(87 days)
SB Indications for Use: The Given PillCam® Platform with the PillCam® SB Capsules is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The Given PillCam® Platform is comprised of three main subsystems; { } } the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware. 1. Ingestible PillCam Capsule The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the DataRecorder located outside the body. RAPID Software The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms. Given Workstation and Hardware 3 The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The PillCam® SensorBelt receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table format. Instead, it describes a clinical validation study aimed at demonstrating the device's performance in a specific population (overweight individuals) to support the removal of a warning statement. The "performance" described is the device's ability to operate without new risks or issues in this expanded population.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No new risks or issues when using PillCam® SensorBelt in subjects with BMI ≥ 30 kg/m^2. | The clinical validation test conducted with 25 healthy volunteers (BMI ≥ 30 kg/m^2) who underwent the SB procedure using PillCam® SB2 capsule, DR2 DataRecorder, and PillCam® SensorBelt showed no new risks. The performance of the SensorBelt has not been studied in patients with BMI greater than 43.3 kg/m^2. |
| Substantial equivalence to the predicate device for the aforementioned use case. | The clinical validation data demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 25 healthy volunteers.
- Data Provenance: The text does not explicitly state the country of origin but is associated with Given Imaging Ltd. in Israel. The study appears to be prospective as it involves healthy volunteers undergoing the procedure.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth in this particular study. The study focuses on the performance of the SensorBelt in overweight individuals, implying an assessment of technical function and safety rather than diagnostic accuracy against a "ground truth" of disease.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The study's focus was on the performance of the SensorBelt in overweight individuals, assessing for new risks or failures rather than diagnostic discrepancies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study, as typically understood in the context of diagnostic AI, was not performed. The study aimed to validate the device's performance in an expanded population, not to compare human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? The device itself (PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt) is a medical imaging system, not purely an algorithm. The "Suspected Blood Indicator (SBI)" feature is mentioned as an intended function to mark frames, but no specific standalone performance study for this algorithmic component (e.g., sensitivity/specificity of SBI flagging against a ground truth of bleeding) is detailed in this document. The clinical validation was for the overall system in an overweight population.
7. Type of Ground Truth Used
The "ground truth" for this specific clinical validation study was the observation of the device's performance and the absence of new risks or adverse events in the healthy overweight volunteers. It was not a ground truth for a diagnostic condition (e.g., pathology-confirmed lesions or outcomes data).
8. Sample Size for the Training Set
The document does not mention a training set. This study is a clinical validation of the device's operation in a specific population, not a study involving the training of a new AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or ground truth for a training set is mentioned.
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”