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The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

The Single-use Flexible Ureteroscope is intended to be used with Vathin Digital Video Monitor. During diagnosis and treatment, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.

The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. It is for use in professional Healthcare Facility Environment.

The provided FDA 510(k) clearance letter and its associated summary for the "Single-use Flexible Ureteroscope" does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the way one might expect for an AI-enabled device or a diagnostic accuracy study. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Therefore, the requested information cannot be fully extracted from the provided text. I will provide the acceptance criteria as implied by the non-clinical tests conducted to prove substantial equivalence, and note where specific information is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each bench test, nor does it provide specific numerical performance results. Instead, it states that the device "complies with" or "met its design specifications" or "has been validated according to" relevant standards.

Missing Information Details:

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The studies were non-clinical bench tests and biocompatibility tests, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the studies were non-clinical bench tests and material safety tests, not studies requiring expert interpretation of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench tests.
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. This document describes a medical instrument, not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically defined by the specified performance limits or standards outlined in the applicable international standards (e.g., ISO, IEC, ASTM). For biocompatibility, it's the lack of adverse biological reactions.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the provided FDA document details the non-clinical testing performed to demonstrate the safety and effectiveness of a physical medical device (a single-use flexible ureteroscope) for substantial equivalence to a predicate device. It does not contain information related to diagnostic accuracy studies, AI performance, or clinical trials with human readers or patient data.

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The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. The compatible Digital Video Monitor: Model: DVM-A1. The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same. The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.

The provided text describes the regulatory filing for a medical device (Single-use Flexible Ureteroscope) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to its performance in a clinical setting or its impact on human readers, especially regarding AI assistance. The document focuses on physical, optical, electrical and biocompatibility performance.

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance or studies involving human readers/AI assistance based on the text.

However, I can extract information regarding the non-clinical performance acceptance criteria and proof as described in the document.

Here's an interpretation based on the provided text, focusing on the available non-clinical performance and acceptance testing:

Device: Single-use Flexible Ureteroscope

Study Type: Non-clinical Performance Testing and Biocompatibility Testing (for 510(k) Substantial Equivalence)

1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:

The document mentions that "All evaluation acceptance criteria were met" for biocompatibility and that the device "complies with" relevant electrical safety and EMC standards. For functional, mechanical, and optical performance, it lists the tests performed, implying that the device passed these tests to demonstrate equivalence. Specific quantitative acceptance values are not explicitly stated for all tests, but compliance with standards and successful completion of tests serve as the "proof."

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

• Sample Size: Not explicitly stated for each test. These are non-clinical (bench) tests, so the "sample size" would refer to the number of device units tested. This might range from a few units to a statistically significant number depending on the specific test and standard, but the document does not specify.
• Data Provenance: The tests were conducted internally by the manufacturer (Hunan Vathin Medical Instrument Co., Ltd.) or by accredited labs on their behalf, likely in China given the company's location. This is inherently retrospective data gathered for the purpose of the 510(k) submission.

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

• Not Applicable. This section typically applies to studies where human interpretation of medical images or clinical data is involved. Since this document describes non-clinical, bench testing, no human experts were used to establish a "ground truth" in the clinical sense. The "ground truth" for these tests are the objective measurements against engineering specifications and international standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As no human interpretation and subsequent need for consensus are involved in these non-clinical tests, no adjudication method was used.

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

• No. The document does not describe any MRMC study. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

• No. This device is an endoscope, not an AI algorithm. Therefore, "standalone" AI performance is not applicable. The performance described is the inherent performance of the optical, mechanical, and electrical components of the device itself.

7. Type of Ground Truth Used:

• For Biocompatibility, Electrical Safety, EMC, and Sterility: Adherence to International Standards (e.g., ISO 10993, ISO 11607, ISO 11135, IEC 60601 series) and Regulatory Requirements.
• For Functional, Mechanical, and Optical Performance: Engineering Specifications and Design Requirements agreed upon during device development.

8. Sample Size for the Training Set:

• Not Applicable. This device is a physical instrument, not an AI model that requires a training set of data.

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

• Not Applicable. As above, no training set is involved.

In summary, the provided FDA clearence letter and supporting summary pertains to the substantial equivalence of a physical medical device (endoscope) based on its non-clinical performance and safety characteristics, not on the performance of a diagnostic AI algorithm or its impact on human readers.

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