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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 Bronchoscope has been designed to be used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. Single-use Sampler is designed as an add-on for use during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedures which enable aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.

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 Video Bronchoscope System is for use in professional Healthcare Facility Environment.

The Video Bronchoscope System consists of Single-use Flexible Bronchoscope, Single-use sampler and digital video monitor. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The video monitor receives the real-time image signal from Bronchoscope and displays the live image. During the bronchoscope sputum aspiration and collection, the fluid in the patient's body can be sucked out by pressing the suction button on the bronchoscope. The sampler control switch can collect liquid into the sampler.

The provided text is a Premarket Notification 510(k) Submission for the Hunan Vathin Medical Instrument Co. Ltd.'s Video Bronchoscope System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain specific acceptance criteria, reported device performance metrics in a tabular format, details about a clinical study (sample size, data provenance, expert qualifications, adjudication methods), information on multi-reader multi-case (MRMC) studies, standalone algorithm performance, or details about training set ground truth.

The submission focuses on non-clinical tests to demonstrate safety and performance. Here's a summary of the information that is available based on your request, and what is missing:

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

• Not provided in the document. The document lists the performance tests conducted but does not provide specific numerical acceptance criteria or the measured performance values.

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

• Not provided in the document. The document details non-clinical tests (biocompatibility, sterilization, electrical safety, software verification, performance testing) but does not describe a clinical test set with human subjects or data provenance.

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)

• Not provided in the document. This information would typically be relevant for a clinical study involving interpretation of images or data, which is not detailed here.

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

• Not provided in the document. This is relevant for clinical studies with expert reviewers, which are not 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

• Not mentioned in the document. The device is a physical bronchoscope system; there is no indication of it incorporating AI or being subject to an MRMC study.

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

• Not applicable/Not mentioned in the document. The device is a bronchoscope system, not an AI algorithm. While it has software, standalone algorithm performance is not a focus here.

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

• Not provided in the document. For non-clinical tests, "ground truth" often refers to engineering specifications or validated test methods. The document states that "All evaluation acceptance criteria were met" for biocompatibility and that electrical safety and EMC tests comply with relevant IEC standards. Performance tests were conducted based on engineering specifications.

8. The sample size for the training set

• Not applicable/Not mentioned in the document. This device is hardware with integrated software, not a machine learning model that requires a "training set" in the typical sense. Software verification and validation were conducted.

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

• Not applicable/Not mentioned in the document. See point 8.

Summary of Conducted Studies (from the document):

The document primarily describes non-clinical tests to demonstrate the safety and effectiveness of the Video Bronchoscope System, ensuring its substantial equivalence to predicate devices. These tests include:

• Biocompatibility testing: Evaluated according to ISO 10993-1:2018 for "Surface – Mucosal Membrane" body contact for "Limited (

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The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

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 Video Bronchoscope System is for use in professional Healthcare Facility Environment.

The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen.

The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.

The provided text is a 510(k) summary for the "Video Bronchoscope System" and does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document discusses substantial equivalence to predicate devices and lists various non-clinical tests performed, along with a general statement that "All tests were passed." However, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance for performance studies.
• Information about experts, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance (as this is a physical device, not an AI algorithm).
• Specific ground truth types used for performance evaluation.
• Training set sample size or ground truth establishment for training.

The document focuses on:

• Biocompatibility testing: Evaluated according to ISO 10993-1:2018 (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity). All evaluation acceptance criteria were met.
• Sterilization and shelf-life testing: Validated according to ISO 11135.
• Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 for EMC.
• Software Verification and Validation Testing: Conducted as recommended by FDA guidance.
• Performance testing: Included optical tests (color rendering index, illuminance, correlated color temperature, geometric distortion, color restoration, resolution, depth of field, field of view, direction of view, signal-to-noise ratio, dynamic range, geometric distortion, image brightness uniformity, field of view) and mechanical tests (working length, minimum instrument channel width, outer diameter of main hose, max. outer diameter, bending angle, water delivery capacity and attractive volume capacity test).
• Shelf-life verification test and Packaging verification test.

Without more specific detailed performance data from the confidential section of the 510(k) submission, it is not possible to provide the requested information in the specified format. The document only offers a high-level summary of tests conducted and their successful completion.

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