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AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

The Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a sterile single-use endoscope which is used with the video processor (Model: EOS-H-01. FDA cleared #K211169) produced by AnQing for providing endoscopic imaging within the bile duct for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version). The Flexible Choledochoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector. The handle includes a deflection lever, a lever lock, an aspiration button, an aspiration connector, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning a Flexible Choledochoscope. This type of document is for a medical device that does not rely on complex algorithms or AI for its primary function. Therefore, the concepts of "AI algorithm," "acceptance criteria for an AI model," "training dataset," "test set," "ground truth establishment," "MRMC studies," and "standalone performance" as they relate to AI are not applicable to this submission.

The acceptance criteria and performance data provided in this document are entirely related to the physical and functional characteristics of the choledochoscope itself, not an AI component.

Here's an analysis of the document in relation to the questions asked, noting where the questions are not applicable due to the nature of the device:

Acceptance Criteria and Device Performance (Non-AI Device)

Since this is a physical medical device (a choledochoscope), the "acceptance criteria" are related to its physical properties, safety standards, and functional performance compared to a predicate device.

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

The document presents a comparison table between the subject device (Flexible Choledochoscope, Models CS50H-20EU, CS50H-20US) and its predicate device (Olympus CHF TYPE V), showing "acceptance criteria" as functional and physical similarities and differences. The "reported device performance" is essentially that the subject device meets or is comparable to the predicate device in these aspects, and where there are differences, non-clinical tests were conducted to demonstrate equivalence without raising new safety/effectiveness concerns.

Summary of Non-Clinical Tests conducted to support equivalence for differences:

• Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601 series standards.
• Photobiological safety: Compliance with IEC 62471:2006 for LEDs.
• Mechanical and Optical Performance: Compliance with ISO 8600 standard parts for optical measurements, and testing of leakage tightness, bending, deflection endurance, withstand of channel. Comparative testing related to image quality parameters was also performed against the predicate.
• Biocompatibility: Evaluation according to ISO 10993-1 and FDA Guidance, including Cytotoxicity, Sensitization, Material-mediated pyrogenicity, and Acute systemic toxicity.
• Sterilization and shelf life testing: Validation to ISO 11135:2014, EO/ECH residual test to ISO 10993-7:2008, and accelerated aging to ASTM F1980-21.
• Package Validation: Compliance with ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15, and transport testing to ASTM D4169-22.

Regarding AI-specific questions (Not Applicable to this Device):

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

• Not Applicable. This is a physical device, not an AI algorithm. There is no "test set" of data in the AI sense. Testing involved laboratory and bench testing of the physical properties and performance of the device and its components.

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. Ground truth, in the context of an AI algorithm, refers to verified labels for training/testing. For a physical medical device, "ground truth" is established through engineering specifications, international standards (ISO, IEC, ASTM), and validated manufacturing processes. Expert review in this context would be part of the design and quality control processes by engineers and manufacturing specialists.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling of AI datasets. This does not apply to the testing of a physical endoscope.

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. MRMC studies are used to evaluate diagnostic imaging systems with human readers, often in the context of AI assistance. This device is an endoscope that provides the image, not an AI system that interprets it or assists in its interpretation. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

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

• Not Applicable. There is no AI algorithm to test in a "standalone" fashion.

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

• Not Applicable. See point 3. "Ground truth" for this device includes compliance with recognized standards, engineering specifications, and validated performance characteristics.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" to establish ground truth for.

In conclusion, the provided FDA 510(k) submission pertains to a conventional medical device, a Flexible Choledochoscope, and does not involve AI or machine learning algorithms. Therefore, the questions related to AI acceptance criteria, datasets, and ground truth establishment are not relevant to this specific document.

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