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The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel 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.
  It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults and children from two years of age.
  The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC1600-B
• MiroCam® Receiver: MR2000
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
• MiroView™ Software: MiroView™ U 4.0
  The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

The provided text describes the MiroCam® Capsule Endoscope System and its substantial equivalence to predicate devices, including performance testing results for the MiroView™ Express 3.0 software. While it refers to "acceptance criteria" through comparison with predicate devices and mentions performance testing, explicit, quantifiable acceptance criteria are not clearly laid out in a dedicated table format with corresponding performance metrics for the AI component (Suspected GI Bleeding Indicator - SGIB).

However, the closest information to acceptance criteria for the software component's performance (specifically the MiroView™ Express 3.0 with its "informatics algorithm" for detecting significant images) can be inferred from the clinical study summary.

Here's an attempt to extract and present the information based on the provided text:

Table of Acceptance Criteria (Inferred) and Reported Device Performance

The document does not provide a formal table of acceptance criteria with "pass/fail" thresholds. Instead, it describes a clinical study to evaluate the performance of the "express view reading mode" (which includes an "informatics algorithm") for the MiroCam® Capsule Endoscope System, particularly concerning the detection of "significant lesions" and "significant images." The implicit acceptance criterion is that the new system's performance, particularly in terms of sensitivity and reading time, is comparable or improved compared to standard reading, while also demonstrating clinical utility.

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The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel 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.
  It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults only.
  The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC2000-B
• MiroCam® Receiver: MR2000
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
• MiroView™ Software: MiroView™ U 4.0
  The MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa and can be used to visualize and monitor lesions related to Crohn's disease, obscure bleeding, and iron deficiency anemia (IDA) not detected by upper and lower endoscopy. It can also detect other small bowel abnormalities in adults. The Suspected GI Bleeding Indicator (SGIB) marks frames suspected of containing blood or red areas.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" with numerical targets. Instead, it describes performance testing conducted to demonstrate that modifications to the device (MC2000-B capsule and MiroView™ U 4.0 software) do not diminish the safety or effectiveness compared to its predicate (MiroCam® Capsule Endoscope System K143663 and Given® PillCam® SB3 K123864). The "reported device performance" is largely framed as equivalency or improvement over the predicate, rather than meeting specific quantitative thresholds.

However, based on the comparative effectiveness section, we can infer some performance aspects that were evaluated.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each performance test. It mentions tests like MTF Measurement, Minimum Distinguishable Contrast Value and Depth of Field, Geometric distortion, Field of View, Color Reproduction, Optical spectra of the light source, Intensity change during shelf life, Bite testing, Water proof testing, pH resistance testing, MR1100 and MR2000 Equivalent Performance Comparison testing, and Shelf life testing.

The data provenance is implied to be from internal lab testing and comparisons, conducted by IntroMedic Co., Ltd. The study appears to be retrospective in the sense that it compares features and performance against already cleared predicate devices. There is no information provided about prospective clinical trials or country of origin for specific data sets, except that the manufacturer is from Korea.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

This document describes a medical device submission focusing on substantial equivalence of hardware and software features, along with physical performance tests. It does not mention any human expert review or ground truth establishment by clinical experts for the purpose of validating image-based diagnostic performance or the "Suspected GI Bleeding Indicator (SGIB)" functionality in the context of this submission. The SGIB is stated to be "intended to mark frames... suspected of containing blood or red areas," but no details are provided on its validation or ground truth.

4. Adjudication Method for the Test Set

As no human expert review or ground truth establishment by experts for specific diagnostic performance is mentioned, there is no adjudication method provided for an expert-based test set.

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

The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The device described is a capsule endoscope system with an "indicator" function (SGIB) for potential bleeding, not an AI diagnostic system designed to assist human readers in interpretation or to quantify improvement in human performance.

