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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.

The Fujifilm video colonoscope model EC-600WL v2 is a modified version of the legally marketed Fujifilm Colonoscope EC-600WL in K132210. Just like K132210, the proposed EC-600WL v2 is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

The EC-600WL v2 is comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains glass fiber bundles, several channels, and a complementary metal-oxide- semiconductor (CMOS) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and light source.

The EC-600WL v2 is used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscopic accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, cart).

The minor modifications to the proposed device were made for the purpose of overall product enhancement and general technological advancement.

The provided text is a 510(k) summary for a medical device, the Fujifilm Video Colonoscope Model EC-600WL v2. It describes the device, its intended use, and its substantial equivalence to a predicate device (Fujifilm 600 series colonoscope EC-600WL).

However, the document does not contain the information necessary to answer most of your specific questions about acceptance criteria derivation, study design details for performance, or AI-related aspects. This is a premarket notification for a traditional medical device (video colonoscope), not an AI/ML-enabled device. Therefore, questions regarding "AI vs without AI assistance," "standalone algorithm performance," "sample size for training set," or "ground truth for training set" are not applicable to this document.

Here's an attempt to answer the applicable questions based on the provided text:

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

The document broadly states: "In all cases, the device met the pre-defined acceptance criteria for the test." It lists the performance tests conducted but does not provide the specific numerical acceptance criteria or the numerical results for each test.

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

The document states "Fujifilm conducted the following performance testing of the EC-600WL v2," but it does not specify the sample size for any of these tests, nor does it provide information on data provenance (country of origin, retrospective/prospective).

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)

This question is not applicable to the type of performance testing described in the document. The tests listed (e.g., field of view, bending capability, resolution) are objective engineering and functional performance tests for the physical device, not interpretative medical tasks requiring expert ground truth.

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

Not applicable. As noted above, the tests are objective functional performance tests, not subjective interpretations requiring adjudication.

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. This is a traditional colonoscope, not an AI-enabled device.

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

Not applicable. This is a traditional colonoscope, not an AI-enabled device.

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

Not applicable. The "ground truth" for the performance tests would be objective physical measurements against engineering specifications, not medical ground truth established by experts or pathology.

8. The sample size for the training set

Not applicable. This is a traditional colonoscope, not an AI-enabled device that requires a "training set."

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

Not applicable. This is a traditional colonoscope, not an AI-enabled device that requires a "training set" or "ground truth for training."

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