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This SpO2 Sensor is intended for the continuous nonitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.

The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. And one side of sensor is designed to locate light emitting diodes (LEDs) and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2).

The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000 Express Patient Monitor, which has been cleared by K070791. And the function alarms and interface accessories are controlled by the monitor, and such information is not available in this submission.

Here's a breakdown of the acceptance criteria and study information for the SpO2 Sensor U401-A, U401-B, U401-C, U401-D, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document explicitly states the SpO2 accuracy of the subject device is ±2%, which is better than the predicate's ±3%. This suggests the acceptance criterion for SpO2 accuracy would have been ≤ ±3% (or a target of ±2% as achieved). The Pulse Rate Accuracy is also better than the predicate's ±3 bpm.

Study Details

2. Sample size used for the test set and the data provenance

• Sample Size: The document states "The volunteer population in the studies composed of local healthy men and women from age 18 to 55, with variations of skin pigmentations." It also specifies that "darkly pigmented subjects are included in the desaturation study is three." However, the exact total number of human subjects (the sample size) is not explicitly stated in the provided text, beyond mentioning the composition of the volunteer population.
• Data Provenance: The study was conducted with "local healthy men and women," implying it was conducted domestically where the manufacturer is located (Shenzhen, P.R. China), or where the clinical study site was. The study involved human subjects undergoing desaturation, which is a prospective clinical study methodology.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: This information is not provided in the text.
• Qualifications of Experts: This information is not provided in the text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The document references the "Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment." This guideline details methods for determining accuracy against a reference, but it does not specify an adjudication method in the context of expert review for a test set. The ground truth method described (CO-oximeter) is a direct physiological measurement, not an interpretative expert adjudication.

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. This device is an SpO2 sensor, which provides direct physiological measurements (SpO2 and pulse rate). It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance study was done. The clinical data section describes the device's accuracy being validated against arterial blood samples measured with a CO-oximeter. This directly assesses the algorithm's (or the device's) performance in determining SpO2 and pulse rate without human interpretation as part of the measurement process. The device's specified SpO2 Accuracy of +/- 2% and Pulse Rate Accuracy of +/- 2 bpm are results of this standalone testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth Type: For the clinical study, the ground truth for SpO2 accuracy was established using arterial blood sample reference measured with a CO-oximeter.

8. The sample size for the training set

• Not applicable. This device is a sensor that directly measures physiological parameters. The provided documentation does not describe a machine learning algorithm that requires a separate "training set" in the context of AI. The "clinical data" section pertains to the validation of the device's accuracy.

9. How the ground truth for the training set was established

• Not applicable for the reasons stated in point 8.

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The indications for use of the Hypervisor IX Monitoring System include:

• · Real time viewing of patient clinical data and alarms
• · Storage and Historical review of patient clinical data and alarms
• · Printing of real time and historical patient data
• · Configuration of local settings as well as synchronizing settings across the network to a remote device
• · Transfer of patient clinical data and settings between several CentralStations

The Hypervisor IX Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in a hospital or clinical environment to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WiFi (WLAN), and Wireless WMTS. The Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors.

The Hypervisor IX Monitoring System includes several Telemetry monitoring subsystems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

· The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS-6016.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data. The Centralstation will support ECG, Heart Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the Panorama Telepack-608.

· The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The physiological data can be reviewed locally on the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

The Hypervisor IX Monitoring System is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.

The Hypervisor IX Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in a hospital or clinical environment to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WiFi (WLAN), and Wireless WMTS.

The Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors.

The Hypervisor IX Monitoring System includes three telemetry monitoring systems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

The Hypervisor IX Monitoring System consists the following components:

• 1. Central Station
• 2. View Station
• 3. Work Station
• 4. Telemetry Systems (TMS 6016, Telepak-608, TMS60)

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hypervisor IX Monitoring System, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., target accuracy, sensitivity, specificity). Instead, it describes general claims of meeting specifications and equivalence to a predicate device. The performance data section focuses on types of testing performed rather than specific quantitative results against pre-defined criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not provide information regarding:

• The specific sample size (number of patients, records, or tests) used for performance testing (test set).
• The country of origin of the data.
• Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on:

• The number of experts, if any, used to establish ground truth for the test set.
• The qualifications of such experts.

