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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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