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The Proteus® Patch, also called the Patch, is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral heart rate, activity, and body position is desirable.

Like the Proteus Personal Monitor (K113070), the Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics including heart rate, activity, body angle, and time-stamped user-logged events generated by swallowing the Proteus Ingestible Sensor. The Ingestible Sensor is embedded inside an inactive tablet (the Pill) for ease of handling and swallowing. Once the Ingestible Sensor reaches the stomach, it activates and communicates its presence and unique identifier to the Patch. The Patch stores and wirelessly sends the physiologic, event, accelerometry, and Ingestible Sensor data to a general computing device for display.

Here's a breakdown of the acceptance criteria and study information for the Proteus Patch including Ingestible Sensor, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides functional descriptions and validation methods for different parameters, but does not present explicit, quantitative acceptance criteria in a table format. However, based on the Summary of Non-Clinical Performance Data, we can infer the tested characteristics and the type of validation performed.

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

The summary states:

• "No additional clinical data were required to confirm substantial equivalence to predicate devices."
• The "Summary of Non-Clinical Performance Data" describes laboratory testing.

Therefore, there appears to be no distinct clinical test set used for this 510(k) submission as no additional clinical data was required. The "testing" mentioned refers to non-clinical, laboratory-based validation.

• Sample Size for Test Set: Not applicable for clinical data. For non-clinical validation, specific sample sizes for the accelerometer and Ingestible Sensor tests are not provided in this summary.
• Data Provenance: Not applicable for clinical data. The non-clinical testing would have been performed by the manufacturer, Proteus Digital Health, Inc.

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

Not applicable, as no additional clinical test set was used, and ground truth in this context would likely refer to clinical expert consensus. For the non-clinical tests:

• For the accelerometer, ground truth was "known acceleration."
• For the heart rate, the ANSI/AAMI EC 13 standard provides the reference for accurate ECG measurement.
• For the ingestible sensor, activation time and lifetime would be objectively measured, not requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring human adjudication was utilized for this submission based on the provided information.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or submitted as part of this 510(k). The document explicitly states "No additional clinical data were required." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

This device does not involve an "algorithm only" or "AI" in the sense of image interpretation or diagnostic assistance. It's a data logger and sensor. The "non-clinical performance data" describes the validation of the device's sensing capabilities (accelerometer, heart rate measurement algorithm, ingestible sensor activation). These are standalone functional tests of the device components.

• Heart Rate Algorithm Standalone Performance: The biopotential low-frequency amplifier and its accompanying algorithm (modified Hamilton-Tompkins) were "tested using guidelines set forth in the ANSI/AAMI EC 13 standard." This indicates a standalone validation of the algorithm's performance against a known standard.

7. The Type of Ground Truth Used

• Accelerometer: "Known acceleration applied against each of its three axes." (Physics-based objective measurement)
• Heart Rate: Adherence to "ANSI/AAMI EC 13 standard" which provides criteria for accurate ECG measurement, implying a reference standard for ground truth.
• Ingestible Event Marker: Objective measurement of "activation time and lifetime after activation."

8. The Sample Size for the Training Set

The document does not mention any "training set." This type of device (data logger, physiological sensor, ingestible event marker) typically undergoes engineering verification and validation, not machine learning model training.

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

Not applicable, as there is no mention of a training set for machine learning.

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