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

The document mentions the "Suspected GI Bleeding Indicator (SGIB)" as an "intended to mark frames... suspected of containing blood or red areas." This suggests an algorithmic function. However, the document does not provide any data on the standalone performance of this SGIB algorithm (e.g., sensitivity, specificity, accuracy) using a defined ground truth. Its presence is mentioned as a feature, not a validated diagnostic tool in this submission.

7. The Type of Ground Truth Used

For the physical and functional performance tests (e.g., bite testing, water resistance, pH resistance, optical system, operation time), the ground truth is derived from engineering specifications, physical measurements, and direct observation against established standards or predicate device performance. For the SGIB feature, no specific ground truth type (e.g., expert consensus, pathology, outcomes data) for its performance validation is described in this submission.

8. The Sample Size for the Training Set

This document concerns a capsule endoscopy system, not a machine learning model requiring a training set in the typical sense. While the SGIB feature might use some form of internal algorithm, no information on the sample size of a training set is provided.

9. How the Ground Truth for the Training Set Was Established

As no training set for an AI model is explicitly mentioned or detailed, no method for establishing ground truth for a training set is provided.

Ask a specific question about this device

The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC1200-B
• MiroCam® Receiver: MR1100
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
• MiroView™ Software: MiroView™ U 3.0, MiroView™ RTV, MiroView™ RTV-i

The MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

I am sorry, but the provided documentation does not contain the information requested in your prompt regarding acceptance criteria and the comprehensive study details (sample sizes, ground truth provenance, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).

The document is an FDA 510(k) clearance letter for the MiroCam® Capsule Endoscope System. It primarily focuses on demonstrating substantial equivalence to a predicate device (K134005).

While it mentions "Performance Testing" for the device, it explicitly states: "The performance testing are exactly the same as the predicate device (K134005)." This means the details of the performance testing are not included in this document but rather in the prior submission for K134005.

Therefore, I cannot extract the specific information you requested from this text.

Ask a specific question about this device

The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC1200-B
• MiroCam® Receiver: MR1100
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
• MroView™ Software: MroView™ U 3.0, MiroView™ RTV, MroView™ RTV-i

The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the Gl tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

The provided document does not contain information about specific acceptance criteria, device performance, or a study design to prove the device meets acceptance criteria.

The document is a 510(k) summary for the MiroCam® Capsule Endoscope System, focusing on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and states that performance testing was done for the predicate device, with some additional testing for the current device's components. However, it does not detail:

• Specific acceptance criteria: There are no defined metrics (e.g., sensitivity, specificity, accuracy, detection rates, etc.) nor thresholds presented for the device's performance.
• Reported device performance: No quantitative results from any clinical or performance study are provided for the MiroCam® Capsule Endoscope System itself, especially for its "Suspected GI Bleeding Indicator (SGIB)" feature.
• Study design details: Information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment is absent because no such study is described in this summary for the present device in relation to performance metrics.

The document states:

• "The MiroCam® Capsule Endoscope System performance testing was done for the submission of predicate device but it was not included when Sensor Bench testing, Exposure Measurement testing, Minimum MTF Measurement testing, MTF Time testing, Distinguishable Contrast Value and Depth of View testing, Geometric distortion and Illumination Uniformity testing, Field of View testing, Color Reproduction testing, LED Spectrum Measurement testing, Testing intensity change during the shelf life period and Testing optical spectra of the light source at different time points during the battery life period was done."
• "The results of this performance testing conclude that the material and technological characteristics have not diminished the safety and effectiveness of the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System device when compared to the predicate device."

This indicates that the performance testing was primarily focused on technical characteristics and comparing them to the predicate, rather than evaluating clinical performance metrics against specific acceptance criteria for the new device as a whole, especially its "Suspected GI Bleeding Indicator (SGIB)".

Therefore, I cannot populate the requested tables and information as the necessary details are not present in the provided text.

