(174 days)
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa. The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa. The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM consists of a CAPSULE ENDOSCOPE (EC-Y0006), an ACTIVATOR (MAJ-1478), a RECORDER (RE-Y0002), a CRADLE (MAJ-Y0160), a BATTERY PACK (MAJ-Y016), a RECORDER HOLDER (MAJ-Y0162), an ANTENNA UNIT (MAJ-Y0163), an ANTENNA HOLDER (MAJ-Y0164), an ENDOCAPSULE SOFTWARE SERVER-CLIENT (MAJ-Y0165) and an ENDOCAPSULE SOFTWARE CLIENT (MAJ-Y0166).
The Olympus Small Intestinal Capsule Endoscope System (K123421) was evaluated for its 3D Track function, image quality, and antenna performance through non-clinical bench testing and a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Clinical Study) | Reported Device Performance (Clinical Study) |
|---|---|---|
| 3D Track Accuracy | "predefined acceptance criteria" | "The test results met the predefined acceptance criteria. Therefore, it was verified that the accuracy of the 3D Track function was maintained as we presumed." |
| Image Quality (Resolution, Brightness, Color Tone, Field of View) | Not explicitly stated, implied to be comparable or superior to predicate. | "The principal investigator's comments showed that the subject device is greatly superior to the predicate device in regard to image quality." |
| Antenna Performance (Video Gap Occurrence) | "predefined acceptance criteria" | "The evaluation results met the predefined acceptance criteria. Thus, the reception performance of the subject device is equivalent to that of the predicate device." |
2. Sample Sizes and Data Provenance:
- Test Set (Clinical Study):
- 3D Track Accuracy: 27 healthy volunteers (3 subjects excluded from an initial 30).
- Image Quality: The principal investigator (number of investigators not specified) provided comments based on the 30 healthy volunteers.
- Antenna Performance: 29 subjects (1 subject excluded from an initial 30).
- Data Provenance: The clinical study involved "healthy volunteers." No specific country of origin is mentioned, but the manufacturer is based in Japan, suggesting the study likely took place there. The study appears to be prospective as it involved volunteers undergoing the procedure specifically for this evaluation.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
- 3D Track Accuracy: The ground truth for capsule position was derived from X-ray photography. The number and qualifications of experts interpreting these X-ray images are not specified.
- Image Quality: The assessment was made by the "principal investigator" based on a questionnaire. The number and specific qualifications (e.g., years of experience) of the principal investigator(s) are not specified.
- Antenna Performance: The evaluation used "video gap occurrence" as an indicator. The method of establishing ground truth for video gaps and whether experts were involved is not specified.
4. Adjudication Method for the Test Set:
- The document does not specify an adjudication method for any of the clinical study evaluations (3D Track, Image Quality, or Antenna Performance).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not performed as described. The clinical study involved assessing the device's performance directly, with some comparison to the predicate device based on qualitative feedback (image quality) or equivalence claims (antenna performance). There is no mention of human readers improving with or without AI assistance, as the "Red Color Detection Function" is simply intended to mark suspicious frames, not directly assist human interpretation in a comparative effectiveness study detailed here.
6. Standalone Performance:
- Yes, a standalone study was done for certain functions.
- The 3D Track function was evaluated for its accuracy in estimating capsule position against X-ray derived positions. This is a standalone assessment of the algorithm's performance.
- The Red Color Detection Function is described as a "software feature that highlights frames suspicious for blood or red lesions based upon analysis of red pixels." While the document doesn't detail a specific standalone performance study for its sensitivity/specificity in this summary, its description implies an algorithmic, standalone function.
7. Type of Ground Truth Used:
- 3D Track Accuracy: Ground truth was derived from radiographic image data (X-ray photography) interpreted to determine capsule positions.
- Image Quality: Ground truth was based on the principal investigator's subjective comments via a questionnaire.
- Antenna Performance: Ground truth was based on video gap occurrence, measured from the recorded image data.
8. Sample Size for the Training Set:
- The document does not provide information on the sample size for any training sets. This summary focuses on the verification and validation of the device, particularly the clinical study and bench testing. If the device uses machine learning for functions like Red Color Detection, the training set details are not included in this submission summary.
9. How the Ground Truth for the Training Set Was Established:
- As the document does not provide information on training sets, the method for establishing their ground truth is also not described.
§ 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.”