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BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is a component to the BFlex™ Single-Use Bronchoscope System. The BFlex™ Single-Use Bronchoscope system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The BFlex™ 2 Single-Use Bronchoscope System provides real time viewing and recording for a wide range of airway procedures.

The provided document describes a medical device called the BFlex™ 2 Slim 3.8 Single-Use Bronchoscope and its substantial equivalence to predicate devices. The information primarily focuses on performance testing and usability studies rather than a comparative effectiveness study with AI assistance.

Here's a breakdown of the requested information based on the provided text:

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

The document states that "All testing resulted in acceptance criteria passed" for comprehensive verification and validation testing, but it does not provide specific numerical acceptance criteria or detailed performance metrics for each test. Instead, it lists the types of tests performed.

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

• Test Set (Usability Study):
  • Sample Size: Thirty (30) representative end users.
  • Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted as part of validation testing for the BFlex 2 family and employed methods used for a previously cleared device (K211947). The study was "simulated use scenarios," implying a prospective study design conducted in a controlled environment as opposed to real-world patient data.

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

• Number of Experts: Thirty (30) users were involved in the usability study. These users served as the test subjects, and their performance/feedback established the "ground truth" for usability.
• Qualifications of Experts:
  • Fifteen (15) pediatric anesthesiologists.
  • Fifteen (15) adult intensivists or pulmonologists.

4. Adjudication method for the test set

The document does not describe an explicit adjudication method for the usability study in the sense of resolving disagreements between multiple experts on a specific interpretation. The "ground truth" for the usability study was derived from observed participant performance and subjective assessments, suggesting direct measurement or user-reported feedback rather than a consensus process among reviewers.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
• AI Assistance: The device described (BFlex™ 2 Slim 3.8 Single-Use Bronchoscope) is a physical medical instrument (a bronchoscope). There is no mention of AI assistance or an AI component in its functionality or "human readers" in the context of diagnostic interpretation. Therefore, there's no information on effect size related to AI assistance.

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

• Standalone Performance: Not applicable. The device is a physical bronchoscope, not an algorithm. Its performance is inherent to the instrument's design and functionality, not an algorithmic output that could be tested in a standalone manner.

7. The type of ground truth used

• For Performance Testing (General): The ground truth for functional performance was established by compliance with recognized international and national standards (e.g., IEC, ISO) and internal design specifications. The document states, "All testing resulted in acceptance criteria passed," implying these standards and specifications defined the "truth."
• For Usability Testing: The ground truth was based on observed participant performance and subjective assessments during simulated use scenarios. The "task success rate" and absence of "crucial use error or unacceptable negative use-safety assessments" formed the basis of this ground truth for usability.

8. The sample size for the training set

This document does not describe a training set as the device is a hardware product, not a machine learning algorithm.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with a video monitor, in conjunction with non-powered endoscopic accessories and other equipment for endoscopy within the airways and tracheobronchial tree.

The GlideScope® BFlex™ 2.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures.

Similar to the predicate GlideScope® BFlex™ 3.8, 5.0, and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitors) for purposes of image display.

The provided text describes the 510(k) submission for the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices through design specifications and performance testing, rather than a clinical study involving AI assistance or complex human-in-the-loop evaluations.

Therefore, many of the requested criteria (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, training set details) are not applicable or not explicitly stated in this document as the device is a bronchoscope, not an AI or imaging diagnostic tool that would typically undergo such rigorous clinical validation studies with ground truth established by experts.

Here's a breakdown based on the provided information:

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

The document states: "All testing resulted in acceptance criteria passed." However, it does not provide a specific table detailing the acceptance criteria and the quantitative reported performance for each criterion. It lists the types of performance tests conducted.

