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The Vathin®H-SteriScopeTM single-use flexible video bronchoscope has been designed to be used with the Vathin display unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in patients.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

The Vathin®H-SteriScopeTM single-use flexible video bronchoscope is a single-use device designed for use in adults, with the BCV1-02 and BCV1-C2 also designed for pediatric use (BCV1-02: 6 months to 6 years; BCV1-C2: 6 years and older).

The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScopeTM Single use flexible Video Bronchoscope (model: BCV1-02, BCV1-C2) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenterTM Digital Video Monitor (model: DVM-B1, DVM-B2) for clinical image processing.

The Vathin®H-SteriScopeTM Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCentereTM Digital Video Monitor provides power and processes the images for medical electronic endoscope.

Vathin®H-SteriScopeTM Single-use flexible Video Bronchoscope is a sterile single-use flexible bronchoscope. Vathin®H-SteriScopeTM Digital Video Monitor is a reusable monitor.

I regret to inform you that the provided FDA 510(k) clearance letter and accompanying 510(k) Summary for the Vathin® Video Bronchoscope System do not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving device performance as it relates to AI/software functionality.

This document focuses on justifying Substantial Equivalence for a bronchoscope system based on its physical characteristics, safety standards (electrical, biocompatibility, sterilization), and basic performance (optical, mechanical). It mentions "Software verification and validation" in Section 7.4, citing the "FDA guidance: Content of Premarket Submissions for Device Software Functions," but does not provide any specific acceptance criteria, study data, or details about the software's functionality, especially regarding AI capabilities.

Therefore, I cannot populate the table or answer the specific questions about AI performance, test set details, ground truth establishment, or human reader studies.

Here's why the document is insufficient for your request:

• No AI/Algorithm Claims: The document describes a video bronchoscope and its display unit. It doesn't mention any AI or advanced algorithmic functions (e.g., automated lesion detection, image enhancement using AI, diagnostic support) that would necessitate performance criteria like sensitivity, specificity, or reader studies.
• Focus on Hardware/System Performance: The performance data section (7.1-7.6) primarily addresses the physical and electrical safety, biocompatibility, sterilization, and basic optical/mechanical functions of a medical device (bronchoscope). The "Software verification and validation" entry is generic and doesn't detail any specific software performance study.
• Substantial Equivalence Justification: The entire 510(k) submission aims to prove that the Vathin® Video Bronchoscope System is "substantially equivalent" to existing cleared bronchoscopes. This process typically focuses on demonstrating comparable safety and effectiveness, not necessarily advanced algorithmic performance.

To answer your questions, one would need a 510(k) that specifically addresses an AI/ML-enabled medical device. Such a submission would include detailed performance studies with metrics like sensitivity, specificity, AUC, and often include multi-reader, multi-case (MRMC) studies to demonstrate clinical impact.

If you had provided a 510(k) document for an AI-powered device, the table and answers would look something like this (conceptual example):

Conceptual Example - This section is not based on the provided document as it does not contain the necessary information.

For an AI-powered medical device, the acceptance criteria and study proving its performance would be detailed as follows:

1. Acceptance Criteria and Reported Device Performance

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

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging 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 of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging 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 Single-use Bronchoscope are identical.

The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.

This FDA 510(k) summary describes the Bronchoscope System (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1). The submission indicates that no clinical studies were performed to demonstrate substantial equivalence. Instead, a series of non-clinical (bench) tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate devices (K231107 and K191828).

Therefore, I will provide the acceptance criteria and performance as reported for the non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are typically compliance with recognized standards or meeting specific performance benchmarks defined in the device's design specifications. The "reported device performance" refers to the results of these tests confirming that the device meets those standards/specifications.

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test performed. However, these tests are typically performed on a statistically representative number of manufactured units according to the applicable standard requirements (e.g., a certain number of devices for electrical safety, biocompatibility batches, etc.).
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human subjects. The manufacturer is Shenzhen Sanping Image Technology Co., Ltd. located in Shenzhen, Guangdong, China. The data would therefore originate from testing facilities associated with the manufacturer or their designated testing laboratories. The data is prospective in the sense that it was generated specifically to support this 510(k) submission.

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

Not applicable. Since no clinical studies were performed, there was no test set requiring expert ground truth establishment for diagnostic or clinical performance. The non-clinical tests relied on validated reference methods and calibrated equipment to assess various physical and performance characteristics against established international standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no reported effect size regarding human reader improvement with or without AI assistance.

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

This device is not an AI/algorithm-only device. It is a Bronchoscope System, which functions as a direct visualization tool for medical professionals. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" implicitly refers to the specifications defined by the international consensus standards (e.g., IEC, ISO) and the device's own design specifications. The tests verify that the device's physical, electrical, mechanical, and imaging properties meet these predefined engineering and safety benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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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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The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, 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 Bronchoscope is a disposable device designed for use in adults.