The testing described (functional, system-level, wireless) appears to be primarily engineering verification against specifications rather than clinical validation requiring expert ground truth on patient data. The statement regarding QT monitoring references a predicate device (Philips ST/AR ST and Arrhythmia Software K101521) for establishing the safety/effectiveness of that function, implying reliance on that previous clearance rather than new clinical ground truthing on this specific device.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set. Given the nature of the described testing, formal adjudication by experts is unlikely to have been part of these specific tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not indicate that an MRMC comparative effectiveness study was done. This type of study is more relevant for diagnostic AI devices where human reader performance is a key metric. The Hypervisor IX Monitoring System is described as a networked patient monitoring system that displays, stores, prints, and transfers data; it explicitly states "No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors." This implies the system's role is data management and display, not AI-driven interpretation or diagnosis that would typically warrant an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document does not describe the device as incorporating an AI algorithm that would typically require standalone performance evaluation. The statement "No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors" suggests its function is passive.

7. The Type of Ground Truth Used

Based on the description of testing (functional, system-level, wireless compliance, and comparison to predicate specifications), the "ground truth" for the tests performed would likely be:

• Engineering Specifications: For functional and system-level tests.
• Regulatory Standards: For compliance with consensus standards.
• Predicate Device Performance/Clearance: For demonstrating equivalence and justification for new features like QT monitoring.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set. This is consistent with the description of the device as not performing data processing or incorporating AI that would require machine learning training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied, there is no information on how ground truth for a training set would have been established.

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The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (ECG, SpO2, IBP)
• Pulse Oximetry (SpO2 )
• ST Segment Analysis derived from 3 or 5 lead measurements
• Arrhythmia Detection derived from 3 or 5 lead measurements
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) up to two (2) channels .
• Carbon Dioxide (CO2)
• Respiration Rate derived from ECG or CO2
• Temperature
• IV Drug Calculations

The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

The Passport V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Passport V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Passport V may be powered by a rechargeable Lithium ion battery or through line-power. The Passport V may be equipped with optional infrared or predictive temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.

The provided 510(k) summary for the Passport V Monitor does not contain specific acceptance criteria or a dedicated study section with detailed performance metrics. It generally states:

"The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements."

This indicates that various performance tests were conducted to demonstrate compliance with relevant standards, but the summary does not explicitly list the acceptance criteria or the reported device performance in a table format.

Therefore, many of the requested details cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated as not available based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with "recognized safety, performance and electromagnetic compatibility standards" and "appropriate test requirements" for software verification and validation, but specific numerical or qualitative criteria for each parameter (e.g., accuracy for heart rate, SpO2) are not provided.
• Reported Device Performance: Not explicitly stated in the document. The document confirms that the device was tested and found to be in compliance, but it does not present the results of those tests (e.g., measured accuracy, bias, or precision of physiological parameters).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified.
• Data Provenance: Not specified.

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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified.

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:

• This device is a patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or expected for this type of device and is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The Passport V monitor is a standalone device with algorithms for various physiological measurements (ECG, SpO2, NIBP, etc.). The statement "The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" implies that its standalone performance was evaluated against these standards. However, specific details of these standalone performance tests (e.g., how accuracy of Heart Rate was measured without human intervention) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For a patient monitor, ground truth would typically involve reference measurement devices (e.g., a calibrated ECG simulator for heart rate accuracy, a reference oximeter for SpO2, a calibrated pressure transducer for blood pressure). The document does not specify the exact methods or reference standards used to establish ground truth for its performance tests.

8. The sample size for the training set:

• This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense (i.e., for an AI model learning from data). It is a traditional patient monitor. Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established:

• As a traditional patient monitor, the concept of a "training set" and its associated ground truth establishment is not applicable.

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The PM-60 handheld Pulse Oximeter is intended for continuous monitoring, spotchecking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.

The PM-60 Pulse Oximeter is a handheld device that measures parameters of functional pulse oxygen saturation (SpO2) and pulse rate (PR). It suits for adult, pediatric and neonatal patients. The SpO2 measurement of PM-60 is based on the absorption of pulse blood oxygen to red and infrared light by means of sensor and SpO2 measuring unit. The light-electronic transducer in sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The pleth curve and numeral value of SpO2 will be obtained. PM-60 can be used in spot-check mode and continuous monitoring mode, which is selectable. It can be powered by alkaline batteries or Li-ion battery, and the latter is rechargeable with a charger stand. Through a color TFT display, users can view the data and operate the device. The audible and visual alarms are also adjustable. During SpO2 measuring, operators can export the data in real-time through the infrared port, and export trend data through the multi-functional connector. After exporting, operators can review and printing the data with the PC data management system (PMS) software.

The provided text does not contain information about specific acceptance criteria related to numerical performance metrics (e.g., accuracy, sensitivity, specificity) for the PM-60 Pulse Oximeter, nor does it detail a study that evaluated such criteria.

