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The Compex® Rehab is an adjunctive multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES).

The Compex® Rehab is indicated for the following conditions:

• Re-educating muscles
• Relaxation of muscle spasm
• Increasing local blood circulation
• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion

The Compex® Rehab system consists of the following components:

• 1x Stimulator
• 1x Wire Set
• 2x Small Performance Snap Electrode package
• 2x Large Performance Snap Electrode package
• 1x Fast Charger
• 1x Belt clip
• 1x User Manual

These components are packaged together in a carrying case.

The stimulator is a microprocessor controlled 4 channels neuro-muscular electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of four (4) different menus that allow the following functions:

• Options Menu: set up the device, e.g. operating languages, LCD contrast, LCD backlight, Audio output level;
• Body Area Menu: select a desired muscle group, e.g. Shoulder, Hip or Knee;
• Treatments Menu: select a preset program, e.g. Massage, Endurance, Strength;
• Stimulation Menu: select lead wire channels and adjust the stimulation intensities.

The stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.

The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable program. The LCD is used to display system information to the user.

The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it.

Power for the device is provided from a 4.8 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover.

Each of the four (4) lead wires will connect the output of the stimulator to each of the electrodes for each respective output channel. Each lead wire will be connected to the stimulator using a high friction, and forced fitting, mechanically shielded connection is a mechanically shielded snap connector (compliant with the 21 CFR §898.12 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES).

Each electrode set requires a lead/connector assembly. The electrode connector is compatible with the cable connector. Up to four Active/Passive sets of electrodes are required.

The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10.

For patient safety, the device is designed to prohibit use of the device on patients while the battery is being charged. A red plastic cover inside the charging socket blocks the charger pin when the lead wires are still connected to the device. Unplugging the lead wire cables unlocks the red plastic cover and allows the charger pin plug in the charging socket. Connecting a charger to the stimulator automatically starts the charging procedure. A battery symbol on the LCD indicates the status of the battery charging.

The battery pack of the stimulator is charged by a switching adapter which supplies an output current of 1.4 A +/-100 mA and an output voltage of 9V DC +/- 2%. The primary plug is an American 2 pin AC type able to handle input voltage from 90 to 240V AC and at a maximum input current of 0.5 A. The secondary plug on the stimulator is a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger has a short circuit protection. Maximum dimensions of the charger are 72 x 52 x 35 mm.

The Compex Rehab provides three muscle stimulation training programs which correspond to target muscle groups (Shoulder, Knee, Hip) of the patient intended for use during rehabilitation. These rehabilitation programs are:

• Massage
• Endurance
• Strength

This is a marketing application for a class II medical device, a powered muscle stimulator. The information provided does not describe a clinical study or acceptance criteria. It states that Compex Rehab is substantially equivalent to a predicate device, Globus Genesy 1100 Electro-Stimulator (K071431), because it has the same intended use, output mode (NMES), NMES output parameters, and energy delivered. It further claims that "any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety or effectiveness."

Therefore, for this submission, no specific acceptance criteria or study details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement are present. The basis for substantial equivalence relies on the comparison to the predicate device's existing regulatory clearance.

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Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffiess, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.

Generally accepted indications for use:

• Pain Relief .
• Reduce Muscle Spasm .
• . Decrease Joint Stiffness
• . Contractures
• Increase Blood Flow
• Chronic Inflammatory Conditions .
• . Bursitis
• Tenosynovitis
• Synovitis .
• Chronic Inflammatory Pelvic Disease

The Intelect® SWD 100/ Senior Shortwave Diathermy devices consists of a power supply that provides power to a radio frequency oscillator. This radio frequency oscillator provides stable, drift-free oscillations at the required frequency. The power amplifier generates the power required to drive the different types of electrodes. The output resonant tank tunes in the patient as part of the circuit and allows maximum power to be transferred to the patient.

The output intensity controls the percentage of maximum power transferred to the patient circuit. The tuning control adjusts the output circuit for maximum energy transfer from the radio frequency oscillator. The power output meter monitors only the current that is drawn from the power supply and not the energy being delivered to the patient.

The power output produces sufficient energy to raise the tissue temperature into a therapeutic range. The specific absorption rate (SAR) represents the rate of energy absorbed per unit area of tissue mass.

