Search Results

The Given® Diagnostic System with the PillCam™ ESO2 Capsule is intended for visualization of the esophageal mucosa

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

The modifications to the Given® Diagnostic System, which are subject of this Special 510(k) is the addition of a new model of esophageal capsule, the PillCam™ ESO2 Capsule, and the addition of an alternative ingestion procedure, the simplified ingestion procedure (SIP) for the esophageal capsules.

The provided text describes a 510(k) submission for the Given® Diagnostic System with PillCam™ ESO2 Capsule, focusing on its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that directly proves the device meets specific performance criteria beyond the general statement of substantial equivalence.

The 510(k) summary explains that the submission is for a modification to an existing device, specifically the addition of a new esophageal capsule model (PillCam™ ESO2) and an alternative ingestion procedure. The core of the submission is to demonstrate that these modifications do not introduce new safety or efficacy issues and that the modified device is "substantially equivalent" to already cleared devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document. The 510(k) process primarily relies on demonstrating equivalence rather than on de novo performance studies against pre-defined acceptance criteria (unless a special controls guidance document specifies them, which is mentioned as being complied with in a general sense, but no specific performance endpoints are given).

Here's an analysis of the information that can be extracted or inferred based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: NOT PROVIDED. The document doesn't detail a specific clinical study for performance testing of the PillCam™ ESO2 capsule against a ground truth. The submission likely relies on previous studies for the predicate device and potentially bridging studies that confirm the new capsule's similar performance.
• Data provenance: NOT PROVIDED. No information on country of origin of data or whether it was retrospective or prospective.

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

• Number of experts: NOT PROVIDED. Since no specific performance study with a test set is detailed, information on experts used to establish ground truth is absent.
• Qualifications of experts: NOT PROVIDED.

4. Adjudication method for the test set

• Adjudication method: NOT PROVIDED. No test set or corresponding adjudication method is mentioned in this document.

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

• MRMC study: NOT APPLICABLE / NOT PROVIDED. The device is an "Ingestible Telemetric Esophageal Capsule Imaging System" which typically functions as a diagnostic tool for visualization, not an AI-assisted diagnostic. There is no mention of AI integrated into the system described in this document, nor any MRMC study comparing human readers with and without AI assistance.

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

• Standalone algorithm performance: NOT APPLICABLE / NOT PROVIDED. The device is a capsule imaging system, not an algorithm, and the document does not describe any standalone algorithmic performance evaluation.

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

• Type of ground truth: NOT PROVIDED. The document does not describe a specific study with a defined ground truth for the PillCam™ ESO2 capsule's performance. The basis for equivalence is likely derived from the predicate device's demonstrated ability to visualize the esophageal mucosa, which would have implicitly relied on a comparison to standard clinical evaluations (e.g., endoscopy findings by expert clinicians, or possibly biopsy results for pathology).

8. The sample size for the training set

• Sample size for training set: NOT APPLICABLE / NOT PROVIDED. As this is an imaging device and not an AI/ML algorithm that requires a training set in the typical sense, this information is not relevant or provided in the document.

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

• Ground truth for training set: NOT APPLICABLE / NOT PROVIDED. Same as above, not relevant for this type of device and submission.

Summary of what IS provided:

• Device Name: Given® Diagnostic System with PillCam™ ESO2 Capsule
• Intended Use: Visualization of the esophageal mucosa.
• Predicate Device: Given® Diagnostic System with PillCam™ ESO Capsule (cleared under K041149 and K042960).
• Basis for Clearance: Substantial equivalence to the predicate device.
• Modifications: Addition of the PillCam™ ESO2 Capsule and an alternative ingestion procedure (simplified ingestion procedure - SIP).
• Regulatory Compliance: Complies with "Class II Special Controls Guidance in Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001. (However, the specific performance requirements from this guidance are not detailed in this 510(k) summary).

In essence, this document is a summary of the 510(k) submission, not a detailed clinical study report. It focuses on the regulatory argument for substantial equivalence rather than reporting explicit performance metrics from a specific new clinical study with the ESO2 capsule.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.

The Given® AGILE Patency System is a simple and easy to use device for verifying the patency of the GI tract. It consists of the following components:

• · Given AGILE Patency capsule
• · Given AGILE Patency Scanner
• · TesTag (interference tester)
  Once the patient ingests the Given AGILE Patency capsule it is propelled through the GI tract by normal peristalsis. If the AGILE Patency capsule is excreted structurally whole, then this indicates patency of the GI tract of the patient and a PillCam capsule can be administered. The capsule is designed to dissolve starting 30 hours following ingestion, during a period of approximately 12 hours. If anytime before 30 hours after capsule ingestion the AGILE Patency capsule cannot be detected in the patient's body by the Given AGILE Patency Scanner, it indicates that the GI tract is patent and that the capsule was excreted naturally.
  The Given AGILE Patency Scanner is used to detect the presence of the Given AGILE Patency capsule in the patient's body. If a scanner is not available, or if localization of a retained capsule is desired, fluoroscopy can be used.
  If the Given AGILE Patency Scanner detects the Given AGILE Patency capsule in the GI tract 30 hours post-ingestion, then patency of the GI tract is not indicated. Eventually, the capsule dissolves into small fragments and is naturally excreted.