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

• Sample Size: Not explicitly stated for each test. For the Usability study, it mentions "All participants" were able to operate the device safely, but no specific number of participants is given.
• Data Provenance: Not specified regarding country of origin. The testing appeared to be internal performance testing of the device itself, rather than data collected from patients.
• Retrospective or Prospective: Not applicable as these are performance/engineering tests, not a clinical study on 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 ground truth was established by engineering specifications and recognized electrical, optical, and safety standards, rather than expert consensus on diagnostic imaging. The usability study involved users (likely healthcare professionals), but their role was to test the device's usability, not to establish diagnostic ground truth.

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

This is not applicable as it's not a diagnostic study requiring adjudication of image interpretation or clinical outcomes.

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:

This is not applicable. This submission is for a medical device (flexible bronchoscope), not an AI-powered diagnostic system. No MRMC study was mentioned or required.

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

This is not applicable. The device is a bronchoscope, not an algorithm.

7. The type of ground truth used:

The ground truth or "acceptance criteria" for this device are established by engineering design specifications and compliance with international and national standards for medical electrical equipment, optical performance, biocompatibility, and usability (e.g., AAMI/ANSI, IEC, ISO standards).

8. The sample size for the training set:

This is not applicable. This is a hardware medical device; there is no "training set" in the context of an AI algorithm.

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

This is not applicable as there is no training set for an AI algorithm.

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GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.

The provided text is a 510(k) Summary for the GlideScope® BFlex™ 3.8 Single-Use Bronchoscope. This document focuses on demonstrating substantial equivalence to predicate devices and describes the results of performance testing.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text states, "Results: All testing resulted in acceptance criteria passed." However, specific quantitative acceptance criteria or detailed device performance metrics are not explicitly provided in the summary. The "Technological Characteristic" table compares the proposed device to predicates, indicating "Same" or specific values for certain features, but these are characteristics, not performance metrics against acceptance criteria.

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

The document does not specify sample sizes for the performance tests conducted. It details types of tests performed (e.g., electrical safety, optical testing) but not the number of units tested. The data provenance is not explicitly stated as country of origin, retrospective or prospective for these engineering and performance tests, but it is implied to be internal testing by the manufacturer (Verathon Medical (Canada) ULC).

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

This information is not provided. The performance testing described appears to be engineering and design verification/validation against established standards and internal specifications, rather than clinical studies requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and hence not provided. The testing described does not involve expert adjudication as it is not a clinical study or a study comparing interpretations.

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

No MRMC comparative effectiveness study was conducted or mentioned in the document. The device is a bronchoscope, not an AI-powered diagnostic tool for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was conducted or mentioned. The device is a physical medical instrument (bronchoscope), not an algorithm.

7. The Type of Ground Truth Used

For the engineering and performance testing described, the "ground truth" would be the acceptance criteria defined by the relevant international standards (e.g., ISO, AAMI, IEC) and the manufacturer's own design specifications. It is not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

No training set is mentioned or applicable, as this device is a physical bronchoscope, not an AI/machine learning system 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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GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.

This document describes the FDA's 510(k) clearance for the Verathon GlideScope® BFlex™ 5.8 Single-Use Bronchoscope. It is a PMA (Premarket Approval) submission, which means it evaluates the substantial equivalence of a new device to a predicate device already on the market. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through performance testing, rather than a clinical trial for diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document states: "Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 5.8 Single-Use Bronchoscope meets the safety and performance requirements established in the design specifications." and "Results: All testing resulted in acceptance criteria passed."

However, the specific acceptance criteria and detailed performance results (e.g., numerical values for each test) are not provided in this summary. The table below lists the types of performance tests conducted, implying that the acceptance criteria are related to the successful outcome of these tests as defined in the design specifications.

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 does not specify the sample sizes for the performance tests. It states that "The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This implies that the testing was primarily lab-based performance testing of the device and its components, rather than human clinical data. Therefore, data provenance in terms of patient data (country, retrospective/prospective) is not applicable.

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

Not applicable for this type of submission. The "ground truth" for this device, being a bronchoscope, is primarily its physical and functional performance according to engineering and safety standards, not a diagnostic accuracy against a clinical ground truth established by experts.

