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1. The Z4 Li-Battery Powered OTC TENS/EMS Combination Stimulator is intended for over-the-counter (OTC) use. It integrates both TENS and EMS functions in a single unit. However, the device can only operate in one mode (either TENS or EMS) at a time; simultaneous operation of both modes is not possible.

2. TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P19 programs)

3. EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P20 to P30 programs)

The Li-Battery powered OTC TENS/EMS Combination Stimulator, model Z4, is a four-channel electrical stimulation device intended for pain relief and muscle training. It delivers electrical current through electrodes placed on the user's skin. Each operating mode delivers a fixed, pre-configured waveform (e.g., asymmetrical bi-phasic square pulse) and output characteristics; users may only adjust intensity and treatment duration within predefined limits.

The device primarily consists of two components: the stimulation generator and adhesive electrodes. The generator produces the stimulation current, which is delivered to the body via lead wires connected to the electrodes. Depending on the selected mode—TENS or EMS—the device helps achieve either temporary pain relief or improved muscle performance.

The Z4 includes the following preset programs:

• TENS Mode (Programs P1–P19): Intended for temporary relief of pain in the lower back, arms, and legs due to exercise or household/work strain. Users are advised to begin with the lowest intensity and gradually increase to a comfortable "tingling" sensation. Each program differs in waveform parameters and may produce varied sensations.

• EMS Mode (Programs P20–P30): Designed to stimulate healthy muscles to enhance or support muscle performance. These programs cause the muscles to contract and relax. Users should start at low intensity for warm-up and increase gradually as needed.

The Z4 device package includes the following accessories:

• Adhesive Electrode Pads × 24
• Lead Wires × 4
• USB Cable × 1
• Instruction Manual × 1
• Carrying Case × 1

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TENS: The device is designed to be used for temporary relief of pain associated with the 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.

The Globus Triathlon Pro TENS and EMS stimulator is an over-the-counter transcutaneous electrical nerve stimulator and electronic muscle stimulator (TENS/EMS) device providing peripheral nervous system stimulation and muscular electrostimulation in order to reduce atrophy, spasticity, and to increase muscular power. It can be used for arm, shoulder, neck, back, waist, abdomen, and legs.

The stimulation channels transfer the desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing muscle contractions. The accessory electrodes are FDA-cleared. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to the patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.

The Triathlon Pro provides electro stimulation through the surface electrodes. Electrode position during electro stimulation depends on the body part involved and on the type of program that is being carried out. For all programs that cause significant muscle contraction, it is important to place the electrode on the muscle motor point, which is the most sensitive to stimulation. The electro stimulator keeps track of the last 10 executed programs so that they are available for very simple and fast execution. Recording takes place automatically at the end of the execution of a program.

Electrostimulations are designed to be used in domestic environments, clinics, physiotherapy centers, rehabilitation in general, pain treatments in general, for aesthetic and sport purposes. The user of this device must be adult.

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The Motive™ Muscle Stimulator for Lower Back is intended for the stimulation of healthy muscles to improve or facilitate muscle performance.

The Motive™ Muscle Stimulator for Lower Back is not intended to be used in conjunction with therapy or treat diseases or medical conditions of any kind.

The Motive™ Muscle Stimulator for Lower Back device is indicated for adults of 22 years of age and older.

The Motive™ Muscle Stimulator for Lower Back is an over-the-counter electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) used to stimulate healthy muscles to improve or facilitate muscle performance. The Motive Muscle Stimulator for Lower Back applies an electrical current through a power regulated output NMES system to strengthen muscles through repeated contractions. The device is placed over the applicable muscle groups to deliver NMES treatment to the user.

4.1 Electrical Muscle Stimulator (NMES therapy)

The Motive™ Muscle Stimulator for Lower Back (subject device) and the Motive™ Knee Wrap (reference device, K220738) utilize the same Controller and deliver an identical neuromuscular electrical stimulation (NMES) waveform, protocol, and pulse amplitude to strengthen muscles. The device uses a patented waveform, delivered through a power-regulated output and a closed-loop feedback NMES system, to stimulate healthy muscles and enhance muscle performance through repeated contractions. The waveform is generated by a pulse generator (Controller) and delivered non-invasively via electrodes placed on the skin. The patented waveform in the subject Motive™ Muscle Stimulator for Lower Back device is identical to the reference Motive™ Knee Wrap device. The NMES waveform information and rated outputs for both subject and reference devices are identical.

4.2 Mobile Application (App)

The electrical stimulation therapy is initiated and managed wirelessly by the User using the MyMotive™ App which is developed for use on smart devices that interact with the system's Controller.

