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The Flexible Suction Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. It is also used as a steerable ureteral catheter that establishes a conduit for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.

The Flexible Suction Ureterorenoscope (Model: US27G-12-EU; US27G-12-US; US33G-17-EU; US33G-17-US; US38G-20-EU; US38G-20-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Suction Ureterorenoscope is also used as a steerable ureteral catheter. The Flexible Suction Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Suction Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is steered 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, optical fibers for transmitting illumination from the LED inside the Handle, 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. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).

Mechanism of action:

The light emitted from the distal tip of the Flexible Suction Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope. The suction button enables aspiration through the working channel.

Flexible Suction Ureterorenoscope has the following physical and performance characteristics:

• Steerable tip controlled by the user
• Flexible insertion cord
• Camera at the distal tip
• LED in the handle and transmitted to the distal tip by optical fibers
• Suction button and connector
• Sterilized by Ethylene Oxide
• For single use

N/A

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AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

The Flexible Cystoscope is intended for use in a hospital environment or medical office environment.

The Flexible Cystoscope is designed for use in adults.

The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a sterile single-use endoscope which is used with the video processor cleared via K243497 for providing endoscopic imaging of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.

The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Cystoscope 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, 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 section 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.

Mechanism of action:
The light emitted by the LED cold light source at the distal tip of the disposable Flexible Cystoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the video processor. The video processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the built-in screen or attached external monitor. The video processor also controls the brightness of the LEDs on the endoscope.

Flexible Cystoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use

N/A

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The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Flexible Bronchoscope is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Flexible Bronchoscope (Model: BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is intended to be used with the Portable Video Processor (cleared via K243497). The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy, and when used with the compatible video processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Bronchoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the video processor, and two optical fibers to transmit illumination from the handle to the distal tip. 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, optical fibers for transmitting illumination from the LED inside the handle, 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. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).

This document is an FDA 510(k) clearance letter for a Flexible Bronchoscope, indicating substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The provided text focuses on the physical and performance characteristics of the bronchoscope itself, its intended use, technological comparison to a predicate device, and various non-clinical tests (electrical safety, photobiological safety, mechanical/optical performance, biocompatibility, sterilization, shelf life, and package validation).

There is no mention of an AI component, an algorithm, or any study involving human readers, ground truth establishment, or performance metrics like sensitivity, specificity, or AUC. The "device performance" in this context refers to the bronchoscope's mechanical and optical functionality, not the diagnostic accuracy of an AI algorithm.

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

Here's an attempt to answer based on the provided text, highlighting what is missing:

1. Table of acceptance criteria and reported device performance

The document does not present a formal table of "acceptance criteria" for a diagnostic algorithm with corresponding "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC). Instead, it states that various non-clinical tests were performed to demonstrate compliance with recognized standards and that the device is "as safe, as effective, and performs as well as the legally marketed device identified above."

Below is a table summarizing the types of tests and the general conclusion, but without specific quantitative acceptance criteria or performance metrics related to diagnostic accuracy.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable/Not mentioned. This document describes a medical device (bronchoscope) itself, not an AI algorithm performing a diagnostic task on a dataset. The "tests" mentioned are non-clinical engineering and biological safety tests, not tests on a dataset.
• Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no mention of "ground truth" in the context of an AI algorithm's diagnostic performance for which experts would be needed. The "ground truth" for the non-clinical tests would be the established performance specifications and standards for a bronchoscope.

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

• Not applicable. As no expert ground truth establishment for a diagnostic AI is mentioned, no adjudication method would be relevant.

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

• No. This document describes the clearance of a flexible bronchoscope, a physical medical device. It does not mention any AI component or a MRMC study.

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

• Not applicable. There is no mention of an algorithm in this document that would perform as a standalone device.

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

• Not applicable. Ground truth in the context of diagnostic AI is not mentioned. For the non-clinical tests, the "ground truth" is compliance with established engineering and safety standards.

8. The sample size for the training set

• Not applicable. There is no mention of an AI model or a training set.

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

• Not applicable. There is no mention of an AI model or a training set.

