(261 days)
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No
The description focuses on basic signal processing, data display, and hardware connections. There is no mention of AI, ML, or any advanced algorithms for interpretation or prediction.
No.
The device is described as a biofeedback device for assessment and monitoring of muscle activity, not for treatment.
Yes
The device description states "The JTech Diagnostic Electromyograph is a device used by professional healthcare examiners to measure the bioelectrical signal produced by peripheral muscles." The name itself, "JTech Diagnostic Electromyograph," also indicates its diagnostic purpose.
No
The device description explicitly states that the JTech Dynatrack SEMG microprocessor is comprised of electronic hardware in an aluminum box and uses standard patient electrodes, indicating it is not a software-only device.
Based on the provided text, the JTech Dynatrack Surface Electromyograph is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The JTech Dynatrack Surface Electromyograph measures the bioelectrical signal produced by peripheral muscles directly from the patient's body. It is a biofeedback device that monitors muscle activity in real-time.
- Intended Use: The intended use is to monitor a patient's muscle activity and provide a visual signal corresponding to that activity. This is done in vivo (within the living body).
Therefore, since the device is used to measure a physiological signal directly from the patient's body and does not analyze specimens in vitro, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JTech Dynatrack Surface Electromyograph is a biofeedback device that provides a visual signal corresponding to the status of a patient's muscle activity. Healthcare professionals can use the machine to monitor the patient's muscle activity. This is a precise biofeedback instrument for quick and accurate assessment and recording of the bioelectric muscle signal. It is compliant with the National Bureau of Standards calibration standards for microvolts.
Product codes
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Device Description
The JTech Diagnostic Electromyograph is a device used by professional healthcare examiners to measure the bioelectrical signal produced by peripheral muscles. The main display of data (See Exhibit 1, page 20) is a simple chart recorder display which shows the clinician and patient the level of muscle tension in the body. Thus, neuromuscular activity may be monitored.
The data displayed on the monitor includes muscle activity in microvolts, the median frequency curve or power spectral curve. Display 3a of exhibit 3, shows the actual level of muscle tension in microvolts; display 3b shows the median bioelectric signal generated by the muscle over time; display 3c shows the bioelectric frequencies generated by the muscles at a moment in time.
The Dynatrack SEMG microprocessor is comprise of electronic hardware in a 5.5"W x 7.2"L x 1.75"H aluminum box. Standard patient electrodes with protected male and female connectors are attached to the Dynatrack microprocessor. These receive the muscle signal from the patient and convert it to a digital signal. The Dynatrack SEMG microprocessor may be used in two ways: It may be connected by cable directly to the PC's RS232 Serial Port, and the screen will display muscle activity. Or it may be connected through the JTech Tracker microprocessor, and readout multiple patient measurements on the PC screen. The latter configuration connects the Tracker microprocessor directly to the PC RS232 Serial Port. The firmware of the Tracker microprocessor first processes the muscle signal of the Dynatrack SEMG microprocessor, followed by signals from measurement peripherals linked to other electrode ports.
JTech Dynatrack SEMG electrodes and lead wires coming in contact with the patient are equipped with male jack connectors which can receive only shrouded female lead electrodes, in accordance with the FDA Public Health Advisory, December 28. 1993. This prevents the examiner from inadvertently plugging the electrodes into a power outlet.
The JTech Dynatrack SEMG microprocessor may be used in series with the JTech Tracker microprocessor. The Tracker has 12 channels to the PC, enabling comparison of Dynatrack muscle activity results with other patient conditions such as muscle strength.
The JTech Dynatrack SEMG System uses the Tracker software of the JTech Large Muscle Strength Gauge to drive the SEMG software module. The SEMG module provides the same records, trends, and files as the Large Muscle Strength Gauge with one exception: the information is electromyograph muscle activity rather than muscle strength data. In all other ways, the SEMG software is equivalent to Tracker software of the Large Muscle Strength Gauge.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional healthcare examiners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
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JTECH DYNATRACK SURFACE ELECTROMYOGRAPH SYSTEM PREMARKET NOTIFICATION 510(K)
12. Summary of Safety and Effectiveness Data
12.1 Identification of Legally Marketed Device
The JTech Dynatrack SEMG System is substantially equivalent to the class II Targus Concepts Biostar SEMG System Device (K912938), the Tracker Microprocessor, and the Tracker PC Software of the Large Muscle Strength Gauge (K944630).
