(268 days)
The Otsuka Digital Feedback Device-RW consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and timestamped patient-logged events, including events signaled by the co-incidence with, or co-ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device-RW is intended to log, track and trend intake times. When co-ingested with medication, the tracking of intake times may be used as an aid to measure medication adherence. The Otsuka Digital Feedback Device-RW may instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.
The Otsuka Digital Feedback Device-RW consists of three components: a wearable sensor, an ingestible sensor accessory, and software that aggregates, processes and enables display of data collected by the sensors. The wearable sensor is a body-worn sensor (also called the patch) that collects physiological and behavioral metrics such as heart rate, activity, body angle, and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. The wearable sensor in the Otsuka Digital Feedback Device-RW is a 2-component patch known as the RW2 wearable sensor or RW2 patch. The ingestible sensor is embedded inside an inactive tablet (the pill or sensor-enabled pill) for ease of handling and swallowing. After the ingestible sensor reaches the stomach, it activates and communicates its presence with a unique identifier (ID) to the wearable sensor. When the ingestible sensor is co-ingested with medication, the Otsuka Digital Feedback Device-RW is intended to log, track and trend medicine intake times to measure medication adherence. The software on a general computing device (eg, mobile device) receives the data from the body-worn sensor or patch for further processing and analysis of the behavioral and physiological metrics. The processed data is then sent to the user interface (UI) for display as well as being saved in a local record database for storage.
The provided text describes the Otsuka Digital Feedback Device-RW, which is an ingestible event marker with a wearable patch. The primary function highlighted is logging and trending medication intake times to aid in measuring medication adherence, as well as tracking physiological and behavioral metrics.
However, the document is an FDA 510(k) clearance letter and its associated summary. While it mentions "acceptance criteria" for "firmware verification, mechanical verification, electrical verification, biocompatibility evaluation, and system verification testing," it does not provide specific numerical acceptance criteria for the device's performance in its intended use (i.e., accurately tracking ingestion or medication adherence). It also clarifies that no new clinical studies were performed to support the changes in this submission, indicating that the performance data for the core functionality would likely be derived from previous predicate device studies or non-clinical testing.
Therefore, many of the requested details about a study proving the device meets acceptance criteria related to its clinical performance (e.g., accuracy of ingestion detection, improved human reader performance with AI) cannot be extracted directly from this document. The document focuses on showing substantial equivalence to a predicate device, based on similar technology, non-clinical testing, and existing clinical data from the predicate for some aspects.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions acceptance criteria were met for:
- Firmware verification
- Mechanical verification
- Electrical verification
- Biocompatibility evaluation
- System verification testing
No specific numerical acceptance criteria or performance metrics related to the core function of "logging, tracking, and trending intake times" or "measuring medication adherence" are provided in this document. The document states "The results demonstrate that the acceptance criteria for firmware verification, mechanical verification, electrical verification, biocompatibility evaluation, and system verification testing were met," but it does not quantify these.
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 explicitly states: "However, new clinical studies were not performed to support the changes proposed in this submission." It implies that any performance data for the core functions relies on the predicate devices. Therefore, details about sample size, provenance, and retrospective/prospective nature of a new clinical test set are not available in this document.
The document mentions: "Clinical studies were conducted to support the expanded wear location of the patch to include the entire front abdomen." This suggests some clinical data was generated for this specific change, but details on sample size, design, or performance metrics for that specific study are not provided.
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)
Not applicable, as no new clinical study on the primary function is detailed, and the document does not describe efforts to establish ground truth with experts for the device's performance (e.g., in medication adherence).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study on the primary function is detailed.
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
Not applicable. This device is an ingestible event marker and wearable sensor, not an AI-assisted diagnostic imaging device that would typically involve human "readers" interpreting images. Its purpose is data collection (ingestion times, physiological metrics), not interpretation by human experts.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is essentially a "standalone" data collection system. It's intended to continuously log data without constant human intervention.
- Performance: The document indicates non-clinical verification and validation testing was done (firmware, mechanical, electrical, system testing), and those "acceptance criteria were met." However, no quantifiable performance metrics for the device's accuracy in detecting ingestion events are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the method for establishing ground truth for ingestion events or medication adherence from any past studies. Given the nature of the device (detecting ingestion), ground truth likely involves direct observation or very high-fidelity data from a controlled setting.
8. The sample size for the training set
Not applicable to this document. The document describes a medical device cleared via 510(k), not an AI/ML model for which a "training set" in the computational sense would be explicitly outlined. While the device contains firmware and software, the development process and data used for its internal algorithms are not detailed here as a separate "training set."
9. How the ground truth for the training set was established
Not applicable, as explained in point 8.
§ 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.