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The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.

The McPulse Photo-Plethysmograph is intended to be used to measure pulse waveform and heart rate in the finger by lighting a fingertip with combination of infrared LED and photodiode. The measurement probe is an optoelectronic sensor consisted of a light-emitting diode(infrared LED) and a photodiode placed on opposite side as a light receiver. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on LCD screen. Pulse rate is measured using the time between successive pulses and displayed digital values on LCD screen. The McPulse system consists of an optoelectronic sensor that is applied to the patient and a microprocessor-based system that processes and displays the measurement. The optoelectronic sensor contains a light-emitting diode(infrared LED) and one photodiode as a light receiver. The light from the LED is transmitted through the tissue at the sensor site. The photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed.

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device based on functional and safety aspects.

Here's a breakdown of the information that can be extracted or inferred, and points where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria or detailed performance results in the way one might expect for a clinical study comparing an AI system to a baseline. Instead, it offers a comparison of features to a predicate device.

Missing Information:

• Specific numerical acceptance thresholds for pulse waveform accuracy, heart rate accuracy, signal-to-noise ratio, or other relevant performance metrics.
• Quantitative results from "bench and user testing" that would show the McPulse's measured performance against these thresholds.

2. Sample size used for the test set and the data provenance:
The document mentions "bench and user testing." However, it does not specify:

• The sample size of participants or data points used in these tests.
• The provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document refers to "user testing" but does not provide any details about:

• The number of experts involved.
• Their qualifications.
• How ground truth was established, if applicable, in the context of this device (which measures physiological signals rather than interpreting images or complex diagnostic data).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Provided. The nature of this device (photoelectric plethysmograph measuring pulse/heart rate) typically doesn't involve adjudication methods like those used for image interpretation in AI studies.

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 not an AI-assisted diagnostic tool for human readers. It's a physiological monitoring device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone measurement instrument. The "bench and user testing" would have evaluated its performance in this standalone capacity. However, no specific details or results of these tests are provided beyond a general statement of equivalency.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a device measuring pulse waveform and heart rate, ground truth would typically be established by:

• Bench testing: Using calibrated signal generators or phantoms to simulate physiological signals with known characteristics.
• User testing: Comparing the device's measurements to a gold standard reference device (e.g., an ECG for heart rate, or a highly accurate plethysmograph) on human subjects.
  The document does not specify which methods were used for "bench and user testing" to establish ground truth for this device.

8. The sample size for the training set:
Not applicable. This device is a hardware-based physiological monitor, not a machine learning algorithm that requires a "training set" in the common sense of AI development.

9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" described for an AI model.

Summary of the Study:

The document describes a 510(k) submission for the "McPulse Photoelectric Plethysmograph" seeking substantial equivalence to the Novametrix Pulse Oximeter, Model 500 (K853124). The "study" proving the device meets its (largely inferred) acceptance criteria is described as "bench and user testing."

The conclusion is a qualitative statement: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." It further states that the McPulse is "as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

While the document confirms that testing was performed, it lacks the specific quantitative details regarding sample sizes, expert qualifications, ground truth methodology, and performance metrics that would typically be expected for a detailed description of acceptance criteria and a proving study in the context of more complex diagnostic devices or AI systems.

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