12.2 JTech Dynatrack SEMG System Description
The JTech Diagnostic Electromyograph is a device used by professional healthcare examiners to measure the bioelectrical signal produced by peripheral muscles. The main display of data (See Exhibit 1, page 20) is a simple chart recorder display which shows the clinician and patient the level of muscle tension in the body. Thus, neuromuscular activity may be monitored.
The data displayed on the monitor includes muscle activity in microvolts, the median frequency curve or power spectral curve. Display 3a of exhibit 3, shows the actual level of muscle tension in microvolts; display 3b shows the median bioelectric signal generated by the muscle over time; display 3c shows the bioelectric frequencies generated by the muscles at a moment in time.
Although the modalities of the three results appear to be the same, thev provide different information to the healthcare professional.
12.3 Intended Use
The JTech Dynatrack Surface Electromyograph is a biofeedback device that provides a visual signal corresponding to the status of a patient's muscle activity. Healthcare professionals can use the machine to monitor the patient's muscle activity. This is a precise biofeedback instrument for quick and accurate assessment and recording of the bioelectric muscle signal. It is compliant with the National Bureau of Standards calibration standards for microvolts.
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JTECH DYNATRACK SURFACE ELECTROMYOGRAPH SYSTEM PREMARKET NOTIFICATION 510(K)
12.4 Summary of Technological and Performance Characteristics of the JTech SEMG System as compared to the Biostar SEMG System and Large Muscle Strength Gauge
12.4.1 Dynatrack SEMG Microprocessor
The Dynatrack SEMG microprocessor is comprise of electronic hardware in a 5.5"W x 7.2"L x 1.75"H aluminum box. Standard patient electrodes with protected male and female connectors are attached to the Dynatrack microprocessor. These receive the muscle signal from the patient and convert it to a digital signal. The Dynatrack SEMG microprocessor may be used in two ways: It may be connected by cable directly to the PC's RS232 Serial Port, and the screen will display muscle activity. Or it may be connected through the JTech Tracker microprocessor, and readout multiple patient measurements on the PC screen. The latter configuration connects the Tracker microprocessor directly to the PC RS232 Serial Port. The firmware of the Tracker microprocessor first processes the muscle signal of the Dynatrack SEMG microprocessor, followed by signals from measurement peripherals linked to other electrode ports.
JTech Dynatrack SEMG electrodes and lead wires coming in contact with the patient are equipped with male jack connectors which can receive only shrouded female lead electrodes, in accordance with the FDA Public Health Advisory, December 28. 1993. This prevents the examiner from inadvertently plugging the electrodes into a power outlet.
The JTech Dynatrack SEMG microprocessor may be used in series with the JTech Tracker microprocessor. The Tracker has 12 channels to the PC, enabling comparison of Dynatrack muscle activity results with other patient conditions such as muscle strength. This is an improvement over the Biostar system, which has the limited capability of recording only the EMG muscle activity signal through the microprocessor and PC software.
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JTECH DYNATRACK SURFACE ELECTROMYOGRAPH SYSTEM PREMARKET NOTIFICATION 510(K)
12.4.2 SEMG Software Module of the Tracker System
The JTech Dynatrack SEMG System uses the Tracker software of the JTech Large Muscle Strength Gauge to drive the SEMG software module. The SEMG module provides the same records, trends, and files as the Large Muscle Strength Gauge with one exception: the information is electromyograph muscle activity rather than muscle strength data. In all other ways, the SEMG software is equivalent to Tracker software of the Large Muscle Strength Gauge.
12.5 Conclusion
The requirements of JTech's Dynatrack SEMG System are the same as the basic functionality of the predicate device, as well as conventional SEMG systems that acquire and display SEMG data on computer monitors.
12.6 Statement of Truthfulness and Accuracy
JTech certifies to the best of our knowledge that all the data and information submitted in the JTech SEMG Premarket Notification are truthful and accurate and that no material facts have been omitted.