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The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Flexible Video-Choledochoscope is a kind of medical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. This device must be used with a duodenoscope. The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a Flexible Video-Choledochoscope, which asserts substantial equivalence to a predicate device based on technical and performance characteristics.

Specifically, the document mentions:

• No Clinical Study is included in this submission. (Section 5.9 Clinical Test Data)
• Non-clinical Performance Data: "The following performance tests were conducted to substantial equivalence: mechanical performance: duodenosoone compatibility testing and flexible surgical instrument compatibility testing and comparison performance testing." (Section 5.8 Non-clinical Performance Data)

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. The product is equipped with tiny size digital imaging parts -- photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.

This document is a 510(k) premarket notification for a new medical device, the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. Therefore, the "study" referred to is primarily a non-clinical performance evaluation comparing the proposed device to a predicate device, rather than a clinical trial or AI-specific validation study typically associated with AI/ML devices.

Here's an analysis of the provided information concerning acceptance criteria and the "study":

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparative table between the proposed device (PL-2100) and its primary predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686, Model: PL-1000). The "acceptance criteria" are implied by the predicate device's characteristics, and the "reported device performance" are the proposed device's characteristics. The goal is to show they are "Same" or "Similar" in ways that don't raise new questions of safety or effectiveness.

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CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.

HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

CHOLESTEROL: The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.

HDL-Cholesterol: The Accelerator Selective Detergent method is applied. The determination of HDL-Cholesterol is based on the following reactions: LDL, VLDL, and chylomicrons are neutralized by the combined action of the enzymes Cholesterol Oxidase, Peroxidase, accelerators and N,N-bis-(4-sulfobutyl)-m-toluidine-disodium (DSBmT). HDL remaining in the sample is disrupted by the action of a selective detergent and cholesterol is converted to △4 Cholestenone by the enzymatic action of Cholesterol Esterase and Cholesterol Oxidase, with the subsequent production of H2O2, which reacts with DSBmT and 4-aminoantipyrine in the presence of Peroxidase to a colored complex that absorbs light at 590 nm. The absorbance measured is proportional to the concentration of HDL-Cholesterol in the sample.

LDL-Cholesterol: The Selective Detergent method is applied. The method is in a two-reagent format and depends on the properties of a unique detergent. The first detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. The second detergent solubilizes the remaining LDL particles, and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-Cholesterol in the presence of the coupler at 590 nm produces color that is proportional to the amount of LDL cholesterol present in the sample.

TRIGLYCERIDES: The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and the study information for the Medicon Hellas Cholesterol, HDL-Cholesterol, LDL-Cholesterol, and Triglycerides test systems, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to legally marketed predicate devices and alignment with clinical laboratory guidelines (CLSI). The document presents a clear comparison in the "Device Comparison Table" sections. For this summary, I'll focus on the key performance indicators for each analyte.

CHOLESTEROL

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Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.

The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor.

The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

The Choledochoscope System consists of a single-use choledochoscope to provide illumination and intuitive images in endoscopic surgery of the pancreatic ductal system and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing.

The single-use choledochoscope is a sterile single-use flexible choledochoscope and has the following 4 models: CH-M50, CH-M52, CH-M40, CH-M32. The four models are the same except for the difference in the characteristics of the insertion tube, including diameter of the insertion tube, maximum insertion portion width and minimum insertion channel width.

The image processor is a reusable monitor.

The single-use choledochoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the choledochoscope and outputs video signals to a display.

The provided text describes the regulatory clearance of a medical device, the "Choledochoscope System," and highlights the tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not include the detailed information needed to answer many of the questions regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics related to AI or image analysis beyond general optical performance.

Specifically, the document states: "No clinical study is included in this submission" which is critical. This means the device's performance was primarily demonstrated through bench testing and compliance with standards, not through clinical trials or comparative effectiveness studies with human readers.

Therefore, for many of the requested points, the answer will be that the information is "Not available in the provided text" or "Not applicable as no clinical or AI-based performance study was conducted."

Here's the breakdown based on the provided text:

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

The document mentions several performance tests and compliance with standards, but does not provide a table with specific acceptance criteria (e.g., minimum resolution, specific SNR values) and reported performance values for each. It generally states "Comply with" or "evaluated in accordance with."

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

• Sample Size (Test Set): Not applicable for human-data based test sets, as "No clinical study is included in this submission." For bench tests (e.g., optical, mechanical), the sample sizes are not specified in the document.
• Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company is based in Shenzhen, Guangdong, China. The testing appears to be primarily bench-top and engineering performance testing rather than human clinical data.
• Retrospective/Prospective: Not applicable, as no clinical studies were conducted using human data.

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)

• Number of experts: Not applicable. No clinical expert-driven ground truth was established, as no clinical study was conducted.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No clinical test set requiring expert adjudication was used.

