(241 days)
The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit.
The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, 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 electrical nerve stimulation and the measurement of acceleration in the corresponding muscle (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 device and all of the settings associated with it are designed for use on adult patients in hospital or health institutions so that the patient's curare level can be monitored.
The WiTOF system is composed of the station, the wireless sensor (hand), and the US AC power supply unit. The wireless sensor itself consists of the 3D accelerometer in the splint.
The WiTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice:
- 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 and 100 Hz
The station displays the various stimulation settings, the time elapsed 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 display screen.
The accessories that can be used with the device include:
- Optic-serial (RS232) cable to transfer data
- Fixation clamp – regular size (10–40 mm / 0.4–1.6 inches)
- Fixation clamp – large size (20–60 mm / 0.8–2.4 inches)
The provided FDA 510(k) clearance letter for the WiTOF device does not contain the detailed performance study results, acceptance criteria, or specific data points typically found in clinical validation reports for AI/software-driven medical devices.
The document states that the software for the WiTOF device was considered of "moderate" level of concern and that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" However, it does not explicitly describe the acceptance criteria or the specific methodology/results of these tests.
Moreover, the letter explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness." This indicates that the regulatory clearance was based on demonstrating substantial equivalence primarily through technical comparison and non-clinical performance data (electrical safety, EMC, software V&V) rather than a comparative clinical study.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, because this level of detail is not present in the provided 510(k) clearance letter. The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on a detailed clinical validation study as might be conducted for novel AI algorithms.
If this were an AI/ML medical device submission requiring a detailed performance study, the 510(k) summary would typically include a section describing that study with the elements you've requested (e.g., sample size, ground truth establishment, reader studies). The absence of such a section, along with the statement that no animal or clinical testing was required, confirms that these specific study details are not part of this clearance document.
§ 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).