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The Handheld Pulse Oximeter is intended for measuring the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.

This SP-20 Handheld Pulse Oximeter is an integrated product with a modular design. It simultaneously measures physiological parameters by integrated modules and corresponding accessories. The measurement results are displayed, stored and transferred by the central processing unit. The SP-20 Handheld Pulse links with the compatible 510(k) cleared IR Ear thermometer Device (option). Since the SP-20 receives data from the 510(k) cleared IR Ear thermometer and no data is transmitted to the thermometer, it does not affect the operations or accuracy of the linked IR Ear thermometer Device.

Here's an analysis of the acceptance criteria and study information for the Shenzhen Creative Industry Co., Ltd. Handheld Pulse Oximeter, SP-20 based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices and adherence to various safety and performance standards rather than explicitly stating numerical acceptance criteria for SpO2 and Pulse Rate accuracy with corresponding numerical performance results. However, it does state compliance with the general requirements of the standards.

Based on the information, the primary performance standard for the pulse oximeter function is:

Important Note for SpO2 and Pulse Rate: While ISO 80601-2-61 covers the particular requirements for pulse oximeter equipment, the document does not explicitly state the specific accuracy (e.g., Arms value) or bias results for SpO2 or Pulse Rate as acceptance criteria or reported performance results. It only states general compliance with the standard. Typically, pulse oximeter standards define specific accuracy requirements (e.g., Arms ≤ 3% for SpO2 between 70-100%). It's implied that the device meets these within the standard, but the specific numbers are not provided in this summary.

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

• Sample Size: Twelve (12) subjects.
• Data Provenance: The subjects consisted of volunteers (3 women and 9 men) with no known illnesses and no anemia. They represented a mixture of ethnic backgrounds with skin colors ranging from light to dark, and ages from 22 to 38. A total of 24 samples were obtained per subject.
• Study Type: This appears to be a prospective clinical testing for performance validation. The location of the test is not explicitly stated as a country, but it says "Data was recorded by Bickler-Ye Lab and provided for analysis," which might hint at a US-based lab given Dr. Jeffrey Bickler's affiliation with UCSF.

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

The document does not mention the use of experts to establish ground truth for the clinical testing in the traditional sense of consensus reading for diagnostic imaging. Instead, for pulse oximetry, the "ground truth" for oxygen saturation is typically established through direct arterial blood gas analysis, a recognized clinical standard. However, this document does not explicitly state how ground truth for SpO2 was established in the clinical test. It states "Testing validated the submitted device was effective in determining SPO2."

4. Adjudication Method for the Test Set

Not applicable in the context of this pulse oximeter performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers are interpreting images or data and their disagreements need to be resolved. For pulse oximetry, the comparison is usually against a physiological standard (e.g., co-oximetry).

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

No. An MRMC study was not done. The study described is a clinical validation of the device's accuracy in measuring SpO2 and pulse rate, not a comparative effectiveness study involving human readers with and without AI assistance.

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

Yes, the described "Clinical testing" focuses on the device's performance in measuring SpO2. This is a standalone performance test of the device (algorithm/sensor system) without human interpretation in the loop. The device directly provides numerical readings (SpO2, Pulse Rate).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the method for establishing ground truth for SpO2 in the clinical trial. For pulse oximeters, the accepted gold standard for SpO2 is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from an arterial blood sample. While the document mentions "Testing validated the submitted device was effective in determining SPO2," it doesn't detail the comparison method.

8. The Sample Size for the Training Set

No information about a training set is provided. This device is a pulse oximeter, not an AI/ML-driven diagnostic algorithm that typically requires a separate training set. Its principle of operation is based on optoelectronics and signal processing, which doesn't usually involve a "training phase" in the same way an AI model does.

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

Not applicable, as a training set for an AI/ML algorithm is not relevant to this type of device based on the provided information.

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The All-in-One Health Monitor PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP);

Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement.

This device is applicable for Adult and Pediatic (age>3 years old) use in clinical institutions and has no conditions or factors of contraindication.

The All-in-One Health Monitor, PC-303 is mobile modular designed patient monitor. It monitors the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

Additionally, the device is also capable to link and communicate with the compatible Blood Glucose Meter and ECG monitor to make the measurement.

This device system measure the patient's physical parameters with variety modules. It takes digital signals from NIBP, SpO2, Temperature module through COM ports, and receives ECG data, blood glucose data from compatible legally marketed ECG Monitor or BLOOD GLUCOSE MONITORING Device. The software to process the data, then display parameters on the screen and storage some useful information.

This device is applicable for use in clinical institutions and has no conditions or factors of contraindication.

The provided document describes the All-in-One Health Monitor, PC-303, and its substantial equivalence to a predicate device (UP-7000 Patient Monitor, K123711). The acceptance criteria are primarily based on meeting relevant international standards for medical electrical equipment and specific performance characteristics in comparison to the predicate device.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are not explicitly stated as distinct numerical targets in a single table within the document but are inferred from the comparison with the predicate device and the adherence to recognized international standards. The "reported device performance" is the claim of compliance with these standards and the equivalent performance to the predicate.

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

The document states that "Clinical testing was performed for the NIBP functions and are submitted as part of this submission." However, it does not specify the sample size used for this clinical testing or the data provenance (e.g., country of origin, retrospective/prospective).

For biocompatibility testing, the "In Vitro Cytotoxicity Test" used L929 mouse fibroblast cells, and the "Tests for irritation and skin sensitization" used guinea pigs. These are standard biological test methods, not human clinical sample sizes.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the performance or clinical studies.

4. Adjudication method for the test set

The document does not describe any adjudication method used for the test set.

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 with built-in and external measurement capabilities for physiological parameters (SpO2, NIBP, TEMP, Blood Glucose, ECG). It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable and was not reported.

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

The device is a medical instrument that provides physiological measurements. Its performance is inherent in its measurement capabilities and adherence to performance standards. The "standalone" performance is essentially its ability to accurately measure the parameters as specified, which is verified through testing against standards and comparison to a predicate device. The document mentions "Performance testing was performed to ensure that all of the device operated within specified parameters independently and with all other functions of the device operating." This indicates standalone performance testing of its direct measurement capabilities.

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

The ground truth for the measurements would typically be established by highly accurate reference instruments or established clinical methods, as dictated by the specific IEC/ISO/ASTM standards (e.g., for NIBP, a reference sphygmomanometer; for SpO2, a co-oximeter with induced hypoxia studies; for temperature, a reference thermometer). The document implies adherence to these standards for validation rather than explicitly stating ground truth derivation methods for each measurement. For NIBP, the reference to "clinical testing" would imply comparison to a clinically accepted gold standard.

8. The sample size for the training set

This device is a physiological monitor, not an AI/machine learning device that typically requires a "training set" in the context of algorithm development. Therefore, the concept of a training set sample size does not apply here.

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

As the device does not employ a machine learning algorithm requiring a "training set," this question is not applicable.

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