(119 days)
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs.
The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
The Ultraview DM3 Monitor is a portable patient monitor intended to be used by clinicians and medical qualified personnel for spot check and continuous monitoring of non-invasive blood pressure (NIBP), pulse oximetry (SpO2), and temperature.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ultraview DM3 Monitor, structured to address your specific points.
Acceptance Criteria and Device Performance for Ultraview DM3 Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific numerical acceptance criteria for performance metrics (like accuracy or precision). It lists general categories of testing and concludes that the device "complies with its predetermined specification."
Since explicit numerical acceptance criteria and corresponding reported performance values are not provided in this document, the table below reflects what can be inferred.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from documentation) | Reported Device Performance |
|---|---|---|
| Non-Invasive Blood Pressure (NIBP) | Performance equivalent to predicate device (Spacelabs Healthcare / élance Vital Signs Monitoring System) as per pre-determined specifications. | "The Ultraview DM3 Monitor was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements." |
| Pulse Oximetry (SpO2) | Performance equivalent to predicate device (Spacelabs Healthcare / élance Vital Signs Monitoring System) and conforming to ISO 9919:2005. | "Clinical performance testing was performed according to ISO 9919:2005 to demonstrate safety and effectiveness of the oximetry feature of the Ultraview DM3 Monitor." |
| Temperature | Performance equivalent to predicate device (Cardinal Health / Model 2082 Temp Plus III Thermometer) as per pre-determined specifications. | "The Ultraview DM3 Monitor was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements." |
| Software Functionality | Compliance with Zoe Medical's software development process and predetermined specifications. | "Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification." |
| Electrical Safety | Compliance with applicable electrical safety standards. | "Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification." |
| Electromagnetic Compatibility (EMC) | Compliance with applicable EMC standards. | "Test results indicated that the Ultraview DM3 Monitor complies with its predetermined specification." |
| Bench Performance | Compliance with internal requirements and procedures for performance, functional, environmental, and shipping/transportation testing. | "Test results indicated that the device complies with the predetermined requirements." |
Important Note: The document consistently states "complies with its predetermined specification" or "complies with its predetermined requirements" which indicates acceptance was met for these general categories. However, the exact numerical specifications themselves (e.g., NIBP accuracy range, SpO2 bias and precision) are not disclosed in this summary.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated for NIBP or Temperature. For Pulse Oximetry (SpO2), the document mentions "Clinical performance testing was performed according to ISO 9919:2005." ISO 9919:2005 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment) typically requires a minimum of 10 healthy adult volunteers whose arterial blood hemoglobin oxygen saturation can be reduced and stabilized over a specific range to perform accuracy testing. While the exact number isn't in this document, this is the standard typically applied.
- Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether the study was retrospective or prospective, except for the clinical performance testing for oximetry, which by its nature (involving human subjects in a controlled setting) would be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The provided document details a 510(k) submission for a physiological monitor, not a device requiring expert interpretation of diagnostic images or signals. The "ground truth" for a monitor like this typically comes from reference devices or direct physiological measurements, not expert consensus in the diagnostic sense.
- Qualifications of Experts: Not applicable or not specified, as "experts" for ground truth are not mentioned in the context of interpretation, but rather skilled personnel performing measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret ambiguous cases in diagnostic studies (e.g., radiology for AI algorithms). For a vital signs monitor, the comparison is usually against a reference standard, not a consensus of human interpretations.
5. 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
- MRMC Comparative Effectiveness Study: No, this type of study was not performed and is not relevant for the Ultraview DM3 Monitor. This device is a physiological monitor that measures vital signs, not an AI-assisted diagnostic tool that helps human readers interpret data. The comparison is between the device's measurements and a reference standard, not between human performance with and without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, the described "Performance Testing - Bench" and "Clinical performance testing... to demonstrate safety and effectiveness of the oximetry feature" can be considered standalone performance assessments. These tests evaluate the device's ability to accurately measure physiological parameters independently, without necessarily involving human intervention in the data processing itself, beyond setting up the device and potentially interpreting its output clinically. The document states that the software was "verified and validated" confirming its standalone function.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- For SpO2 (Pulse Oximetry): Likely arterial blood gas analysis (co-oximetry) as a reference standard, which is the gold standard for SpO2 accuracy testing as per ISO 9919:2005.
- For NIBP (Non-Invasive Blood Pressure): Likely a reference NIBP device that has been validated against an invasive arterial manometer or a double-auscultation method using qualified observers, following recognized standards (e.g., ANSI/AAMI/ISO 81060-2).
- For Temperature: Likely reference thermometers that are calibrated to a known standard.
- For Software, Electrical Safety, EMC, Bench Performance: Ground truth is established by the specifications of applicable standards (e.g., ISO, AAMI, IEC standards) and the manufacturer's own predetermined internal requirements.
8. The Sample Size for the Training Set
- Sample Size for the Training Set: Not applicable or not specified. This document pertains to a traditional physiological monitor, not a device developed using machine learning or AI that would typically have distinct "training sets." The device's algorithms for NIBP, SpO2, and temperature processing are based on established physiological principles and signal processing, not a data-driven training process in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for the Training Set Was Established: Not applicable. As explained above, this device does not utilize a training set in the context of machine learning. The "ground truth" for the development of its algorithms would stem from established medical and engineering principles, physiological models, and empirical testing during the design phase, rather than a formally labeled "training set" with ground truth generated by experts.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).