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The Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

The Oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult patients in the home and hospital. The oximeter features a small size, low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. Principle of the oximeter as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones. Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor. The four models (JZK-301, JZK-303, JZK-305, and JZK-307) have the same intended use, working principle, characteristic, and conformance standards, only in appearance have some different (appearance design, dimension, and weight).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Please note that the acceptance criteria for SpO2 and Pulse Rate accuracy are directly stated as the target performance matching the predicate device. The narrative details how this performance was verified. Other criteria are related to compliance with recognized standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 12 subjects (healthy, non-smoking, light-to-dark-skinned adults).
• Data Provenance: The study was a prospective clinical hypoxia accuracy testing conducted during induced hypoxia studies in an independent research laboratory. The country of origin is not explicitly stated, but the manufacturing and submission details point to China.

3. Number of Experts and Qualifications for Ground Truth

• The document implies the use of a CO-oximeter as the control device to establish the ground truth for arterial hemoglobin oxygen (SaO2) values from blood samples. While clinical experts are involved in conducting the study and collecting samples, the direct measurement of SaO2 by a CO-oximeter serves as the objective ground truth, rather than expert interpretation.
• The qualifications of individuals operating the CO-oximeter or collecting blood samples are not specified in this summary but are implicit in conducting a clinical study according to ISO 80601-2-61.

4. Adjudication Method for the Test Set

• The ground truth for SpO2 and Pulse Rate accuracy was established by comparing the device's readings against arterial hemoglobin oxygen (SaO2) values determined from blood samples with a CO-oximeter. This is an objective measurement rather than a subjective expert adjudication process.
• The analysis of the data included Bland and Altman statistics and assessing outliers. This indicates a statistical method for evaluating agreement rather than a consensus-based adjudication from multiple human readers. Therefore, an adjudication method like 2+1 or 3+1 is not applicable here as it's not based on expert interpretation of images or other subjective data.

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

• No, an MRMC comparative effectiveness study was not done.
• This study focused on the accuracy of the device itself against a reference standard (CO-oximeter), not on how human readers perform with or without AI assistance. The device is an oximeter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The entire clinical study described is about the standalone performance of the Oximeter device, without human-in-the-loop assistance for interpretation. The device itself produces the SpO2 and PR readings.

7. Type of Ground Truth Used

• The ground truth for SpO2 and Pulse Rate accuracy was outcomes data / objective measurement: arterial hemoglobin oxygen (SaO2) values determined from blood samples using a CO-oximeter.

8. Sample Size for the Training Set

• Not applicable / Not specified. This device is a pulse oximeter, which operates on established opto-electronic principles (Lambert Beer Law, Photoelectric Oxyhemoglobin Inspection Technology) rather than a machine learning or AI algorithm that typically requires a distinct training set. The clinical study performed is a validation (test set) study.

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

• Not applicable / Not specified. As there is no explicit training set mentioned for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission. The device's operational principles are physics-based, not data-driven in the sense of AI training.

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