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The Smartsigns MP1 and MP1R handheld pulse oximeter is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. It is intended for use by healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities. The specific medical indications for the use of this device is : - This device is a prescription device - . This device is re-useable and is intended for spot or continuous measurement - 트 This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal. - This device is intended to indicate an alarm if the measured saturation or 트 heart rate are outside user-set alarm limits.

The Smartsigns Minipulse MP1 is a hand held, battery powered pulse oximeter used for monitoring pulse rate and saturated oxygen in arterial blood. It is also available as a rechargeable unit (MP1R). The MP1R is supplied with four rechargeable batteries, a Deskstand charger unit and power supply. The MP1R is recharged by docking it on the Deskstand charger unit. The Smartsigns MP1 and MP1R provide audible alarms, a membrane keypad and LED displays to display digital values of heart rate and saturation. Pulse amplitude is displayed by means of a bargraph LED array. The keypad allows the unit to be switched ON and OFF, it also allows the user to set alarm limits for saturation and heart rate.

Here's a breakdown of the acceptance criteria and the study information for the Huntleigh Healthcare Ltd Smartsigns Minipulse MP1-MP1R, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state quantitative acceptance criteria for SpO2 and pulse rate accuracy (e.g., "within +/- 2% for SpO2"). It broadly states "within specification" and "verified".

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for the desaturation trial. "In-house testing" is mentioned, likely referring to further tests, but no sample size is given.
• Data Provenance: The desaturation trial was "conducted by the oximeter OEM." No specific country of origin is mentioned, but the manufacturer is based in the United Kingdom. It is implied to be a prospective study, as it was conducted for the purpose of testing this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. The desaturation trial is mentioned, which typically involves comparing the device's readings to laboratory co-oximeter reference values, but no details about human experts or their qualifications for establishing ground truth are given.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The study focused on the device's technical performance and equivalence to a predicate device, not on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance assessment was done. The entire study described assesses the performance of the Smartsigns Minipulse MP1 and MP1R device itself (which includes its internal algorithms and hardware) without direct human intervention in the measurement process for the SpO2 and pulse rate. The device is a diagnostic tool, and its accuracy is evaluated on its own.

7. The Type of Ground Truth Used

• For SpO2 accuracy, the ground truth for the desaturation trial would typically be laboratory co-oximetry measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated, this is the standard method for such trials.
• For pulse rate accuracy, the ground truth would likely be an ECG reference or a precise heart rate monitor.
• The document also mentions "comparison to the legally marketed predicate device BCI 3303," implying the predicate device's readings served as a comparative reference.

8. The Sample Size for the Training Set

• This information is not applicable as the document describes a hardware medical device with embedded algorithms, not a machine learning model that requires a discrete training set. The "oximeter OEM" would have developed and validated the underlying oximetry technology, but details of their internal development or validation datasets are not provided.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated in point 8.

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