(183 days)
The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components:
- Capsule (AKES-11SW, AKES-11SI): The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body.
- Data recorder (AKR-1, AKRI-1): The Data Recorder is an external receiving and recording unit that receives and stores the acquired images from the capsule.
- ESView Software: The ESView is a software application for processing, analyzing, storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas.
- Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it.
The NaviCam Small Bowel Capsule Endoscopy System was assessed for its performance primarily through a comparative clinical study against a predicate device, the PillCam SB3 Capsule Endoscopy System, and also through various bench/in-vitro tests.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Bench/In-Vitro Tests | Successfully passed all listed tests. | |
| Biting Test | Ability to withstand applied forces similar to accidental biting. | Pass |
| Angular Resolution Test | Measurement of MTF using ISO 12233 slanted edge methodology and new angular resolution method using LEDs. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Temperature Safety Test | Temperature change during operation within safe limits. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| pH Test | Integrity of the capsule during exposure to simulated extreme pH levels. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Image Intensity Uniformity | Uniformity of image intensity. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Image Frame Rate Test | Higher frame rate provides good transmission property. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Geometric Distortion Test | Determination of geometric distortion and local magnification. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Field of View (FOV) Test | Determination of FOV value. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Battery Life Test | Battery life of at least 8 hours and capturing over 57,500 images. | Pass (demonstrated to last at least 8 hours and capture over 57,500 images). |
| Image Resolution Test | Testing of image resolution. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| Magnetic Field Test | Measurement of magnetic flux density on capsule surface and non-optical bottom, and determination of safety distance. (Specific thresholds for "pass" are not provided in the document but implied successful meeting of design specifications.) | Pass |
| DOV Test | Measurement of MTF in air and underwater at different distances within claimed DOV range using ISO 12233 slanted edge methodology and angular resolution method. (Specific thresholds for "pass" are not provided but implied successful meeting of design specifications.) | Pass |
| Color and Gray Scale Test | Evaluation of optical performance. (Specific thresholds for "pass" are not provided but implied successful meeting of design specifications.) | Pass |
| Data Integrity Test | Data transmission between capsule, data recorder, and ESView software. (Specific thresholds for "pass" are not provided but implied successful meeting of design specifications.) | Pass |
| Clinical Study | ||
| Diagnostic Overall Percent Agreement with predicate device | Not explicitly stated as a strict threshold, but achieving substantial equivalence to the predicate device (PillCam SB3) in diagnostic performance. The document implies that the observed agreement rate demonstrates similarity. | 89.66% (81.50%, 94.46%) overall percent agreement with the PillCam SB3. Overall percent agreement Kappa of 0.6652 (0.4653, 0.8652). This was deemed to demonstrate similar performance and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the clinical study was a prospective study (NCT05086471).
However, the specific sample size (number of patients or cases) used for the test set is not provided in the given text.
The data provenance (e.g., country of origin) for the clinical study is also not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text. The text only states that the NaviCam system was compared to the PillCam SB3 in terms of diagnostic performance, but it doesn't detail how discrepancies or consensus was handled for establishing ground truth or comparing diagnostic findings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance
A comparative clinical study was performed, but it was to compare the device's performance (NaviCam Small Bowel Capsule Endoscopy System) to a predicate device (PillCam SB3 Capsule Endoscopy System), not specifically an MRMC study assessing human reader improvement with or without AI assistance. The study evaluates the diagnostic agreement between the two capsule endoscopy systems. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable/not reported in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The NaviCam Small Bowel Capsule Endoscopy System includes "ESView Software...for processing, analyzing, storing, and viewing the acquired images... The software also includes a reporting function". While the software performs analysis, the clinical study appears to evaluate its overall diagnostic performance in detecting abnormalities, which would typically involve human review of the generated images/reports. The text does not explicitly state if a standalone algorithm-only performance study was conducted separate from human interpretation. The reported "diagnostic Overall Percent Agreement" is for the system, which implies the combined interpretation of the images.
7. The Type of Ground Truth Used
The ground truth for the clinical study is based on the detection of abnormalities of the small bowel by both the NaviCam system and the predicate PillCam SB3 system. The phrase "diagnostic Overall Percent Agreement" implies that the agreement was measured against the findings of another diagnostic tool (the predicate device), which often serves as a form of "ground truth" in equivalence studies when a gold standard (like pathology) is not universally available for every finding. The document does not explicitly state that pathology or outcomes data were used as the definitive ground truth for every finding. It strongly suggests the predicate device's findings were used as the reference point for comparison.
8. The Sample Size for the Training Set
This information is not provided in the given text. The document focuses on the performance study data, not the training dataset for any underlying AI/software components.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given text, as details about a training set are absent.
§ 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.”