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The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The device models are Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, and Y-12-50.

The device is composed of access sheath and dilator. The access sheath consists of sheath tube and connector. The dilator consists of dilator tube and dilator base. Single-use Ureteral Access Sheath is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided FDA 510(k) clearance letter details the substantial equivalence for a "Single-use Ureteral Access Sheath." This document does not contain information about an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance.

The information provided describes a medical device, its intended use, and various performance tests to ensure its safety and effectiveness compared to a predicate device. These tests are standard for a physical medical device (like biocompatibility, sterility, shelf-life, and mechanical bench tests) and are not related to artificial intelligence or machine learning performance metrics found in an AI/ML-driven medical device study.

Therefore, I cannot fulfill your request to describe acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document clearly states "VIII. Clinical study: Not applicable" for this device, which further confirms the absence of data related to human reader performance with or without AI assistance, or algorithm-only performance.

If you have a document describing an AI/ML device, I would be happy to analyze it according to your requested criteria.

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The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope (model:CL-A, CL- B), and the Image Processor (model: HUV-02). The Single-use Biliary Pancreaticobiliary Scope is a flexible scope, introduced into the pancreatico-biliary system via a duodenoscope. The Single-use Biliary Pancreaticobiliary Scope comprises a handle, an insertion tube, and a connection cable.

I am sorry, but the provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for a device to meet those criteria. The document is a 510(k) clearance letter from the FDA for a "Biliary Pancreaticobiliary Scope System."

Here's what I can tell you based on the provided text, and what is missing:

Information Present in the Document:

• Device Name: Biliary Pancreaticobiliary Scope System
• Intended Use/Indications for Use: The system is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system, including the hepatic ducts. It provides direct visualization, illumination, and guidance for accessory devices.
• Non-Clinical Tests Summary: The document lists various non-clinical tests performed, including:
  • Biocompatibility (Cytotoxicity, Intracutaneous reactivity, Sensitization, Acute systemic toxicity, Pyrogen)
  • Sterilization and shelf life testing (ISO 11135:2014, ISO 10993-7:2008, ASTM F1980-21, ISO 11607-1.2019, ASTM F 1886/F1886M-16, ASTM F88F88M-15, ASTM F 1929-15)
  • Electrical safety and electromagnetic compatibility (EMC) (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2)
  • Software Verification and Validation Testing (according to FDA guidance)
  • Bench performance testing:
    • Optical performance (ISO 8600 series)
    • Color performance (color reproduction), optical performance (resolution, depth of field, image intensity uniformity), SNR, dynamic range, frame frequency, and system delay test compared with the predicate device.
    • Mechanical testing (water resistance, deflection, working channel system leakage, articulation reliability, attachment to duodenoscope reliability, irrigation pump compatibility)
  • Animal testing (referring to FDA Guidance-General Considerations for Animal Studies Intended to Evaluate Medical Devices)
• Clinical Testing: "Not Applicable." This explicitly states that clinical testing was not performed for this submission.
• Predicate Device: SpyGlass DS Direct Visualization System (K142922)

Information NOT Present in the Document (and therefore cannot be provided by me):

1. A table of acceptance criteria and the reported device performance: While various tests are listed, the document does not provide specific quantitative acceptance criteria (e.g., "resolution must be X lp/mm") or the measured performance results of the device against these criteria. It only states that the device "complies with" certain standards or that tests were "performed."
2. Sample size used for the test set and the data provenance: This information is not provided for any of the tests, nor is there a "test set" in the context of clinical or AI performance. The animal test simply states it was conducted, but no details on size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no clinical or AI performance study with human expert review is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Irrelevant due to no clinical or AI performance study.
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, as this is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the non-clinical tests described. For the animal study, the ground truth would be based on observations during the animal procedure, but no details are given.
8. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence through non-clinical performance, safety, and compatibility testing, rather than a detailed clinical effectiveness study with acceptance criteria and performance data. The phrase "Performance testing and compliance with voluntary standards demonstrate that the proposed Biliary Pancreaticobiliary Scope System is substantially equivalent to the predicate device" serves as the overall conclusion for meeting FDA's requirements for this 510(k) pathway.

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The Ureterorenoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.

The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management with accessories and an image processor, previous clearly by K231118, for clinical image processing.

The single-use Ureterorenoscope 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 Ureterorenoscope and outputs video signals to a display.

The provided text is a 510(k) summary for the Ureterorenoscope System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on bench performance, biocompatibility, sterilization, and electrical safety.

Crucially, the document explicitly states "Clinical study: Not applicable." This means that the submission did not include a study that proves the device meets specific acceptance criteria based on clinical performance with human subjects, especially concerning AI-driven functionalities for diagnosis or assistance.

Therefore, I cannot provide details regarding acceptance criteria for a study related to AI performance, sample size for a test set, ground truth experts, adjudication methods, MRMC studies, or standalone algorithm performance, as such a study was not part of this 510(k) submission.

The "performance data" section (Section 8 of the 510(k) summary) details various engineering and safety tests, not clinical efficacy or AI performance.

Below is a breakdown of what can be extracted from the provided text regarding device performance, categorized to best fit your request, while acknowledging the absence of AI-specific clinical study data.

