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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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With PillCam SB 2 and SB 3 Capsules

The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa.

• o PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules ● may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

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

The PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

With PillCam ESO 3 Capsule

The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age..

With PillCam UGI Capsule

The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least 18 years of age.

With PillCam COLON Capsule

The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

The RAPID Web is a client server based version of the RAPID video review and report creation components of the cleared RAPID 8 software. The RAPID Web is designed to allow users to review and analyze videos created using the cleared RAPID software, and to create reports over a private intranet network or over a secure internet connection. The PillCam capsule studies are created at workflow-relevant locations and stored at a central repository. The RAPID Web server is installed on a central server in an intranet or internet environment with access to the study repository. After the capsule endoscopy procedure was conducted using the cleared RAPID software, Given Workstation/User PC, PillCam capsule, and DR 3 PillCam recorder, end users will use an internet browser with authorization login to access, review, and manage the studies in the repository using workstation, user PC, a laptop or an Apple™ (screen size > 9.7").

The provided text describes the 510(k) submission for RAPID Web, comparing it to its predicate device, RAPID 8.0. The core of the submission revolves around demonstrating that RAPID Web is substantially equivalent to RAPID 8.0, and thus, RAPID Web's "performance" is implicitly tied to how well it replicates the established performance of RAPID 8.0.

Here's an analysis of the acceptance criteria and study as presented in the document:

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

The document does not explicitly state numerical acceptance criteria in a table format for RAPID Web's diagnostic performance. Instead, it states the acceptance criterion informally as "RAPID 8.0 met the pre-specified sensitivity" in the context of a comparative performance study. The reported performance is that the analysis of "matched and un-matched pathologies" showed this criterion was met.

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

• Sample Size for Test Set: The document states that a "comparative performance study wherein trained professionals identified pathologies in the same video and video segments that we displayed using RAPID Web and RAPID 8.0 was performed." However, it does not specify the number of cases (videos or video segments) used in this test set.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was collected retrospectively or prospectively.

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)

• The document implies that "trained professionals" were involved in identifying pathologies. However, it does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., years of experience, medical specialty). The study design appears to be a comparison of user performance with two different software versions, rather than a separate ground truth establishment phase by independent experts for the test set itself. The "ground truth" for this comparative study seems to be derived from the consensus or established interpretations of "trained professionals" using the predicate device.

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

• The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. The study compares "matched and un-matched pathologies," suggesting a direct comparison of findings between the two software versions, likely relying on individual assessments by the trained professionals.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• The study described is a "comparative performance study" where "trained professionals identified pathologies in the same video and video segments that we displayed using RAPID Web and RAPID 8.0." This sounds like a multi-reader, multi-case study (MRMC) in the sense that multiple readers would use the two different software versions on the same cases.
• However, this is not a study on human readers improving with AI vs. without AI assistance. RAPID Web and RAPID 8.0 are video review and analysis software. The "Suspected Blood Indicator (SBI) feature" is mentioned as "intended to mark frames of the video suspected of containing blood or red areas," which is an algorithmic assistance feature. The study assessed if this feature, within the new web-based context, maintained its performance from the predicate.
• The document does not report any effect size demonstrating improvement of human readers with either RAPID Web or RAPID 8.0 over a non-assisted reading scenario. The study aims to demonstrate substantial equivalence between the two software versions.

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

• The document does not describe a standalone algorithm-only performance study. The performance evaluation is explicitly framed as a "comparative performance study wherein trained professionals identified pathologies," indicating human-in-the-loop performance. The SBI feature is an algorithm, but its performance is assessed within the context of human review.

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

• The ground truth for the "pathologies" identified in the comparative study appears to be based on the interpretations of "trained professionals" themselves, as they "identified pathologies." The comparison is between the findings obtained using RAPID Web and those obtained using RAPID 8.0, with RAPID 8.0's established performance serving as the reference. There is no mention of an independent, higher-standard ground truth like biopsy/pathology reports or long-term clinical outcomes data being used to validate the accuracy of these identified pathologies in this particular comparative study. The study's goal is equivalence, not re-proving clinical accuracy against an external gold standard for the new platform.

8. The sample size for the training set

• The document does not provide any information about a training set or its sample size. This submission is for a new version of existing software (RAPID Web being a client-server version of RAPID 8.0), not necessarily a new AI model that would require a distinct training phase described in the submission. The "Suspected Blood Indicator (SBI) feature" is part of the established functionality from the predicate device, not a new AI algorithm being introduced or trained for RAPID Web.

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

• As no training set is described in the document, there is no information on how ground truth for a training set was established.

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The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible, In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories.

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 PillCam Recorder located outside the body.
2. DR 3 PillCam Recorder Recorder is an external The DR 3 PillCam receiving/recording unit that receives and stores the acquired images from the capsule. The Sensor Array/belt receives data from the PillCam capsule and transfers the data to the PillCam Recorder.
3. RAPID Software The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms.
4. Given Workstation and Accessories The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.

This document is a 510(k) summary for the PillCam COLON 2 Capsule Endoscopy System. It requests an expanded indication for use for detection of colon polyps.

