(123 days)
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.
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It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
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It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
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It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia(IDA) not detected by upper and lower endoscopy.
The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding. angioectasia, red spot, ulcer or erosion.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa.
This system consists of capsule endoscopes which capture images and transmit the data, an antenna unit and a recorder which are secured around the patient and receive data from the capsule, and workstation software which downloads the image data from the recorder and processes images for visualization.
The provided document, a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM, details the device and its performance testing, specifically focusing on the "Red Lesion Detector" function.
Here's a breakdown of the acceptance criteria and study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criteria (Implicitly based on comparison to predicate device) | Reported Device Performance (Red Lesion Detector) |
|---|---|---|
| Red Lesion Detection | Specificity for red lesions (active bleeding, bleeding, angioectasia, red spot, ulcer or erosion) of small intestine should be comparable to or better than the predicate device's Red Color Detection function. | Performance was "equal to or higher than Red Color Detection function of PD" (predicate device). |
| Sensitivity for red lesions (active bleeding, bleeding, angioectasia, red spot, ulcer or erosion) of small intestine should be comparable to or better than the predicate device's Red Color Detection function. | Performance was "equal to or higher than Red Color Detection function of PD" (predicate device). | |
| Active Bleeding Detection | Specificity for active bleedings of small intestine should be comparable to or better than the predicate device's Red Color Detection function. | Performance was "equal to or higher than Red Color Detection function of PD" (predicate device). Additionally, "all active bleedings were detected." |
Study Details Proving Device Meets Acceptance Criteria
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Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample size of the clinical test set (i.e., the number of patients or capsule endoscopy videos used). It only refers to "the clinical performance testing."
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.
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Number of Experts and Qualifications for Ground Truth:
- The document does not provide details on the number of experts used to establish the ground truth for the test set or their specific qualifications. It only mentions "clinical performance testing" and the evaluation of the Red Lesion Detector's performance.
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Adjudication Method:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set's ground truth establishment.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers is mentioned. The study described focuses on the comparison of the algorithm's performance (Red Lesion Detector) against that of the predicate device's algorithm (Red Color Detection function of PD), not on how AI assistance improves human reader performance.
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Standalone (Algorithm Only) Performance:
- Yes, a standalone (algorithm only) performance study was implicitly done. The "clinical performance testing" evaluates the Red Lesion Detector's performance in terms of specificity and sensitivity for various red lesions and specifically for active bleeding, and compares it directly to the predicate device's algorithm. This suggests an evaluation of the algorithm's capability independent of direct human interaction during the detection process.
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Type of Ground Truth Used:
- The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for a device visualizing lesions, it is highly probable that the ground truth for "red lesions" and "active bleedings" would have been established by expert clinical review (e.g., gastroenterologists or endoscopists) of the capsule endoscopy videos themselves, possibly with additional clinical context or follow-up.
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Training Set Sample Size:
- The document does not provide any information regarding the sample size of the training set used for the development or training of the Red Lesion Detector algorithm.
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Ground Truth Establishment for Training Set:
- The document does not describe how the ground truth for the training set was established. It only mentions "Updating the software for the workstation - Improvement of the Red Color Detection function by updating the software algorithm (Red Lesion Detector)." This implies that the algorithm was refined or retrained, but the specifics of that process and its ground truth are not provided.
§ 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.”