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TS-F-D
The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds)

TS-E-D
The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds)

TS-W-D
The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 6.6 pounds)

TS-SE-3
The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are singlepatient use. Patient weight range All patients

TS-AF-10 and TS-AF-25
The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range All patients

Trusignal SpO2 Interconnect cables
The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.

Pulse oximeter sensors and interconnect cables connecting to patient monitors

Here's a breakdown of the acceptance criteria and the study details for the TruSignal® SpO2 Sensors and Interconnect Cables, based on the provided 510(k) summary:

1. Acceptance Criteria and Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 10 healthy adult volunteers.
• Data Provenance: The study consisted of induced hypoxia studies conducted in an independent research laboratory. It involved human subjects (ages 18-42 yr, 105-227 lbs, with light to dark pigmentation). This suggests the data is prospective and likely collected in a controlled research environment, though a specific country of origin is not mentioned beyond the submitter's address being in Finland.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Number of Experts: Not applicable. The study did not rely on human experts to establish ground truth in the traditional sense for image or clinical assessment.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (Test Set)

• Adjudication Method: Not applicable. Ground truth was established using a reference oximeter system and co-oximeter based arterial hemoglobin saturation values. There was no expert adjudication process described for the test set.

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

• Was an MRMC study done? No. This type of study is not applicable to a device like a pulse oximeter sensor, which directly measures physiological parameters rather than providing data for human interpretation. The study focused on the accuracy of the device's measurements against a reference.

6. Standalone Performance Study

• Was a standalone study done? Yes. The clinical verification test directly measured the arterial hemoglobin saturation values of the proposed devices and compared them to a reference oximeter system. This demonstrates the algorithm's (or device's) performance without human intervention.

7. Type of Ground Truth Used (Test Set)

• Type of Ground Truth: The ground truth was established by comparing the proposed devices' readings to a "reference oximeter system whose readings were converted to Co-oximeter based arterial hemoglobin saturation values using empirical linear regression translation equation." This is a form of reference standard measurement from another medical device, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Sample Size: Not explicitly stated or applicable in the context of this device and study type. The device employs "transmission based optical SpO2 measurement" technology, which is a physical measurement technique rather than a machine learning algorithm that typically requires a training set. The study focuses on verifying the accuracy of the physical measurement system.

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

• How Ground Truth was established: Not explicitly stated or applicable, as there isn't a traditional "training set" for an algorithm in this context. The device's underlying technology relies on established physical principles rather than a trained model.

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