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The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Bronchoscope System comprises two components: (1) a Portable Video Processor (model: EA101) and (2) a compatible Flexible Bronchoscope (model: BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US).
The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope. The Portable Video Processor consists a 13.3" LCD touch screen. It is powered through a Lithium-ion battery or a separate power adaptor.
The Flexible Bronchoscope has following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• CMOS Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use
  Portable Video Processor has following physical and performance characteristics:
• Displays the image from the Flexible Bronchoscope on the built-in screen.
• Can be connected to an external monitor.
• Non-sterile Reusable device.

The provided 510(k) clearance letter and summary for K243497 indicate that the device in question is a Flexible Bronchoscope System. This submission appears to be a change to an already cleared flexible bronchoscope (K211169) to make it compatible with a new Portable Video Processor (EA101).

Crucially, there is no mention of any AI or machine learning component in the device description, indications for use, or the non-clinical and/or clinical tests summary. The document describes standard performance testing for medical devices, focusing on electrical safety, EMC, photobiological safety, optical performance, biocompatibility, sterilization, shelf life, and package validation. Software verification and validation are mentioned in the context of IEC 62304, which covers medical device software lifecycle processes, but this does not imply AI.

Therefore, many of the questions related to AI-specific acceptance criteria, study methodologies (like MRMC studies, standalone AI performance), ground truth establishment for AI training/testing sets, and expert involvement for AI adjudication are not applicable to the information provided in this document.

The document does provide information relevant to the overall device's performance validation, which can be presented as acceptance criteria and proof for a non-AI medical device.

Non-AI Device Acceptance Criteria and Study Proof

Since the device described is not an AI/ML device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of regulatory clearance for a traditional medical device rather than for AI performance. The studies performed are primarily bench testing and phantom/component level evaluations to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by compliance with recognized standards and demonstration of equivalent performance to a predicate device. The "reported device performance" is the evidence presented to show this compliance.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Sizes: Not explicitly stated as "sample sizes" in the manner of a clinical trial. For bench testing (electrical safety, EMC, optical, biocompatibility, sterilization, shelf life, packaging), samples of the device and/or its components were tested to meet specific standard requirements. For example, biocompatibility involves testing material extracts, and sterilization validation involves processing batches of devices. The exact number of units tested for each specific bench test is not detailed in this summary.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given the applicant is in Shanghai, China, it is highly likely the testing was conducted in China. These were non-clinical bench tests, not clinical studies collecting patient data, so "retrospective or prospective" doesn't directly apply in the typical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable in the context of AI/ML ground truth. For traditional device validation, "ground truth" is established by the specifications in recognized consensus standards (e.g., ISO, ASTM, IEC) and the performance characteristics of the predicate device. Expert involvement would be in the form of engineers, test technicians, and quality assurance personnel who perform and verify the tests according to established protocols and standards. Their qualifications are inherent in their professional roles, but not quantified as "number of experts" for ground truth establishment as would be done for clinical image annotation.

4. Adjudication Method for the Test Set

• Not applicable in the context of AI/ML adjudication. For traditional device testing, the "adjudication" is compliance with objective, measurable parameters defined by standards. Test results either meet the specified limits/criteria or they do not. QA processes would review and approve test reports, but there isn't a human "adjudication" process in the way it's used for clinical data interpretation differences.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI/ML device. MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved and needs to be evaluated for improvement with or without AI assistance. This device is a bronchoscope system for visualization and intervention, not for diagnostic image interpretation by humans that would necessitate an MRMC study.

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

• No. This is not an AI/ML device. Standalone performance is relevant for AI algorithms. The performance of this device is assessed through its physical, electrical, and optical properties as a medical instrument.

7. The Type of Ground Truth Used

• For this traditional medical device, "ground truth" equates to compliance with recognized industry standards and the specifications / validated performance of the predicate device. For example:
  • Electrical Safety: Ground truth is defined by the limits and test methods of IEC 60601-1.
  • Biocompatibility: Ground truth is established by the accepted biological responses defined in ISO 10993 series.
  • Optical Performance: Ground truth is established by the parameters defined in ISO 8600 and comparative measurements against the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML model; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no AI/ML model or training set, this question is not relevant.

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The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Flexible Ureterorenoscope (Model: US27F-12-EU; US27F-12-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. 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, optical fibers for transmitting illumination from the LED inside the Handle, 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.