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

• MRMC study: No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."
• Effect size: Not applicable, as no MRMC study was conducted.

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

• Standalone performance: Not applicable. This device is an endoscope system (hardware and image processor), not an AI algorithm analyzing medical images. Its performance is related to its ability to capture and display images, not interpret them. The document refers to "Software Verification and Validation Testing" but treats the software as a "moderate" level of concern, indicating it's mainly for control and image processing, not diagnostic AI.

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

• Type of ground truth: For the engineering and performance tests (optical, mechanical, electrical, biocompatibility), the "ground truth" would be established physical measurements, engineering standards, chemical analyses, and standardized test methodologies. There is no biological/clinical "ground truth" in the form of expert consensus or pathology within this submission.

8. The sample size for the training set

• Sample size (Training Set): Not applicable. This submission is for a medical device (endoscope system), not an AI/ML model for which a training set would be described in this context. The software mentioned is for device operation and image display, not for learning from data.

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

• Ground truth (Training Set): Not applicable, as this device does not involve a machine learning training set with biological or clinical ground truth.

In summary, the provided document focuses on demonstrating the substantial equivalence of the Choledochoscope System to a predicate device through adherence to established regulatory standards for medical device safety and performance (biocompatibility, sterilization, electrical safety, mechanical, and optical bench tests), rather than clinical efficacy or AI-driven performance.

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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.

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The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:

The Lipid Profile GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density Ilpoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.

The TC GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.

The Lipid Profile cassette is for the quantitative determination of total cholesterol. HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.

The TC cassette is for the quantitative determination of total cholesterol in whole blood.

· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

· Triglyceride measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette®.

The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads.

The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.

The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides.

The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry.

A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.

The provided text is a 510(k) summary for the Cholestech LDX™ System and primarily discusses device modifications and comparison to a predicate device. It certifies that verification studies were performed as required by risk analysis and all acceptance criteria were met. However, it does not provide the specific details of the acceptance criteria or the reported device performance for these studies. It also does not contain information about the sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for test and training sets.

Therefore, based solely on the provided text, I cannot fulfill most of the requested information regarding the study that proves the device meets the acceptance criteria. The document states that such studies were done and met acceptance criteria, but omits the specifics.

Here's what can be inferred or stated from the provided text, and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Information Not Available in the Text: The document explicitly states, "Verification studies were performed as required by risk analysis and all acceptance criteria were met." However, it does not list the specific acceptance criteria (e.g., specific accuracy thresholds, precision ranges, etc.) or the detailed reported device performance (e.g., actual measured accuracy, precision values, etc.) from these studies. The modification pertains to updating the performance claim related to conjugated and unconjugated Bilirubin interference. While it mentions that less than 10% interference was seen at specified levels for various substances, this is a general statement from the predicate device's limitations, not a specific acceptance criterion for the current modification or the exact performance data achieved.

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

Information Not Available in the Text: The document states that "verification studies" were performed, but it does not specify the sample size (e.g., number of patients, number of samples) used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective nature of the data collection).

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

Information Not Available in the Text: The document details changes to an in vitro diagnostic (IVD) device for measuring cholesterol, triglycerides, and glucose. For IVD devices, ground truth is typically established by reference laboratory methods, not by human experts interpreting images or clinical cases. Therefore, the concept of "experts" as in radiologists or pathologists establishing ground truth is not applicable here. Even if it were (e.g., for method comparison studies requiring expert clinical correlation), the document does not mention any role for experts in establishing ground truth.

4. Adjudication Method for the Test Set

Information Not Available in the Text: Since the ground truth for an IVD device is generally established using reference methods (as opposed to human interpretation needing adjudication), an adjudication method as typically used in AI studies of imaging (e.g., 2+1, 3+1) is not applicable or described in this document.

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

Information Not Applicable/Available in the Text: This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies comparing human readers with and without AI assistance are not relevant to this type of device and are not mentioned in the documentation.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Information Not Applicable/Available in the Text: The Cholestech LDX™ System is a chemical analyzer, not an AI algorithm. Its performance is inherent to the device's enzymatic and solid-phase technology. The concept of "standalone algorithm performance" without human-in-the-loop is not directly applicable in the same way it would be for a software-as-a-medical-device (SaMD) that processes and interprets data for human review. The document describes the device's direct measurement capabilities.

7. The Type of Ground Truth Used

Inferred from Text: For an in vitro diagnostic device measuring analytes (cholesterol, HDL, triglycerides, glucose), the ground truth is typically established by reference laboratory methods (e.g., highly accurate and precise methods run on core laboratory instruments). While the document does not explicitly state "reference laboratory comparison" for ground truth, the context of an IVD device submission, especially one measuring these specific analytes, strongly implies this method.

8. The Sample Size for the Training Set

Information Not Applicable/Available in the Text: This is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the computational sense. The device's operation is based on established enzymatic and chemical reactions, not on data-driven learning. Therefore, there is no "training set" in the context of AI/ML.

