Search Results

The Compact II is indicated for:

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

The Compact II device generates (or induces) electric current in targeted tissues. affected by a high induction magnetic field to stimulate those tissues to treat the indicated conditions.

The device includes a transducer, which is used to provide the magnetic stimulation, which creates electrical fields by pulse current flowing from a capacitor according to the principle of Faraday's Law. Whenever the capacitor bank is discharged by the action of the control system, a pulse of current flows through the stimulating coil. The magnetic stimulation creates intense, rapidly changing magnetic electrical fields.

The Compact II device consists of a console and transducer for magnetic stimulation. The function of magnetic stimulation is operated by adjusting parameters such as Mode, Intensity and Time. These parameters can be controlled by users on the LCD Touch Screen.

N/A

Ask a specific question about this device

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.

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

• Sample Size: Not applicable in the context of a 510(k) clearance for this type of device, which relies on a comparison to predicate devices and adherence to performance standards rather than a clinical study with patient samples. The "test set" would be the device itself undergoing various engineering and safety tests.
• Data Provenance: The document details non-clinical testing for compliance with international standards (e.g., IEC, ISO). This is primarily bench testing, not patient-derived data. The manufacturer is Syrma Johari Medtech Limited, located in Jodhpur, Rajasthan, India. This suggests the testing and engineering data would originate from their facilities or contracted labs.

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)

• Number of Experts/Qualifications: Not applicable. For demonstrating substantial equivalence for a powered muscle stimulator, the "ground truth" is defined by the technical specifications, safety standards, and established performance of the predicate devices. It does not involve expert consensus on clinical findings in a test set, as would be the case for an AI-driven image analysis or diagnostic device.

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

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication of medical findings.

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: Not applicable. The truFlex is a physical medical device (muscle stimulator), not an AI-assisted diagnostic or image analysis tool for human readers.

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

• Standalone Performance: Not applicable. This device is an electrical muscle stimulator; it does not operate as a standalone algorithm in the way an AI diagnostic tool would. Its "performance" is its ability to generate specified electrical impulses safely and effectively.

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

• Type of Ground Truth: The "ground truth" in this 510(k) submission is primarily established by:
  • International Consensus Standards: Compliance with recognized IEC and ISO standards (e.g., IEC 60601-1 series for safety, IEC 62304 for software, ISO 10993 series for biocompatibility).
  • Technical Specifications of Predicate Devices: The specific electrical output parameters (voltage, current, waveform, frequency, pulse width), operational modes, and physical characteristics of the legally marketed predicate devices. The new device must demonstrate it meets or is equivalent to these parameters.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The truFlex is a hardware device cleared through substantial equivalence to predicate hardware devices. It does not involve AI/ML models that require a "training set" in the computational sense. The "training" for such devices involves product development, engineering, and manufacturing processes aimed at meeting specifications.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the development and testing of this device (if one were to use that term broadly) derived from engineering requirements, known electrical stimulation principles, and regulatory standards.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Study Proving Acceptance: The document states "Verification testing demonstrates that the modified device functions as specified and is as safe and effective as the cleared predicate device. In all instances, the subject Pure Impact device performed as intended." Specific tests mentioned for verification include:

• Software verification and validation
• Cybersecurity testing
• Electrical Safety (IEC 60601-1)
• Electromagnetic Compatibility (IEC 60601-1-2)
• Specific medical electrical equipment standards (IEC 60601-1-6, IEC 60601-2-10)
• Risk analysis (ISO 14971)

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

The document does not detail a specific "test set" in terms of patient data or clinical images, as this is a modification of an existing EMS device primarily cleared based on technical and safety equivalence. The testing described is primarily engineering verification testing of the device's hardware and software components.

• Sample Size for Test Set: Not applicable in the context of patient data or clinical performance. The "test set" refers to the specific Pure Impact device and its components undergoing engineering and software verification.
• Data Provenance: Not applicable in the context of patient data. The "data" pertains to the results of internal engineering and software validation tests.

