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The PillCam 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 PillCam Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.

Therefore, the PillCam Patency System is intended to be used:

• prior to PillCam SB capsule in adults and children from 2 years of age, or
• prior to PillCam UGI, COLON, and Crohn's capsules in adults

The PillCam Patency System is an accessory to the PillCam capsule endoscopy (CE) System and it is used for verifying the patency of the Gastrointestinal (GI) tract. The PillCam Patency System consists of the following components; The PillCam Patency capsule, the Patency scanner and TesTag (interference tester).

The Patency capsule is an ingestible and dissolvable capsule, similar in size to the PillCam CE. It is comprised of a body that surrounds a small Radio Frequency Identification (RFID) tag. The body is coated with an impermeable membrane, except for two small windows that are plugged by the Timer Plugs. The Timer plugs seal the capsule's body. If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule. However, if the capsule is retained in the GI tract, the Timer Plugs erode, allowing the penetration of body fluids into the capsule and the dissolution of the capsule's body. The remaining fragments of the capsule can pass even small orifices.

The Patency scanner may be utilized to detect RF signals from the RFID tag, to verify the PillCam Patency capsule presence in the body.

The only difference between the PillCam Patency System and the predicate device is the proposed labeling modification, to allow the use of the existing Patency capsule with the PillCam capsules that are slightly longer (PillCam COLON, Crohn's and UGI capsules). The intention of the proposed change is to offer physicians a clinical tool to evaluate the suitability of patients for CE, as an alternative to magnetic resonance enterography (MRE) or Computed Tomography (CT) which are already used in practice for this purpose.

The provided text is a 510(k) summary for the PillCam Patency System. It references a previous submission (K053639) for clinical testing data, but the details of that study, including specific acceptance criteria and detailed device performance, are not explicitly laid out in the current document. However, based on the information provided, I can construct a response with the available data and highlight where information is missing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The current document (K180171) itself does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily digestible table. Instead, it refers to prior clinical testing (K053639) and general statements about the system's performance.

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

• Test Set Sample Size: Not explicitly stated in K180171. It refers to "patients with known strictures" in the leveraged K053639 study.
• Data Provenance: Not specified in K180171 (e.g., country of origin). The previous study (K053639) from which the data was leveraged would contain this information. The current submission is a regulatory document concerning a device from Israel (Given Imaging Ltd.).
• Retrospective or Prospective: Not explicitly stated for the leveraged K053639 study. However, the description "patients with known strictures ingested the Patency capsule and underwent periodic scanning until the capsule was excreted" suggests a prospective clinical study design.

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

This information is not provided in the K180171 document. The document primarily focuses on the device's physical and functional characteristics and references prior clinical safety and efficacy without detailing the methodology of ground truth establishment in the studies themselves.

4. Adjudication method for the test set

This information is not provided in the K180171 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

This is not applicable to the PillCam Patency System as described. The Patency System's function is to verify GI tract patency, primarily through the detection of an RFID tag or the capsule's dissolution, not through interpretation of images by human readers or AI. It's an accessory to a video capsule, but its own function doesn't involve image interpretation where "human readers improve with AI" would be a relevant metric.

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

Yes, the core function of the PillCam Patency System, as described, is a standalone process. The Patency scanner detects RF signals from the RFID tag, and the capsule's dissolution is a physical process, both occurring without direct human interpretive intervention during the patency verification itself. The "human-in-the-loop" aspect would be the physician's decision based on the outcome (intact capsule excreted or not), but the patency test itself does not involve AI or human image interpretation.

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

The ground truth for the efficacy aspect (successful patency verification) would likely be based on:

• Direct observation of capsule excretion: If the capsule is excreted whole, patency is confirmed.
• Follow-up outcomes: The success of the subsequent capsule endoscopy (e.g., no retention) after a positive patency test would serve as an outcome-based ground truth.
• Clinical assessment: The resolution or passage of the capsule (or its fragments) and the patient's clinical status.

The K180171 document states: "If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule." This indicates direct observation as a primary ground truth.

8. The sample size for the training set

The K180171 document does not mention a training set. This is because the device is a physical capsule system, not an AI/ML algorithm that requires a training set. The "design" and "performance" of the capsule are based on engineering principles and clinical testing, not model training.

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

As there is no training set for this type of device, this information is not applicable.

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SB Indications for Use:

The Given PillCam® Platform with the PillCam® SB Capsules 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 Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

AGILE Indications for Use:

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 in adults and children from two years of age.

The Given PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.

1. Ingestible PillCam Capsule

The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the DataRecorder located outside the body.

2. RAPID Software

The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms.

3. Given Workstation and Hardware

The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The SensorArray receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.

The Given Agile Patency System is designed to determine which patients with known or suspected intestinal strictures can safely ingest a PillCam video capsule. The system consists of an ingestible and dissolvable capsule that is the same size as the PillCam SB capsule, and an external scanner.

The provided text is a 510(k) summary for the Given® AGILE Patency System and Given PillCam® Platform with PillCam® SB Capsules. While it mentions that "Clinical data has been summarized to show safety and effectiveness for the proposed indications for use" and that "The devices meet the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001," it does not include any specific performance data, acceptance criteria, or details of a study that proves the device meets acceptance criteria.

Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance, sample size, ground truth details, or information about MRMC studies. The document states that the technological characteristics are "exactly the same as the predicate devices," suggesting the approval is based on substantial equivalence rather than a new performance study.

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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.

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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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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.

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