Search Results

Powered Muscle Stimulator Device:
1-Relaxation of Muscle Spasm.
2-Prevention or retardation of disuse atrophy.
3-Increasing local blood circulation.
4-Muscle re-education.
5-Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
6-Maintaining or increasing range of motion.
TENS Device:
Symptomatic relief of chronic intractable pain.

The EGS4000 is a Powered Muscle Stimulator and TENS device. It is a small battery operated device, as its predecessor, the EGS 300. The additional operational features include a second channel, a timer, additional switching rates, a change in lead wire receptacles -- to comply with the newest proposal on lead wire attachment. Additionally, potentiometers are used. To enhance the versatility of the predicate this unit may also operate with an a/c adaptor. For recording time elapsed in usage, a data port allows for accessing the information. These last two features are performed with all the appropriate mechanisms to ensure patient safety. The waveform, intensity available and pulse rates available are all as in the predicate device. Battery operation of the EGS4000 is performed with a 9 volt battery as opposed to the previous special 14.4 volt battery. This will allow the end user greater convenience while additionally allowing longer operating time with a single battery.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document (K955666, April 15, 1997, for device EGS4000), it's important to note that this is a 510(k) premarket notification and not a detailed clinical study report like what would be seen for a new drug or a more complex medical device. The focus of a 510(k) is to demonstrate "substantial equivalence" to a predicate device, not necessarily to perform extensive new clinical trials.

Therefore, many of the requested elements for a comprehensive study description (like sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details) are not present in this document because they were not required for this type of submission.

Acceptance Criteria and Device Performance (as inferred from the document):

Given the nature of a 510(k) for a powered muscle stimulator/TENS device, the "acceptance criteria" discussed are primarily related to maintaining the functional equivalence and safety of the device compared to its predicate.

Study Details (as per the document):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable / Not mentioned. The "tests" performed were non-clinical engineering and electrical measurements, not clinical trials with human subjects as a "test set" in the context of AI or diagnostic device evaluation.
   • Data Provenance: Not applicable. The "data" comes from engineering measurements and calculations (oscilloscope comparisons, timing checks, calculations for pulse charge, current density, and power density).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not mentioned. Ground truth in this context would likely refer to established electrical engineering principles and compliance standards for medical devices, not expert consensus on medical diagnoses.

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

   • Not applicable / None specified. Adjudication methods are relevant for subjective interpretations (like radiology reads), which is not the case here.

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:

   • No. An MRMC study was not conducted and is not relevant for this type of device (a physical electrical stimulator) or 510(k) submission. There is no AI component mentioned.

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

   • No. This concept is not applicable as this is a physical medical device, not an algorithm.

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

   • The "ground truth" for demonstrating substantial equivalence relied on engineering and electrical measurement standards and direct comparison of electrical output characteristics (waveform, intensity, pulse rates) to those of the legally marketed predicate device, EGS 300. Compliance with FDA requirements for cables and lead wires also served as a "ground truth" for safety updates.

7. The sample size for the training set:

   • Not applicable / Not mentioned. This device does not use machine learning or AI that would require a training set.

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

   • Not applicable. There is no training set for this device.

Summary of the "Study" (Non-Clinical Tests Performed):

The "study" described in the 510(k) is a series of non-clinical tests focused on electrical and functional characteristics to demonstrate substantial equivalence to a predicate device.

• Methods: Oscilloscope comparisons for waveforms and characteristics, timing checks, and calculations for pulse charge, current density, and power density.
• Purpose: To verify that the EGS4000's output (waveform, amplitude, duration, frequencies) is identical or acceptably similar to the predicate EGS 300, and that new features comply with safety standards.
• Conclusion: The non-clinical tests (engineering measurements) confirmed that the function and output of the EGS4000 have not changed compared to the predicate, and that new features meet FDA requirements and enhance patient safety and convenience. Clinical tests were explicitly stated as "Non-Applicable."

Ask a specific question about this device