The Bronchoscope System consists of Single-use Bronchoscope (Model: BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3) to be introduced within the airways or tracheobronchial tree and Monitor for Single-Use Endoscopy (Model: P1-A, P1-C, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E) for clinical image processing. The Single-use Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Monitor provides power and processes the images for medical electronic endoscope.

The Single-use Bronchoscope is a sterile single use flexible bronchoscope. The Monitor for Single-Use Endoscopy is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the disposable video 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 Monitor for Single-Use Endoscopy via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals and outputs the processed video signal. The Monitor also controls the brightness of the LEDs on the endoscope.

The provided document is a 510(k) Premarket Notification and primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a novel AI/ML-driven medical device. Therefore, it does not contain the specific information required to answer many of the questions about acceptance criteria, detailed study design, ground truth establishment, or human-in-the-loop performance.

This document describes a "Bronchoscope System," which includes a "Single-use Bronchoscope" and a "Monitor for Single-Use Endoscopy." The core technology described involves an optical system with a CMOS sensor to capture images for display, which is a common technology for endoscopes, not necessarily an AI/ML device in the sense of image analysis/decision support.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

The document does not present a formal table of acceptance criteria with reported quantitative performance metrics in the format usually seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through various non-clinical tests compared to a predicate device.

The "Summary of Testing" section lists the types of tests performed. The acceptance criteria are implicitly that the device performs "as well as" the predicate or meets established ISO standards.

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

The document states: "Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification."

This means there was no clinical test set in the traditional sense for evaluating something like diagnostic accuracy of an AI/ML model. The evaluation was done through non-clinical bench testing, electrical safety, biocompatibility, and software V&V. Therefore, information on sample size, data provenance (country, retrospective/prospective) for a clinical test set is not applicable to this submission.

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)

Since no clinical studies were performed, no expert ground truth establishment for a clinical test set was required or conducted.

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

Not applicable as no clinical test set using expert adjudication was conducted.

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 diagnostic device submission requiring MRMC studies. The device is a bronchoscope system for visualization.

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

This refers to an AI algorithm's performance. The Bronchoscope System is a hardware device for direct visualization, not an AI algorithm. Therefore, "standalone performance" in the AI sense is not applicable.

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

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ISO standards), and comparisons against the predicate device's established performance parameters. For example:

• Electrical Safety/EMC: Compliance to IEC standards.
• Optical Performance: Measurement against ISO 8600 series specifications.
• Biocompatibility: Results of standard biological tests (e.g., cytotoxicity, sensitization) against established safe thresholds.

8. The sample size for the training set

The document does not mention a "training set" because it is not an AI/ML device that requires machine learning training.

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

Not applicable, as no training set for an AI/ML model was used.

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The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Vathin® Video Bronchoscope System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a standard FDA clearance document that states the device has been found substantially equivalent to a legally marketed predicate device. It discusses regulatory aspects, such as general controls, potential additional controls for Class II/III devices, and compliance with various FDA regulations.

It does not include details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., expert consensus, pathology).
• How ground truth for any set was established.

Therefore, I cannot fulfill your request for this information based on the provided text. To obtain such details, you would typically need to refer to scientific publications, clinical trial reports, or other technical documentation directly submitted to the FDA, which are not part of this clearance letter.

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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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PENTAX Medical Single Use Video Bronchoscope EB-S01 is sterile single use flexible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endo-therapeutic procedures within the airways and tracheobronchial tree.

PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation.

PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to be attached to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices:

• . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01
• . PENTAX Medical Mobile Processor ONE-M
• . PENTAX Medical Mobile Processor Plug-in ONE-Dock

The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

Based on the provided text, the document is a 510(k) Premarket Notification for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials for new indications or technologies. Therefore, the information provided focuses on demonstrating equivalence through non-clinical performance data and technological comparisons, rather than a clinical study with detailed acceptance criteria and a human-in-the-loop performance study as might typically be found for AI/ML device submissions.

The document does not describe a study that proves the device meets specific acceptance criteria related to an AI/ML algorithm's diagnostic performance, as it is a bronchoscope system, not an AI/ML diagnostic aid. It lists various non-clinical performance tests to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not applicable or not detailed in this submission because it is not an AI/ML device submission for diagnostic accuracy.

However, I can extract the relevant information that is present and explain why other requested information is not available:

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

The document describes general performance equivalency rather than specific quantitative acceptance criteria for image analysis or diagnostic performance of an AI system. The key "acceptance criteria" here relate to demonstrating equivalence to a predicate device and meeting recognized standards for safety and performance (e.g., electrical safety, biocompatibility).

