(267 days)
The ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
The ToFscan is a neuromuscular transmission (NMT) monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for:
-
- Objective neuromuscular transmission monitoring
-
- Subjective neuromuscular transmission monitoring
The continuous monitoring of NMT blocking involves the stimulation of the ulnar nerve and the corresponding measurement of acceleration in the adductor muscle of the thumb (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level.
The apparatus and all of the settings associated with it are designed for use on adult and paediatric patients in hospital or health institutions so that the patient's curare level can be monitored.
The ToFscan system is composed of the monitor, the hand sensor, and the US AC power supply unit. The hand sensor itself consists of the thumb splint/3D accelerometer, the electrode clamps, and the cable which connects to the monitor.
The ToFscan can perform several different modes of electrical stimulation in accordance with usual clinical practice:
- Subjective neuromuscular transmission monitoring
- -TOF (Train Of Four)
- PTC (Post Tetanic Count) -
- -ATP (Automated TOF PTC)
- DBS (Double Burst) (3,3) (3,2) -
- ST (Single Twitch) 0.1 Hz and 1 Hz -
- -TET (Tetanus) 50 Hz
The monitor displays the various stimulation settings, the time elansed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a rotary knob.
The provided text is a 510(k) summary for a medical device called ToFscan, a neuromuscular transmission monitor. The summary focuses on establishing substantial equivalence to a predicate device (TOF-Watch) and includes performance data related to biocompatibility, electrical safety, EMC, and software. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or efficacy for its intended use.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate." This indicates that the approval was based on demonstrating similar technical specifications and intended use to an already approved device, rather than new clinical performance data proving specific efficacy or accuracy metrics against defined acceptance criteria.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).