(123 days)
The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of: Non-invasive blood pressure, Impedance respiration, Invasive blood pressure, Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia & ST-segment, 12-Lead resting ECG, Cardiac output. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
The Mortara Instrument, Inc. Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Models within the Mortara Surveyor family come in two different sized viewing areas (11.6" and 18.5") and offer selected monitoring features.
The provided text describes the Mortara Surveyor Patient Monitor (S12 and S19) and aspects of its performance testing for its 510(k) submission. However, it does not include detailed acceptance criteria or the specific study data that would allow for a table of acceptance criteria versus reported device performance. It mainly states that the device "complies with its predetermined specification" and is "substantially equivalent to the predicate device" based on various tests.
Based on the provided document, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This specific table cannot be constructed from the provided text. The document repeatedly states that test results indicated the device "complies with its predetermined specification" for various categories (Software, Electrical Safety, EMC, Bench Performance). It does not, however, spell out what those predetermined specifications (acceptance criteria) were, nor does it provide quantitative performance data to report against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes for test sets. It mentions "Software Testing," "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Performance Testing - Bench" but does not detail the number of cases or samples used in these tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned, as no clinical study data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. No clinical study was performed, and therefore, no experts were needed to establish ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided. As no clinical test set requiring expert ground truth was performed, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor." This implies the device doesn't involve human interpretation that would be enhanced by AI, making an MRMC study irrelevant in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is an "algorithm only" in the sense that it's a physiological monitor, the document does not describe a standalone algorithm performance study in the way this question typically implies (e.g., for AI/ML devices). Instead, it refers to "Software Testing" and "Performance Testing - Bench" which validated the device's adherence to its predetermined specifications. No specific performance metrics or studies analogous to those for AI algorithms are detailed.
7. The Type of Ground Truth Used
For the specific testing mentioned (Software, Electrical Safety, EMC, Bench Performance), the ground truth would inherently be based on the device's predetermined specifications and engineering standards. For example, for electrical safety, the "ground truth" is compliance with applicable electrical safety standards. For software, the "ground truth" is that the software performs according to its design requirements. This is not "expert consensus," "pathology," or "outcomes data" as typically thought of in diagnostic imaging or clinical decision support.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this device's submission description. The described device is a physiological monitor, not an AI/ML-driven device that typically undergoes a "training" phase with data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
Summary of what is present:
- Device Description: The Mortara Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitor for ECG, Respiration, NIBP, Temperature, SpO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG, and cardiac output.
- Intended Use: For knowledgeable healthcare professionals in a healthcare facility for continuous monitoring in stationary or portable applications, indicated for adult & pediatric patient populations.
- Performance Testing Categories (general statements of compliance):
- Software Testing
- Electrical Safety
- Electromagnetic Compatibility Testing (EMC)
- Performance Testing - Bench (functional, environmental, vibration/shock)
- Missing from the document:
- Specific quantitative acceptance criteria.
- Specific quantitative reported device performance data.
- Sample sizes for any tests.
- Data provenance.
- Details on ground truth establishment if clinical data were used (which they weren't for performance).
- MRMC or standalone algorithm studies (as the device is not presented as an AI/ML diagnostic system).
This document mainly focuses on engineering and regulatory compliance as opposed to detailed clinical performance metrics typically found in submissions for AI/ML diagnostic aids.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.