Search Results

The intended use of the Model ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training.

The ME3000P is a portable, battery powered EMG recorder. The ME3000P is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training. The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two or more channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.

The provided text describes the ME3000P Professional Muscle Tester, an EMG device. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a modern AI/ML device submission would. This document is from 1997, and the regulatory requirements and practices for device testing, especially regarding performance criteria and clinical study methodologies, were different then.

Based on the provided text, here's what can be extracted and what is explicitly not available:

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

Information NOT available in the text for this section:

• Quantitative performance metrics (e.g., accuracy, sensitivity, specificity, signal-to-noise ratio specific to EMG signals).
• Specific numerical thresholds for "acceptance criteria" related to device performance in signal acquisition or display.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The "Testing" section only mentions "The ME300P was tested for electrical and EMC safety." There is no mention of a human or patient test set for performance evaluation in the context of its intended use to record EMG signals for muscle re-education and relaxation training.
• Data Provenance: Not applicable, as no test set of human data is described. The safety tests would have been performed on the device itself, likely in a laboratory setting.

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

• Not applicable. No ground truth establishment for a test set of clinical data is described.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication 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. This device is a biofeedback device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not described and would not be relevant.

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

• No. The device described, the ME3000P, is a signal recorder and display unit for EMG signals. It is explicitly stated that "The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities." Its function is to provide raw data to a human user for re-education and training, not to perform an automated standalone diagnostic or therapeutic function.

7. The type of ground truth used

• Not applicable for the EMG signal recording performance, as no clinical performance study is described. For the safety tests, the "ground truth" would be the specifications and requirements of the relevant IEC and EMC standards.

8. The sample size for the training set

• Not applicable. This device is an electronic signal acquisition and display device, not an AI/ML model that requires a training set.

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

• Not applicable, as no training set is relevant for this type of device.

Ask a specific question about this device