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The Ortivus AB Mobimed™ is a cardiac monitoring system consisting of a portable and stationary unit which communicate with each other using the Mobitex radio-based cellular telecommunications network. The cardiac data includes ECG, SpO2, NIBP, GCS, and patient information. The system is intended for use by trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.

The Mobimed™ System consists of one or several stationary units called Polaris (typically hospital located) receiving patient cardiac information from mobile units called Pegasus. A mobile unit can be permanently mounted in an ambulance or operate as a portable unit. The Mobimed™ equipment can telemonitor (using radiobased cellular telecommunications network) a patient where he or she is at the moment. This makes it possible to monitor the patient and acquire data during transportation to the hospital. The system can acquire and transmit the following information: VCG or 12-Lead ECG (automatically and manually acquired reports). One channel ECG or VCG reports. Monitoring ECG (not transmitted). Trends (automatically and manually acquired). Patient records/forms. Alarms (presented on the Pegasus and not transmitted to Polaris). Messages.

This submission (K973318) for the Mobimed™ System is a 510(k) summary and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device's performance against predefined criteria. Instead, it relies on a comparison to a predicate device and general performance testing to argue for substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of acceptance criteria and the reported device performance

The submission does not explicitly define acceptance criteria in a quantitative table format. Instead, it describes general categories of testing performed and states that these were "successfully completed."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information regarding the sample sizes used for performance testing, data provenance, or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Given the nature of the device (cardiac monitoring system used for data acquisition and transmission), ground truth for performance testing would likely involve standardized test signals, calibrated equipment, and potentially human review of acquired waveforms. However, the specifics are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed based on this document. The device is a "cardiac monitoring system" that acquires and transmits physiological data, including ECG and SpO2. It is not an AI-based diagnostic tool that would typically involve human readers interpreting output to improve diagnostic accuracy. The interpretive ECG feature is present in the predicate device, but explicitly not present in the Mobimed™ System.

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

This concept doesn't directly apply as the Mobimed™ System is a hardware-based monitoring and transmission system, not an algorithm performing interpretation. The performance testing described (electrical safety, ECG performance, SpO2 performance, etc.) assesses the standalone function of the device in acquiring and handling physiological signals.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for each test. However, based on the types of tests mentioned:

• Electrical Safety, Environmental, EMC, Power Source: Ground truth would be defined by the standards themselves (e.g., specific thresholds for leakage current, acceptable levels of shock resistance, battery life specifications).
• ECG Performance: Ground truth would likely be established using standardized ECG simulators or calibrated signal generators whose output is known and compared against the device's acquired waveforms. The phrase "appropriate sections of IEC 601-2.27" suggests reliance on established technical standards for ECG measurement accuracy.
• SpO2 Performance: Similarly, "Using ISO 9919" indicates reliance on an international standard for oximeter performance, which would define the ground truth for SpO2 measurements.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the Mobimed™ System is a hardware device for monitoring and transmitting physiological data, not a machine learning or AI-based system that requires training data.

9. How the ground truth for the training set was established

Not applicable (as explained in point 8).

Summary of the Study (Based on Submitted Document):

The Mobimed™ System's "study" consists of a collection of performance tests against various international and industry standards, electrical safety regulations, and environmental specifications. The core argument for its market clearance is its substantial equivalence to existing predicate devices (LifePak® Cardiac Monitor/LifeNet RS100 and Nellcor MP204P for SpO2). The submission highlights that the Mobimed™ System successfully completed these standard-based tests and offers an enhanced communication capability through cellular digital technology. There is no mention of a clinical trial or a study involving human subjects for performance evaluation in a comparative sense. The document focuses on technical compliance and functional equivalence.

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