Mechanism of action:
The light emitted from the distal tip of the Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera at the distal tip
• LED in the handle and transmitted to the distal tip by optical fibers
• Sterilized by Ethylene Oxide
• For single use

The provided FDA 510(k) clearance letter and summary for the Flexible Ureterorenoscope (K243857) does not contain details about a study evaluating AI performance directly or outlining acceptance criteria for such a study.

This document primarily focuses on the substantial equivalence of a medical device (endoscope) based on its physical properties, performance characteristics (mechanical, optical), electrical safety, biocompatibility, sterilization, and packaging. The "non-clinical tests summary & conclusions" explicitly state "Clinical Testing: Not Applicable."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human reader improvement with AI, or standalone AI performance, as this information is not present in the provided text.

The closest relevant information is about the device's optical performance and image quality, which are foundational for any imaging device, and would implicitly establish a baseline for an AI to process.

Here's what I can provide based on the given information, primarily highlighting the device's tested performance attributes, which serve as foundational acceptance criteria for the hardware itself, not an AI component:

Acceptance Criteria and Device Performance (Flexible Ureterorenoscope - K243857)

Since the provided document is for a medical imaging device (uroscope) and not an AI/software as a medical device (SaMD), the "acceptance criteria" discussed are for the physical and functional performance of the endoscope itself, rather than for an AI algorithm built upon imagery from such a device. There is no mention of AI in this clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists "applicable parts" of standards and general categories of testing rather than specific numerical acceptance thresholds or quantitative performance metrics. The reported performance is adherence to these standards and the successful execution of these tests.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for mechanical performance). The testing is primarily bench/lab-based.
• Data Provenance: The tests are non-clinical, hardware-focused performance evaluations. Data is generated during these laboratory tests performed by the manufacturer, Shanghai AnQing Medical Instrument Co., Ltd. (China). This is implied to be prospective testing for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. The document explicitly states "Clinical Testing: Not Applicable." Ground truth, in this context, would relate to clinical outcomes or expert review of images for diagnostic purposes, which are not part of this 510(k) submission for the device itself. Performance is evaluated against engineering standards and specifications.

4. Adjudication Method for Test Set

• Not applicable. No clinical test set or expert review requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states "Clinical Testing: Not Applicable." No MRMC study or AI assistance evaluation is mentioned.

6. Standalone Performance (Algorithm Only)

• Not applicable. This submission is for the endoscope hardware, not a standalone AI algorithm. No algorithm performance is described.

7. Type of Ground Truth Used

• Engineering/Technical Standards: The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC, ISO, ASTM, ANSI AAMI) for medical device safety, electrical performance, optical quality, biocompatibility, sterilization, and mechanical integrity. Performance is measured against these technical specifications.

8. Sample Size for Training Set

• Not applicable. There is no mention of an AI component requiring a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. There is no mention of an AI component or a training set.

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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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AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.

The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) 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 of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.

The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Cystoscope 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, 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 does not describe the acceptance criteria and study proving device meets acceptance criteria in the format requested. Specifically, it does not include a table of acceptance criteria vs. device performance, or details regarding sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) premarket notification for a Flexible Cystoscope, primarily focusing on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical testing.

Here's a breakdown of the information that is available in relation to your request, and what is missing:

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

• Not explicitly provided in the requested format. Instead, the document provides a "Comparison with Predicate Device" table (pages 5-6) which compares various physical, optical, and technological characteristics of the subject device to the predicate device. However, this table lists characteristics and indicates "Same" or "Similar" for comparison, rather than specific acceptance criteria and quantitative performance results for each criterion.
• "Summary of Testing" (page 8-9) lists the types of non-clinical tests performed (Electrical Safety, EMC, Photobiological safety, Mechanical and Optical Performance, Biocompatibility, Sterilization, Shelf life, Package Validation) and the standards they comply with, but does not provide specific acceptance criteria or performance values for the subject device against these criteria.

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

• Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for these tests or the origin of any data (as it's physical device testing, not data collection from patients).