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

Not applicable. This device is an electrical muscle stimulator, and its clearance is based on technical equivalence and safety testing, not on the interpretation of medical images or other diagnostic data where expert ground truth would be established. The "ground truth" for this device's performance would be against its own design specifications and relevant safety standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers or expert panels to resolve discrepancies in diagnoses or assessments. This type of study was not conducted for this 510(k) clearance.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of AI assistance on human reader performance. This device is an electrical muscle stimulator where the primary demonstration of effectiveness for this submission is substantial equivalence to a predicate's technical and safety characteristics.

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

While the device itself is a "standalone" product (meaning it's not a module of the SofWave system anymore), the clearance does not describe an "algorithm only" performance study in the context of diagnostic AI/ML. The "standalone" aspect refers to its physical change from a module to an independent device with its own PC and GUI. The performance evaluation focuses on the engineering and software functionality of the device itself.

7. The Type of Ground Truth Used

The ground truth used for this submission is primarily:

• Predicate Device Specifications: The technical and safety characteristics of the predicate device (Pure Impact Module of the SofWave System K250146) served as the "ground truth" for the subject device to demonstrate substantial equivalence.
• Regulatory Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), specific EMS standards (IEC 60601-2-10), and risk management (ISO 14971) constitutes another form of "ground truth" for safety and performance.
• Design Specifications: The internal design specifications for the device, confirmed through verification testing, served as the "ground truth" for its functional performance.

8. The Sample Size for the Training Set

Not applicable. This is not a submission for an AI/ML device that requires a training set of data. The "training" here refers to manufacturing the physical device to specifications and programming the software.

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

Not applicable. As this is not an AI/ML device requiring a training set, the concept of establishing ground truth for a training set does not apply. The "ground truth" for the device's development involves adherence to engineering design specifications, safety standards, and functional equivalence to the predicate.

Ask a specific question about this device

1) 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.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided FDA 510(k) Clearance Letter for the "3 in 1 TENS UNIT" (K250759) does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/algorithm-based medical devices.

This document is a standard FDA clearance letter for a Class II medical device (Powered Muscle Stimulator, TENS/EMS unit). It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations like the Quality System (QS) regulation.

Specifically, the letter does not mention:

• Any AI or algorithmic components of the device.
• Specific performance metrics (e.g., sensitivity, specificity, AUC) that would require a clinical study with acceptance criteria.
• Test sets, training sets, ground truth establishment, expert readers, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based solely on the provided text. The information required for your request (1-9) is typical for AI/ML-based medical devices that require performance validation, which is not described in this standard 510(k) clearance letter for a TENS/EMS unit.

This device, being a "Powered Muscle Stimulator" (TENS/EMS unit), typically undergoes electrical safety, electromagnetic compatibility (EMC), and performance testing related to its electrical output, waveform, and ability to deliver stimulation as intended, rather than AI-driven diagnostic or treatment algorithms.

Ask a specific question about this device

The Synchrony (20-3000) is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES).

• Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES).

• Maintenance and/or increase of hand range of motion.
• Prevention and/or retardation of disuse atrophy.
• Increase in local blood circulation.
• Reduction of muscle spasm.
• Re-education of muscles.

The Synchrony (20-3000) system is a functional electrical stimulation (FES) device and a powered muscle stimulator. It is specifically designed to enhance hand functionality in patients with arm paresis through a range of customizable therapies. The system integrates five major components: the Stimulator, Sensor, Patient Interface (electrodes), Motor Point Probe, and Clinician App. The therapies are directed and programmed by a clinician through an iOS based application and then the patient may apply the therapy at their home with the Stimulator and Sensor.

