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The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring.

The TOF3D is intended for use by specialists, anesthetists and nurses with specialization in anesthesia care.

Patients:
The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.

Excluded operating environment:
The device is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive, flammable and oxygen rich environment or environment with sources of intense electromagnetic disturbances. (e.g. Radio Frequency (RF) shielded room of magnetic resonance imaging equipment, electrophysiology laboratories or areas where short or micro wave therapy equipment is used)

The TOF3D is a neuromuscular transmission (NMT) monitor used for objectively monitoring the neuromuscular transmission of patients during surgery or in the intensive care unit. It is intended to be used by specialists, anesthetists and nurses with specialization in anesthesia care. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The TOF3D is battery powered and uses 4 x 1.5 V AA batteries. The TOF3D has no external power supply.

The neuromuscular transmission is monitored by measuring muscle contraction following stimulation. The TOF3D can perform several different modes of electrical stimulation in accordance with usual clinical practice:

• TOF (Train Of Four)
• PTC (Post Tetanic Count)
• TET (Tetanic Stimulation) 50 Hz or 100 Hz
• DBS (Double Burst Stimulation) (3.2 / 3.3)
• ST (Single Twitch) 0.1 Hz and 1 Hz

The TOF3D uses acceleromyograph (AMG) or mechanomyography (MMG) measurement for recording of evoked muscle responses. By using acceleromyograph (AMG) the acceleration of e.g. the thumb is measured with a three-dimensional acceleration sensor to obtain the muscle force according to the second law of Newton. Different locations for monitoring by using the AMG sensor are for instance the ulnar nerve/adductor pollicis muscle, the posterior tibial nerve/flexor halluces brevis muscle and the facial nerve orbicularis oculi muscle or corrugator supercilii muscle. Mechanomyography (MMG) and the corresponding Mechanomyography sensor (MMG) TOF3D can only be used by stimulating the ulnar nerve and the corresponding measurement of the thumb force with a pressure sensor. All results are shown on the LCD display of the device.

With the optional temperature sensor or with the integrated temperature sensor in the Mechanomyography sensor (MMG) TOF3D the TOF3D is capable to measure the skin surface temperature (no physiological parameter) during its use.

Based on the force of contraction resulting from stimulation, it is possible to draw conclusions on the level of neuromuscular transmission which shall aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.

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The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.

The Neuromuscular Transmission Monitor TOF3D is capable to monitor the level of neuromuscular transmission (NMT) during surgery of in the intensive care unit by stimulating different nerves and measuring the response of the respective muscles to the stimulation. The different locations for monitoring are for instance the ulnar nerve/adductor pollicis muscle, the posterior tibial nerve/flexor halluces brevis muscle and the facial nerve/orbicularis oculi muscle. The Neuromuscular Transmission Monitor TOF3D uses acceleromyography (AMG) measurement for recording of evoked muscle responses. The results are shown on the LCD display of the device and shall aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.

The provided text is a 510(k) summary for the Neuromuscular Transmission Monitor TOF3D. It describes the device, its intended use, and its substantial equivalence to a predicate device (TOF-WATCH SX).

However, the document explicitly states that no animal or clinical testing was required to demonstrate substantial equivalence (Section 5.7, "Animal and Clinical Studies"). This means there is no study described in this document that proves the device meets acceptance criteria through clinical performance metrics, effect sizes, or expert evaluations. The acceptance criteria and performance data provided are related to non-clinical testing, such as electrical safety, EMC, software verification, validation, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical efficacy as requested in the prompt, nor can I answer questions about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types for clinical use.

The available information about "acceptance criteria" and "device performance" in this document pertains to engineering and safety standards, not clinical effectiveness.

Here's what can be extracted regarding the non-clinical acceptance criteria and "performance":

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample sizes for the test set and data provenance:

• Not applicable for clinical performance studies. The testing was non-clinical (electrical safety, software, biocompatibility).

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

• Not applicable, as no clinical ground truth was established for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable, as no clinical ground truth was established for performance testing.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, explicitly stated that "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate."

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

• Not applicable, as the device is a hardware monitor, not an AI algorithm.

7. The type of ground truth used:

• For non-clinical testing, the "ground truth" was compliance with established engineering and safety standards (e.g., IEC standards, FDA software guidance, ISO biocompatibility standards).

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device that requires a training set.

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

• Not applicable.

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