Based on the provided text, the device itself (PillCam COLON 2 Capsule Endoscopy System) is identical to a previously cleared device (DEN 120023). No new clinical testing was performed or relied upon for this specific 510(k) submission for the expanded indication. The submission relies on the substantial equivalence of the existing device and its performance against "special controls for colon capsule imaging systems, as described in 21CFR 876.1330."

Therefore, the input does not provide information about a new study directly demonstrating the device meets specific acceptance criteria for this expanded indication. Instead, it states that the device's technological characteristics and optical features are the same as the predicate device (DEN 120023).

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, because the submission claims substantial equivalence without new clinical testing.

However, given the constraint to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, I will extract what is explicitly stated in the document about general performance data and and the basis for the approval.

Here's a breakdown of the available information:

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

The document does not provide a specific table of acceptance criteria and reported device performance for this expanded indication. It only states that the "device meets the special controls for colon capsule imaging systems, as described in 21CFR 876.1330."

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

Not applicable. The document explicitly states: "No clinical testing was performed or relied on for a determination of substantial equivalence."

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 applicable, as no new clinical testing was performed for this submission.

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

Not applicable, as no new clinical testing was performed for this submission.

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, as no new clinical testing was performed for this submission. This device is not an AI-assisted device in the context of this submission.

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

This would not apply to a capsule endoscopy system. The system provides visualization, and a human (physician) interprets the images.

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

Not applicable, as no new clinical testing was performed for this submission.

8. The sample size for the training set

Not applicable, as no new clinical testing was performed for this submission, and the device is not described as involving a machine learning algorithm that undergoes a "training set" in the context of this approval.

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

Not applicable.

Conclusion based on the provided text:

The submission for the expanded indication of the PillCam COLON 2 Capsule Endoscopy System relies on the substantial equivalence to a predicate device (DEN 120023). The document explicitly states: "No clinical testing was performed or relied on for a determination of substantial equivalence." The acceptance criteria are broadly described as meeting "the special controls for colon capsule imaging systems, as described in 21CFR 876.1330," rather than specific performance metrics from a new clinical study.

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The PillCam COLON 2 Capsule Endoscopy System is indicated to provide visualization of the colon. It is intended to be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

The PillCam® COLON 2 capsule endoscopy system includes a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon. The PillCam COLON 2 capsule is designed to withstand the mechanical forces and chemical environment of the digestive system. The system is comprised of four main subsystems; (1) the ingestible PillCam COLON 2 capsule, (2) the DR 3 PillCam® Recorder, (3) the RAPID® software, and (4) the Given® Workstation.

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

Note: The document does not explicitly state numerical acceptance criteria values, but rather presents the study's performance characteristics as part of the overall demonstration of effectiveness. The table above reflects the reported performance that supports the device's acceptance.

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

• Sample Size for Effectiveness Analysis: 700 subjects successfully completed an investigation with both CCE and OC and were included in the effectiveness analysis.
• Data Provenance: Prospective, multi-center study.
• Country of Origin: 11 enrollment sites in the US and 6 in Israel.

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)

The document states that a "central reader" interpreted the CCE results. For the optical colonoscopy (OC) results, "colonoscopists" evaluated their findings. The number and specific qualifications (e.g., years of experience) of these experts are not explicitly stated in the provided text.

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

The document mentions an initial phase where "colonoscopists were blinded to CCE results when evaluating their OC findings." Following this, if a polyp detected on CCE was not identified by the initial colonoscopy, "the results of the CCE evaluation were unblinded and the colonoscopy was repeated in a second attempt to identify the polyp identified on CCE." This suggests a form of sequential adjudication or unblinding with repeat examination rather than a consensus-based adjudication (like 2+1 or 3+1). The "reference OC polyp chosen for the final determination was the one that was in favor of the device" when there were multiple equally large polyps, which implies a specific rule for handling discrepancies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The study was a "multi-center study" comparing CCE (the device) with optical colonoscopy (OC). It primarily evaluated the standalone performance of the CCE system against OC as the ground truth. There is no information provided about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. The focus is on the device's ability to detect polyps, not on enhancing human reader performance using the device as an AI assistant.

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

Yes, a standalone performance evaluation was conducted. The study "compared CCE with optical colonoscopy (OC) for agreement on absence or presence of colon polyps." The CCE system, including its RAPID software for video viewing and report generation, functions as an algorithm-driven system that outputs video for interpretation. The performance metrics (positive and negative percent agreement) specifically refer to the CCE as a device, implying standalone performance in detecting polyps. The "centralized reader" interpreted the CCE results, but the CCE itself is the classification device.

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

The ground truth used was Optical Colonoscopy (OC) findings, specifically the identification and sizing of colon polyps (≥6 mm or ≥10 mm). OC is considered a clinically acceptable alternative structural imaging method.

8. The sample size for the training set

The provided document does not specify the sample size for a training set. The clinical study described is for evaluating the performance of the already developed device, not for training it.

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

Since no information on a training set is provided, how its ground truth was established is not detailed in this document.

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