2. Sample size used for the test set and the data provenance:

• Test Set: Not applicable in the context of an AI/ML "test set" for diagnostic performance. Performance testing involved various engineering and animal studies. For the "Animal Image Capture Study," an animal model was used, but the specific number of animals is not provided. The data provenance is implied to be from internal testing by PENTAX Medical.
• Data Provenance: Implied to be from internal testing and validation studies conducted by PENTAX Medical (e.g., "PENTAX Medical coordinated with HA2 Medizintechnik GmbH (German company) to validate the use of EO sterilization"). The animal study location and specifics are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The ground truth for this device's performance does not involve human expert adjudication of images for diagnostic purposes in the way it would for an AI/ML algorithm. The performance evaluation focused on physical, electrical, and optical properties as well as safety and biocompatibility.

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

Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results.

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 device is a bronchoscope system, not an AI-assisted diagnostic tool for image interpretation. No MRMC study was conducted or required for this type of submission.

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

Not applicable, as this is a medical device for direct visualization and not an AI algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for this submission are the established performance specifications for medical devices, relevant ISO standards, and the performance of the predicate device, against which the subject device's non-clinical performance was compared (e.g., electrical safety standards, biocompatibility testing results, optical measurements, and visualization capabilities in an animal model).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.

WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree. This system includes a single-use digital bronchoscope and an image system.

• The image system OTU-A is the currently marketed in the United States by OTU Medical Inc. under 510(k) # K181977.
• The single-use bronchoscope is comprised of a control body with an articulation lever, a suction connector, a suction button, and a working channel port, and a flexible insertion tube with an on-tip camera module and LED lighting source.

The provided document is a 510(k) summary for the WiScope® Digital Bronchoscope System. It details the device's characteristics, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence. Crucially, it explicitly states "No clinical study is included in this submission" in section 10, "Performance Data-Clinical".

Therefore, based on the provided text, there is no information available regarding acceptance criteria based on clinical performance, nor any study that proves the device meets such criteria through clinical data. The submission relies entirely on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.

However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted and the reported non-clinical device performance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance (Non-Clinical)

Given that "No clinical study is included in this submission," the acceptance criteria and performance data relate entirely to non-clinical testing and established industry standards for medical devices. The device is deemed to meet acceptance criteria if it passes these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since the submission explicitly states "No clinical study is included in this submission," the following points directly related to clinical studies or AI/human-in-the-loop performance cannot be addressed from the provided text.

2. Sample size used for the test set and the data provenance: Not applicable for clinical data. For non-clinical, the sample sizes would refer to the number of devices or components tested, which is not specified but implied by the "All tests were passed" statements for various categories (e.g., biocompatibility testing of specific materials, sterilization validation on a batch of devices). Data provenance is not described for these non-clinical tests (e.g., where manufacturing/testing was performed).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there are no clinical studies or ground truth established by experts for such studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for clinical studies.

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 there is no clinical study and no mention of AI assistance. The device is a physical bronchoscope system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a physical system, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical data. For non-clinical tests, the "ground truth" is adherence to national and international testing standards (e.g., ISO, ASTM, IEC).

8. The sample size for the training set: Not applicable, as there is no AI component requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

Not Found

The provided text is an FDA 510(k) clearance letter for the Vathin Video Bronchoscope System. It does not contain any information about acceptance criteria, device performance studies, or details regarding AI algorithms.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this data is not present in the given document.

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The flexible bronchoscope have been designed to be used with the video 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 Flexible Bronchoscope is a single-use device designed for use in adults.

The Bronchoscope System consists of Flexible Bronchoscope (twelve models shown in below) to be introduced within the airways or tracheobronchial tree and Video Processor (model: EOS-H-01) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope.

The Flexible Bronchoscope is a sterile single used flexible bronchoscope. The Video Processor is a reusable monitor.

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

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective. The document is a 510(k) summary for a Bronchoscope System, which is a medical device, but it does not describe an AI/ML-driven diagnostic or assistive technology.

The "Performance Data" section details various engineering and biological tests conducted for the Bronchoscope System, such as biocompatibility, sterilization, electrical safety, EMC, software verification, and bench performance testing. These tests ensure the device's physical and functional safety and effectiveness, but they do not involve AI/ML performance metrics like sensitivity, specificity, or AUC against a ground truth.

Specifically, there is no mention of the following in the provided text:

1. A table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth type related to an AI/ML model for a test set.
3. Sample size or ground truth establishment for a training set of an AI/ML model.

The document explicitly states under "Clinical Testing": "Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This further confirms that no studies involving human interpretation augmented or replaced by AI, or studies evaluating AI performance metrics, were part of this submission.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and study data from this document.

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