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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 LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures.

The LumiRex Single-Use Ureteroscope is a flexible video-based medical device designed for insertion through the urethra into the urinary tract. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the urinary tract and interior of the kidney. The ureteroscope also features a working channel that allows for installation of fluids, the passage of various instruments, such as biopsy forceps, cytology brushes, biopsy brushes, and stone retrieval baskets to facilitate urology and ureteroscopy procedures.

The ureteroscope can be used wired or wireless through a Wireless Scope Adapter or Wired Scope Adapter. The adapters transmit images from the ureteroscope to the Video Processor Unit where the user can view the image from the ureteroscope, control the LED, and save and export images from the ureteroscope onto USB removable media.

The provided FDA 510(k) Clearance Letter for the LumiRex Ureteroscope does not detail a clinical study with acceptance criteria and device performance in the way typically expected for an AI/software as a medical device (SaMD) clearance. The document focuses on hardware aspects of the ureteroscope, such as sterilization, biocompatibility, electrical safety, and basic bench testing (e.g., field of view, depth of field, image quality).

Specifically, there is no mention of an AI component, an algorithm, or any study involving human readers or ground truth for diagnostic accuracy. The "Software" section primarily refers to verification and validation of the device's operating software (e.g., for image processing, LED control) according to IEC 62304, not an AI or diagnostic algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device (in the context of an AI/diagnostic algorithm) meets acceptance criteria, an MRMC study, or the establishment of ground truth for a diagnostic task. The document provided does not contain this information.

Based on the provided text, the LumiRex Ureteroscope is a physical medical device (endoscope) and not an AI/SaMD product that would typically involve the type of diagnostic performance studies you are asking about.

To answer your prompt with the available information:

Acceptance Criteria and Device Performance for LumiRex Ureteroscope (as per 510(k) Summary)

Based on the provided FDA 510(k) Premarket Notification (K243532) for the LumiRex Ureteroscope, the "acceptance criteria" and "study" described are primarily focused on the physical and functional performance of the medical device itself, rather than the diagnostic performance of an AI algorithm. The rigorous detail for AI/diagnostic studies (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies) is not present because this is not an AI-driven diagnostic device.

The clearance is for a ureteroscope, which is a tool for visualization and intervention. Its performance is evaluated against engineering standards and comparison to a predicate device, not against clinical diagnostic accuracy metrics established by human experts reading images with or without AI assistance.

Here's an interpretation of the "acceptance criteria" and "reported device performance" based on the document, framed by the categories you requested, but noting where information is absent due to the nature of the device:

1. Table of Acceptance Criteria & Reported Device Performance

Since the device is a ureteroscope and not an AI/SaMD, the subsequent points of your request are not applicable or details are not provided in this type of 510(k) summary.

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

• Not Applicable in the context of an AI diagnostic test. The "test set" here refers to physical product units subjected to bench testing (e.g., specific endoscopes for image quality testing, or multiple cycles for endurance testing). No specific "sample size" for patient data or cases is mentioned because this is not an AI diagnostic device.
• Data Provenance: Not applicable for diagnostic data as described. The testing is laboratory-based and engineering-focused.

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

• Not Applicable. "Ground truth" in this context (pathology, clinical outcome) is not established or used for the clearance of an endoscope's basic imaging and physical functionality. Experts might be involved in evaluating usability or design, but not for "ground truth" to validate a diagnostic algorithm.

4. Adjudication Method for the Test Set:

• Not Applicable. No diagnostic test set requiring adjudication (e.g., 2+1, 3+1) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• No. Such a study is typically performed for AI-assisted diagnostic tools. This 510(k) does not describe any MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• No. There is no standalone diagnostic algorithm described for this device.

7. The Type of Ground Truth Used:

• Not Applicable. No diagnostic ground truth (e.g., pathology, outcomes data) is used for the clearance of this device as described. Performance is measured against engineering standards and comparison to a predicate device's physical and functional attributes.

8. The Sample Size for the Training Set:

• Not Applicable. There is no AI/machine learning component described that would require a "training set" of diagnostic data.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth establishment method is mentioned.

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