Ask a specific question about this device

The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC1000-B
• MiroCam® Receiver: MR1100
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L)
• MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i

The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the Gl tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

The provided text does not contain detailed information about specific acceptance criteria or an exhaustive study proving the device meets those criteria. The 510(k) summary states that "The performance testing are exactly the same as the predicate device (K123428)," implying that the current submission relies on the testing of its predicate device. This usually means that the device is shown to be substantially equivalent to the predicate through similar technological characteristics and equivalent intended use, rather than a new de novo performance study with specific acceptance criteria.

However, based on the structure of a typical 510(k) submission, and the limited information provided, I can infer some aspects and highlight what is missing.

Here's a breakdown of the requested information, indicating where the document provides details and where it is silent:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide a table of reported device performance for this specific submission (K140751). It states that its performance testing is "exactly the same as the predicate device (K123428)." This implies that the current device is considered to have met the performance established for its predicate. Without access to K123428's full submission, specific quantitative acceptance criteria cannot be extracted from this text.

The closest to a performance claim is the intended function of the "Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas." However, no metrics (e.g., sensitivity, specificity, accuracy) or acceptance criteria (e.g., >90% sensitivity for SGIB detection) are provided for this feature.

2. Sample size used for the test set and the data provenance

The document does not provide details about the sample size for a test set or data provenance for K140751, as it refers back to the predicate device (K123428) for performance testing.

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

The document does not provide this information for K140751.

4. Adjudication method for the test set

The document does not provide this information for K140751.

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

The document does not indicate that an MRMC comparative effectiveness study was done for K140751. The device description mentions "MiroView™ U provides some kinds of Modes and Views to help the user review patient video data quickly and conveniently; however, IntroMedic Co., Ltd. recommends that the doctor review the patient video in the Normal Mode / Single View to prevent from a wrong diagnosis." This statement suggests a recommendation against relying solely on AI-assisted views for diagnosis and doesn't claim an improvement in human reader performance with AI assistance.

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

The document does not explicitly present data on standalone algorithm performance for K140751. The "Suspected GI Bleeding Indicator (SGIB)" feature could imply an algorithm-only function, but no performance metrics are given.

7. The type of ground truth used

The document does not provide information on the type of ground truth used for K140751.

8. The sample size for the training set

The document does not provide information on the sample size for any training set for K140751.

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

The document does not provide information on how ground truth was established for any training set for K140751.

Summary of what is known from the provided text for K140751:

The submission for the MiroCam® Capsule Endoscope System (K140751) states that its "Technological Characteristics" and "Performance Testing" are "exactly the same as the predicate device (K123428)." This means that the current device is deemed substantially equivalent based on its similarity to a previously cleared device, rather than requiring new, detailed performance studies to be included in this specific 510(k) summary.

The only specific "performance" mentioned is the Suspected GI Bleeding Indicator (SGIB), which is "intended to mark frames of the video suspected of containing blood or red areas." However, no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or acceptance criteria for this feature are provided in the document.

To get the detailed information requested, one would need to access the full 510(k) submission for K123428, which is the predicate device for performance testing.

Ask a specific question about this device

MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC1000-B
• MiroCam® Receiver: MR1100
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L)
• MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i

The MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

The provided text describes a 510(k) submission for the MiroCam® Capsule Endoscope System, focusing on its substantial equivalence to a predicate device rather than presenting a standalone clinical study with specific acceptance criteria and performance data. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, and MRMC studies are not explicitly stated in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics as would be found in a standalone clinical study. Instead, it relies on substantial equivalence to a legally marketed predicate device (MiroCam® Capsule Endoscope System K111450). The performance testing mentioned is primarily for safety and functional characteristics, not clinical efficacy metrics like sensitivity or specificity.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set with a specific sample size. The performance testing mentioned are "bench testing" and "non-clinical performance testing," which typically refers to laboratory or engineering tests rather than patient studies. Therefore, details regarding country of origin or retrospective/prospective nature of a clinical test set are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as the submission relies on substantial equivalence and does not detail a clinical study with expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with expert adjudication is described.

