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The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console is capital equipment that is reusable and displays the patient information.

The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console. The Chartis Console is a previously cleared device (under K180011) and the subject 510(k) is solely for the Chartis Precision Catheter.

Here's a breakdown of the acceptance criteria and the study information for the Chartis Precision Catheter based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various non-clinical tests performed to demonstrate the safety and efficacy of the Chartis Precision Catheter. However, it does not explicitly list quantitative acceptance criteria or specific reported performance values in a single table as typically expected for device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document states that "The Chartis Precision Catheter completed the following functional testing after being subjected to sterilization, conditioning and distribution" and that "The Chartis Precision Catheter successfully completed repeated functional testing..." and "Packaging validation testing..." and "Sterilization validation testing..." These statements imply that the device met predetermined, internally established acceptance criteria for each test. The "reported device performance" is essentially that the device passed these tests.

Below is a table summarizing the types of tests performed, which indirectly represent the areas where acceptance criteria were applied:

• Tensile testing of all fittings and joints of catheter, obturator, and connector set: Implies components can withstand specified tensile forces without failure.
• Airway resistance testing: Implies the catheter functions to allow measurement of airflow and pressure for resistance calculation as intended.
• Bronchoscope deflection angle testing: Implies the catheter does not impede bronchoscope movement beyond acceptable limits.
• Obturator removal force testing: Implies the obturator can be removed with an acceptable force.
• Torque transmission and kink testing: Implies the catheter can transmit torque effectively and resists kinking.
• Leak testing: Implies the system maintains integrity and prevents leaks during operation.
• Catheter insertion and withdrawal force testing: Implies the catheter can be inserted and withdrawn smoothly with acceptable force.
• Dimensional and visual inspection verifications: Implies the catheter meets specified dimensions and visual quality standards.
• Simulated use testing: Implies the device performs as intended in a simulated clinical environment. |
  | Shelf-life Testing | - Repeated functional testing: Implies the device maintains functional performance after accelerated aging.
• Pouch seal tensile strength testing: Implies the packaging maintains integrity over the specified shelf-life. |
  | Packaging Validation Testing | - Visual inspection, bubble leak testing, pouch seal tensile strength testing: Implies packaging integrity and sterile barrier are maintained after sterilization, conditioning, and distribution. |
  | Biocompatibility Testing | - Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity: Implies no unacceptable biological response to device components.
• Gas Pathway Testing (Particulate Matter, Volatile Organic Components, Toxicological Risk Assessment): Implies gas pathway is safe and free from harmful contaminants. |
  | Sterilization Validation | - Electron beam irradiation process at a sterility assurance level (SAL) of 10^-6: Implies the device achieves the required sterility level after sterilization. |

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

The document does not specify sample sizes for the individual non-clinical tests (e.g., how many catheters were used for tensile testing, or how many packages for shelf-life). It indicates that the tests conform to design controls (21 CFR §820.30) and relevant ASTM and ISO standards, which would dictate appropriate sample sizes for each test.

The data provenance is non-clinical bench and lab testing conducted by the manufacturer, Pulmonx Corporation, in Redwood City, California. It does not involve patient data (retrospective or prospective) in the way a clinical study would.

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

This question is not applicable to the provided information. The tests described are non-clinical, mechanical, and material-based. They do not involve expert interpretation or subjective evaluation that would require establishing "ground truth" by experts in a clinical sense. The ground truth for these tests is based on objective measurements against established engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus. The tests performed here are objective performance tests with pass/fail criteria based on measured values.

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 question is not applicable. The Chartis Precision Catheter is a medical device for measuring pressure and flow to quantify collateral ventilation, not an AI-powered diagnostic tool that assists human readers in interpreting images or data. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

This question is not applicable. The Chartis Precision Catheter is a physical medical device. While it works in conjunction with the Chartis Console (which processes data), the submission does not describe an "algorithm only" or "AI" component in the context of its performance evaluation. The device's performance is intrinsically linked to its physical interaction and measurements.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is based on established engineering specifications, industry standards (ASTM, ISO), and predefined performance metrics. For example:

• Functional Testing: Ground truth is defined by specified force limits, pressure ranges, dimensional tolerances, and successful operation during simulated use.
• Shelf-life Testing: Ground truth is the maintenance of functional performance and sterile barrier integrity over the specified shelf-life.
• Biocompatibility Testing: Ground truth is the absence of adverse biological reactions as per ISO 10993.
• Sterilization Validation: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.

8. The Sample Size for the Training Set

This question is not applicable. This device does not use machine learning or AI models that require a "training set" of data. The evaluation is based on traditional engineering and medical device testing principles.

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

This question is not applicable, as there is no training set for this device.

