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The Accutorr 3/Rosebud Vital Signs monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP) and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by physicians or appropriate medical staff under the direction of physicians.

The subject Vital Signs Monitors includes two monitors: Accutorr 3 Vital Signs Monitor and Rosebud Vital Signs Monitor. The Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by physicians or appropriate medical staff under the direction of physicians.

This FDA 510(k) summary describes the Accutorr 3/Rosebud Vital Signs Monitor, which includes two devices: the Accutorr 3 Vital Signs Monitor and the Rosebud Vital Signs Monitor. The key change in this submission is the introduction of a new Mindray Temperature Module (TrueTemp) with updated temperature measurement capabilities.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the temperature module are based on the requirements of ISO 80601-2-56:2017 and ASTM E1112-00 for temperature accuracy. The performance data is specifically for the "Predictive mode" of the new TrueTemp module.

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

• Sample Size: The clinical accuracy study for the TrueTemp module evaluated:
  • 106 valid cases for oral temperature
  • 110 valid cases for axillary temperature
  • 109 valid cases for rectal temperature
• Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical investigation conducted to meet ISO 80601-2-56 requirements. The age of subjects ranged from 4 days to 67 years old. The study ensured that the total number of febrile subjects was not less than 30% and not greater than 50% of all subjects in the selected age group and body site.

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

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical temperature study. However, the ground truth was established by comparing the device's readings to those of a WelchAllyn SureTemp PLUS 690 in direct mode, which is a legally marketed and presumably accurate reference thermometer. This implies the "experts" were the established accuracy of this reference device.

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690 in direct mode) rather than an interpretation requiring multiple human adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, and the clinical study focused on the accuracy of temperature measurement against a reference standard, not on human interpretation or decision-making aided by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

Yes, the clinical accuracy study for the temperature module can be considered a standalone performance evaluation of the device's temperature measurement capabilities. It directly compared the device's readings to a ground truth established by a reference thermometer, without human interpretation of the device's output as the primary endpoint.

7. The Type of Ground Truth Used

The ground truth for the temperature accuracy study was established by comparison to a legally marketed and accurate reference device, specifically the WelchAllyn SureTemp PLUS 690 in direct mode. This can be categorized as a form of reference standard measurement.

8. The Sample Size for the Training Set

The document does not provide information about a training set size. This is typical for vital signs monitors, where the device's algorithms for parameters like temperature (e.g., predictive mode calculations) are developed and then validated through bench and clinical testing against established standards, rather than requiring large labeled clinical datasets for typical machine learning training.

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

As no training set is described, information on how its ground truth was established is not applicable here. The development of the TrueTemp module's algorithm would have involved engineering and calibration against known temperature standards and thermometry principles.

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