The 510(k) summary states for "Testing":
"Laboratory testing was conducted to validate and verify that the PM-60 Pulse Oximeter met all design specifications, including EMC, electrical, mechanical durability, safety, temperature/humidity, and etc. Results of these tests demonstrate compliance to the requirements of all applied standards."

This indicates that testing was performed against design specifications and applied standards, but it does not provide the specific quantitative acceptance criteria or the reported device performance against those criteria as would typically be presented for clinical performance or AI algorithm validation.

Therefore, I cannot populate the requested information in the table or answer questions 2 through 9 based on the provided text. The document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety/effectiveness, rather than detailed clinical performance metrics from a specific study.

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The PM-7000 Patient Monitor is intended to be used for monitoring, recording, and alarming of multiple physiological parameters in health care facilities by qualified health care professionals trained in the use of the equipment.

The physiological parameters that can be monitored by the PM-7000 Patient Monitor are: ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO₂), Temperature (TEMP), Invasive Blood Pressure(IBP), Pulse Rate(PR), Carbon Dioxide (CO2), and Anaesthetic Gases(AG).

Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The target populations are human patients ranging from adult to neonate with the exception of the arrhythmia detection and ST Segment analysis, for which the target populations are adult and pediatric only.

The Monitor is not intended for use in a patient's home or residence, or when it has not been ordered by a physician.

The PM-7000 Patient Monitor is battery or line-powered patient monitor. The patient monitor acquire the physiological signals such as ECG respiration (RESP), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2), temperature (TEMP), invasive pressure (IBP), carbon dioxide (CO2) and anaesthetic gases (AG). These physiological signals are converted into digital data and processed. The monitor examines the data for alarm conditions and presents them on the color TFT display. The monitor also provides advantageous operating control for the user. The optional built-in recorder, the optional CF memory card provides hard copies of all digital data and waveforms as well as tabular and graphic trend information, and storage the previous monitoring data information when power off accidentally.

The provided document is a 510(k) summary for the PM-7000 Patient Monitor. It asserts the substantial equivalence of the PM-7000 to a predicate device, the PM-9000 Express Patient Monitor (K070791), rather than presenting a de novo study with specific acceptance criteria and performance data for the PM-7000 itself.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria. Instead, it relies on the predicate device's prior clearance and claims that the PM-7000, sharing the same parameters modules, measurement accessories, software/hardware, and main board, should perform equivalently.

However, I can extract the information that is present regarding the basis for equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria or quantitative performance data for the PM-7000 Patient Monitor. It relies on the equivalence to its predicate device, the PM-9000 Express. The implicitly accepted performance is that the PM-7000 performs "as well as" the PM-9000 Express.

2. Sample Size for the Test Set and Data Provenance:

The document does not describe a specific test set or sample size used for a standalone study of the PM-7000's performance. The basis for equivalence is that the PM-7000 shares "identical parameters subsystems," "main board and host software," and "identical screen layout" with the predicate, PM-9000 Express. The "verification and validation" conducted were "caused by differences between PM-7000 and PM-9000 Express" and used "testing methods that have been cleared in PM-9000 Express (K070791)."

Therefore, information on data provenance (e.g., country of origin, retrospective/prospective) for a PM-7000 specific test set is not available in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document, as no specific test set or ground truth establishment for a de novo performance study of the PM-7000 is described.

4. Adjudication Method:

This information is not provided in the document, as no specific test set or ground truth establishment for a de novo performance study of the PM-7000 is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study is not mentioned in the document. The submission focuses on device equivalence, not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study for the PM-7000 is not explicitly described with specific results. The document states, "Parameter measurement performance and function specification of PM-7000 could be proved by the verification and validation of PM-9000 Express (K070791) because both are ensured by same modules and same software." This implies that the standalone performance is assumed to be equivalent to the predicate device due to shared internal components and software.

7. Type of Ground Truth Used:

The type of ground truth used to establish the performance of the PM-7000 is not specified within this document, as it defers to the "verification and validation" of the predicate PM-9000 Express. For vital sign monitoring devices, ground truth would typically come from reference standards and calibrated instruments.

8. Sample Size for the Training Set:

The document does not discuss a training set for the PM-7000. This is expected as the PM-7000 appears to be a direct physical and software equivalent to the predicate, PM-9000 Express, with minor changes in power supply, keyboard, and display screen. The functionality, including any algorithms (e.g., for arrhythmia detection), would have been developed and "trained" (if applicable) for the predicate device.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided in the document, as no training set for the PM-7000 is discussed.

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