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The Pulmonx LIA software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LIA software can be used to support physician in the diagnosis and documentation of pulmonary tissue images (e.g. abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments (including lung structures), volumetric analysis, density evaluation, and reporting tools are provided.

The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a dedicated table format with specific numerical thresholds (e.g., "accuracy > 90%"). Instead, it describes an equivalence study where the acceptance criteria were met if the results from the subject device (LIA) were "similar" to the predicate device (Thirona LungQ). The study compared specific measurements, implying that the LIA's ability to produce comparable values for these measurements constituted meeting the acceptance criteria.

Table of Acceptance Criteria (Inferred) and Reported Device Performance

Note: The term "similar" is subjective without defined statistical thresholds (e.g., p-value, correlation coefficient, absolute difference thresholds). However, the FDA’s clearance implies they deemed the similarity sufficient for substantial equivalence.

Study Details

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

   • Sample Size: 30 scans.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

   • The document does not mention using experts to establish ground truth for the test set in the context of the equivalence study. The study appears to directly compare the LIA device's output to the predicate device's output, with the predicate device's output implicitly serving as a reference.

3. Adjudication Method for the Test Set:

   • Not applicable as the study compares the LIA's output directly to the predicate device's output, rather than to an expert-adjudicated ground truth.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on comparing the algorithmic measurements of the LIA to a predicate device's algorithmic measurements.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance study described is a standalone (algorithm-only) study. It compares the computational output of the LIA software directly with the computational output of the predicate device (Thirona LungQ) for specific measurements (fissure calculations, lobar volumes, voxel density scores). There is no human-in-the-loop component described for this comparison study.

6. The type of ground truth used:

   • The "ground truth" for the equivalence study was effectively the measurements provided by the legally marketed predicate device (Thirona LungQ). The study's goal was to show that LIA's measurements were "similar" to those of the predicate.

7. The sample size for the training set:

   • The document does not specify the sample size used for the training set for the LIA software. The provided text only describes the validation/test set for the equivalence study.

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

   • The document does not specify how the ground truth for any potential training set was established. This information is typically proprietary to the manufacturer and not always included in a 510(k) summary focused on validation.

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The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Clartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is capital equipment that is reusable and displays the patient information.

The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

The Pulmonx Chartis Tablet Console, a diagnostic spirometer, was submitted for 510(k) premarket notification (K180011). The device is intended for use by bronchoscopists during a bronchoscopy in adult patients with emphysema to measure pressure and flow, calculate airflow resistance, and quantify collateral ventilation in isolated lung compartments.

Here's an analysis of its acceptance criteria and the study proving its adherence:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Test samples passed all acceptance criteria" for each listed test, indicating that the device met the pre-defined standards for each respective test. The specific numerical or qualitative acceptance criteria are not detailed in this summary document.

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

The document does not explicitly state the specific sample sizes for the test sets in the performance data section. It refers to "Test samples" for each evaluation.

The data provenance (e.g., country of origin of the data, retrospective or prospective) is not explicitly mentioned in this summary.

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

This information is not provided in the document. The tests listed are primarily engineering and software validation tests, not clinical studies requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are objective engineering and compliance tests, not subjective interpretations requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not performed or reported. The performance data focuses on technical and safety compliance rather than human reader performance with or without AI assistance. The device is a diagnostic spirometer, not an AI interpretation tool.

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

The device itself is a diagnostic spirometer that provides measurements to a human operator (bronchoscopist). Its performance described relates to the accuracy and reliability of its measurements and hardware/software functionality, effectively its "standalone" performance as a measurement device. However, this is not a standalone AI algorithm being evaluated for diagnostic accuracy against a human expert.

7. The Type of Ground Truth Used

For the reported performance data (software, electrical safety, EMC, hardware, etc.), the ground truth is based on engineering specifications, regulatory standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62366, ASTM D4332, ASTM 4169), and functional requirements for the device. There is no mention of expert consensus, pathology, or outcomes data as a ground truth for these specific tests.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic spirometer, not an AI or machine learning algorithm that requires a training set in the typical sense. The software verification and validation would be based on development processes and testing against requirements, not on a "training set" of medical data.

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

Not applicable, as there is no mention of a training set for an AI or machine learning component.

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The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

The Chartis Console is an integrated, self-contained, 12 VDC powered system designed to be used in the bronchoscopy suite in conjunction with the Chartis Catheter. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Cathter isolates the lung compartment of interest. The hardware components of the Console translate air flow and pressure detected through the Chartis Catheter into electrical signals. The Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

This 510(k) submission (K111764) describes a
Special 510(k) for the Chartis™ Console,
which is a modification of an already cleared device (K083199). As such, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel clinical effectiveness through extensive new studies.