Patient sensation provides the basis for recommendations of continuous shortwave diathermy dosage and thus varies considerably with different patients. The following are recommended dosage guidelines: Dose I (lowest): No sensation of heat

Dose II (low): Mild heating sensation

Dose III (medium): Moderate (pleasant) heating sensation

Dose IV (heavy): Vigorous heating that is tolerable below the pain threshold

Therapy may be delivered to the patient via either capacitance or induction techniques. The Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy devices use the following accessories:

• Capacitive Electrodes
• Pair of 80mm round
• Pair of 120mm round
• Pair of 165mm round
• 180mm x 120mm flexible rubber electrodes
• 250mm x 145mm flexible rubber electrodes
• Inductive Electrodes
• Monode 14cm
• Diplode 18cm x 39cm

Each of these techniques can affect different biological tissues, therefore selection of the appropriate electrodes is essential for effective treatment.

This 510(k) premarket notification for the Intelect® SWD 100/Senior Solutions® Shortwave Diathermy device does not contain the kind of study design and results that are typical for devices that rely on AI or complex algorithms requiring performance metrics like sensitivity, specificity, or AUC.

This submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through adherence to recognized consensus standards for safety and electrical compatibility, and by proving similar indications for use. It is a traditional medical device submission, not one for an AI/ML-driven diagnostic or therapeutic support system.

Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance with AI, etc.) are not applicable to this specific submission.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for AI/ML)

The "acceptance criteria" for this type of device submission are generally met by demonstrating:

1. Compliance with recognized safety and performance standards: The device fulfills the requirements of relevant IEC and UL standards.
2. Substantial equivalence to predicate devices: The device operates with the same fundamental technology and has similar indications for use as previously cleared devices.
3. Ability to produce therapeutic deep heat: Implied by the device description and its function as a shortwave diathermy unit.

Since this is a physical therapy device that generates heat, its "performance" is more related to its electrical output and energy transfer capabilities, rather than diagnostic accuracy metrics. The document describes how it works (radio frequency oscillator, power amplifier, output resonant tank, intensity controls, tuning control, power output meter) and mentions the specific absorption rate (SAR) as a measure of energy absorbed. Therapeutic dosage is described in terms of patient sensation (Dose I-IV).

Table of Acceptance Criteria and Reported Device Performance

Study Details (Not Applicable for AI/ML performance studies)

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

   • N/A. This submission is for a physical therapy device based on established technology, not an AI/ML diagnostic or predictive device with a "test set" in the computational sense. The "study" here is primarily one of engineering design verification and validation against pre-defined standards.

2. 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):

   • N/A. Ground truth as understood in AI/ML performance evaluation (e.g., expert labels on images) is not relevant for this device. The "ground truth" here is the established scientific and engineering principles of shortwave diathermy and regulatory compliance.

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

   • N/A. Not applicable, as there is no "test set" requiring expert adjudication in this context.

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

   • N/A. This is a standalone therapy device, not an AI-assisted diagnostic or decision support tool. Therefore, MRMC studies comparing human readers with and without AI are not applicable.

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

   • N/A. While the device operates standalone in the sense that it delivers therapy without continuous intervention from an algorithm, the concept of "standalone performance" in the AI context (e.g., sensitivity/specificity of an algorithm making a diagnosis) is not relevant here. Its performance is about safely generating radiofrequency energy and heat.

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

   • N/A. The "ground truth" for this device's acceptance is based on:
     • Compliance with recognized industry standards (UL, IEC).
     • Scientific principles of shortwave diathermy.
     • Regulatory precedent established by substantially equivalent predicate devices.
     • Engineering verification and validation to ensure the device performs as designed.

7. The sample size for the training set:

   • N/A. This device does not use a "training set" in the AI/ML sense. Its operational parameters are based on physics and engineering, not learned from data.

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

   • N/A. Since there's no training set, this is not applicable.

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The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The Compex® Sport Plus electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones 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 Compex® Sport Plus can impose on the stimulated muscles are able to improve or facilitate muscle performance.

The Compex® Sport Plus may therefore be considered a technique of muscle training.

The Compex® Sport Plus system consists of these components:

• 1x Stimulator
• 1x Wire Set
• 2x Small Performance Snap Electrode package .
• 2x Large Performance Snap Electrode package
• . 1x Fast Charger

These components are packaged together in a carrying case along with the user manual, belt clip and a battery charger.

The stimulator is a microprocessor controlled 4 channels neuro-muscular electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).

The stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.

The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable exercise routine. The LCD is used to display system information to the user.

The device is equipped with a keypad composed of push buttons which is located below the LCD. The function is defined by a symbol on the LCD corresponding to the button below.

Power for the device is provided from a 4.6 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover.

