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The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.

The STM 9000 are magnetic stimulators used for magnetic stimulation. Magnetic stimulation is a noninvasive technique for stimulating neural and cortical tissue. Application areas of magnetic stimulation are a subset of the application areas for current stimulation. The STM 9000 is connected to a magnetic coil which transfers the magnetic stimulation to the tissue. The STM 9000 consists of power electronics to generate the magnetic field in the magnetic coil. The STM 9000 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is capable of biphasic and monophasic waveforms and the stimulate with a frequency up to 100 pulses per second (pps).

This document is a 510(k) Premarket Notification for the STM9000 device, which is an evoked response electrical stimulator. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies heavily on showing that the new device has similar technological characteristics and performance to existing devices, rather than comprehensive clinical trial data for novel claims.

Therefore, the structure of the provided text does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/Machine Learning (ML) enabled medical device. The STM9000 is a magnetic stimulator, and the performance data presented is focused on demonstrating its safety and basic functionality in comparison to a predicate device, as required for a traditional 510(k).

The document addresses:

• Biocompatibility Testing: To ensure the device materials are safe for contact with the human body.
• Electrical Safety and Electromagnetic Compatibility (EMC): To ensure the device operates safely in its electromagnetic environment and does not pose electrical hazards.
• Software Verification and Validation Testing: To ensure the software functions correctly and reliably, commensurate with its "Moderate" level of concern.

It does not contain the kind of performance data (e.g., sensitivity, specificity, AUC, accuracy) that would be derived from a study proving an AI/ML diagnostic or prognostic device meets acceptance criteria. There are no mentions of:

• A test set of patient data (e.g., images, physiological signals).
• Ground truth established by experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set details for an ML model.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert involvement, or MRMC studies, as this information is not present in the provided 510(k) document for the STM9000. The performance data provided is about the device's inherent safety and functional compliance, not its diagnostic or prognostic accuracy on a dataset.

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