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The Fukuda Denshi model HG-500 Pulse Oximeter Module is indicated in those situations where it is desirable to perform continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate for adult, pediatric and neonatal patients who are under the care of a physician, within the confines of a health care facility. It is is not intended for home use

The Fukuda Denshi model HG-500 Pulse Oximeter (SpO2) module is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when used as part of the DS-5300 Patient Monitoring System (K964187). The HG-500 is a module not a stand-alone device. As a module it will only operate when installed into a DS-5300 Patient Monitoring System. The Fukuda Denshi model HG-500 Pulse Oximetry module will function with all Nellcor reusable and disposable oximeter sensors.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:

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

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, it does describe the general performance and safety goals for the device. The reported device performance is largely qualitative, asserting substantial equivalence to predicate devices and compliance with relevant standards.

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: The document mentions a "non-invasive controlled hypoxia study was performed by Nellcor Inc., to validate the HG-500 compliance to sensor accuracy specification when used with all eighteen models of Nellcor oxygen transducers." It does not specify the number of human participants or data points in this study.
• Data Provenance: The study was performed by "Nellcor Inc." No explicit country of origin is mentioned, but Nellcor is a US-based company. The study is described as a "controlled hypoxia study," which implies a prospective, interventional design where oxygen levels are intentionally varied.

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)

This information is not provided in the summary. For a hypoxia study, ground truth for arterial oxygen saturation is typically established using a co-oximeter (a device that directly measures different hemoglobin species from an arterial blood sample). However, the number and qualifications of individuals interpreting these results or validating the setup are not mentioned.

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

This information is not provided in the summary. Given the nature of a pulse oximeter accuracy study, adjudication of readings is less common than for, say, image interpretation. The comparison would likely be directly against a gold standard (e.g., co-oximetry).

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where human interpretation is a key component, often with AI assistance. The HG-500 is a direct measurement device (pulse oximeter) that provides numerical output (SpO2, pulse rate).

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

• Yes, in essence, standalone performance was assessed. The "non-invasive controlled hypoxia study" directly tested the HG-500's accuracy (an algorithm-driven device) against a gold standard in a simulated physiological environment. The module itself operates without direct human interpretive input into its primary SpO2 and pulse rate measurements. The submission focuses on the device's ability to measure accurately, not on how humans interpret those measurements.

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

• The ground truth for the accuracy assessment (hypoxia study) would have been arterial blood gas analysis using a co-oximeter. This is the accepted gold standard for determining actual arterial oxygen saturation. The summary mentions "sensor accuracy specification," which implicitly refers to this type of comparison.

8. The sample size for the training set

• This information is not provided and is generally not applicable in the way it is for AI/machine learning models that learn from vast datasets. The HG-500 utilizes algorithms licensed from Nellcor and identical to those in the Nellcor N-395, which are based on established physiological principles of light absorption by hemoglobin. While these algorithms were developed and refined using empirical data, the "training set" in the context of modern machine learning is not explicitly detailed here. It's more about validated engineering and physiological modeling.

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

• As above, details about an explicit "training set" for the algorithms are not provided. The algorithms are described as licensed from Nellcor and identical to existing, validated devices. The development of such algorithms historically involved extensive physiological studies where arterial blood gas measurements (co-oximetry) served as the gold standard for correlating light absorption patterns with actual oxygen saturation. This would have been done during the original development of pulse oximetry technology and specific manufacturer algorithms, rather than being a specific "training set" for this particular 510(k) submission.

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