Here's a breakdown of the acceptance criteria and the study information for the Given AGILE Patency System, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, the core function and intended outcome of the device serve as the de facto "acceptance criteria." The device's performance is reported in relation to its ability to confirm or deny GI tract patency.

Study Information:

The provided 510(k) summary does not contain details of a clinical study that provides specific data on the device's performance, such as sensitivity, specificity, accuracy, or a breakdown of results from a test set. The document focuses on describing the device, its intended use, and its substantial equivalence to predicate devices. It states that "Given Imaging Ltd. believes that, based on the information provided in the submission, the Given® AGILE Patency System is substantially equivalent to its predicate devices without raising any new safety and/or efficacy issue." This implies that the justification for clearance is primarily based on equivalence to existing cleared devices rather than a de novo clinical performance study demonstrating specific metrics against a test set.

Therefore, for the following points, the answer is "Not provided in the document" as the requested details would typically be found in a clinical study report, which is not part of this 510(k) summary.

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

• Not provided in the document.

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)

• Not provided in the document.

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

• Not provided in the document.

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 applicable / Not provided in the document. This device is a patency system, not an imaging analysis system that would involve human readers interpreting images with or without AI assistance.

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

• While the device operates somewhat "stand-alone" in determining retention (scanner detects presence), the overall system relies on human interpretation of the scanner results (and potentially fluoroscopy) to make a clinical decision. However, no specific "standalone performance study" data is presented.

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

• Not provided in the document. Given the nature of the device, the ground truth for patency would likely be established by direct observation of capsule passage, subsequent passage of a PillCam, or alternative diagnostic procedures (e.g., endoscopy, imaging).

8. The sample size for the training set

• Not applicable / Not provided in the document. This device does not appear to be an AI/machine learning system that requires a "training set" in the conventional sense. Its function is based on physical dissolution and a scanner detection mechanism.

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

• Not applicable / Not provided in the document. (See point 8).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 intended for the visualization of the esophagus.

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 primarily focuses on regulatory information for the "Given® Diagnostic System with PillCam™ ESO Capsule" and does not contain details about specific acceptance criteria, study methodologies, or performance results in the way typically expected for a detailed scientific study review. The document is a 510(k) summary and FDA clearance letter, which establishes substantial equivalence rather than presenting comprehensive clinical trial data.

Therefore, many of the requested items cannot be definitively answered from the provided text. However, I can extract what is implied or stated generally.

Here's an analysis based on the provided text, highlighting what's missing:

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

This information is not provided in the given text. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance table with specific acceptance criteria and results.

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

This information is not provided in the given text.

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 provided in the given text.

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

This information is not provided in the given 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

This information is not provided in the given text. The description is of a capsule imaging system for visualization, not explicitly an AI-assisted diagnostic tool for human readers.

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

This information is not provided in the given text. The "Given® Diagnostic System" described includes a "RAPID® Workstation" for processing and viewing by the physician, implying human-in-the-loop performance is key.

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

This information is not provided in the given text.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

Summary of what can be inferred or explicitly stated from the provided text:

• Device Name: Given® Diagnostic System with PillCam™ ESO Capsule
• Intended Use: Visualization of esophageal mucosa (and visualization of the esophagus).
• Classification: Class II device, product code 78NZE (later referred to as 78 NSI in the FDA letter).
• Predicate Device: Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.)
• Compliance: Complies with "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001. This implies that the device meets the general performance and safety requirements outlined in this guidance. The guidance document would contain the "acceptance criteria" at a regulatory level, but not the specific quantitative performance metrics from a study report.
• Substantial Equivalence: The applicant believes the device is substantially equivalent to the cleared Given® Diagnostic System (with the M2A® SB Capsule) without raising new safety and/or efficacy issues. The FDA concurred with this assessment for market clearance.

To answer your questions thoroughly, you would need access to the actual clinical trial or validation study report that led to this 510(k) submission, which is not part of the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

The RAPID 2.0 software, 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.

The provided text is a 510(k) summary for the Given® Diagnostic System. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain any information about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on regulatory approval, stating compliance with special controls guidance and asserting substantial equivalence. There is no mention of a clinical study, performance metrics, or the methods used to validate the Suspected Blood Indicator (SBI) feature's accuracy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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 available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document only states the intended use of the SBI feature: "The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas." and mentions that "The analysis is based on detection of colorimetric abnormalities, or deviations from an expected spectrum, corresponding to normal tissue." This describes what the feature does, but not how well it does it or how that performance was verified.

Ask a specific question about this device

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.

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-M2ATM 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, 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.

The provided text is a 510(k) summary for the Given® Diagnostic System with the Suspected Blood Indicator (SBI) feature. It describes the device, its intended use, and states that it meets performance standards and special controls. However, this document does not contain the specific details of a study that proves the device meets acceptance criteria, nor does it define explicit acceptance criteria in a quantifiable manner.

The document only states that the system "complies with the requirements presented in Ingestible Telemetric Gastrointestinal Capsule Imaging System: Final Guidance for Industry and FDA issued on November 28, 2001." It also asserts substantial equivalence to predicate devices "without raising any new safety and/or efficacy issue."

Therefore, I cannot fulfill your request for the following sections based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document is a regulatory submission summary stating compliance and substantial equivalence, not a detailed clinical study report. Such details would typically be found in the actual studies conducted to support the 510(k) submission, which are not part of this summary document.

Ask a specific question about this device