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

Information Not Applicable/Available in the Text: As noted above, there is no "training set" for this type of IVD device in the context of AI/ML. The device's calibration and performance are based on chemical principles and validation studies, not on learning from a training dataset.

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The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. The Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.

This system is intended for use in a hospital environment or medical office environment.

The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System includes a Single Use Flexible Video Cystoscope/Choledochoscope and an HD Medical Video Endoscope Image Processor.

This system is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.

• The Pusen Single Use Flexible Video Cystoscope/Choledochoscope is provided sterile and has the following 4 models: PC200-AS, PC200-AR, PC200-S, and PC200-R.
• The Pusen Single Use Flexible Video Cystoscope/Choledochoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system, and it is powered by the latter.
• The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope/Choledochoscope and display the real-time video on its LCD screen, which enables visual examination of target site.

This document is a 510(k) premarket notification for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." It seeks to establish substantial equivalence to a predicate device for an expanded indication (examination of bile ducts) from a previously cleared device (Pusen Single Use Flexible Video Cystoscope System K222602) which only covered the lower urinary tract.

The information provided does not contain acceptance criteria for device performance measured against the indicated use for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System," nor does it describe a study to prove its performance in meeting such criteria. Instead, it relies on non-clinical performance data (bench testing) and substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document presents a comparison of technological characteristics between the subject device, a predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686), and a reference device (Pusen Single Use Flexible Video Cystoscope System, K222602). This comparison (found on pages 5 and 6) lists specifications such as field of view, depth of field, working length, etc., but these are not presented as acceptance criteria for performance related to clinical outcomes or diagnostic accuracy.

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

This information is not provided. The document states, "No animal study or clinical study is included in this submission." This means there was no "test set" of patient data in the context of a clinical performance study. The "non-clinical performance data" mentioned refers to bench testing, for which sample sizes of tested units are not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. Since no clinical or animal studies were conducted, there was no need for experts to establish ground truth based on patient or animal data.

4. Adjudication Method

This information is not applicable/provided. No clinical studies with expert adjudication were performed.

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

This information is not applicable/provided. No such study was performed, as explicitly stated by "No animal study or clinical study is included in this submission." Therefore, no effect size of human readers improving with or without AI assistance can be reported.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable/provided. The device described is an endoscope system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

This information is not applicable/provided for clinical performance. As stated, no clinical studies were performed. The "ground truth" for the non-clinical performance data would be based on engineering specifications and measurements (e.g., measuring angles of deflection, illumination intensity, image resolution in a lab setting).

8. Sample Size for the Training Set

This information is not applicable/provided. Since no AI or machine learning component is described for clinical decision-making, there is no "training set" in that context.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/provided. As above, there is no training set for an AI algorithm.

Summary of what the document does provide regarding performance:

The document relies on the following points to support the substantial equivalence:

• Non-Clinical Performance Data: "The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System and reference Pusen Single Use Flexible Video Cystoscope System (K222602) share the same fundamental technology and physical characteristics except for the Direction of view and the Maximum insertion portion width, verification reports on these two performances are provided." This indicates that specific bench tests were performed to verify these two differences. The document asserts that "The other performance data described in the cleared Pusen Single Use Flexible Video Cystoscope System, K222602, is also applicable to the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." This implies that prior bench testing for the K222602 device is considered sufficient for this new expanded indication, with only the differences verified.
• Substantial Equivalence Argument: The core of the submission is that the device is substantially equivalent to existing legally marketed devices, primarily the predicate device (K211686), which already has indications for both urinary tract and bile duct examination. The subject device is a modification of a previously cleared device (K222602), with the only change being an expanded "Indications for Use" to include bile ducts, matching the predicate. "No changes were made to the device design. Only the product name, indications for use and applicable labeling were updated."
• Conclusion: "Performance testing and compliance with voluntary standards, demonstrate that the subject device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use."

In essence, the device's "performance" for its intended use, particularly the newly added choledochoscope indication, is justified by its similarity in design and technology to a predicate device that already holds that indication, combined with non-clinical (bench) testing to confirm that minor physical differences do not raise new questions of safety or effectiveness. No clinical studies directly demonstrating performance for the bile duct indication were submitted or required for this 510(k) clearance based on substantial equivalence.

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The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source).

The Flexible Video-Choledochoscope is indicated for use in diagnostic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.

Flexible Video-Choledochoscope System is composed of sterile Flexible Video-Choledochoscope and a non-sterile Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is composed of Operation section, Light-guide Section, Insertion a Distal tip and bending section. The Operation Section is pulled by the wire rope to control the bending direction of the Distal tip.

The Light-guide section transmits the illumination light from the image processor to the Distal tip. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal tip contains a camera system and a lighting system for illumination and observation.

Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface.

Flexible Video-Choledochoscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends.

The product is equipped with tiny size digital imaging parts --photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.

The provided FDA 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it details the device's technical specifications and compares them to a predicate device to establish substantial equivalence.

Therefore, I cannot provide the requested information.

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The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. The Cholesterol2 assay is to be used as an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Cholesterol2 assay is an automated clinical chemistry assay for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide oxidatively couples with N,N-Bis(4-sulfobutyl)-3-methylaniline (TODB) and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which is quantitated at 604 nm.

The provided text describes the Abbott Cholesterol2 assay, an in vitro diagnostic device for quantifying cholesterol in human serum or plasma.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for each performance characteristic. Instead, it presents the results of various studies as proof of device performance. The table below summarizes the reported performance, which implicitly serves as the "met" criteria.

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

• Precision Study: 2 controls and 3 human serum panels were tested. Each sample was tested in duplicate, twice per day for 20 days. This means 80 measurements per sample (2 duplicates x 2 times/day x 20 days).
• Lower Limits of Measurement Study: n ≥ 60 replicates for LoB, LoD, and LoQ determinations. They used low-analyte level samples and zero-analyte samples.
• Linearity Study: The number of samples for the linearity study is not explicitly stated, but it covered the range of 5 to 748 mg/dL.
• Interference Studies: Each endogenous substance was tested at 2 analyte levels (approximately 150 mg/dL and 220 mg/dL). Exogenous substances were tested at various specified interferent levels. The number of samples for each interferent is not provided.
• Method Comparison Study: 138 serum samples were used.
• Tube Type Study: Samples were collected from a minimum of 40 donors.
• Dilution Verification: 8 human serum samples.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the context of medical device regulatory submission, these are typically prospective studies conducted in a controlled laboratory environment. The "human serum panels" and "human serum samples" imply human-derived biological samples.

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 device is an in vitro diagnostic (IVD) chemistry assay. The concept of "experts establishing ground truth" as it applies to image interpretation or clinical diagnosis by medical professionals (like radiologists) does not directly apply here in the same way.

For IVDs like this, the "ground truth" or reference values are established through:

• Reference methods: The Cholesterol2 reagent is certified to be traceable to the National Reference System for cholesterol, against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). The Abell-Kendall method is considered the gold standard for cholesterol measurement.
• Analytically Validated Methods: For values outside the AMI but within the EMI, samples were "value assigned using the analytically validated method."
• Known concentrations: For studies like linearity, spiked samples with known concentrations are used.

Therefore, the "experts" are the methodologists and laboratory professionals overseeing and validating the reference methods and the analytical validation processes. No specific number or qualification of clinical experts (e.g., radiologists) is relevant for establishing the ground truth for a quantitative chemistry assay.

This is a standalone performance evaluation of the assay itself, demonstrating its analytical accuracy, precision, and robustness.

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

The concept of "adjudication" (e.g., 2+1, 3+1 where multiple human readers agree or have a tie-breaker by an expert) is not applicable to this type of quantitative diagnostic assay. The results are numerical values generated by the automated instrument and reagents. Deviations or discrepancies would be resolved through re-testing, quality control, or investigation into instrument or reagent issues, rather than human expert adjudication of a "diagnosis."

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 comparative effectiveness study was not done. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Its output is a quantitative measurement of cholesterol, not an interpretation that requires human "reading" or decision support.

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

Yes, a standalone performance evaluation of the device (Cholesterol2 assay on the ARCHITECT c8000 System) was done. The studies described (reportable interval, precision, lower limits of measurement, linearity, interference, method comparison, tube type, dilution verification) all evaluate the analytical performance of the assay and instrument directly, without human interpretation as part of the primary outcome measure. The output is a numerical concentration of cholesterol.

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

The ground truth used for this quantitative assay primarily relies on:

• Reference Methods: Specifically, the Abell-Kendall reference method, which is considered the gold standard for cholesterol measurement and is used in CDC-Certified Cholesterol Reference Method Laboratory Networks (CRMLN). The device's traceability to this method is explicitly stated.
• Analytically Validated Methods: For verifying values in the extended measuring interval.
• Known Spiked Concentrations: For studies such as linearity and dilution verification, where samples are prepared with precisely known concentrations.

This is an analytical ground truth, not a clinical ground truth derived from pathology or patient outcomes.

8. The sample size for the training set

This document does not describe a typical "training set" in the context of machine learning or AI. This is a chemistry assay that uses reagents and enzymatic reactions, not an algorithm that is "trained" on data. Therefore, the concept of a training set as used in AI development is not applicable here. The assay's analytical characteristics are determined through standard laboratory validation studies.

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

As explained above, there is no "training set" in the AI sense for this device. The analytical accuracy and reliability are established through comparisons to certified reference methods and known standard concentrations, as described in point 7.

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