(18 days)
The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel
The Given® Diagnostic System is comprised of three subsystems: M2A™ Capsule, Data Recorder Set, and RAPID® Workstation.
The M2A® Capsule is a wireless, disposable capsule designed to glide smoothly through the digestive system by the peristaltic activity of the intestinal muscles and is excreted naturally. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the DataRecorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician.
Please note that the provided text is a 510(k) summary for the Given® Diagnostic System and primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth methodologies.
Therefore, many of the requested details about specific study design, acceptance criteria, multi-reader studies, and detailed ground truth establishment are not explicitly present in the provided document. I will extract what is available and note when information is missing.
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating compliance with "Special Controls Guidance Document" and "substantial equivalence" to predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicate devices for its intended use.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not explicitly stated in the document. The key acceptance criterion appears to be "substantial equivalence" to predicate devices and compliance with regulatory guidance. | The device was cleared by the FDA, implying it met the regulatory standard of substantial equivalence and safety/effectiveness. This means it is considered to perform acceptably for its intended use as an "adjunctive tool in the detection of abnormalities of the small bowel" for "visualization of the small bowel mucosa." |
Detailed Study Information:
Due to the nature of a 510(k) summary, which often focuses on demonstrating substantial equivalence rather than presenting a detailed de novo clinical trial, much of the requested information about a specific performance study is not available in the provided text.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not explicitly stated in the provided document. The document mentions "verification activities" but does not detail the size or nature of a clinical test set.
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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 explicitly stated in the provided document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated in the provided document.
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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 explicitly stated in the provided document. The device is a diagnostic visualizer, and the summary focuses on its function rather than human-in-the-loop performance improvements. It is not an AI-assisted device in the contemporary sense.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated in the provided document. The device is described as providing images for viewing by a physician, implying a human-in-the-loop system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the provided document. Given the "visualization of the small bowel mucosa" and "detection of abnormalities," it is highly probable that ground truth would involve expert endoscopist review, surgical findings, or pathology, but this is not mentioned.
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The sample size for the training set:
- Not applicable/Not explicitly stated in the provided document. The Given® Diagnostic System (M2A™ Capsule, Data Recorder Set, and RAPID® Workstation) described in this 510(k) appears to be a hardware-software system for image acquisition and viewing, not a machine learning or AI-driven diagnostic algorithm that would typically require a distinct "training set" in the modern sense. Its "training" would be more related to engineering and calibration.
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How the ground truth for the training set was established:
- Not applicable/Not explicitly stated in the provided document. (See above point for training set relevance).
Summary of Device Performance (from the document):
The 510(k) filing for the Given® Diagnostic System (K022362) was reviewed by the FDA and determined to be "substantially equivalent" to its predicate devices (K010312 and K020341). This determination means the FDA found the device to be as safe and effective as a legally marketed device. The document states: "The verification activities demonstrated that the proposed modifications do not raise any new safety and/or effectiveness issue."
The "intended use" and implicit performance are:
- "visualization of the small bowel mucosa"
- "adjunctive tool in the detection of abnormalities of the small bowel"
The study supporting this approval, as described in the 510(k) summary, primarily focused on demonstrating substantial equivalence to existing predicate devices and compliance with relevant special controls guidance, rather than presenting a standalone clinical trial with explicit quantitative performance metrics against defined acceptance criteria. The document does not provide details on specific clinical study designs, patient cohorts, reader evaluations, or ground truth methodologies that would typically be found in a detailed study report.
§ 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.”