do not describe a study involving "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven medical device performance study, which is implied by the detailed questions about sample sizes, expert ground truth, MRMC studies, and training sets.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (Bemer Classic Set, K151834 and K210174) based on:

• Indications for Use: Identical.
• Technological Characteristics: Similar primary mode of action (non-invasive tissue stimulation via magnetic field induction), comparable frequency and intensity ranges (ELF PEMF), and compliance with the same safety standards. Differences in waveform shape, pulse duration, and treatment timing are argued to be equivalent without raising new safety or effectiveness concerns.
• Safety and Performance Testing: Compliance with relevant electrical safety (IEC 60601-1, -1-2, -1-6, -1-11), software (EN 62304, EN 62366), quality/risk management (EN ISO 14971), and labeling standards (EN ISO 15223-1, IEC TR 60601-4-2).

The document explicitly states:

• "No animal testing of the subject device was necessary. The performance tests are sufficient."
• "No clinical testing of the subject device was necessary. The performance tests are sufficient."

This type of 510(k) submission, common for devices deemed substantially equivalent to existing, cleared devices, generally does not require new de novo clinical studies demonstrating effectiveness, especially if the device operates on the same principles and within similar parameters as its predicates. The "performance tests" mentioned refer to engineering and electrical safety testing, not clinical performance studies with patient outcomes or expert reviews.

Therefore, I cannot extract the information requested about acceptance criteria, test set details, expert ground truth, MRMC studies, standalone performance, or training set specifics from this document because such studies were not required or performed for this specific 510(k) clearance. The device is cleared based on its substantial equivalence to previously cleared devices through technical comparisons and compliance with relevant safety and performance standards.

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The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.

The Pure Impact module is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
• The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.

The SofWave System consists of three main functional components: 1) the console; 2) the applicator; and 3) EMS Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

The provided FDA 510(k) clearance letter and summary for the SofWave System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in relation to AI/software performance.

The document details the device's technological characteristics, comparison to predicate devices, and regulatory compliance (electrical safety, EMC, software V&V). However, it explicitly states under "Clinical Summary": "No clinical test data was required to support substantial equivalence." This means there was no clinical performance study conducted to demonstrate the device's effectiveness in achieving its stated indications (e.g., improvement of facial lines, muscle tone) through a study with human subjects, let alone one involving AI assistance or a standalone AI algorithm.

Therefore, many of the requested points cannot be extracted from this document because the type of study you are asking about (a performance study with acceptance criteria, human readers, ground truth establishment, etc.) was not performed or submitted for this 510(k) clearance.

Below, I will fill in the requested table and answer the questions based only on the information available in the provided text. Where information is not present, it will be explicitly stated.

Acceptance Criteria and Device Performance Study (Based on Provided Document)

Summary: The provided FDA 510(k) clearance document for the SofWave System demonstrates substantial equivalence through comparisons to predicate devices and non-clinical performance testing (software verification and validation, electrical safety, functional bench testing), but explicitly states that no clinical test data was required. Therefore, a clinical study with acceptance criteria related to device efficacy (e.g., improvement in facial lines, muscle tone) and involving a test set, expert ground truth, or AI performance metrics was not conducted and is not described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that "No clinical test data was required to support substantial equivalence," the document does not present clinical acceptance criteria for efficacy or performance in the way one might expect for a diagnostic AI device. The acceptance criteria mentioned are related to non-clinical performance and regulatory compliance.

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

• Sample Size for Test Set: Not applicable / Not provided. The document explicitly states, "No clinical test data was required." The functional and software testing conducted would not typically involve a "test set" in the context of patient data or clinical outcomes.
• Data Provenance: Not applicable / Not provided. No patient data or clinical data is mentioned as being used for a test set.

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

• Not applicable / Not provided. Since no clinical test data was required, there was no need for experts to establish ground truth in this context.

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

• Not applicable / Not provided. No clinical test set or ground truth adjudication took place.

