(226 days)
The Surveyor S4 Mobile Monitor is indicated for use:
- The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals.
- The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.
- The Surveyor S4 mobile monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- The Surveyor S4 mobile monitor is indicated for use to acquire and output electrocardiographic data.
- The Surveyor S4 mobile monitor is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
- The Mortara Li-Ion Battery Charger is intended for charging only the Mortara Rechargeable Li-Ion battery pack.
The Surveyor S4 incorporates wireless electrocardiographic technology to achieve real-time acquisition and RF transmission of simultaneous diagnostic quality 12-lead ECG data to a network access point while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals through the network access point to a compatible monitoring device where the signals are displayed. The Surveyor S4 Mobile Monitor allows the patient complete freedom of movement. Extended range can be obtained with additional network access points). The Surveyor S4 Mobile Monitor uses a similar patient cable as the T12S. The S4 requires use of a proprietary ECG patient cable for use with snap electrode hookups. The patient cables use the same wire as present Mortara predicate lead-form cables. The cable is unique to the S4 and is distributed as a device component with the device. The patient cable acquires a continuous ECG signal. A design option will allow the user to set the patient cable type in case of reduced lead (less than 12-lead) options. ECG patient cable is worn by the patient in a standard torso electrode hook-up, which connects to snap type electrodes. Utilizing a frequency range of 2400.96Mhz to 2482.56MHz. ECG data is acquired, processed and transmitted via a Wi-Fi wireless network comprised of one or more network access points. The wireless network is used for patient data transmission and for other system-level command / control and communication. The data network uses modulation / control schemes that share spectrum based on standard IEEE 802.11 Wi-Fi at 2.5GHz range. The Surveyor S4 includes data integrity checks and bi-direction protocols to provide robust data transmission. The device also includes a mechanism to inform the user through a compatible centralized monitor of various device states including low battery, lead quality issues, or out of range condition. It has a color, touch-screen display as the primary interface for user input and graphical display of physiological waveforms, measured parameters, demographic data and other status information. The unit operates with a set of single-use commonly available disposable, non-spillable batteries or from a specified rechargeable battery back that is compatible standards. The battery charger is capable of charging up to five multi-use (rechargeable) batteries at one time and prevents overcharging. The Surveyor S4 uses a touch screen user interface for operator interaction that allows control over the device via selection of menu items and icons as well as entry of relevant configuration. While in normal operation, the display will show other status information such as a battery level indicator, Wi-Fi Signal Strength and Central Station Slot information.
The provided text is a 510(k) premarket notification for the Mortara Surveyor S4 Mobile Monitor. It does not contain specific acceptance criteria, reported device performance data, details of a study proving the device meets acceptance criteria, or information on ground truth establishment, sample sizes for test/training sets, adjudication methods, or MRMC studies.
The document generally states that the device was tested against recognized standards and internal requirements, and that these tests demonstrated compliance and similar safety/effectiveness to predicate devices. However, it does not provide quantitative acceptance criteria or detailed results of these tests in a way that would allow for the direct completion of your requested table and study details.
Here's how to break down what is and isn't available based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document lists the standards the device complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-25, IEC 60601-2-27, IEC/EN 62304, IEC 62366). However, it does not specify quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity, measurement ranges with tolerances) for any performance aspect of the device (ECG signal acquisition, transmission, display). It also does not report specific device performance metrics against any such criteria. It only states, "Test results indicated that the Mortara Surveyor S4 Mobile Monitor complies with its predetermined specification" for software and EMC, and "test results indicated that the device complies with the predetermined requirements" for bench performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document explicitly states:
- "Performance Testing – Animal – Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor S4 Mobile Monitor."
- "Performance Testing - Clinical - Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor S4 Mobile Monitor."
- This indicates that no clinical or animal test sets were used for performance evaluation that would necessitate a sample size or data provenance. The testing mentioned appears to be bench testing, software verification/validation, and electrical/EMC safety testing against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Available. Since no clinical or animal test sets are mentioned, there would be no ground truth established by experts for such data. The device's function is explicit data acquisition and transmission, not interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. See above point.
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
- Not Applicable / Not Available. This device (Mortara Surveyor S4 Mobile Monitor) is a "radiofrequency physiological signal transmitter and receiver" designed for "acquiring and transmitting 12-lead cardiac signals." It does not involve AI assistance, diagnostic interpretation, or reader performance improvement. Its function is to provide the raw data to a compatible monitoring device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Available. This device is a hardware module that acquires and transmits physiological signals. It does not have a standalone algorithm for diagnosis or interpretation in the way an AI algorithm would. Its "performance" refers to its ability to acquire and transmit signals according to specifications.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Available. As it's a signal acquisition and transmission device, "ground truth" in the diagnostic sense (e.g., for disease detection) is not relevant to its stated performance evaluation. Its performance is likely evaluated against signal integrity and transmission fidelity standards.
8. The sample size for the training set
- Not Applicable / Not Available. This device does not use machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. See above point.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices through compliance with general safety and performance standards for hardware and software. It explicitly states that animal and clinical performance testing (which would typically involve test and training sets, ground truth, and expert review for diagnostic devices) were "not performed and are not necessary" for this device. Therefore, most of your requested detailed study information cannot be extracted from this text.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).