Search Results

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.

Ask a specific question about this device