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SPM is indicated for monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations.

SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatic populations only (not intended for use on neonatal populations).

SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, or via the Saad Patient Monitoring network (SPMS).

SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments.

MR Environment Compatibility Statement:

The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).

Not Found

This FDA clearance letter for the Saad Patient Monitor (SPM) does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The letter is a 510(k) clearance, which designates that the device is substantially equivalent to a predicate device.

Here's why the requested information is absent from this document and what is typically found in such a clearance:

• Acceptance Criteria and Device Performance Table: This type of detail would be in the 510(k) submission document, specifically within the performance testing sections. The clearance letter itself only summarizes the FDA's decision based on that submission.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All of these details are part of the device's validation and verification studies, which are contained within the full 510(k) submission. The FDA clearance letter only affirms that the submitted information was sufficient for clearance.

What the provided document does tell us:

• Trade/Device Name: Saad Patient Monitor (SPM)
• Regulation Number/Name: 21 CFR 870.1025, Patient Monitor
• Regulatory Class: Class II
• Product Code: MHX
• Indications for Use:
  • Monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric, and neonatal populations.
  • Monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatric populations only (not for neonatal).
  • Produces visual and audible alarms for out-of-preset-limit physiological parameters, leading to timed or alarm recordings.
  • Connects to an R50 Bedside recorder or via the Saad Patient Monitoring network (SPMS).
  • Limitations: DOES NOT perform ST Segment analysis, not intended for transport or ambulatory environments, and not compatible for use in an MR Environment (MR Unsafe).
• Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)
• 510(k) Number: K133222

To obtain the detailed information you are requesting, you would need to access the full 510(k) submission for K133222, which is typically available through an FDA Freedom of Information Act (FOIA) request, though portions may be redacted for proprietary reasons.

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