(183 days)
The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.
The TeslaDUO is intended for use in the Adult and Pediatric populations for continuous monitoring of Pulse Oximetry (SpO2).
The TeslaDUO is intended for use in the Adult, Pediatric and Neonatal populations for continuous monitoring of Non-Invasive Blood Pressure (NIBP).
The TeslaDUO is intended for use by health care professionals.
The MRI Patient Monitor TeslaDUO ("TeslaDUO") is a magnetic resonance compatible patient monitoring device for use in MRI rooms (HF-proof, magnet-resistant) to monitor and display data from vital signs sensors during MRI examinations (MRI procedures) of patients.
It is capable of continuously monitoring and displaying data in graphic and numeric form from the following sensors/measurement modules:
- Pulse Oximetry (SpO2 and Pulse Rate)
- Non-Invasive Blood Pressure (NIBP and PR)
The provided text describes the 510(k) submission for the MRI Patient Monitor TeslaDUO. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML study.
Therefore, many of the requested elements for an AI/ML study (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device clearance and not an AI/ML-driven device.
However, I can extract information related to the device's performance against established standards which serve as "acceptance criteria" for this type of device.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are compliance with various national and international standards for patient monitors, electrical safety, electromagnetic compatibility, and specific vital sign measurements. The reported device performance is simply "Passed" for each of these criteria.
| Test Title | Pass / Fail Criteria | Reported Device Performance |
|---|---|---|
| Electrical safety | Compliance to IEC 60601-1:2012 | Passed |
| Electromagnetic Compatibility | Compliance to EN/IEC 60601-1-2: 2007; Compliance to EN/IEC 60601-1-2: 2014 | Passed |
| Multifunction Patient Monitor | Compliance to IEC 60601-2-49: 2011-02 | Passed |
| Alarms | Compliance to IEC 60601-1-8:2006+A1:2012-11 | Passed |
| Biocompatibility | Compliance to ISO 10993-1 | Passed |
| Risk Management | Compliance to ISO 14971:2007 | Passed |
| Software | Compliance to IEC 62304:2006 | Passed |
| Pulse Oximeter | Compliance to ISO 80601-2-61: 2011 | Passed |
| NIBP (Non-Invasive Blood Pressure) | Compliance to IEC 80601-2-30:2009-01 (ed.1.0) | Passed |
| Batteries | IEC 62133:2012 | Passed |
| Usability | IEC 60601-1-6:2010-01 + A1:2013; IEC 62366:2007 (Ed. 1) + A1: 2014 | Passed |
| MRI Environment Compatibility | Measurement of Magnetostatic Forces, Magnetic Immunity, MRI Immunity, Radio Frequency field induced and Gradient field induced Heating | All tests passed |
2. Sample size used for the test set and the data provenance
Not applicable to this type of device submission. The testing involves compliance with standards, which typically involve specific test configurations and simulated data or controlled measurements, not a "test set" of clinical cases in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these compliance tests is established by documented scientific/engineering principles outlined in the standards, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, which is not the case for these objective performance and safety standard tests.
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
No. This device is a patient monitor, not an AI-driven diagnostic or interpretative tool. Therefore, an MRMC study is not relevant or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device measures vital signs and displays them; it does not contain an AI algorithm that performs a standalone diagnostic function. The "performance" is the accuracy and reliability of its measurements against established benchmarks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For vital sign measurements (SpO2, NIBP), the "ground truth" implicitly refers to the accuracy and precision of the measurements compared to reference standards or established physiological parameters as defined within the relevant IEC/ISO standards (e.g., ISO 80601-2-61 for Pulse Oximeter, IEC 80601-2-30 for NIBP). The other tests involve compliance with safety and compatibility standards, where "ground truth" is adherence to the specified technical requirements and limits.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).