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The iTOF is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.

The iTOF is an accelerometery based Quantitative Neuromuscular Blockade Monitor that provides continuous, non-invasive neuromuscular transmission (NMT) monitoring by measuring the acceleration of muscle movement (acceleromyography) during controlled electrical stimulations. The iTOF allows medical professionals to accurately monitor and evaluate the depth of neuromuscular blockade of an adult or paediatric patient in the intensive care ward, operating theatre, or recovery room. It is used by health professionals - anaesthesiologists, doctors, or fully qualified nurse anaesthetists for objective or subjective neuromuscular transmission monitoring. The iTOF system consists of a mobile device app (User Interface Software), a Bluetooth connected nerve stimulation device (Hardware and Firmware) powered by a 9 Volt nonrechargeable battery, an Accelerometer Sensor, and Stimulation Cables. The App displays user interface elements including the various stimulation settings controls, the time elapsed between stimulations (all modes), and the results for the measurements made in response to types of stimulation chosen by the user (TOF, PTC, and DBS) (TET and TWI responses are gauged visually by the health professional). The hardware device portion of the iTOF system provides the electrical stimulation patterns via the Stimulation Cables and quantitatively measures the resulting twitch via the Accelerometer Sensor. The iTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice: TOF (Train Of Four), PTC (Post Tetanic Count), DBS (Double Burst) (3.3), TWI (Single Twitch) (0.1Hz, 1 Hz, 2Hz), TET (Tetanus) (50Hz). The accessories that can be used with the device include: iTOF Splint (included).

The provided text does not contain information about specific acceptance criteria related to accuracy or performance metrics for the iTOF device. It primarily focuses on demonstrating substantial equivalence to a predicate device through functional, biocompatibility, electrical safety, wireless coexistence, software, and cybersecurity testing.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document indicates:

• No animal or clinical testing was required to demonstrate substantial equivalence, meaning no patient-level performance data is presented in this summary.
• Functional performance testing was performed on "output waveforms, voltage and current of different stimulation modes and simulated skin resistances." However, no specific metrics or acceptance criteria for these tests are provided.
• Software verification and validation testing was conducted, and the software was considered a "moderate" level of concern. No specific performance metrics or acceptance criteria for the software are detailed.
• The sample size for the training set and how its ground truth was established are not mentioned, as the document does not describe the development or training of any AI/ML components with performance metrics, but rather the verification and validation of software functionality.

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