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

Not applicable. Adjudication methods like 2+1 are used in clinical studies where expert consensus is needed for ground truth establishment. This submission focuses on engineering and performance validation.

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

No MRMC study was done. This is a medical device (bronchoscope) clearance based on substantial equivalence, not an AI diagnostic algorithm.

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

This is not an algorithm, so "standalone" performance in that context is not applicable. The device's "standalone" performance is its ability to physically function according to its specifications, which was tested during performance testing.

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

The "ground truth" for this device's performance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) and the specifications derived from the predicate device. This is primarily objective, measurable test results, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "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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GlideScope® BFlex™ Single-Use Bronchoscope System are intended to work with the video monitor, in conjunction with non-powered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in adult patients.

The GlideScope® BFlex™ Single-Use Bronchoscope System consists of a single-use flexible bronchoscope (5.0), a reusable monitor, and a reusable cable. The system is intended to provide real time viewing and recording for a wide range of airway procedures. The GlideScope® BFlex™ Single-Use Bronchoscope System is distributed sterile and is for single use only. The BFlex bronchoscope operates with a portable reusable GlideScope video monitor (GVM) for purposes of image display.

Here's an analysis of the provided text regarding the GlideScope® BFlex™ Single-Use Bronchoscope System, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) premarket notification for the GlideScope® BFlex™ Single-Use Bronchoscope System. For this type of submission, the primary method of demonstrating safety and effectiveness is through substantial equivalence to a legally marketed predicate device. This often means demonstrating that the new device has similar technological characteristics and performs comparably to the predicate device, meeting established design specifications and relevant standards.

The document does not provide a direct table of specific numerical acceptance criteria and reported device performance values in the way one might expect for a standalone diagnostic algorithm with metrics like sensitivity, specificity, or AUC. Instead, the "acceptance criteria" are implied by successful completion of various engineering and performance tests against established standards and design specifications. The "reported device performance" is a general statement that these tests were passed.

Here's an interpretation based on the provided text:

Study Details

Based on the provided text, here are the answers to your specific questions:

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

   • As detailed above, the document implies passing various engineering and performance tests against recognized standards and internal design specifications. A direct table of numerical "acceptance criteria" for metrics like sensitivity/specificity for a diagnostic AI is not present because this is a hardware device (bronchoscope) and a 510(k) submission, not an AI/diagnostic software submission. The overall reported performance is that "All testing resulted in acceptance criteria passed."

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 does not specify a "test set" in the context of clinical data or AI model evaluation. The performance testing refers to engineering verification and validation testing of the hardware device, not evaluation against a clinical dataset with ground truth. Therefore, information on sample size, data provenance (country, retrospective/prospective) for a clinical test set is not applicable or provided.

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 and not provided. The "ground truth" here is compliance with engineering standards and design specifications, which is typically assessed by engineers and quality assurance personnel, not clinical experts for diagnostic accuracy.

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

   • This information is not applicable and not provided. Adjudication methods are relevant for ambiguous clinical cases in a diagnostic study, which is not what this document describes.

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:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The GlideScope® BFlex™ Single-Use Bronchoscope System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a bronchoscope, not an AI-powered diagnostic tool, so a study of human readers with/without AI assistance is outside the scope of this submission.

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

   • This question is not applicable. The device is a bronchoscope, a hardware medical device with an imaging component, not a standalone algorithm.

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

   • The "ground truth" in this context is the successful demonstration of compliance with established engineering standards, design specifications, and regulatory requirements (e.g., ISO, IEC, AAMI standards for medical devices, biological evaluation, electrical safety, etc.). It's not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

   • This information is not applicable and not provided. This device is a hardware bronchoscope, not an AI algorithm that undergoes "training" on a dataset.

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

   • This information is not applicable and not provided for the same reasons as point 8.

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