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/Not provided. This type of information is typically relevant for AI/ML-based devices where expert-labeled datasets are used to establish ground truth. The Flexible Cystoscope is a physical medical device, and its performance is evaluated against engineering specifications and standards, not against expert-established ground truth on medical images or diagnoses.

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

• Not applicable/Not provided. As above, this is relevant for AI/ML evaluation, not for the direct performance 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

• No, not done. The document explicitly states under "Summary of Clinical Tests" (page 9): "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means no human-in-the-loop or MRMC studies were conducted.

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

• Not applicable/Not done. The device is a physical cystoscope, not an algorithm.

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

• Not applicable/Not provided. The "ground truth" for this device's performance relies on established engineering standards (e.g., ISO 8600 for optical measurements, IEC 62471 for photobiological safety, ISO 10993 for biocompatibility) and direct physical measurements and tests of the device's characteristics (e.g., outer diameter, working length, deflection, depth of field).

8. The sample size for the training set

• Not applicable/Not provided. There is no AI/ML component, so no training set.

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

• Not applicable/Not provided. There is no AI/ML component, so no training set or ground truth for it.

In summary, the provided document details the non-clinical testing and comparison of a flexible cystoscope to a predicate device to demonstrate substantial equivalence, rather than providing the specific AI/ML-related performance evaluation details requested.

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The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Flexible Ureterorenoscope (Model: US31E-12-EU; US31E-12-US) is intended to be used with the Video Processor (cleared in K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a working channel port for accessory devices and a Luer port for irrigation. The insertion section contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion is controlled by the user via the deflection lever on the handle. The distal end of the insertion 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 connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection), which is the only difference between the two proposed models.

The provided text describes a 510(k) premarket notification for a medical device called "Flexible Ureterorenoscope." This document is a regulatory submission to the FDA proving substantial equivalence to a predicate device, not a study of an AI/ML algorithm. Therefore, many of the requested details, such as AI-specific acceptance criteria, test set Ground Truth establishment, MRMC studies, or training set information, are not applicable to this kind of device and its regulatory pathway.

The device discussed is a standard medical instrument, an endoscope, not an AI-powered diagnostic or therapeutic device. The "study" mentioned refers to non-clinical performance data and testing to demonstrate that the modified device performs comparably to its predicate and meets safety standards, not a clinical trial involving AI.

Here's an attempt to answer the questions based on the provided text, highlighting where the requested AI-specific information is not applicable:

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

The document states that the device passed all testing in accordance with internal requirements and applicable standards. The acceptance criteria are generally implied to be the successful demonstration that the device's characteristics (mechanical, optical, material, etc.) are equivalent to or better than the predicate device and meet relevant regulatory standards. Specific numerical acceptance criteria were not explicitly provided in the summary, but rather implied by the statement "passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device."

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

The text describes non-clinical performance testing of a physical device. It does not refer to a "test set" in the context of a dataset for an algorithm. There is no information regarding sample sizes for human subjects or origin of data (e.g., retrospective/prospective, country of origin) because clinical studies were not required for this submission. The testing was performed on physical samples of the device.

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. "Ground truth" in the context of expert review for medical image analysis or similar AI applications is not relevant here. The ground truth for device performance is based on established engineering standards, material science, and biocompatibility protocols.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among human readers for establishing ground truth in clinical data, which is not what was done for this device.

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

No. An MRMC study was not stated or implied. This type of study would be relevant for an AI-assisted diagnostic or decision-support system, which this device is not. 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

No. This question is not applicable. The device is a physical endoscope that is used by a human operator; it is not a standalone algorithm.

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

The "ground truth" for demonstrating substantial equivalence for this device is based on:

• Compliance with recognized international standards (e.g., ISO, ASTM).
• Demonstration of physical and optical characteristics being equivalent or better than the predicate device.
• Successful completion of specific mechanical, biocompatibility, sterilization, and packaging tests based on established laboratory protocols.

No diagnostic or clinical outcomes ground truth was established by experts for this submission.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm requiring training data.

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

This question is not applicable for the same reason as above.

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The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Flexible Ureterorenoscope (Model: US31D-12-EU, US31D-12-US) is an endoscope which is used with the Video Processor (Model: EOS-H-01) (FDA cleared K211169) produced by AnQing for providing endoscopic imaging of the ureter and the renal pelvis 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 Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, 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 section contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion 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.

