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This device is intended for the visualization of the lower digestive tract, specifically. for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previouslycleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which includes rectum, sigmoid colon, and large intestine, which remains the same as K041903.

The endoscopes are comprised of three general sections: an operation section, a flexible portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The flexible insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD). The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity thereby providing enough light to the CCD to capture an image and display the image on the monitor. The endoscope also contains several channels to deliver air/water, provide suction and a working channel. The forceps channel or working channel is used to introduce endoscope accessories such as biopsy forceps. The umbilicus contains electronic components needed to operate the endoscope when plugged to the video processor and the light source.

The modified models are used in combination with Fujinon's video processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices.

This 510(k) premarket notification describes the Fujinon Colonoscopes EC-530HL2 and EC-530LS2, which are modified versions of previously cleared devices (K041903). The submission asserts substantial equivalence to the predicate devices and does not describe a new AI/ML-based device or a clinical study that evaluates its performance against acceptance criteria.

Therefore, most of the requested information cannot be found in the provided document.

Here's what can be extracted based on the input:

This submission did not involve an AI/ML device. It is for a medical device (colonoscope) and thus the following information is not applicable in the context of an AI/ML study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for diagnostic performance in the context of an AI/ML algorithm. Instead, it refers to compliance with safety and performance requirements for the colonoscope.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test was conducted.

4. Adjudication method for the test set: Not applicable. No clinical test was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: Not applicable. No clinical test was conducted. The ground truth for device safety and performance here would be compliance with the cited international standards and successful third-party validation for reprocessing.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary from the provided document:

The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5, K041903). The modifications are described as minor dimensional changes, material changes, and relocation of the water jet inlet, which are stated not to adversely affect safety and effectiveness.

The "studies" mentioned are primarily focused on compliance with recognized international safety and performance standards for medical electrical equipment and biocompatibility, along with validation of reprocessing instructions. No clinical tests were conducted for this 510(k) submission to evaluate diagnostic performance of a new feature or an AI algorithm, as this is a device modification submission.

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