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The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.

MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device called the MYOTouch Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document explicitly states in Section VIII, "No clinical tests were submitted to support this 510(k)."

Therefore, based on the information provided, I cannot answer your request regarding the acceptance criteria and the study that proves the device meets those criteria, as no such study is presented in this document. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device through technical comparisons and compliance with recognized standards, rather than direct performance studies against acceptance criteria.

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The EasyMed InstrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve.

The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).

The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA.

All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination.

This document describes the validation of the EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EasyMed Peripheral Nerve Stimulator are based on compliance with specific electromagnetic compatibility (EMC) standards. The reported device performance indicates that the device passed all these tests.

Beyond these EMC specific tests, the document also mentions that "All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination." However, the specific acceptance criteria for these physical tests are not detailed in the provided text.

2. Sample Size and Data Provenance

The provided document does not specify the sample size used for the tests mentioned in the "Performance Data" section.
The provenance of the data is not explicitly stated as "country of origin of the data" or "retrospective or prospective." However, given EasyMed Instruments Co., LTD. is located in China, it's reasonable to infer that the testing likely occurred in China. The testing described appears to be prospective testing of the device itself, rather than retrospective analysis of clinical data.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This document describes performance testing for an electrical medical device (peripheral nerve stimulator) against engineering standards (e.g., electromagnetic compatibility). The nature of this testing does not involve establishing ground truth based on expert review of medical images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the testing described is for engineering performance rather than clinical data interpretation, there is no adjudication method involved. The results are binary (Pass/Fail) based on predefined technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This validation is for a medical device (a peripheral nerve stimulator), not an AI algorithm.

6. Standalone (Algorithm Only) Performance

Not applicable. This document describes the validation of a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests described is the established technical requirements and limits defined by the international standards (e.g., EN 60601-1-2, EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8). The device's performance is measured against these objective, verifiable criteria.

8. Sample Size for the Training Set

Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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