Each lead wire will connect the output of the stimulator to the electrodes for each output channel. Each lead wire will be connected to the stimulator using a high friction, forced fitting, mechanically shielded connector. Electrode connection shall be a mechanically shielded snap connector (Compliant with protected lead wire and patient cable safety requirements).

Electrode configurations are made up of existing electrodes are configured for the intended use applications and may be unique to one or more application. Up to four Active/Passive sets of electrodes are required. Each electrode set requires a lead/connector assembly. The electrode connector shall be compatible with the cable connector. The electrode assembly shall be compliant with regulatory requirements.

The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10.

It is not possible to connect the stimulator to the charger at the same time as the lead wires. Connecting a charger to the stimulator results in an automatic start of the charging procedure which is indicated by a symbol on the LCD showing the status of the battery pack. The battery pack of the stimulator shall be charged by a switching adapter able to supply an output current of 1.4 A +/-100 mA and an output voltage of 9 VDC +/- 2%. The primary plug shall be of American 2 pin AC type able to handle input voltage from 90 to 240 VAC and at a maximum input current of 0.5 A. The secondary plug, to be attached to the stimulator, shall be a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger shall have short circuit protection. Maximum dimensions of the charger shall be 72 x 52 x 35 mm.

Here's an analysis of the provided text regarding the Compex® Sport Plus device's acceptance criteria and studies:

Summary of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the device's acceptance criteria are primarily centered around its intended use and functional equivalence to predicate devices, rather than specific quantitative performance metrics. The document explicitly states the device is "substantially equivalent" to predicate devices, implying that its performance is expected to meet similar standards.

Study Information:

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove the device meets novel acceptance criteria. Therefore, most of the requested information about a dedicated study proving acceptance criteria is not present in this document.

Here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance: See the table above for inferred acceptance criteria (based on intended use and general safety/performance expectations for this type of device) and performance described.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document does not describe a specific clinical "test set" or clinical study with patient data for this device. The demonstration of safety and effectiveness appears to be primarily through engineering and biocompatibility testing (implied by adherence to standards like IEC60601-1) and the successful claim of substantial 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. Since there's no described clinical "test set" with ground truth determination, this information is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical muscle stimulator and does not rely on an algorithm for standalone diagnostic performance in the way described for AI/diagnostic devices. Its "performance" is its ability to deliver specified electrical impulses and elicit muscle responses, which is implicitly demonstrated through its design consistency with predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. For substantial equivalence, the "ground truth" is often the well-established performance and safety profile of the predicate device, demonstrated through years of safe marketing.
8. The sample size for the training set: Not applicable/Not provided. This device is not an AI/machine learning device that requires a "training set" in the conventional sense for developing an algorithm.
9. How the ground truth for the training set was established: Not applicable/Not provided.

Conclusion:

The 510(k) submission for the Compex® Sport Plus primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Compex® Sport K011880 and Globus Premium Sport and fitness Muscle Stimulators K061632). This pathway to market clearance does not typically involve new clinical studies with "test sets," "ground truth," or "training sets" as would be seen for novel devices, especially those incorporating AI or new diagnostic methods. Instead, the focus is on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicates. The descriptions of its programs and components serve to illustrate these similarities.

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Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. VitalStim waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are: The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Non-mechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional. VMS™ waveform is a square symnetrical biphasic waveform with the application for use on the musculature of the face, The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation VMS™ waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function. HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in posttraumatic conditions or after neurological insult with impaired neuromuscular function. sEMG™ is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are: The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

Vitalstim Experia therapy is a comprehensive electrotherapy device for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended use is achieved by the benefit of powered muscle stimulation and muscle activity biofeedback in one comprehensive device. The intended patient outcome is to regain control of muscles to swallow food without aspirating.

VitalStim™ waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are: The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Non-mechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional.

VMS™ waveform is a square symnetrical biphasic waveform with the application for use on the musculature of the face, The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation VMS™ waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function.

HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in posttraumatic conditions or after neurological insult with impaired neuromuscular function.

sEMG™ is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are: The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

The provided text describes a 510(k) premarket notification for the Vitalstim Experia device. This review is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving device performance in the typical sense (e.g., accuracy, sensitivity, specificity) is not explicitly present.

Here's an analysis based on the available information:

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

The submission does not define explicit performance-based acceptance criteria in terms of metrics like accuracy, sensitivity, or specificity, nor does it report such performance. The primary "acceptance" is based on demonstrating substantial equivalence to legally marketed predicate devices.

