(26 days)
The Proteus® 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 metrics is desirable.
The Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, 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 physiological, behavioral, event, and ingestion data to a general computing device for display.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., minimum sensitivity, specificity, or accuracy percentages). Instead, it focuses on validating the functionality of different components. Therefore, the table below reflects the validation methods and what was "proven" or "tested."
| Parameter / Acceptance Criteria Category | Reported Device Performance (as tested) |
|---|---|
| Accelerometer (Motion & Angle) | Validated against a known acceleration applied against each of its three axes. (Implies accurate measurement of motion and angle relative to gravity.) |
| Biopotential Low-Frequency Amplifier (Heart Rate) | Tested using guidelines set forth in the ANSI/AAMI EC 13 standard to quantify heart rate by measuring R-wave frequency based on a modified Hamilton-Tompkins algorithm. (Implies accurate heart rate measurement.) |
| Ingestion Sensor (Activation & Lifetime) | Tested for activation time and lifetime after activation. (Implies the sensor activates as intended and performs for a sufficient duration.) |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for each validation. It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the data). The validation efforts appear to be laboratory-based rather than real-world patient data in some cases.
- Accelerometer: "validated against a known acceleration applied against each of its three axes." This suggests controlled laboratory testing.
- Heart Rate: "tested using guidelines set forth in the ANSI/AAMI EC 13 standard." This standard typically involves using databases or simulators for testing, but details are not provided.
- Ingestion Sensor: "tested for activation time and lifetime after activation." This would likely be laboratory testing of the ingestible sensor units.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of human experts to establish ground truth for the device's performance. The validation appears to be against established physical standards, known inputs, or existing guidelines (like ANSI/AAMI EC 13).
4. Adjudication Method for the Test Set
No adjudication method is mentioned. Given the nature of the "testing" described (validation against known physical inputs and standards), an adjudication process among human experts would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. The device, the Proteus Patch Including Ingestible Sensor, is a data-logger and sensor, not an interpretive AI system that assists human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The described performance evaluation is a standalone (algorithm only) evaluation. The validation tests were conducted on the device's sensors and algorithms directly (e.g., accelerometer output, R-wave frequency detection, sensor activation). There is no human-in-the-loop component mentioned in these performance assessments.
7. Type of Ground Truth Used
The ground truth used in the validation studies appears to be:
- Known physical inputs/standards: For the accelerometer, "known acceleration applied against each of its three axes."
- Standardized guidelines/algorithms: For heart rate, "guidelines set forth in the ANSI/AAMI EC 13 standard" and a "modified Hamilton-Tompkins algorithm."
- Intrinsic device characteristics/specifications: For the ingestion sensor, "activation time and lifetime after activation" refers to its expected functional behavior.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific performance validations.
8. Sample Size for the Training Set
The document does not specify a "training set" or its sample size. This device is described as a "data-logger" and sensor system. While it contains algorithms (e.g., for R-wave detection), there is no indication that these algorithms were developed using a machine learning approach that would typically involve a distinct training set. The focus is on validation against established engineering and physiological standards.
9. How the Ground Truth for the Training Set was Established
Since no training set and corresponding machine learning approach are explicitly described, the method for establishing ground truth for a training set is not provided.
§ 880.6305 Ingestible event marker.
(a)
Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.