Search Results
Found 1 results
510(k) Data Aggregation
(297 days)
TOF-Cuff monitor
TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and non-invasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device.
The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment. The monitor should be used only with a single patient.
The device consists of the TOF-Cuff monitor and the TOF-Cuff pressure cuff. The applied part of the device is the TOF-Cuff pressure cuff.
TOF-CUFF monitors the neuromuscular transmission (NMT) using the patented TOF-Cuff® method.
TOF-Cuff® is a new method of monitoring neuromuscular blockade that has several advantages over previous methods. It is based on a modified pressure cuff that incorporates stimulating electrodes. The evoked muscle response is evaluated through the changes in pressure of the cuff generated by the muscular reaction after the electrical stimulus. The modified pressure cuff is also used for NIBP (Non-invasive Blood Pressure) measurement. Thus it is possible to monitor both parameters with only one patient sensor.
NMT can work either in manual or automatic modes. In manual mode the user starts a measurement by touching buttons of main menu. In automatic mode the measurement is performed at reqular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time. The user can stop a NMT measurement at any moment by pressing the NMT Stop key.
TOF-CUFF monitor offers the possibility to start an automatic procedure for Neuromuscular Blockade (NMB) monitoring during the complete surgical process. The Auto-Pilot Program is designed to facilitate the work of the anaesthesiologist and change pattern type and stimulation cycle according to the different blockade phases during surgery, but NMT monitoring requires adequate vigilance and supervision by the anaesthesiologist
TOF-CUFF monitor provides systolic, diastolic and mean arterial pressure values, as well as the pulse rate, in a non-invasive way, by means of an enhanced version of the oscillometric method. The validation has been performed using as reference the intra-arterial pressure measurement
NIBP can work either in manual or automatic modes. In manual mode a measurement is performed only when Start/Stop NIBP key is pressed. In automatic mode, the measurement is performed at regular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time by pressing the Start/Stop NIBP key and the next measurement would start once the selected time interval has elapsed. If Start/Stop NIBP key is pressed while a NIBP measurement is in progress, the process is stopped and the cuff deflated. During the measurement a button is also shown in the main menu area that, when pressed, stops the process.
The RGB Medical Devices' TOF-Cuff monitor, intended for monitoring neuromuscular transmission (NMT) and non-invasive blood pressure (NIBP) in adult surgical patients, underwent two clinical studies to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or precise reported device performance metrics in a table format for the clinical studies. However, it mentions qualitative outcomes related to the device's functionality.
| Acceptance Criteria Category | General Criteria/Goal | Reported Device Performance/Outcome |
|---|---|---|
| NIBP Monitoring | Determine capacity to monitor non-invasive arterial pressure. | "The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device the non-invasive arterial pressure..." (Implies successful monitoring capability) |
| NMT Monitoring | Determine capacity to monitor neuromuscular blockade induced with relaxant drugs. Compare NMB values with a predicate monitor. | "The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device...the level of neuromuscular blockade induced with relaxant drugs." "The main objective of the second study is to compare the values of neuromuscular blockade measured with the TOF-CUFF monitor with neuromuscular blockade values measured with the CARESCAPE B450 monitor...and evaluate the degree of equivalence." (Implies successful monitoring and demonstration of equivalence) |
| Overall Equivalence | Demonstrate substantial equivalence in terms of indication for use, technology, and performance specifications to predicate devices. | "Both studies showed that the TOF-Cuff monitor supports the determination of substantial equivalence regarding its intended use." "Based on the provided information and performed clinical testing our device the TOF-Cuff monitor is substantially equivalent to the primary predicate device BP100A, the secondary predicate device TwitchView System and to the reference device Carescape B450 in terms of indication for use, technology and performance specifications." |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of patients) used in the two clinical investigations. It vaguely states "Two clinical investigations were performed on the TOF-cuff monitor." The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned but clinical investigations typically imply prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document describes a comparative study for neuromuscular blockade (the second study) which compares the TOF-CUFF monitor's measurements with those of a CARESCAPE B450 monitor. However, this is not an MRMC study related to human readers or AI assistance. It compares device performance in measuring a physiological parameter. Human reader involvement, AI assistance, or effect sizes related to human improvement are not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The context of the device (a monitor) implies a standalone performance, meaning the device itself generates the measurements. The studies focus on the device's ability to measure NMT and NIBP and its equivalence to other monitors, rather than human-in-the-loop performance. The term "algorithm only" is not explicitly used, but the device operates to provide measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For NIBP: The document states, "The validation has been performed using as reference the intra-arterial pressure measurement." This indicates that intra-arterial pressure, a direct and highly accurate method, was used as the ground truth for NIBP measurements.
- For NMT: The second clinical study compared NMB values from the TOF-CUFF monitor with those from the CARESCAPE B450 monitor. Therefore, the measurements from the CARESCAPE B450 monitor served as the reference or comparative ground truth for NMT.
8. The sample size for the training set
The document does not mention the sample size for any training set. As this is a medical device clearance document, it focuses on validation and clinical performance rather than AI model training, which may not be directly applicable in the same way.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of AI model training, the method for establishing its ground truth is not applicable or provided. The document focuses on the clinical validation of the device and its measurements against established reference methods.
Ask a specific question about this device
Page 1 of 1