Mechanism of action:

The light emitted by the LED cold light source at the distal tip of the disposable Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use

The provided document is a 510(k) premarket notification for a medical device (Flexible Ureterorenoscope). It does not describe an acceptance criteria or report on a study proving the device meets acceptance criteria in the manner requested.

Instead, the document details the device's technical specifications, indications for use, comparison to a predicate device, and a summary of non-clinical bench testing, electrical safety, EMC, photobiological safety, biocompatibility, sterilization, and packaging validation tests performed to demonstrate substantial equivalence to a legally marketed predicate device.

Specifically:

• No acceptance criteria table or reported device performance for a specific study is provided. The document focuses on demonstrating substantial equivalence through various tests, not on meeting predefined performance criteria for a novel clinical function.
• No sample size for a test set, data provenance, number of experts for ground truth, or adjudication method are mentioned. This information would typically be part of a clinical study, which the document explicitly states was not required.
• No multi-reader multi-case (MRMC) comparative effectiveness study was done.
• No standalone (algorithm only) performance study was done. This device is a medical instrument (endoscope), not an AI algorithm.
• No specific type of ground truth is mentioned for performance evaluation. The evaluation relies on engineering and biological safety standards.
• No sample size for a training set or method for establishing ground truth for a training set are provided. This is not relevant for this device type.

The document explicitly states:

• "Summary of Clinical Tests: The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Instead, the document summarizes non-clinical tests to demonstrate substantial equivalence:

• Electrical Safety and Electromagnetic Compatibility: Compliance with ANSI/AAMI ES: 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-2-18:2009; IEC 60601-1-2:2014.
• Photobiological Safety: Compliance with IEC 62471:2006.
• Mechanical and Optical Performance: Designed to comply with applicable parts of ISO 8600. Optical measurements performed according to applicable parts of ISO 8600. Mechanical tests included leakage tightness, bending, deflection endurance, and tensile strength testing. Comparative testing for image quality (color reproduction, resolution, depth of field, image intensity uniformity, distortion, dynamic range) against the predicate device.
• Biocompatibility: Evaluated according to ISO 10993-1 and FDA Guidance, including tests for Cytotoxicity (ISO 10993-5:2009/(R) 2014), Sensitization/Irritation (ISO 10993-10:2010), Material-mediated pyrogenicity (ISO 10993-11:2017), and Acute systemic toxicity (ISO 10993-11:2017).
• Sterilization and Shelf Life Testing: Validation to ISO 11135:2014, EO/ECH residual test to ISO 10993-7:2008. Shelf life (3 years) determined by stability study including accelerated aging (ASTM F1980-16).
• Package Validation: Conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, including visual inspection (ASTM F1886), seal strength (F88/F88M-15), dye penetration (ASTM F1929-15), bubble emission (ASTM D3078), and transport/shipping (ASTM D4169-16).

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The flexible bronchoscope have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Bronchoscope System consists of Flexible Bronchoscope (twelve models shown in below) to be introduced within the airways or tracheobronchial tree and Video Processor (model: EOS-H-01) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope.

The Flexible Bronchoscope is a sterile single used flexible bronchoscope. The Video Processor is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the disposable video bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective. The document is a 510(k) summary for a Bronchoscope System, which is a medical device, but it does not describe an AI/ML-driven diagnostic or assistive technology.

The "Performance Data" section details various engineering and biological tests conducted for the Bronchoscope System, such as biocompatibility, sterilization, electrical safety, EMC, software verification, and bench performance testing. These tests ensure the device's physical and functional safety and effectiveness, but they do not involve AI/ML performance metrics like sensitivity, specificity, or AUC against a ground truth.

Specifically, there is no mention of the following in the provided text:

1. A table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth type related to an AI/ML model for a test set.
3. Sample size or ground truth establishment for a training set of an AI/ML model.

The document explicitly states under "Clinical Testing": "Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This further confirms that no studies involving human interpretation augmented or replaced by AI, or studies evaluating AI performance metrics, were part of this submission.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and study data from this document.

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