(172 days)
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI
The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam Capsule Endoscope System or the NaviCam Xpress Stomach Capsule Endoscope System.
The provided text does not describe an AI-powered device or a study proving its performance against specific acceptance criteria. Instead, it is a 510(k) summary for a NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether. This system is a medical device for visualizing the stomach and esophagus, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the information requested in the prompt, as it pertains to AI-specific performance criteria and studies, which are not present in the provided document.
Here's an analysis of why the requested information cannot be extracted from the given text:
- No mention of AI/ML: The document does not describe the device as having any artificial intelligence or machine learning components. It's a hardware device (capsule endoscope and tether) for aiding visualization.
- No acceptance criteria for AI performance: Since there's no AI, there are no acceptance criteria related to its performance (e.g., sensitivity, specificity, AUC).
- No study proving AI performance: Consequently, there's no study described that would prove the device meets AI-specific acceptance criteria. The performance data section focuses on non-clinical (biocompatibility, bench testing) and clinical experience (references to scientific literature demonstrating safety and value, and a meta-analysis on battery life), not AI performance.
- No data provenance for AI testing: Without AI, there's no test set, training set, or related data provenance for AI models.
- No experts for AI ground truth: The concept of experts establishing ground truth for AI model performance isn't applicable here.
- No MRMC study: The document does not describe a multi-reader multi-case study, which is typically done to assess the impact of AI assistance on human readers.
- No standalone algorithm performance: As it's not an algorithm, there's no standalone performance to report.
- No ground truth type for AI: The "ground truth" discussed in the context of AI (e.g., pathology, expert consensus for disease detection) is not relevant for this device's submission.
In summary, the provided FDA 510(k) summary is for a physical medical device (capsule endoscopy system) and does not involve AI. Therefore, the questions related to AI-specific performance criteria and studies cannot be answered from this text.
§ 876.1310 Magnetically maneuvered capsule endoscopy system.
(a)
Identification. A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing with the device under anticipated conditions of use must evaluate visualization of the intended region and document the adverse event profile.
(2) Non-clinical testing data must demonstrate the optical, mechanical, and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested, and detailed protocols must be provided for each test:
(i) A bite test must be performed to ensure that the capsule can withstand extreme cases of biting;
(ii) A pH resistance test must be performed to evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;
(iii) A battery life test must be performed to demonstrate that the capsule's operating time is not constrained by the battery capacity;
(iv) A shelf life test must be performed to demonstrate that the device performs as intended at the proposed shelf life date;
(v) Optical testing must be performed to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, geometric distortion, signal to noise ratio, dynamic range, and image intensity uniformity;
(vi) A color performance test must be performed to compare the color differences between the input scene and output image;
(vii) A photobiological safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided;
(viii) Performance testing must demonstrate that the viewing software clearly presents the current frame rate, which is either adjustable manually by the user or automatically by the device. Testing must demonstrate that the viewing software alerts the user when the video quality is reduced from nominal due to imaging data communication or computation problems;
(ix) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the receiver. This test must include controlled signal attenuation for simulating a non-ideal environment; and
(x) Magnetic field strength testing characterization must be performed to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects.
(3) Software validation, verification, and hazard analysis must be provided.
(4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Performance data must validate the reprocessing instructions for the reusable components of the device.
(7) Performance data must demonstrate the sterility of any device components labeled sterile.
(8) Human factors testing must demonstrate that the intended users can safely and correctly use the device, based solely on reading the instructions for use.
(9) Clinician labeling must include:
(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device;
(ii) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;
(iii) The patient preparation procedure;
(iv) A detailed summary of the device technical parameters;
(v) Magnetic field safe zones;
(vi) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet;
(vii) Reprocessing instructions for reusable components;
(viii) Shelf life for single use components; and
(ix) Use life for reusable components.
(10) Patient labeling must include:
(i) An explanation of the device and the mechanism of operation;
(ii) The patient preparation procedure;
(iii) A brief summary of the clinical study; and
(iv) A summary of the device- and procedure-related complications pertinent to use of the device.