4.3. Lower Back Electrodes / Therapy Pad

The Motive™ Muscle Stimulator for Lower Back (subject device) includes a custom-designed lower back therapy pad with three (3) cutaneous electrodes. This pad is made from the identical raw materials as the reference device's knee therapy pad (Motive Knee Wrap), differing only in its geometry. Like the Motive Knee Wrap, the Motive™ Muscle Stimulator for Lower Back therapy pad is supplied non-sterile, intended for single-patient use with multiple applications, and is disposable. During treatment, the pad is placed on the lower back and gluteus medius to deliver electrical stimulation when connected to the Controller.

4.4 Conductive Gel

The Conductive Gel is a salt-free, chloride-free gel designed for electromedical procedures such as NMES and TENS.

4.5 Wireless Communications

The Motive™ Muscle Stimulator for Lower Back device incorporates a Bluetooth Low Energy (BLE) connection module for wireless communication, allowing it to pair with a Bluetooth-enabled mobile device running the mobile application, available on App stores. The App provides a virtual control panel with on-screen buttons for user operation.

The Controller is connected to the Lower Back Electrodes / Therapy Pad through a proprietary interface featuring a keyed design with a magnetic force to ensure connection to the Controller's pogo pins. The Controller serves as the primary safety, ensuring stimulation output never exceeds IEC 60601-2-10 limits. The mobile application allows the user to adjust the treatment level to achieve comfortable muscle contractions. If the Bluetooth connection is lost, the Controller pauses treatment, and the mobile application alerts the user to check the device.

The Controller includes an LED indicator to display status relating to battery charge, stimulation, and Bluetooth activity. The Controller is powered by an internal 3.7V Li-Po rechargeable battery, which can be recharged via the USB-C port using the provided cable.

4.6 Software

The subject Motive Muscle Stimulator for Lower Back operates using embedded Controller firmware, a mobile App, and Web Services software. The Controller's embedded firmware is a core component that manages the selection, adjustment, and delivery of the treatment program. It runs on the Controller, interfacing with the stimulation pulse generator and the mobile application.

Available for free download from app stores (iOS and Android), the mobile application operates on a mobile platform and communicates with the Controller via a Bluetooth Low Energy (BLE) connection. It provides an intuitive interface for users to control the neuromuscular electrical stimulation (NMES) therapy, allowing them to select, administer, and adjust therapy intensities while managing health and wellness related to their treatment.

4.7 Controller and the App

The Controller's primary function is to generate neuromuscular electrical stimulation (NMES) therapy and transmit therapy metrics to the mobile App. Once the mobile application is installed and a wireless connection is established between the Controller and the user's mobile device, the user can access all device features.

The mobile application, downloaded from app stores (iOS or Android), provides an intuitive and interactive graphical user interface that manages interactions between the Controller and the user. Its design emphasizes user engagement and therapy compliance as key features. Help and informational screens are integrated throughout the App, appearing on specific screens to guide users about features or conditions.

Upon downloading the App, users are guided through a series of chronological screens to perform the following tasks such as setting up the device, selecting therapy options, and monitoring treatment progress:

• New user onboarding
• Review and acceptance of Product Warnings
• Reading and accepting the mobile application Terms of Use and Conditions
• Creating a user profile
• Pairing the App with the Controller
• Registering a therapy pad
• Device setup (therapy pad and controller placement over the applicable muscle group)
• Starting the treatment
• Managing the treatment

4.8 Web Services (API, Database)

The Motive™ Web Services, a Medical Device Data System (MDDS), enables the electronic transfer, storage, retrieval, and display of data from the user's App and Controller. It features an encrypted database hosted on secure cloud-based servers and an Application Programming Interface (API) that allows the mobile application to send, receive, read, or write data to the database and perform logic tasks. Web Services ensures persistent storage and retrieval of collected data.

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The Venus Nova device is intended for the treatment of the following medical conditions using the 4D Body (MP2) applicator for delivery of RF energy combined with massage and magnetic field pulses:

• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Nova device is intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

In addition, the Venus Nova device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.

The Venus Nova device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

The Venus Nova device using the FlexMAX applicators is intended to be operated by a trained professional.

The Venus Nova device is a computerized device comprised of a console (main unit), one (1) 4D Body applicator containing RF, PEMF and Vacuum, one (1) Octipolar applicator for large anatomical areas containing RF and PEMF, one (1) Diamondpolar applicators for smaller anatomical areas containing RF and PEMF and four (4) FlexMAX applicators containing Electrical Muscle Stimulation (EMS). The device delivers bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of EMS intensity level, and RF power, in addition to vacuum levels, for each patient.

The console of the Venus Nova device contains a power supply unit, RF and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), a touch-screen user interface and display panel.

The applicators are connected to the console via cables. The RF applicators are comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The EMS applicators are comprised of two electrodes each and a light indicator.

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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.

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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.

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.

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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.

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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.

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.

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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.

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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.

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