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 / Not provided. No clinical study, MRMC study, or AI assistance component (in the clinical efficacy sense) is detailed or claimed in this 510(k) summary. The "Pure Impact module" section describes the device as a "Powered Muscle Stimulator" and refers to "muscle training" but does not indicate any AI-driven diagnostic or interpretative capabilities that would necessitate an MRMC study for improved human reader performance.

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

• Not applicable / Not provided. The device described is a medical system with specific treatment functionalities (ultrasound for aesthetic treatments, EMS for muscle stimulation). It is not described as an AI algorithm intended for standalone diagnostic or evaluative performance. Software verification and validation were performed, but not in the context of an AI algorithm's standalone performance against a clinical ground truth.

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

• Not applicable / Not provided for clinical efficacy. The "ground truth" for the non-clinical testing would be the engineering specifications and established standards (e.g., IEC standards for electrical safety), which the device was verified against.

8. The sample size for the training set

• Not applicable / Not provided. If there were any machine learning components, details about a training set are not included in this 510(k) summary, as it explicitly states "No clinical test data was required."

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

• Not applicable / Not provided. (See point 8).

Conclusion: The provided FDA 510(k) clearance document for the SofWave System focuses on demonstrating substantial equivalence to predicate devices and fulfilling non-clinical performance and safety requirements. It explicitly states that clinical test data was not required for this clearance. Therefore, the detailed information about acceptance criteria for clinical performance, test set characteristics, expert ground truth establishment, or AI performance studies (MRMC, standalone) that you requested are not present in this document.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets such criteria.

The document is a clearance letter from the FDA for a "Wireless TENS & EMS Unit" (K243763). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements for the manufacturer. It also includes the "Indications for Use" for the device.

However, it does not describe any specific performance acceptance criteria for the device, any study conducted to demonstrate that the device meets those criteria, or any details related to sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies.

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The device is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

• · Strengthening, Toning and Firming of buttocks and thigh

The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device.

The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.

This document is a 510(k) summary for a medical device (Electromagnetic Stimulator Device, EMS) for muscle conditioning. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about clinical study acceptance criteria and device performance based on those criteria, which would be typical for an AI/ML medical device.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic accuracy, sample size for test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) are not present in this document because they are characteristic of a different type of medical device submission (e.g., an AI-based diagnostic tool) and are not required for demonstrating substantial equivalence for a physical muscle stimulator.

The provided text details non-clinical tests and comparisons of physical and functional characteristics.

Here's an analysis based on the provided document:

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

The document does not present "acceptance criteria" in terms of diagnostic accuracy metrics or clinical outcomes with corresponding performance values that would be typical for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence in terms of technical characteristics and safety/performance standards.

The acceptance criteria here are implicitly related to meeting the "substantial equivalence" definition, meaning the device is as safe and effective as the predicate. The "performance" is shown through the comparison table and non-clinical testing.

Implicit Acceptance Criteria and Reported Performance (from the Comparison Table and Non-Clinical Tests Summary):

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

This information is not provided in the document. The document describes non-clinical engineering and safety compliance tests, not clinical performance studies with patient data.

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)

This information is not applicable and not provided. Ground truth establishment by experts is relevant for AI-based diagnostic devices where human interpretation is the gold standard or part of the evaluation. This document is for a physical muscle stimulator.

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

This information is not applicable and not provided. Adjudication methods are used in clinical studies, particularly for diagnostic accuracy assessments, which are not detailed here.

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

This information is not applicable and not provided. MRMC studies are typically for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. This device is not an AI-based diagnostic tool.

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

This information is not applicable and not provided. Standalone performance is a metric for AI algorithms. This device does not feature such an algorithm. It's a physical muscle stimulator.

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

This information is not applicable and not provided. "Ground truth" in the context of this submission refers to the performance of the predicate device and the established safety and performance standards (like IEC and ISO). There isn't a "ground truth" derived from patient outcomes or expert consensus on a diagnostic task, as this is not a diagnostic device.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML device that requires machine learning training sets.

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

This information is not applicable and not provided. Similar to point 8, this is not an AI/ML device requiring labeled training data.

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