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The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.

The VS-800 Vital Signs Monitor is used to monitor physiologic parameters including SpO2, PR and NIBP, and to measure Temperature parameter on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.

PM-50 Pulse Oximeter:

The PM-50 is a flexible, portable, battery powered Pulse Oximeter. The PM-50 Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LCD screen.

PM-50 uses a two-wavelength pulsatile system - red and infrared light - to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO2 and pulse rate are obtained and indicated on the LCD screen.

VS-800 Vital Signs Monitor:

The VS-800 Vital Signs Monitor is a prescription device intended for use by health care professionals. And the device is capable of operation from an external AC mains powers source or an internal battery including rechargeable lead-acid battery and lithium battery. The device uses the same or similar technology and materials as the predicate devices, see Legally Marketed Predicate Devices listed above.

The VS-800 Vital Signs Monitor is a configurable monitor with options selected by customer preference. Device's options including module configuration and language setting are configured at the time the monitor is manufactured. Options may be upgrade via upgrade port by the manufacturer. The monitor also provides customer with the convenient operating control and human-machine interface (HMI). All of the patient cable connections are located on the monitor. The LCD and LED display patient information and the menu provides single control operations of all main functions. Operator can adjust parameter alarm settings that give audible and visual indication when a violation occurs. The VS-800 provides option for printing information by a thermal recorder.

This monitor has the following parameters measurement functions:

• V SpO2 measurement: pulse oxygen saturation (SpO2), pulse rate (PR), and SpO2 plethysmogram.
• イ NIBP measurement: systolic pressure (S), diastolic pressure (D), mean pressure (M), and pulse rate (PR).
• V Rectal / oral / axillary TEMP measurement: temperature (TEMP).

The provided 510(k) summary for the PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor states that "Clinical study was conducted based on the modification to verify and validate that the PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor met all design specifications and were substantially equivalent to predicate devices." It also explicitly mentions that a "Clinical Study according to ISO9919" was performed.

However, the 510(k) summary does not provide the specific acceptance criteria, detailed results of the clinical study, sample sizes for the test set or training set, data provenance, number or qualifications of experts, adjudication methods, or information about MRMC or standalone studies. The document only broadly states that the devices are "as safe, as effective, and performs as well as the predicate devices."

Therefore, based solely on the provided text, I can only provide the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document, beyond "Clinical Study according to ISO9919." This ISO standard generally covers "Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse oximeter equipment." Such studies typically involve human subjects under controlled conditions, often in a clinical setting.

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

• Not specified in the provided document.

4. Adjudication Method for the Test Set

• Not specified in the provided document.

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

• Not mentioned or detailed in the provided document. The study described is a clinical study for verification and validation, not a comparative effectiveness study involving human readers with/without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• The device is a physical pulse oximeter and vital signs monitor; the concept of an "algorithm only standalone study" as typically applied to AI/ML software is not directly applicable in the same way. The performance reported would inherently be of the integrated device (hardware and embedded algorithms).

7. Type of Ground Truth Used

• For an SpO2 device, the ground truth in clinical studies is typically established through co-oximetry (arterial blood gas analysis). While not explicitly stated, "Clinical Study according to ISO9919" implies this standard clinical practice for oximetry validation.

8. Sample Size for the Training Set

• Not applicable as the device is a medical device, not an AI/ML model that undergoes a "training" phase with a separate "training set" of data. The device's algorithms are developed and then validated through testing.

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

• Not applicable (see point 8).

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The VS-800 Vital Signs Monitor is used to monitor physiologic parameters including SpO2, PR and NIBP, and to measure Temperature parameter on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.

The VS-800 Vital Signs Monitor is a prescription device intended for use by health care professionals. And the device is capable of operation from an external AC mains powers source or an internal battery including rechargeable lead-acid battery and lithium battery. The device uses the same or similar technology and materials as the predicate devices, see Legally Marketed Predicate Devices listed above.

The VS-800 Vital Signs Monitor is a configurable monitor with options selected by customer preference. Device's options including module configuration and language setting are configured at the time the monitor is manufactured. Options may be upgrade via upgrade port by the manufacturer. The monitor also provides customer with the convenient operating control and human-machine interface (HMI). All of the patient cable connections are located on the monitor. The LCD and LED display patient information and the menu provides single control operations of all main functions. Operator can adjust parameter alarm settings that give audible and visual indication when a violation occurs. The VS-800 provides oplion for printing information by a thermal recorder.

This monitor has the following parameters measurement functions:

• V SpO2 measurement: pulse oxygen saturation (SpO2), pulse rate (PR), and SpO2 plethysmogram.

• NIBP measurement: systolic pressure (S), diastolic pressure (D), mean pressure (M), and pulse rate (PR).

• Rectal / oral / axillary TEMP measurement: temperature (TEMP). V

Here's an analysis of the provided text regarding the acceptance criteria and study details for the KOG3055 VS-800 Vital Signs Monitor:

Based on the provided 510(k) summary, Mindray is asserting substantial equivalence for the VS-800 Vital Signs Monitor. The key aspect of this submission is the addition of a Temperature (TEMP) parameter module to a previously cleared VS-800 monitor (K# 060281). Performance for SpO2, PR, and NIBP parameters are stated to remain unchanged from the previous clearance.

