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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 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 sensors labeled for patients ranging from neonates to adults.

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.

Here's the breakdown of the acceptance criteria and study information for the PM-50 Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable clinical acceptance criteria for all aspects. However, some performance metrics and accuracy statements are made in comparison to the predicate.

Note: The submission states that despite the difference in SpO2 accuracy for neonates, "the specification of the PM-50 meets with the EN865 standard," which would serve as the acceptance criteria for that specific parameter.

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

The document mentions "clinical and laboratory testing" but does not specify the sample size for any clinical test set.

Data Provenance: The document does not explicitly state the country of origin for any clinical data, nor does it specify if the data was retrospective or prospective. It only mentions "clinical and laboratory testing."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in any clinical study. Given the nature of a pulse oximeter (measuring physiological signals directly), ground truth would typically be established through highly accurate reference instruments or arterial blood gas analysis, rather than expert consensus on images or interpretations.

4. Adjudication Method

The document does not mention any adjudication method for a test set. This is consistent with a device that provides direct physiological measurements, where "ground truth" is typically an objective measurement from a reference device.

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

No MRMC comparative effectiveness study was done or reported. The device is a diagnostic tool for measuring SpO2 and pulse rate, not a device that involves human interpretation of complex medical images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states:

• "Laboratory testing was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications..."
• "Additional testing was performed to demonstrate compliance with the Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation."
• "The PM-50 Pulse Oximeter has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-1-2, IEC60601-1-4, EN865, EN475, and ISO14971."

This testing confirms the device's performance characteristics (e.g., accuracy, ranges, safety) without human intervention in the interpretative loop.

7. Type of Ground Truth Used

While not explicitly detailed, for a pulse oximeter, the ground truth would typically be established through:

• Reference Instrumentation: Comparison against highly accurate, gold-standard pulse oximeters or CO-oximeters.
• Arterial Blood Gas Analysis (ABG): Directly measuring arterial oxygen saturation (SaO2) from blood samples for comparison with SpO2 readings.

The document refers to "clinical and laboratory testing," which would imply the use of such objective measurements as ground truth.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. Pulse oximeters generally rely on physiological models and signal processing algorithms derived from established principles, not typically machine learning that requires a "training set" in the conventional sense (e.g., for image recognition). If any adaptive algorithms are used, the training data and methods are not described.

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

Since no training set is mentioned in the context of machine learning, there is no information provided on how ground truth for a training set was established. The device's operation is described based on "two-wavelength pulsatile system - red and infrared light - to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin," which is a physics-based approach rather than a data-driven machine learning approach requiring a labeled training set.

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