(261 days)
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.
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.
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.
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.
Here's an analysis of the provided text regarding the JTech Dynatrack Surface Electromyograph System, focusing on acceptance criteria and study details:
Based on the provided document, there are no specific quantifiable acceptance criteria or a dedicated study (beyond substantial equivalence claims) demonstrating the device's performance against such criteria.
The document primarily focuses on establishing substantial equivalence to existing predicate devices (Targus Concepts Biostar SEMG System and JTech Large Muscle Strength Gauge) rather than presenting a standalone performance study with defined acceptance criteria.
The information provided describes the device, its intended use, and its technological characteristics in comparison to the predicate devices. It asserts that the device's functionality is "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." However, this is a statement of equivalence, not a report of a study meeting specific performance benchmarks.
Therefore, many of your requested items cannot be fulfilled from the provided text.
Here's a breakdown based on the information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The core "acceptance" is based on substantial equivalence to predicate devices, implying similar performance. | Microvolt measurement: The device measures muscle activity in microvolts. Statement of compliance with "National Bureau of Standards calibration standards for microvolts." |
| Median frequency/power spectral curve display: Capable of displaying. | |
| Bioelectric frequencies display: Capable of displaying. | |
| Functionality: "Same as the basic functionality of the predicate device, as well as conventional SEMG systems that acquire and display SEMG data on computer monitors." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No performance study involving a patient test set is described.
- Data Provenance: Not applicable. No performance study data is presented.
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. No performance study with a test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No performance study with a test set is described.
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
- No MRMC or comparative effectiveness study is mentioned. This device is a measurement system, not an AI-assisted diagnostic tool for human readers in the traditional sense described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study is described. The document focuses on the device's function as a measurement tool for healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No performance study requiring ground truth is described. The device's "ground truth" seems to be its ability to accurately measure bioelectrical signals, verified by calibration standards mentioned in the intended use section.
8. The sample size for the training set
- Not applicable. This device is not described as utilizing machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not described as utilizing machine learning or AI that would require a training set.
Summary of what can be inferred from the document:
- Regulatory Pathway: The device is seeking premarket notification (510(k)) based on substantial equivalence.
- Intended Use: Biofeedback for healthcare professionals to monitor patient muscle activity, providing a visual signal corresponding to muscle activity.
- Performance Claim (implicit): The device's performance is assumed to be comparable to the predicate devices (Targus Concepts Biostar SEMG System and JTech Large Muscle Strength Gauge's SEMG module) because it performs "the same as the basic functionality."
- Calibration: The device claims compliance with "National Bureau of Standards calibration standards for microvolts." This is the closest thing to a performance benchmark mentioned for the core measurement functionality.
- Safety Feature: The electrodes are designed with "shrouded female lead electrodes" to prevent accidental plugging into a power outlet, adhering to an FDA Public Health Advisory. This is a safety feature, not a performance metric.
§ 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.