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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

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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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