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This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use.

This device includes the capability for monitoring the following patient parameters:

• ECG .
  Heart Rate .

Pulse Oximetry .

Non-Invasive Blood Pressure ●

. Invasive Blood Pressure

End-Tidal Carbon Dioxide / Nitrous Oxide .

Respiration effort .

. Rra

Not Found

This document is a 510(k) clearance letter from the FDA for a patient monitor and does not contain the detailed study information typically requested for AI/ML device evaluations, such as acceptance criteria, performance metrics, sample sizes, or ground truth establishment.

A 510(k) clearance evaluates a new device for substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety like a PMA (Premarket Approval). Therefore, the document focuses on regulatory approval rather than a detailed performance study report.

Based on the provided text, I cannot extract the following information:

• A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI/ML device, so such a study would not apply.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

The document primarily states:

• Device: Omni-Trak™ 3150 Series Patient Monitor
• Intended Use: Patient vital signs monitor during magnetic resonance imaging (MRI) scans. To be used by or on the order of a physician or similarly qualified healthcare professional in hospital environments (MRI, Radiology Clinic, or similar settings). Not intended for home use.
• Monitored Parameters: ECG, Heart Rate, Pulse Oximetry, Non-Invasive Blood Pressure, Invasive Blood Pressure, End-Tidal Carbon Dioxide / Nitrous Oxide, Respiration effort.
• Regulatory Class: II (two)
• Product Code: 74 MHX
• Determination: Substantially equivalent to devices marketed prior to May 28, 1976.

To obtain the kind of study data requested, one would typically need access to the full 510(k) submission, which would include detailed testing protocols and results demonstrating the device meets its own specifications and is substantially equivalent to a predicate device in terms of safety and effectiveness, but not necessarily advanced AI/ML performance metrics as posed in the question.

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