The Synchrony system supports three primary therapeutic modes: Contralaterally Controlled Electrical Stimulation (CCFES), cyclical Neuromuscular Electrical Stimulation (CNMES), and Functional Task Practice (FTP). The CCFES mode uses sensor data from the patient's unimpaired side to control the timing, intensity, and movement of the paretic hand/arm, synchronizing stimulation with natural motor patterns. The cyclical NMES mode delivers repetitive stimulation to targeted muscles, aiding in muscle re-training, as described in the systematic review of research studies using cyclic NMES. The FTP mode allows for direct control of hand movements during task-oriented exercises, using real-time sensor feedback and stimulator output.

Stimulation is delivered through up to four electrodes placed on identified motor points, using symmetric balanced biphasic pulses. The system offers preset stimulation amplitudes of 20mA, 40mA, and 60mA, with a pulse width adjustable between 1-250 µsec, providing high precision with 1 µsec resolution. The device's enclosure is constructed from biocompatible ABS Cycoloy, ensuring durability and patient safety, and is rated IP22 for ingress protection.

The stimulator can operate independently or in conjunction with the Synchrony Sensor, depending on the therapy mode selected. The Sensor, which communicates wirelessly with the Stimulator via Bluetooth Low Energy (BLE), uses a Class I laser that is compliant with 21 CFR 1040.10 and 21 CFR 1040.11 to measure hand opening and closure distances, enabling accurate therapeutic adjustments. Both the Stimulator and Sensor are wirelessly charged using an FCC Part 15 compliant charging pad, enhancing ease of use and handling.

The Synchrony system is engineered for ease of use with user-friendly control interfaces for both patients and clinicians. It incorporates a range of safety mechanisms to ensure effective and safe operation, making it a versatile and reliable tool for improving hand functionality through personalized therapeutic interventions.

The provided FDA 510(k) clearance letter for the Synchrony (20-3000) device does not contain information about acceptance criteria or a specific study proving the device meets those criteria.

The letter primarily focuses on establishing substantial equivalence to predicate devices, referencing adherence to recognized standards, and outlining performance differences between the new device and the predicates without providing specific acceptance criteria or study details.

However, based on the information provided, we can infer some details and highlight the missing information:

Key Takeaways from the document relevant to performance and safety:

• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to predicate devices (K123636 and K960457).
• Standards Compliance: The device claims compliance with numerous IEC, ISO, ASTM, and ANSI standards related to safety, essential performance, usability, electromagnetic compatibility, software lifecycle, risk management, biological evaluation, laser safety, battery testing, shipping, cleaning processes, wireless coexistence, and cybersecurity. These standards inherently contain their own acceptance criteria that the device must meet.
• Performance Differences: The comparison tables highlight differences in technical characteristics and output specifications. The rationale for these differences consistently asserts "No impact on safety and effectiveness."
• Clinical Data: The document explicitly states: "No clinical data were reviewed in this submission in support of the subject device." This is a crucial piece of information indicating that clinical trials were not part of this 510(k) submission for performance validation against specific clinical outcomes or acceptance criteria.

Inferred and Missing Information:

Since dedicated acceptance criteria and a study proving the device meets them are not explicitly detailed in the provided text, the table below will reflect what is implied by the substantial equivalence and standards compliance, and explicitly state where information is missing.

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

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

• Not Applicable / Not Provided: The document explicitly states: "No clinical data were reviewed in this submission in support of the subject device." Therefore, there is no "test set" of patient data in a clinical sense for this 510(k) submission. Performance testing was primarily based on engineering and bench testing to demonstrate compliance with standards and equivalence.

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 / Not Provided: As no clinical test set was used, no experts were utilized to establish ground truth in this context for this specific submission. The "ground truth" for compliance was adherence to various engineering, electrical, and biocompatibility standards, and demonstrating substantial equivalence to known predicate devices.

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

• Not Applicable / Not Provided: No clinical test set means no adjudication method was employed.

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: This device is an external functional neuromuscular stimulator, not an AI-assisted diagnostic imaging device. An MRMC study is irrelevant for this type of device and was not conducted.

