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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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The Datex-Ohmeda TruSat Pulse Oximeter and Accessories is indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.

The TruSat is the next generation in the Datex-Ohmeda Pulse Oximeter family of products. The Datex-Ohmeda 3800 Series and 3900 Series Pulse Oximeters and Accessories with TruTrak Plus Enhancements and the Datex-Ohmeda TruSat Pulse Oximeter and Accessories are substantially equivalent in design concepts, technologies and materials. The TruSat was validated through rigorous testing that, in part, support the compliance of the TruSat to the above mentioned standards. Additionally, the software for the TruSat was developed following a robust software development process and was fully specified and validated.

The provided text does not contain detailed information regarding acceptance criteria, a specific study proving device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for the Datex-Ohmeda TruSat Pulse Oximeter.

The document is a 510(k) summary for premarket notification, primarily focusing on establishing substantial equivalence to previously cleared devices and compliance with relevant standards. It mentions "rigorous testing" and "fully specified and validated" software but does not elaborate on the specifics of these tests in a way that would allow for a detailed answer to your request.

Therefore, I cannot provide the requested table or detailed information on the study as the input text does not contain this data.

The summary states:

• "The TruSat was validated through rigorous testing that, in part, support the compliance of the TruSat to the above mentioned standards."
• "Additionally, the software for the TruSat was developed following a robust software development process and was fully specified and validated."

These statements indicate that testing and validation occurred, but they do not provide the detailed output or methods of those tests to answer your specific questions about acceptance criteria or study specifics.

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