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The Recom Model 100 battery-operated Ambulatory, Digital Wireless ECG Monitor System is a true 12 lead ambulatory ECG monitor system capable of recording up to 48 hours of ECG data for the purpose of cardiac monitoring and diagnosis by a medical professional where ambulatory (Holter) monitoring is prescribed by a physician. The system includes recording of ECG data from each of the 12 leads, RF transmission of the recorded data to a PDA and storage.

The stored ECG data is then transferred from the PDA to another device, the Phillips Medical TraceMaster ECG Analysis System for ECG analysis. The Recom Model 100 battery-operated, Ambulatory, Digital, Wireless ECG Monitor System is not intended to sound any physiological alarms.

The Recom Model 100 battery-operated, Ambulatory, Digital Wireless ECG Monitor System is only to be used by or on the order of a physician.

The device is a true 12 lead, battery-operated, ambulatory (Holter), digital, wireless, ECG monitor. The device acquires an ECG signal from 10 patient surface contact electrodes. Each electrode is connected to a cable that is connected to the Recom patient worn monitor/transmitter. The ECG signal is transmitted from the electrodes via the cable to a battery-operated ECG monitor unit worn by the patient where the signal is processed utilizing the company's signal processing technology and transmitted via radio frequency (Bluetooth) to a hand held Personal Digital Assistant (PDA) capable of recording up to 48 hours of ECG data.

The PDA converts the signal stream into a specific data format where it is stored on a compact flash card for transmission to and analysis by another device, the Phillips Medical TraceMaster ECG Analysis System K032103.

Monitoring data is not real time but is recorded and stored for further analysis by the Phillips System. The ECG data produced consists of Leads I, II, III, aVR, aVL, aVF and V1 through V6. The Recom Model 100 Ambulatory, Digital, Wireless monitor is not intended to alarm.

The fundamental technology of the Recom battery-operated, Ambulatory. Digital ECG Monitor System is the same as that of the predicate devices. The Recom Ambulatory, Digital, Wireless ECG Monitor System relies on the company's signal processing technology to minimize noise in the ECG signal created by the ambulatory nature of the signal source.

The provided text describes a 510(k) summary for the Recom Model 100 ECG Monitor System, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the way a novel, high-risk device might.

Here's an analysis of the provided text with respect to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria for a performance study evaluating the device's diagnostic accuracy or a specific clinical endpoint. Instead, the "acceptance criteria" appear to be related to the device's ability to accurately and reliably produce ECG tracings that can be analyzed by a separate, already cleared system (Phillips Medical TraceMaster ECG Analysis System).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set for performance or clinical accuracy. The "performance testing" mentioned is described as demonstrating the accurate and reliable production of ECG tracings, but details about the number of cases or subjects in this testing are not provided. There is no information about the country of origin of data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Since the device is a data acquisition system and not a diagnostic algorithm itself, the testing described appears to focus on data fidelity and transfer rather than direct diagnostic accuracy requiring expert ground truth in a clinical trial setting. The "diagnosis by a medical professional" occurs after the data is analyzed by the Phillips system.

4. Adjudication Method 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

There is no mention of an MRMC study or any AI component in the Recom Model 100. This device is an ambulatory ECG monitor system for data acquisition and transfer, not an AI-powered diagnostic tool. The analysis is done by a separate Phillips Medical TraceMaster ECG Analysis System, which is also not described as AI-based in this document.

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

This is not applicable as the Recom Model 100 is an ECG monitoring device, not a standalone diagnostic algorithm. Its function is to record and transmit data for subsequent analysis by another system (and ultimately, a human physician).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not describe the use of specific clinical "ground truth" (like expert consensus or pathology) for the performance testing mentioned. The testing appears to confirm the technical fidelity of the recorded ECG data and its compatibility with the Phillips analysis system. The "ground truth" for cardiac monitoring and diagnosis is implicitly established by the "medical professional where ambulatory (Holter) monitoring is prescribed by a physician" after the data is analyzed by the Phillips system.

8. The Sample Size for the Training Set

This is not applicable. The Recom Model 100 is a hardware device for data acquisition and transmission, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

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