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The Surveyor S2 is indicated for use:

· The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.

· The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.

· The Surveyor S2 is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

· The Surveyor S2 is indicated for use to acquire and output electrocardiographic data.

· The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.

The Surveyor S2 is a patient-worn, battery-powered telemetry transmitter. The Surveyor S2 is intended to acquire ECG signals and transmits waveforms and corresponding status to a receiving S2 Communication Library. The S2 Communication Library, to be integrated in an external monitoring node for processing, exposes an API to obtain ECG signals and push session status, parameters and demographic information to the S2.

The ECG acquired signals are transmitted through the S2 communication Library to the Monitoring Node for further processing, presentation, storage, etc via the hospital/clinic wireless and wired network infrastructure. The Surveyor S2 is designed to be used within the existing network IT infrastructure.

The Surveyor S2 has a 2.8'' color display with a capacitive touch sensitive screen, allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and on-demand visual indication of the status of its connection to the monitoring node. The Surveyor S2 acquires and sends signals to the monitoring node where ECG signal processing and monitoring occurs. The Surveyor S2 displays ECG derived parameters (Heart Rate) and demographic data and monitoring state as received from the monitoring node through the S2 Communication Library.

The Surveyor S2 provides continuous data acquisition which can be visualized on the S2 itself for the ECG waveforms.

The Surveyor S2 utilizes ECG lead cables available in AHA or IEC, snap or clip, 4-wire Lead. ECG data delivered is 3-leads, lossless compressed, 2.5 µV LSB at 500 samples per second.

ECG data is augmented with electrode fail markers, lead identifications, hardware detected pacemaker spikes.

The provided text describes the Mortara Instrument Surveyor S2, a device for monitoring ECG signals, and compares it to its predicate device, the Surveyor S4. However, it does not include specific acceptance criteria or a study with detailed performance metrics. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone performance study against pre-defined acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, clinical studies, and ground truth cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided. The document does not define specific quantitative acceptance criteria or provide a table of performance metrics. The comparison table focuses on technological characteristics and equivalence to the predicate, not on numerical performance against targets.

2. Sample size used for the test set and data provenance:

• Cannot be provided. The document states, "No clinical studies were utilized for the purpose of obtaining data," which implies no human test set was used for performance validation.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Cannot be provided. As no clinical studies were performed, there was no need for experts to establish ground truth from a test set.

4. Adjudication method for the test set:

• Cannot be provided. As no clinical studies were performed, there was no ground truth adjudication.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states, "No clinical studies were utilized for the purpose of obtaining data."

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

• Yes, a standalone non-clinical performance assessment was done. The document states: "Performance testing for the Surveyor S2 includes software verification and validation test, software unit test, integration test, system test and testing to compliance standards for electrical and electromagnetic safety. Wireless coexistence testing and evaluation was performed following FDA Guidance, 'Radio Frequency Wireless Technology in Medical Device', and the device's immunity to proximity fields from radio frequency wireless communications equipment was validated."
  • Effect size of improvement: Not applicable, as this was not an MRMC study comparing human performance with and without AI.

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

• For non-clinical tests: The "ground truth" for the non-clinical tests (software, electrical, electromagnetic) would be defined by the specifications and expected behavior outlined in the various compliance standards (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, IEC 62304, IEC 62366). The device's performance was compared against these established engineering and safety standards. There is no mention of clinical ground truth (e.g., expert consensus on ECGs, pathology, or outcomes).

8. The sample size for the training set:

• Not applicable / Cannot be determined. The document doesn't describe the development of an AI or algorithm that would require a "training set" in the traditional machine learning sense. The device is a physiological signal transceiver.

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

• Not applicable / Cannot be determined. As there's no mention of a training set for an AI/algorithm, this question is not applicable.

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