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

• Partially Applicable / Inferred: The device is a physical medical device that delivers electrical stimulation. Its "standalone" performance is assessed through its compliance with electrical output specifications, safety standards, and functional specifications without a human operator. This is implied by the extensive list of performance testing against standards. For example, the stimulator's ability to deliver a specific pulse width and frequency, or for the sensor to accurately measure hand opening, would be part of its standalone performance. However, there's no "algorithm only" in the sense of a pure software diagnostic or inferential AI system. The "Clinician App" and "Sensor" are components of the system functionality, but their performance tests are part of the overall system validation.

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

• Standards and Predicate Device Specifications: The "ground truth" for this 510(k) submission is derived from:
  • Recognized Consensus Standards: The extensive list of IEC, ISO, ASTM, and ANSI standards (e.g., IEC 60601-1 for basic safety, ISO 10993 for biocompatibility). The acceptance criteria are defined within these standards.
  • Predicate Device Performance: The technical and output specifications of the Bioness H200 and Med Labs EMS-2C served as benchmarks for comparison, implying that the performance of the predicate devices is an established "truth" for safe and effective similar functionality.

8. The sample size for the training set

• Not Applicable: As no clinical data was used and this is not an AI/ML device relying on a training set of patient data, this concept does not apply to this submission. "Training" refers to the engineering development and testing inherent in any device.

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

• Not Applicable: See point 8.

Ask a specific question about this device

EMS is used for:

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

TENS is used for:

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

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable.

EVE Synergy has Synergy mode and Pro mode.

Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.

Pro mode has low frequency function that uses the Pro handpiece with tip.

It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the EVE Synergy (EVE-20M) device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a comparative effectiveness study involving AI assistance or human-in-the-loop performance.

Therefore, many of the requested details regarding acceptance criteria for AI performance, specific study designs (MRMC, standalone), ground truth establishment for AI training/test sets, and sample sizes for these, are not present in this type of regulatory submission. This document primarily describes the physical and electrical characteristics of the device and compares them to predicate devices, along with standard electrical safety, EMC, and software validation testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not present "acceptance criteria" in the traditional sense of a specific performance metric (like accuracy, sensitivity, specificity) for a clinical outcome or an AI model's performance. Instead, it demonstrates compliance with safety and performance standards and similarity to predicate devices.

The "acceptance criteria" are implicitly met by showing:

• Compliance with various IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) for electrical safety, EMC, and software.
• The device's technical specifications (e.g., output voltage, current, pulse width, frequency, power density) are comparable to or within the safe limits established by the predicate devices.

Table of Performance (extracted from comparison tables):

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

This document does not describe a test set or data derived from human subjects. The testing described is non-clinical bench testing:

• Electrical safety tests
• Electromagnetic compatibility tests
• Performance tests (measuring output parameters against specifications)
• Software verification and validation
• Usability testing (presumably, for the device's user interface, not clinical user performance)

There is no mention of "country of origin for data" or "retrospective/prospective" as these are not relevant to bench testing for device parameters.

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 is not applicable. "Ground truth" in the context of AI or clinical diagnostic studies (e.g., for radiologists interpreting images) is not established or referenced here because this is a physical medical device (muscle stimulator) undergoing bench testing for safety and performance specifications, not an AI diagnostic tool.

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

Not applicable. There are no clinical or image-based test sets requiring adjudication by experts.

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 muscle stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed or required for this type of submission.

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

Not applicable. There is no AI algorithm being cleared as a standalone device. The "software validation testing" mentioned (IEC 62304) relates to the safe and effective operation of the device's inherent control software, not an AI-driven clinical function.

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

Not applicable in the context of AI or clinical ground truth. For this submission, "ground truth" implicitly refers to the engineering specifications and established safety limits as defined by relevant IEC standards and comparison with predicate devices. The device's output parameters were measured against these defined standards and specifications.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model. There is no training set for an AI algorithm mentioned or required.

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

Not applicable. As above, there is no AI training set.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device