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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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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 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.

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 PillCam™ Capsules are wireless, disposable capsules designed to glide smoothly through the GI tract. 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 new RAPID® software application, RAPID® 4, for the RAPID® Workstation is the subject of this submission.

The provided text describes the RAPID® 4 software for the Given® Diagnostic System. However, it does not include a detailed study proving the device meets specific acceptance criteria. The document primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the document. The submission is for a software update (RAPID® 4) to an existing diagnostic system, and the clearance is based on substantial equivalence to previous versions, not on a new set of performance acceptance criteria and a study to meet them.

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

This information is not present. Since no new clinical performance study is detailed, there's no mention of a test set, its sample size, or data provenance. The document only references the existing system's intended use and design.

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

This information is not present. Again, due to the nature of the submission (substantial equivalence for a software update), there is no mention of a new test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not present. As no test set is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

This information is not present. The document does not describe any MRMC study or any comparison of human readers with and without AI assistance. The RAPID® 4 is a software for processing and viewing images, not explicitly an AI-assisted detection tool with a comparative effectiveness study detailed here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

This information is not present. There is no mention of a standalone algorithm performance study.

7. The Type of Ground Truth Used:

This information is not present. Without a specific performance study outlined, the type of ground truth used is not described.

8. The Sample Size for the Training Set:

This information is not present. The document focuses on the regulatory submission for a software update and does not detail the development or training of any underlying algorithms.

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

This information is not present. Similar to point 8, the document does not describe the establishment of ground truth for any training set.

Summary of what is available in the document:

• Device Name: RAPID® 4 (for Given® Diagnostic System)
• 510(k) Number: K052184
• Applicant: Given Imaging Ltd.
• Intended Use:
  • With PillCam™ SB Capsule: Visualization of small bowel mucosa for detection of abnormalities in adults and children (10+). The Suspected Blood Indicator (SBI) feature marks frames with suspected blood or red areas.
  • With PillCam™ ESO Capsule: Visualization of esophageal mucosa.
• Device Description: Comprised of PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation. The RAPID® 4 is a new software application for the RAPID® Workstation.
• Predicate Device: Given® Diagnostic System with previous versions of RAPID® software, and the Given® Diagnostic System with PillCam™ ESO Capsule.
• Basis for Clearance: Substantial equivalence to previously cleared devices, without raising new safety and/or efficacy issues. The system complies with "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System."

Conclusion:

The provided document is a 510(k) summary for a software update and emphasizes regulatory clearance based on substantial equivalence to existing devices. It does not present a detailed study outlining specific acceptance criteria and proving the device meets them via a new clinical performance study with associated sample sizes, expert ground truth, or comparative effectiveness studies. The assumption is that the previous versions of the software and system met these criteria, and RAPID® 4 maintains that performance.

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

The Given® Diagnostic System with the PillCam™ ESO Capsule is comprised of three subsystems: PillCam™ ESO Capsule, Data Recorder Set, and RAPID® Workstation. The PillCam™ ESO Capsule is a wireless, disposable capsule designed to glide smoothly through the esophagus. 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 provided text is a 510(k) summary for the Given® Diagnostic System with PillCam™ ESO Capsule. It focuses on the device's substantial equivalence to a predicate device due to modifications in the capsule model and software. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria, a specific study proving those criteria, sample sizes, ground truth establishment, or MCRM comparative effectiveness.

Here's an analysis of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds.
• Reported Device Performance: Not detailed in this document. The submission is for modifications and asserts substantial equivalence rather than presenting new performance data against specific criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not available in the provided text. The document discusses device modifications and substantial equivalence, not a new clinical study with a test set.

3. 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)

• This information is not available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not available in the provided text.

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 study is not mentioned in the provided text. The device described, the "Given® Diagnostic System with PillCam™ ESO Capsule," is an imaging system, and while it processes images ("RAPID® Workstation"), the submission does not describe it as an AI-assisted diagnostic tool that would typically involve a comparative effectiveness study of human readers with vs. without AI assistance. The modifications are to the capsule's frame rate and the RAPID software, suggesting system improvements rather than AI integration for diagnostic improvement.

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

• This information is not available in the provided text. The system is described as providing images for viewing by a physician, implying a human-in-the-loop workflow.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• This information is not available in the provided text.

8. The sample size for the training set

• This information is not available in the provided text.

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

• This information is not available in the provided text.

Summary of available information from the document:

• Device Name: Given® Diagnostic System with PillCam™ ESO Capsule
• Intended Use: For the visualization of esophageal mucosa.
• Predicated Device: Given® Diagnostic System with PillCam™ (M2A®) ESO Capsule (K041149).
• Reason for Submission: Implementation of two modifications:
  1. Improved capsule model (transmits images at 14 frames per second (fps)).
  2. Improved version of the RAPID Software application.
• Equivalence Claim: Substantially equivalent to the predicate device without raising any new safety and/or efficacy issues.
• Regulatory Status: Class II device, reviewed under special controls guidance for "Ingestible Telemetric Gastrointestinal Capsule Imaging System."
• Approval Date: November 24, 2004 (FDA issued substantial equivalence determination).

The provided text serves as a regulatory submission for device modifications and substantial equivalence. It does not include the detailed technical study information that would define acceptance criteria for a new device's performance demonstration. For such details, one would typically need to consult a comprehensive technical report or clinical study summary, which is not part of this 510(k) summary.

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