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The EC-3870CILK, Confocal Video Colonoscope, is intended to provide optical visualization (via a video monitor), (confocal) microscopic visualization of (via a video monitor), and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

The EC-3870CILK, Confocal Video Colonoscope, must be used with a Pentax Video Processor (software controlled device) and with Pentax Confocal Laser System (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Confocal Electrical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, forward water jet tube, and a confocal scanner. The instrument contains a working channel through legally marketed endoscopic accessories may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a lamp that provides white light and is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects color image data. Image data and other screen display information are formatted and presented to the video outputs of the Video Processor for display on the endoscopic image monitor. The endoscope confocal scanner contains an optical fiber that transmits laser light to, and receives return light from, the subject tissue. The confocal electrical connected to the confocal laser system. The confocal laser system contains a laser light source which produces visible laser light and contains signal detection circuitty to transmit/ receive the light signals through the endoscope confocal imaging module. The detected signal is sent to the system computer. The System Computer processes the confocal image information for display on the confocal monitor, controls the laser light source, and acts as an image storage device for still frame images. The endoscope is immersable (with the use of supplied cleaning accessories).

The provided text is a 510(k) summary for the Pentax EC-3870CILK Confocal Video Colonoscope.

Based on the information provided, no clinical performance study demonstrating the device meets specific acceptance criteria was conducted or is documented in this summary.

Here's why and what can be extracted:

The critical statement is: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly states that clinical studies for the device's performance against acceptance criteria were not part of this submission.

Therefore, most of the requested information cannot be provided from this document.

However, I can still address the relevant points based on what is available:

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

• Acceptance Criteria: Not specified in this document as part of a formal performance study for substantial equivalence.
• Reported Device Performance: Not reported in this document as it explicitly states clinical performance data was not assessed for substantial equivalence.

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. No clinical performance study was conducted or reported.

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. No clinical performance study was conducted or reported.

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

• Not applicable. No clinical performance study was conducted or reported.

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. No MRMC study was mentioned. This device is a colonoscope, not an AI-assisted diagnostic tool in the context described.

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

• Not applicable. This is a medical device (colonoscope), not a standalone algorithm.

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

• Not applicable. No clinical performance study was conducted or reported.

8. The sample size for the training set

• Not applicable. This relates to machine learning models, which are not the subject of the performance assessment in this document.

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

• Not applicable. This relates to machine learning models, which are not the subject of the performance assessment in this document.

Summary of what was used for substantial equivalence:

The submission for substantial equivalence was based on:

• Literature including specifications of the EC-3870CILK.
• Identification of standard set components.
• Identification of optional accessories.
• Comparison tables illustrating similarities to the predicate devices (EC-3800L, Video Colonoscope, and Zeiss CLSO Confocal Laser Scanner Ophthalmoscope).

This 510(k) relies on the device being substantially equivalent to existing legally marketed predicate devices, meaning it shares similar technological characteristics and is intended for the same use, rather than requiring new clinical performance data to establish safety and effectiveness.

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