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The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.

• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.

• 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.

• 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

Study Details Proving Device Meets Acceptance Criteria

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.

• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• 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.
• 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 Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
  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. After the visualization, the diagnostic review (also known as reading) of images would start with user selectable OMNI mode feature. OMNI mode is an algorithm that assists the physician in reviewing the Capsule Endoscopy(CE) case data.

The provided text describes the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM and its performance. However, it does not explicitly define specific "acceptance criteria" in a quantitative table or directly state that the device meets pre-defined acceptance criteria in all aspects. The document focuses on demonstrating substantial equivalence to a predicate device and presenting the results of a clinical study for the OMNI mode.

Based on the provided text, here's an attempt to answer your request, highlighting where information is directly available and where it's inferred or not explicitly stated:

1. Table of acceptance criteria and the reported device performance

The provided text does not contain a specific table of quantitative acceptance criteria for the entire device or the OMNI mode, nor does it explicitly state that the device "meets" acceptance criteria in a comparative table.

However, the clinical study's outcome regarding reading efficiency can be considered a performance metric and, implicitly, a criterion for the OMNI mode's improvement claim.

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The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.
• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• 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.
• 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 Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine.

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 devices comprising this system, device design, and specifications are identical with the legally marketed predicate device. K142680. with the exception of minor modications that did not trigger the need for a new 510(k) and were documented internally at Olympus.

• The ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE (OLYMPUS EC-10) is operated by mercury-free silver oxide batteries while the batteries for the predicate device contain mercury.
• The ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE (MAJ-2190) is an upgraded software version to the previous models listed below:
• ENDOCAPSULE SOFTWARE 10 SERVER-CLIENT (Ver.1.00 and Ver.1.01)
• ENDOCAPSULE SOFTWARE 10 CLIENT (Ver.1.00 and Ver.1.01)
  Expanding the indications for use to include the detection of Crohn's disease, obscure bleeding, and iron deficiency anemia (IDA) for this system is the scope of this submission.

The provided text is a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing (battery changes, software upgrades) and a literature review to support expanded indications for use.

Crucially, the document does NOT describe an AI or algorithm-based device that requires acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC) from a test set of data. Instead, the "Red Color Detection Function" is mentioned as an intended function to mark frames suspected of containing blood or red areas, but there's no performance study data provided for this function.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not present in the provided document.

The "study that proves the device meets the acceptance criteria" in this context refers to the summary of non-clinical testing and the summary of clinical literature review aiming to support the expanded indications for use by demonstrating safety and efficacy comparable to the predicate device and the broader class of capsule endoscopy devices.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria for Device Functionality (Non-Clinical): The document implies acceptance criteria related to the testing for battery life, temperature and humidity tolerance (medical environment, transportation, storage), and software validation (functional, performance, security, usability engineering, database, operation/maintenance requirements).
• Reported Device Performance (Non-Clinical):
  • Battery Change Validation: "the following tests were conducted. - Battery Life - Test on Temperature and Humidity in Medical Environment - Test on Temperature and Humidity During Transportation and Storage" (Implies successful completion, but no specific performance metrics like 'battery life > X hours' are given).
  • Software Upgrade Validation: "The software validation activities were performed in accordance with the FDA Guidance... The validation tests were performed against each function in regards to the following points [listed]." (Implies successful completion according to requirements, but no specific software performance metrics are provided).
• Acceptance Criteria for Expanded Indications (Clinical Literature Review): The implicit acceptance criteria for the expanded indications (Crohn's disease, obscure bleeding, IDA) are that the device, being technologically identical to the predicate (except for minor changes not affecting safety/efficacy) and similar to other clinically accepted CE devices, should demonstrate comparable safety and diagnostic utility as evidenced by existing clinical literature.
• Reported Device Performance (Clinical Literature Review):
  • Iron Deficiency Anemia (IDA): Meta-analysis of four studies (264 IDA patients) revealed a higher diagnostic yield of 66.6% (95% CI, 61.0%-72.3%) for detecting sources of IDA using CE (specifically the reference device PillCam™ SB1). Complication rates were low (0-5%, pooled 1.4% retention).
  • Obscure Gastrointestinal Bleeding (OGIB): Diagnostic yield generally ranges from 70%, with an overall positive diagnostic yield of ~50% for CE.
  • Crohn's Disease (CD):
    • Chong et al. (established CD): CE diagnostic yield 77.3% (17/22 patients), leading to change in clinical management in 76%.
    • Dubcenco et al.: CE sensitivity 89.6%, specificity 100% (compared to histopathology in 39 patients with established/suspected CD), diagnostic yield 66.6%.
    • CE for post-ileocolonic surgery CD: Diagnostic findings in 68% of patients, therapeutic modification recommended in 72.7%.
    • Voderholzer et al.: CE diagnostic findings in 60.9% of patients. Therapy changed in 24% of patients.
  • Safety: Low complication rates reported across studies (e.g., 1.4% retention for all indications, 1 in 800-1,000 procedures for aspiration).

2. Sample sized used for the test set and the data provenance:

• Test Set (for expanded indications): Not a single, unified test set. The clinical performance is supported by a review of existing clinical literature.
  • For IDA: Four studies summarized, involving 264 IDA patients.
  • For CD: Multiple studies cited (e.g., Chong et al. 22 patients; Dubcenco et al. 39 patients).
• Data Provenance: The document implies the data is retrospective, drawn from published clinical studies. Countries of origin are not specified but are likely international given the nature of academic publications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as the "test set" is composed of data from numerous existing clinical studies, where ground truth would have been established by the methods, diagnoses, and follow-up defined within each individual study (e.g., endoscopic findings, surgical findings, histopathology, clinical outcomes). The document does not describe a new study where a panel of experts retrospectively reviewed cases for ground truth.

4. Adjudication method for the test set:

• Not applicable for the same reasons as #3. Ground truth was established within the original studies cited, not through a unified adjudication process for this 510(k) submission.

5. 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:

• No MRMC study was done. This device is a capsule endoscope system, not an AI-assisted reading tool beyond the "Red Color Detection Function" which is not subjected to performance testing in this document. The submission focuses on the performance of the capsule endoscopy system itself for visualization and detection, not on improving human reader performance with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No standalone algorithm performance study was done for the "Red Color Detection Function." The document mentions its intended purpose but provides no performance data for it. The overall device performance is described in terms of its ability to visualize and identify lesions, which generally requires human interpretation of the captured images.

7. The type of ground truth used:

• For the clinical literature review, the ground truth types would vary depending on the original study but generally include:
  • Histopathology (e.g., from biopsies or surgical resections)
  • Other endoscopic findings (upper and lower endoscopy, push enteroscopy)
  • Radiological findings (e.g., enteroclysis, small bowel radiology)
  • Clinical follow-up and outcomes data
  • Consensus diagnoses from the original study's clinical team.

8. The sample size for the training set:

• Not applicable. The "Red Color Detection Function" is mentioned, but there is no description of an AI model or machine learning component that would require a distinct training set. The software validation detailed in the document is for the general functionality of the software, not for training a specific image analysis algorithm.

9. How the ground truth for the training set was established:

• Not applicable. As per #8, there's no mention of an AI model with a training set.

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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:

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.

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