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The Given® Diagnostic System with the PillCam™ SB Capsule 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 10 years of age and up

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-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.

The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include (1) improved PillCam™ SB capsule; and (2) labeling change, which does not affect the intended use of the device, related to the Automatic Mode of the RAPID® Software Application.

The provided text is a 510(k) summary for the Given® Diagnostic System, a medical device for visualizing the small bowel mucosa. The document focuses on regulatory approval and does not contain detailed information about acceptance criteria for device performance or a specific study proving it meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based solely on the provided text. The document clearly states it's a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against defined acceptance criteria.

The information sought, such as detailed performance metrics (sensitivity, specificity, etc.), sample sizes for training and test sets, expert qualifications, and ground truth establishment, would typically be found in a separate clinical study report or a more comprehensive technical and clinical data submission, which is not included in this 510(k) summary.

The only performance-related statement is about the "Suspected Blood Indicator (SBI) feature" being "intended to mark frames of the video suspected of containing blood or red areas," which is an intended function, not a performance metric with acceptance criteria.

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with PillCam™ SB Capsule

The Given® Diagnostic System with the PillCam™ SB Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the lor vivalies abnormalities of the small bowel in adults and children from 10 years of age and up

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas

with PillCam™ ESO Capsule

The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.

The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.

The RAPIDAccess optional accessory system, which is the subject of this Special 510(k) application, is designed to facilitate access to PillCam Capsule Endoscopy by allowing the performance of CE procedure without requiring the use of a full Given® Diagnostic System. It comes in two versions: RAPIDAccess RT (Real-Time), which is a standalone accessory that also allows monitoring the advancement of the capsule through the GI tract, and RAPID Access SW (software application).

The provided text is a 510(k) summary for the RAPIDAccess optional accessory system for the Given Diagnostic System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

The closest relevant information from the document is:

• Performance Standards and Special Controls: "The Given® Diagnostic System complies with the requirements presented in 'Class II Special Controls Guidance Document; Telemetric Gastrointestinal Capsule Imaging System; Ingestible Final Guidance for Industry and FDA' issued on November 28, 2001." This indicates general compliance with regulatory guidance but does not provide specific acceptance criteria or an associated study for the RAPIDAccess system's performance.
• Substantial Equivalence Argument: "Given Imaging Ltd. believes that the Given® Diagnostic System with RAPIDAccess optional accessory system is substantially the equivalent to the market-cleared Given® Diagnostic System without raising any new safety and/or efficacy issue." This is a regulatory statement, not a scientific study with performance metrics.

To answer your request, I would need a different document that details performance studies, acceptance criteria, and their results for the RAPIDAccess system.

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The Given® Diagnostic 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 10 years of age and up.

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. A Pediatric Accessory Kit for use of the system on pediatric (age 10 and up) population has been added.

The provided text focuses on the 510(k) summary for the Given® Diagnostic System, specifically regarding the addition of a Pediatric Accessory Kit. It establishes substantial equivalence to previous versions of the device and outlines its intended use and general description.

However, the document does not contain any information about specific acceptance criteria, study methodologies, performance metrics (like sensitivity, specificity, or F1 score), sample sizes for test or training sets, ground truth establishment, or details about expert involvement for performance evaluation. The information provided is primarily regulatory in nature, confirming the device's classification and substantial equivalence to a predicate device.

Therefore, I cannot populate the requested table or provide answers to most of the specific questions.

Here's a summary of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be created. The document does not specify acceptance criteria or report specific device performance metrics in numerical terms. It states the device "complies with the requirements presented in 'Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System'," but does not detail what those requirements are or how performance against them was measured for this specific submission.

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

• Not provided.

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

• Not provided.

4. Adjudication method for the test set:

• Not provided.

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:

• Not provided. The document describes the "Suspected Blood Indicator (SBI) feature" which marks frames "suspected of containing blood or red areas," implying an algorithmic assist, but no MRMC study or effect size is detailed.

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

• Not provided.

7. The type of ground truth used:

• Not provided.

8. The sample size for the training set:

• Not provided.

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

• Not provided.

In conclusion, the provided text serves as a regulatory submission for substantial equivalence and does not include the detailed performance study information typically found in a scientific publication or a more comprehensive technical report.

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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

Study Information (Based on provided text)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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