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The MLS Electromyographic preamplifier enables researchers and clinicians to acquire EMG signals from active subjects. It is intended to be used in hospital, university and other research facilities to acquire EMG signals for display and analysis by, or under the direction of, a health care professional.

The purpose of the MLS Electromyographic preamplifier is to amplify the myoelectric signals that are generated by muscles when they contract.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a quantitative sense that the MLS Electromyographic Preamplifier must meet to be cleared. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing key specifications. Therefore, the "acceptance criteria" can be inferred as matching or being acceptably similar to the predicate device's performance.

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

• Sample Size: "A sample of both the predicate B&L Active Electrode and the proposed MLS Electromyographic preamplifier were tested." The exact number of units or recordings in this sample is not specified.
• Data Provenance: The location or country of origin of the data is not specified. The study is prospective in the sense that the testing was performed specifically for this submission to compare the devices, but no further details on the study design or subject population are provided.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study report mentions "myographic recordings... were found to be substantially identical," implying an expert evaluation, but no details are given.

4. Adjudication Method for the Test Set

• Adjudication method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an EMG preamplifier, a hardware component, not an AI-powered diagnostic tool for human readers.

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

• Standalone Performance Study: No, a standalone algorithm performance study was not done. This is a hardware device; thus, performance is characterized by its signal amplification and filtering properties rather than algorithmic output. The study focused on comparing the amplified signal characteristics from two devices.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" was established by direct comparison of the electrical signals generated by both devices from a single muscle. The primary criterion was that "Myographic recordings from the skin surface over a single muscle were found to be substantially identical in frequency content and power spectrum for both devices." This represents a direct experimental comparison to an already legally marketed device, rather than an independent "ground truth" derived from pathology or clinical outcomes.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a hardware component and does not utilize a "training set" in the context of machine learning or AI algorithms.

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

• Ground Truth Establishment for Training Set: Not applicable. As above, there is no training set for this type of device.

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