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The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.

The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a noninvasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing Datex-Ohmeda disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults.

The Datex-Ohmeda TuffSat 3000 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. The device was validated through rigorous testing, both in-house and at a Nationally Recognized Testing Lab, in accordance with applicable portions of several standards including IEC 601-1, IEC 601-1-1, IEC 601-1-2, CAN/CSA C22.2 #601, UL 2601-1, ISO 9919, EN 865, ASTM 1415, EN 1441 and IEC 601-1-4. The software for the device was developed following a robust software development process and was specified and validated by Datex-Ohmeda.

Based on the provided document, the following information regarding the acceptance criteria and study cannot be fully extracted:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document indicates that the device was deemed "substantially equivalent" to predicate devices (Ohmeda 3770 / 3775 Handheld Pulse Oximeters) based on design concepts, technologies, and materials, and compliance with mentioned standards. However, specific performance metrics against defined acceptance criteria (e.g., accuracy, precision, bias) are not detailed in this summary. The summary highlights adherence to safety and performance standards rather than providing a direct comparison of a specific performance metric against a quantitative acceptance criterion.

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