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

A MRMC comparative effectiveness study is not mentioned. The submission is for a medical device that assists physicians (Gastroenterologists) in reviewing images, but it does not detail a study comparing human performance with and without the device's assistance. The document mentions the "Suspected GI Bleeding Indicator (SGIB)" as a feature to "mark frames of the video suspected of containing blood or red areas," which implies an assistive function, but no study measuring its impact on reader performance is presented.

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

A standalone performance study for an algorithm like the SGIB is not explicitly detailed. The SGIB is described as an "indicator" intended to "mark frames," implying it's a feature within the system. The submission mainly focuses on the physical and functional aspects of the capsule endoscopy system itself, establishing substantial equivalence to a previous version.

7. The Type of Ground Truth Used

For the bench testing described, the "ground truth" would be established through engineering specifications, known physical properties, and controlled experimental conditions (e.g., specific field of view measurements, battery discharge curves, pH levels). For the SGIB, the nature of its "ground truth" for marking frames is not specified but would likely be based on visual characteristics of blood or redness. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth in this submission.

8. The Sample Size for the Training Set

No training set is mentioned. This submission is for a device, not a machine learning algorithm requiring a distinct training phase documented here for its efficacy claims. While the SGIB feature might be algorithm-based, no details of its development or training are provided.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set is mentioned in the document.

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MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule
• Data Cables
• MiroCam® Receiver
• MiroView™ Software and Workstation

The MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the MiroView™ workstation and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

Here's a breakdown of the acceptance criteria and study details for the MiroCam® Capsule Endoscope System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance Study

The primary effectiveness endpoint for the MiroCam® Capsule Endoscope System was to compare its agreement with a predicate device (Given Diagnostic Imaging System, K070475) regarding the detection and identification of sources of small bowel bleeding.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 105 subjects were enrolled. 89 subjects were evaluable for the effectiveness analysis (having at least 2 hours of small bowel imaging time successfully). The concordance rate was estimated based on 79 evaluable subjects where small bowel bleeding was identified.
• Data Provenance: The study was a "multi-center, prospective, randomized, open-label clinical trial." The country of origin is not explicitly stated, but the company is based in South Korea, suggesting it could involve centers there.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, it mentions that the "physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel," implying gastroenterologists are the primary reviewers. The comparison was made against a predicate device, suggesting that the 'ground truth' for the study's primary endpoint was the finding of the predicate device.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1). The study compared the MiroCam® with the predicate device, implying a direct comparison of findings rather than a separate expert-adjudicated ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an explicit MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance was not described. The study compared the device itself to a predicate device, focusing on agreement in detecting and identifying small bowel bleeding. While the MiroView™ software includes features like a "Suspected GI Bleeding Indicator (SGIB)" to "optimize the efficiency of the diagnostic review," the clinical study primarily assessed the overall diagnostic performance of the MiroCam® system in comparison to the predicate, rather than the impact of these specific AI features on human reader performance.

6. Standalone (Algorithm Only) Performance

The study design described is a comparison of the entire MiroCam® Capsule Endoscope System against a predicate device. It does not isolate the performance of an algorithm only (i.e., standalone AI performance without human-in-the-loop). The "Suspected GI Bleeding Indicator (SGIB)" is part of the MiroView™ software, which aids the physician, but its standalone performance or its specific contribution to the main effectiveness endpoint is not detailed as a separate study.

7. Type of Ground Truth Used for the Test Set

The ground truth for the effectiveness endpoint was established by comparing the findings of the MiroCam® device to the findings of the predicate device (Given Diagnostic Imaging System) regarding the detection and identification of sources of small bowel bleeding. It's a comparative effectiveness study rather than using an independent, definitive "gold standard" like pathology report in all cases.

8. Sample Size for the Training Set

The document does not provide information regarding a training set sample size. This summary primarily details the clinical validation (test set) for regulatory approval.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, this information is not available in the provided text.

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