The acceptance criteria implicitly relate to:

• Safety and Effectiveness: Demonstrated through compliance with recognized consensus standards (UL 60601-1: 2003, IEC 60601-1-2: 2001) for electrical and electromagnetic safety.
• Intended Use and Technology: The device's waveforms and intended uses (VitalStim, VMS, HVPC, sEMG) are compared to the predicate devices.
• Accessories: The use of special patient electrodes and lead wires.
• Certification Program: Recommendation for healthcare provider certification.

There is no quantitative performance data reported in the document that would typically be presented in a table for device performance metrics.

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

No clinical test set or data provenance is mentioned as this is a 510(k) submission focused on substantial equivalence to existing devices rather than a new clinical performance study. The "test set" in this context refers to the comparison against predicate devices.

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. The ground truth for this submission is based on regulatory compliance and the established safety and effectiveness of the identified predicate devices, as approved by the FDA. There is no mention of experts establishing a ground truth for a test set of clinical data.

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

Not applicable. There was no clinical test set requiring an adjudication method. The review process involved the FDA evaluating the submission against regulatory requirements and comparison to predicate devices.

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

Not applicable. This device is an electrotherapy device (powered muscle stimulator and biofeedback device), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This is not an algorithmic or AI-based device. It is a physical medical device delivering electrotherapy and biofeedback.

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

The "ground truth" in the context of this 510(k) submission is the established regulatory compliance and presumed safety and effectiveness of the predicate devices. The submission asserts that the Vitalstim Experia is substantially equivalent to these already-approved devices, implying that their established 'truth' (i.e., that they are safe and effective for their intended use) extends to the new device.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. Since there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.

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The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:
➤ Protruding discs
➤ Bulging discs
➤ Herniated discs
➤ Degenerative disc disease
➤ Posterior facet syndrome
➤ Acute facet problems
➤ Radicular pain
➤ Prolapsed discs
➤ Spinal root impingement
➤ Hypomobility
➤ Degenerative joint disease
➤ Facet syndrome
➤ Compressions fractures
➤ Joint pain
➤ Discogenic pain

EMG (a.k.a. sEMG)
Determination of the activation magnitude and timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education

The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner.

The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch.

The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician.

The provided information does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics or clinical outcomes. Instead, it details the submission for 510(k) premarket notification for the Triton/ Tru-Trac/ TX/ Triton DTS Traction device, which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices.

The acceptance criteria mentioned are related to compliance with recognized consensus standards for medical equipment safety and electromagnetic compatibility, rather than clinical efficacy or specific performance benchmarks.

Here's a breakdown of the requested information based on the provided text, with notes where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify performance acceptance criteria related to clinical effectiveness (e.g., specific pain reduction percentages, range of motion improvements, or target success rates). The primary "performance" reported is compliance with safety and EMC standards and technical similarity to predicate devices.

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

• Sample Size of Test Set: Not applicable. The submission is for a medical device seeking market clearance through substantial equivalence, not a clinical study with a test set of patient data for performance evaluation against ground truth. The "test set" here refers to the device itself being tested for compliance with technical standards.
• Data Provenance: Not applicable for a clinical test set. The data provenance described is the device's technical specifications and comparisons to predicate devices for substantial equivalence.

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

• Number of Experts: Not applicable. This document does not describe a study where experts established ground truth for a clinical test set. The "ground truth" for this submission revolves around established safety and EMC standards, and the technical characteristics of predicate devices.
• Qualifications of Experts: Not applicable for a clinical test set. The compliance with standards would be assessed by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of an adjudication process for a clinical test set in this 510(k) submission.

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

• Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted, and the device is a powered traction unit, not an AI-assisted diagnostic or interpretative system. The optional EMG biofeedback feature provides data for the clinician but isn't described as an AI-driven interpretive tool.

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

• Was a standalone study done? No. The device is a physical therapy traction unit, and its function involves direct human application and interaction (clinician administering treatment, patient interacting with the device). There is no "algorithm only" performance that would be evaluated in a standalone study without human involvement.

