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This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

The provided text is an FDA 510(k) clearance letter and summary for a Urology Videoscope System. It details acceptance criteria based on non-clinical performance data and various tests. However, it does not include information about a study proving device meets acceptance criteria related to human reader performance with or without AI assistance, a multi-reader multi-case (MRMC) comparative effectiveness study, or any AI component for which such an evaluation would be relevant.

The document primarily focuses on bench testing and technical performance of the Ureteroscope, Cystoscope, and Image Processor, rather than the diagnostic interpretive performance of an AI algorithm.

Therefore, many of the requested points in the prompt (2-9) are not applicable or cannot be answered from the provided text, as they pertain to AI/machine learning model evaluation in a diagnostic context.

Here's the information that can be extracted or deduced from the text, with explanations for what cannot be answered:

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

The document lists various performance tests conducted to demonstrate compliance with standards, implying these are the acceptance criteria for the respective tests. However, it does not provide specific numerical acceptance thresholds or detailed "reported device performance" values for each criterion, only that "The test results demonstrated that the subject device complies with the standard requirements" or that testing was "conducted on the subject device" to "demonstrate the subject endoscope can function as intended."

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

This information is not provided in the document as the studies described are non-clinical, bench-top, and engineering performance tests, not studies on image datasets. The device is manufactured in China.

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 information is not applicable/not provided. The ground truth for the non-clinical tests would be established by engineering specifications, physical measurements, and adherence to international standards, not by clinical experts reading images.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical image interpretation studies, not for the technical performance tests described.

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

There is no mention of an AI component or any MRMC study in this document. The device is an endoscope system for visualization and therapy, not an AI-assisted diagnostic tool. The document explicitly states: "The clinical data is not applicable."

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

There is no mention of an AI algorithm in this document, therefore no standalone algorithm performance study was indicated.

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

For the non-clinical tests described, the "ground truth" would be the engineering specifications, physical parameters, and established international standards (e.g., ISO, IEC) against which the device's performance is measured. It is not clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided, as there is no AI or machine learning model mentioned that would require a training set.

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

This information is not applicable/not provided, as there is no AI or machine learning model mentioned.

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The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The devices are for use in professional Healthcare Facility Environment.

The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.

The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.

The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.

Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:

1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):

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The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.

The Cystoscope is intended to provide visualization via displaying unit.

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

VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process.

VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet.

VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip.

The provided text does not contain information about acceptance criteria for a device's performance that would require a study with a test set, expert adjudication, or MRMC studies. The document describes a 510(k) premarket notification for a cystoscope, focusing on substantial equivalence to a predicate device based on technical characteristics and nonclinical tests.

Therefore, I cannot provide the requested information. The document states:

"Clinical Tests
No clinical studies were performed."

This indicates that the submission did not include studies that would typically define acceptance criteria based on performance with a test set and ground truth. The listed nonclinical tests focus on safety, electrical compatibility, sterilization, and basic optical performance specifications, not on clinical performance metrics with a patient dataset.

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The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.

This document describes the validation of a Single-Use Flexible Cystoscope (K221580), comparing it to a predicate device, the Ambu Ascope 4 Cysto (K193095).

Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics suitable for a table of reported device performance. The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the provided information relative to your request:

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

• Acceptance Criteria: The document lists numerous performance tests conducted. For each of these, acceptance criteria would have been established internally by the manufacturer, and the device's performance would have been compared against these. However, these specific acceptance criteria and the quantified reported device performance (e.g., 'Bending angle: device achieved X degrees vs. acceptance criteria Y degrees') are NOT provided in this FDA 510(k) summary. The document only states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies" with electrical safety and EMC standards, and that various performance tests were "conducted."

Therefore, a table cannot be fully constructed with the information given. The types of performance tests conducted are:

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