(171 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 Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
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.
The RAPID 2.0 software, the subject of this submission, contains an optional feature called Suspected Blood Indicator (SBI), which automatically marks images that correlate with the existence of suspected blood or red areas. The analysis is based on detection of colorimetric abnormalities, or deviations from an expected spectrum, corresponding to normal tissue.
Here’s a breakdown of the requested information based on the provided text for the Given® Diagnostic System (Suspected Blood Indicator (SBI)):
Acceptance Criteria and Device Performance Study
The provided text focuses on the 510(k) summary and clearance letter for the Given® Diagnostic System with the Suspected Blood Indicator (SBI) feature. It states that "The verification activities demonstrated that the proposed modification does not raise any new safety and/or effectiveness issue." However, it does not explicitly detail specific quantitative acceptance criteria for the SBI feature or present a specific study that quantifies its performance against such criteria. The SBI feature is described as "intended to mark frames of the video suspected of containing blood or red areas."
Given this, the table below reflects what can be inferred or directly stated from the provided document regarding acceptance criteria and performance:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance (Inferred/Stated) |
|---|---|---|
| Intended Functionality | The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. | The device was cleared by the FDA, implying that the verification activities demonstrated its functionality for its intended use and that it does not raise any new safety and/or effectiveness issues. No specific quantitative performance metrics (e.g., sensitivity, specificity for blood detection) are provided in this document. |
| Safety and Effectiveness | The modification (SBI feature) does not raise any new safety and/or effectiveness issues compared to the predicate devices. | "The verification activities demonstrated that the proposed modification does not raise any new safety and/or effectiveness issue." |
| Substantial Equivalence | Substantial equivalence to predicate devices (K010312, K020341, K022362) for the Given® Diagnostic System with the new SBI feature. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
Study Information (Based on 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):
- The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature) for the verification activities related to the SBI feature.
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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):
- The document does not provide details on the number or qualifications of experts used to establish ground truth for any test set or verification activity related to the SBI feature.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method used for a test set.
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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:
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size for human reader improvement with/without AI assistance is provided. The SBI is presented as an "adjunctive tool" or an "optional feature" that "automatically marks images," suggesting it aids interpretation, but no formal comparative study with human readers is detailed here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that standalone performance was assessed for the SBI feature to demonstrate that "the proposed modification does not raise any new safety and/or effectiveness issue." The SBI is described as an automated function: "The analysis is based on detection of colorimetric abnormalities...". However, no specific performance metrics (e.g., sensitivity, specificity, accuracy) from a standalone evaluation are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of ground truth used for evaluating the SBI feature. Given its function ("suspected blood or red areas"), it's likely based on visual identification by experts or possibly correlated with other diagnostic findings, but this is not specified.
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The sample size for the training set:
- The document does not provide any information about the sample size used for a training set for the SBI algorithm.
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How the ground truth for the training set was established:
- The document does not provide any information about how ground truth was established for a training set.
In summary, while the document confirms FDA clearance based on "verification activities" demonstrating no new safety/effectiveness issues and substantial equivalence, it lacks specific quantitative details about the performance of the SBI feature, the methodology of any studies conducted, or the characteristics of the data/experts involved in those studies. The information provided is typical for a 510(k) summary confirming substantial equivalence without extensive performance data for a new software feature on an already cleared device.
§ 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.”