7. Type of Ground Truth Used

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by:
  • Regulatory Standards: Compliance with recognized safety and electromagnetic compatibility standards (UL 60601-1: 2003, IEC 60601-1-2: 2001).
  • Predicate Device Characteristics: The technical specifications and indications for use of the listed predicate devices (e.g., Triton/Tru-Trac/TX Traction, Eskotek EST Trac 401 Traction, etc.) serve as the benchmark for demonstrating substantial equivalence. The argument for substantial equivalence is based on comparing the new device's features, intended use, and technological characteristics to those of legally marketed predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device that requires a training set of data for an algorithm. The device is a physical medical device.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, knee, ankle, wrist, shoulder). Distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with:

• Protruding discs

• Bulging discs

• Herniated discs

• Degenerative disc disease

• Posterior facet syndrome

• Acute facet problems

• Radicular pain

• Prolapsed discs

• Spinal root impingement

• Hypomobility

• Degenerative joint disease

• Facet syndrome

• Compressions fractures

• Joint pain

• Discogenic pain

The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a traction device. It does not contain any information about acceptance criteria or a study proving device performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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For Infrared Lamp (Laser)

Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems are indicated for topical heating for:

• temporary increase in local blood circulation
• temporary relief of minor muscle and joint aches, pains and stiffness
• relaxation of muscles
• temporary relief of muscle spasms
• temporary relief of minor pain and stiffness associated with arthritis

Vectra Genisys Laser System (Intelect XT Laser System)

I am sorry, but based on the provided documents, I cannot answer your request. The documents are a 510(k) clearance letter from the FDA for a medical device (Vectra Genisys Laser System) and its indications for use. They do not contain information about acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.

These documents primarily confirm that the device is substantially equivalent to a legally marketed predicate device and outline its approved indications for use. They do not describe the specific testing and validation studies typically required to demonstrate performance against acceptance criteria in the way your request specifies.

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For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Premodulated (IFS)
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
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS)
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
For FES
Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For DC Continuous Mode
Relaxation of muscle spasm
For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures
2. Relief of pain, muscle spasms and joint contractures that may be associated with:
   a) Adhesive capsulitis
   b) Bursitis with slight calcification
   c) Myositis
   d) Soft tissue injuries
   e) Shortened tendons due to past injuries and scar tissues
3. Relief of sub-chronic and chronic pain and joint contractures resulting from:
   a) Capsular tightness
   b) Capsular scarring

Not Found

I'm sorry, but this document does not contain the information requested about acceptance criteria, device performance, or study details.

The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer (Chattanooga Group / Encore Medical) for their "Vectra GENiSYS" device.

This document primarily states:

• The FDA's determination of substantial equivalence for the device to legally marketed predicate devices.
• The regulation numbers, names, and product codes for the device.
• A list of intended uses (Indications for Use) for various modalities of the device (VMS, Russian, TENS, FES, DC Continuous Mode, Ultrasound).

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

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For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS): 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. Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS): Symptomatic relief or management of chronic, intractable pain, Post-traumatic acute pain, Post-surgical acute pain. For FES: Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait. For DC Continuous Mode: Relaxation of muscle spasm. For EMG: To determination the activation timing of muscles for: a) retraining of muscle activation, b) coordination of muscle activation, An indication of the force produced by muscle for control and maintenance of muscle contractions, Relaxation muscle training, Muscle re-education. For EMG triggered Stim: Stroke rehab by muscle re-education, Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. For Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures, 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis, b) Bursitis with slight calcification, c) Myositis, d) Soft tissue injuries, e) Shortened tendons due to past injuries and scar tissues, 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness, b) Capsular scarring.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria. The document is a 510(k) substantial equivalence letter from the FDA for a device called "Vectra GENiSYS (Intelect Legend XT)".

This document primarily:

• Identifies the trade name, regulation numbers, regulation names, regulatory class, and product codes for the device.
• States that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
• Outlines general controls and additional controls that may apply to the device.
• Lists the specific "Indications for Use" for various modalities offered by the device (e.g., VMS, Interferential, Microcurrent, TENS, FES, DC Continuous Mode, EMG, EMG triggered Stim, Ultrasound).

The text does not contain details on:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Any study design (e.g., sample size, data provenance, ground truth establishment).
• Any performance results or data to demonstrate the device meets acceptance criteria.
• Information about expert involvement, adjudication methods, or MRMC studies.

Therefore, I cannot provide a response filling in the requested table and details because the information is not present in the provided document.

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For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures

2. Relief of pain, muscle spasms and joint contractures that may be associated with:

a) Adhesive capsulitis

b) Bursitis with slight calcification

c) Myositis

d) Soft tissue injuries

e) Shortened tendons due to past injuries and scar tissues

3. Relief of sub-chronic and chronic pain and joint contractures resulting from:

a) Capsular tightness

b) Capsular scarring

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Vectra (Intelect) Genisys Ultrasound." It outlines the device's classification, intended use, and confirms its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment, is typically found in premarket submission documents (like the 510(k) itself or associated test reports), not in the FDA's clearance letter. The clearance letter only states that the FDA reviewed the submission and found the device substantially equivalent based on the information provided by the manufacturer.

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