Therefore, the acceptance criteria and study specifically address the new TEMP parameter.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for the TEMP parameter. Instead, it relies on a comparative performance verification testing strategy against a predicate device.

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

• Sample Size for Test Set: The document does not specify the sample size used for the comparative performance verification testing of the TEMP parameter.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It generally refers to "clinical and laboratory testing."

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

This information is not provided in the summary. The study appears to be a technical performance comparison against a predicate device, rather than one requiring extensive expert-established ground truth in the manner of diagnostic image analysis, for example.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a vital signs monitor, adjudication by multiple independent experts is typically not a primary method for establishing ground truth for objective physiological measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of medical device (vital signs monitor). This device is measuring objective physiological parameters; it is not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For the SpO2, PR, and NIBP functions, it states that the specifications remain unchanged from a previously cleared device, implying the standalone performance was established in the prior submission.

For the new TEMP parameter, the testing described is "comparative Performance verification Testing" against a predicate device. This implies a standalone performance test of the device's temperature measurement accuracy and functionality, compared to a known, legally marketed equivalent.

7. The Type of Ground Truth Used

The ground truth for the TEMP parameter was effectively established by the performance of the predicate device (DINAMAP PRO200 MONITOR). The goal was to show that the new TEMP module's measurements were comparable to those of a device already deemed safe and effective. For SpO2, PR, and NIBP, a similar "ground truth" was established by the previously cleared VS-800 Vital Signs Monitor (K# 060281).

8. The Sample Size for the Training Set

This information is not applicable/not provided. Vital signs monitors typically do not use "training sets" in the machine learning sense. The device's algorithms are based on established physiological principles and signal processing, rather than being "trained" on large datasets.

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

This information is not applicable/not provided for the same reasons as point 8.

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The VS-800 Vital Signs Monitor is used to monitor physiological parameters, including Sp02, PR and NIBP on adults, pediatric and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The device is not intended for transport or home use.

The VS-800 Vital Signs Monitor is battery or line-powered monitor used on human patient. The Vital Signs Monitor acquires the physiological signals non-invasive blood pressure (NIBP) and pulse oxygen saturation of the blood (SpO2). These physiological signals are converted into digital data and processed. The VS-800 Vital Signs Monitor examines the data for alarm conditions and presents them on the front panel. The Vital Signs Monitor also provides user with the convenient operating control and human-machine interface (HMI),

The optional built-in recorder 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.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to a predicate device and adherence to various safety and performance standards rather than reporting specific quantitative performance metrics against pre-defined acceptance criteria.

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

• Test Set Sample Size: Not specified. The document mentions "laboratory testing" and "third-party agencies" for safety testing, but the number of patients or samples used for these tests is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing described is "laboratory testing" and appears to be internal validation and verification, potentially involving some human subjects for performance against standards like SP10, but details are lacking. The country of origin for the testing itself is not explicitly stated, but the submitter is from Shenzhen, P. R. China.

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

• Not applicable/Not specified. The document describes engineering and standards compliance testing, not a clinical study where expert ground truth would typically be established for diagnostic accuracy. The testing for NIBP (ANSI/AAMI SP10) would involve comparison against a reference method, but this is a technical standard, not a subjective expert assessment. The "misdiagnosis" risk area implies the accuracy of "diagnostic data" is critical, but how its ground truth was established for testing purposes is not detailed beyond "inadequate design of the signal processing and measurement circuitry or program can lead generation of inaccurate diagnostic data."

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As mentioned above, the testing described is not a clinical study involving subjective interpretation from experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study was not performed. This device is a vital signs monitor, not an image interpretation or diagnostic aid that would typically involve multiple human readers. The study focuses on the device's technical performance and safety.

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

• Yes, implicitly. The entire testing described ("Laboratory testing," "hazard analysis," "system validation," "safety testing by third party agencies," testing "according to the requirements outlined in the ANSI/AAMI Standards SP10") focuses on the performance of the device itself (the "algorithm only" in the context of a simple monitor) rather than its impact on human reader performance. The device provides "digital data" and "processed" signals, implying standalone functionality.

7. The Type of Ground Truth Used:

• Reference Standards/Predicate Device Comparison:
  • For NIBP, the ground truth is established by the requirements and reference measurements outlined in ANSI/AAMI Standards SP10.
  • For SpO2 and PR, the implied ground truth is the performance "similar to the predicate PM-8000 Patient Monitor" and compliance with EN865 and other general standards.
  • For safety, the ground truth is defined by IEC 60601-1 series, ISO 14971, and other applicable safety standards.

8. The Sample Size for the Training Set:

• Not applicable/Not specified. This device is a vital signs monitor, not a machine learning or AI-driven diagnostic system that typically involves a distinct "training set" in the modern sense. Its development would involve traditional embedded systems engineering and calibration, not machine learning model training.

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

• Not applicable. As a traditional vital signs monitor, there isn't a "training set" in the context of supervised learning. The device's internal algorithms and calibrations would be developed based on engineering principles, physiological models, and empirical testing against reference instruments and standards.

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