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510(k) Data Aggregation
(230 days)
Hypotension Decision Assist is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healtheare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.
Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters.
HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device and meeting various technical and safety standards, rather than defining specific numerical performance acceptance criteria for clinical outcomes. However, it does highlight areas of verification.
| Acceptance Criterion Type | Reported Device Performance (Verification Method) |
|---|---|
| System Functionality | Verified: Interactivity of the system interface and ability to process and display physiologic parameters for intended use. |
| Measurement Accuracy | Verified: Accuracy across the intended measuring range for each physiologic parameter, demonstrated via bench testing following IEC 60601-2-34 Edition 3.0 2011-05. Demonstrated substantial equivalence to reference devices. Verified equivalent performance when connected to specified vital signs monitors. |
| Artifact Detection | Verified: Capability to detect signal artifacts and anomalies that could impact performance, demonstrated via bench testing. |
| Predicate Comparison (Cardiac Output & SVR Events) | Comparable Performance: Demonstrated comparable performance to the predicate device with respect to the detection of cardiac output and systemic vascular resistance events via bench testing. |
| Power Interruption Tolerance | Verified: Tolerates sudden power interruption without data loss or change in operating mode, demonstrated via bench testing following IEC 60601-2-34 Edition 3.0 2011-05. |
| Summative Usability | Fulfilled Needs: Demonstrated that HDA fulfills the needs of its intended users, following FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Software Verification & Validation (moderate level of concern) | Compliant: Documentation provided in accordance with FDA guidance for software in medical devices. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliant: Complies with FDA recognized standards ES60601-1-2005/(R)2012 and A1:2012 for safety and IEC60601-1-2:2014 for EMC. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases for clinical performance assessment. The "test set" primarily refers to hardware and software testing.
- Data Provenance: "Patient data sets obtained from internationally recognized databases" were used for the original system verification and "bench testing performed to compare the performance of HDA to the predicate device." The data was "representative of the range of data input and signal quality that will be encountered in the intended use population and environment of use of the device." No specific countries of origin or whether the data was retrospective or prospective are mentioned beyond being from "internationally recognized databases."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document states that "Clinical studies were not performed." Therefore, there was no expert consensus or ground truth established by human experts for a clinical test set in the traditional sense. The "ground truth" for the bench testing was derived from established standards (e.g., IEC 60601-2-34) and comparison to predicate/reference device measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Since no clinical studies were performed, there was no adjudication of clinical outcomes by multiple experts.
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
No. A MRMC comparative effectiveness study was not performed. The device is a clinical decision support software, not an AI for image interpretation that would typically involve human readers. Clinical studies involving human users were not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "Performance Data" section describes "Measurement accuracy verification," "Artefact Detection Verification," and "Predicate comparison testing" which evaluate the algorithm's direct output and processing capabilities against established standards or predicate device outputs. This represents a standalone performance evaluation of the algorithms and software functionality, rather than human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's technical performance verification (e.g., measurement accuracy) was established through:
- Bench testing methodologies derived from recognized standards (e.g., IEC 60601-2-34).
- Comparison to predicate or reference devices' established performance for specific parameters (e.g., cardiac output, SVR events, physiological parameter derivation).
- Pre-defined specifications for artifact detection and power interruption tolerance.
For claims of "clinical decision support" or "assisting healthcare professionals," the ground truth implicitly relies on the widely accepted understanding that accurate display and processing of vital signs aid clinical decision-making, rather than a specific clinical outcome study being performed with this device.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning or AI model development. The device is described as "clinical decision support software" that "continually processes this data." If machine learning was used implicitly, no details are provided about its training data. The "patient data sets obtained from internationally recognized databases" were used for "original system verification" and "bench testing," which might imply they were used for validation or testing, but not necessarily for training a model.
9. How the ground truth for the training set was established
Not applicable, as a clear "training set" and its ground truth establishment are not described in the provided text. The device's functionality appears to be primarily based on processing established physiological parameters and rules, rather than learning from a labeled training dataset in the AI sense.
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(297 days)
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.
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(191 days)
The TwitchView System is used for the quantitative monitoring of neuromuscular transmission by means of electromyography.
The TwitchView System has been designed to provide a quantitative neuromuscular transmission monitor with a modernized user interface and a single-use electrode array that is placed on the hand of the patient. The degree of neuromuscular block is measured with the TwitchView System by stimulating a peripheral nerve (the ulnar nerve at the wrist), and by evaluating the response of the hand via electromyography. The TwitchView System consists of three components: 1. TwitchView Monitor, 2. TwitchView Charging Station, 3. Single-Use Electrode Array.
The provided text is related to a 510(k) premarket notification for the "TwitchView System," a medical device used for monitoring neuromuscular transmission. However, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.
This document describes technical aspects, regulatory compliance (IEC standards, biocompatibility, electrical safety, etc.), and a comparison to predicate devices, but it does not mention any AI or machine learning components, nor does it describe a study involving a test set, expert ground truth, multi-reader multi-case studies, or standalone algorithm performance. The device primarily relies on electromyography (EMG) measurements and nerve stimulation, which are well-established non-AI technologies in medical monitoring.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning AI/ML performance, because the provided text does not contain this information.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Quantitative monitoring of neuromuscular transmission.
- Technological Characteristics: Stimulating a peripheral nerve with constant current and measuring muscle response. The key difference from the predicate (TOF Watch) is the use of electromyography (TwitchView) versus accelerometry (TOF Watch) for muscle response detection, with the document stating these methods are clinically equivalent.
- Performance Standards & Testing: Compliance with IEC 60601-2-40 (for electromyographs and evoked response equipment), PART 898 (for electrode lead wires and patient cables), biocompatibility, software verification/validation, electrical safety, EMC, and various bench performance tests (stimulation accuracy, EMG accuracy, battery life, etc.).
There is no mention of an AI/ML component, and thus no related acceptance criteria, test sets, or validation studies for AI performance.
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