Table of Acceptance Criteria and Reported Device Performance (Based on Bench Testing and Safety Standards)

Since no clinical study data for AI performance is present, the "acceptance criteria" here refer to compliance with various engineering, safety, and manufacturing standards. The "reported device performance" indicates that the device met these standards.

Regarding AI-Specific Questions (Not Applicable Based on Provided Text):

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from an AI study is provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth data from an AI study is provided.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set data from an AI study is provided.
4. 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. The document explicitly states "Clinical study: Not applicable."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical ureterorenoscope system, not a standalone AI algorithm for diagnostic interpretation in this submission.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI performance. The ground truth for bench testing is defined by engineering specifications and measurements against the predicate device.
7. The sample size for the training set: Not applicable. There is no mention of an AI training set.
8. How the ground truth for the training set was established: Not applicable. There is no mention of an AI training set or its ground truth establishment.

In summary, this 510(k) submission for the Ureterorenoscope System focuses on the physical and functional aspects of the endoscope and image processor, along with compliance to relevant safety and performance standards, rather than clinical performance from an AI perspective.

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The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope. The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.

The document provided is a 510(k) premarket notification for a medical device, the Rhinolaryngoscope System. It details the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, this document does not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers and AI assistance.

The device described is a Rhinolaryngoscope system, which is an endoscope for visualization. The performance data provided are primarily related to the physical and electrical aspects of the device, such as biocompatibility, sterilization, electrical safety, EMC, and bench performance (optical performance, mechanical bending, photobiological safety, thermal safety). There is no mention of an algorithm or AI component that would require an acceptance criteria table for AI performance metrics, a test set with ground truth from experts, or multi-reader multi-case studies.

Therefore, I cannot fulfill the request for information on acceptance criteria and study proving an AI/ML device meets them based on the provided text. The questions regarding sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, training set size, and how training set ground truth was established are irrelevant to the information present in this 510(k) submission, as it does not pertain to an AI/ML component.

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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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The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.

The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing. The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor. The single-use Cystoscope 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 Cystoscope and outputs video signals to a display.

This FDA 510(k) summary (K231118) describes the substantial equivalence of the "Cystoscope System" to a predicate device, the "Ambu aScope 4 Cysto." The submission primarily relies on bench performance testing and compliance with voluntary standards rather than clinical or AI performance studies to establish substantial equivalence.

Therefore, the requested information about acceptance criteria and study data for an AI/device performance assessment is largely not applicable to this specific submission, as it concerns a physical medical device (cystoscope) and its image processing unit, not an AI-driven diagnostic or treatment algorithm.

However, I can extract and present the types of performance data that were provided, framed in a way that attempts to answer your questions where possible, though direct "acceptance criteria" for AI performance or "effect size of human readers with AI" are not present.

Here's a breakdown based on the provided text, indicating "N/A" where the requested information is not relevant to this traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The submission focuses on verification and validation of engineering performance and regulatory compliance, not clinical or image-based diagnostic accuracy. Bench tests would use a sample of manufactured devices.
• Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing, engineering assessments, and quality control processes conducted by the manufacturer (Shenzhen HugeMed Medical Technical Development Co., Ltd. in China).

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

• Number of Experts: Not applicable. This is not an AI/diagnostic algorithm submission requiring expert-established ground truth on medical images.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This submission does not involve an AI component that would necessitate an MRMC study comparing human readers with and without AI assistance. The device is a direct visualization tool.
• Effect Size of Human Readers with AI: Not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Study: No. There is no AI algorithm being submitted for standalone performance evaluation in this context. The "software" mentioned relates to the image processor's operational software, not a diagnostic AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (ISO, IEC, ASTM), and comparison to the predicate device's characteristics. For example, optical performance is measured against ISO 8600 series standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This product is a medical device (cystoscope system), not an AI algorithm requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The Single-use Bronchoscope have been designed to be used with the Image 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 Single-use is a single-use device designed for use in adults.

The Bronchoscope System consists of Single-use Bronchoscope (six models shown in below) to be introduced within the airways or tracheobronchial tree and Image Processor (model: VLM-02) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Image Processor provides power and processes the images for medical electronic endoscope.

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Image Processor is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the Single-use 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 Image Processor via the VI circuit. The Image Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Image Processor also controls the brightness of the LEDs on the endoscope.

The optical components and their arrangement at the distal tip for all models of the Singleuse Bronchoscope are identical.

Single-use Bronchoscope 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

Image Processor has the following physical and performance characteristics:

• Display the image from the Single-use Bronchoscope on the screen ●
• Can record screenshots or video of image from the Single-use Bronchoscope
• Can connect to an external monitor ●
• Reusable device

The provided text is a 510(k) summary for a Bronchoscope System. It details the device description, indications for use, comparison to a predicate device, and performance data. However, it does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device. The document lists bench performance tests according to ISO 8600 series and other parameters, but these are for a standard bronchoscope system, not an AI component.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML component.
• Sample size for the training set for an AI/ML component.
• How ground truth for the training set was established for an AI/ML component.

The document explicitly states: "No clinical study is included in this submission" (Section 10), and the performance data primarily relates to bench testing, biocompatibility, sterilization, electrical safety, and software verification/validation for the traditional bronchoscope system.

To answer your request for an AI/ML device, I would need a different document that describes such a device and its associated clinical or performance studies.

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