Here's an analysis of the provided information regarding acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a Special 510(k) for device modifications, the "acceptance criteria" here refer to demonstrating that the modified device performs equivalently to the predicate device and that the changes do not raise new questions of safety or effectiveness. The submission explicitly states:

"The modified Chartis Console is substantially equivalent to the predicate Chartis Console with regard to technological characteristics. The minor changes to graphic display, hardware, software, packaging and service/calibration do not raise new types of safety or effectiveness questions."

"Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device."

Note: The document does not provide specific numerical performance metrics, such as accuracy, sensitivity, or specificity, as it's a Special 510(k) focused on demonstrating equivalence of modifications to an already cleared device. The "performance data" mentioned are likely internal verification and validation testing to ensure the modified components function as intended and do not degrade the overall system's performance compared to the predicate.

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

The provided document does not specify a sample size for a "test set" or detail data provenance in the context of a clinical study or a comparative study against a ground truth. The submission refers to "verification and validation test results," which are typically internal engineering and performance tests on the device itself, rather than clinical data from patients.

This type of submission often relies on:

• Engineering bench testing: To confirm the functionality and accuracy of the modified hardware and software components.
• Software validation: To ensure the software changes do not introduce errors and perform as designed.
• System integration testing: To verify that all components work together correctly.

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

The provided document does not mention the use of experts to establish ground truth for a test set. This is consistent with a Special 510(k) for device modification, where the focus is on the device's functional equivalence rather than a new clinical claim requiring expert-adjudicated clinical endpoints.

4. Adjudication Method

The document does not specify an adjudication method. This is because the submission does not detail a clinical study where expert review and adjudication would be necessary to establish a "ground truth" for patient cases.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Such studies are typically performed for devices that involve human interpretation (e.g., imaging devices) to assess the impact of AI on human reader performance. The Chartis Console is a diagnostic spirometer that measures physical parameters (pressure, flow) and displays them, not a device requiring human interpretation of complex visual data in the same way an imaging AI would.

6. Standalone (Algorithm Only) Performance

The document does not present data on standalone (algorithm only without human-in-the-loop) performance. The Chartis Console is described as displaying real-time data for a bronchoscopist, implying it's always used with a human in the loop for clinical decision-making. The device itself is the "algorithm" that calculates and displays pressure and flow, so its "standalone performance" would be its accuracy in measuring and calculating these physical parameters. The "verification and validation test results" likely cover this aspect without detailing specific metrics in the summary.

7. Type of Ground Truth Used

The type of ground truth used here would be physical and engineering measurements to confirm the accuracy and calibration of the device's sensors and algorithms for measuring pressure and flow, and its ability to quantify collateral ventilation. It would not be expert consensus, pathology, or outcomes data, as these are typically associated with clinical efficacy studies for new devices or new indications.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This type of device, which measures physical parameters, typically does not rely on machine learning or AI models that require extensive training data in the same way an image recognition algorithm would. The "algorithm" here is likely based on established physiological principles and formulas for calculating resistance and flow, embedded in the software.

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

Since there is no mention of a training set or specific machine learning algorithms that require one, the document does not describe how ground truth for a training set was established. The "ground truth" for the device's functionality would be established through engineering standards, calibration procedures using known accurate references, and verification against physiological models or simulations.

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The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

The Chartis™ Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Catheter lumen during spontaneous respiration.

The provided document, K111522 for the Chartis Catheter, is a Special 510(k) submission. Special 510(k)s are used for modifications to a manufacturer's own legally marketed device where the modification does not affect the intended use or alter the fundamental scientific technology of the device.

Therefore, the "acceptance criteria" and "study" described in such a submission typically focus on demonstrating that the modifications to the device do not raise new questions of safety or effectiveness and that the modified device performs equivalently to the predicate device. It is not a study to prove initial clinical effectiveness or diagnostic accuracy in the way an AI/ML device might be evaluated.

Based on the provided text, here's a breakdown of the information requested, with an emphasis on what's available and what's not for a Special 510(k):

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

The document states: "Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device."

This implies that the acceptance criteria for this Special 510(k) were based on demonstrating equivalence of the modified device to the predicate device in terms of performance characteristics. Specific quantitative criteria and detailed performance results are not provided in this summary. Instead, the general conclusion is that the modified device meets the implied acceptance criteria of equivalence.

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

This information is not provided in the 510(k) summary. For a Special 510(k) focused on minor material, packaging, and shelf-life changes, the "test set" would likely refer to engineering and bench testing rather than a clinical dataset.

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 therefore not provided. This 510(k) is not about diagnostic accuracy where expert ground truth would be established. It's about demonstrating that modifications to an existing device (Chartis Catheter) do not negatively impact its performance or raise new safety/effectiveness concerns.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies for diagnostic devices to establish ground truth or resolve discrepancies, which is not the purpose of this Special 510(k).

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 information is not applicable and therefore not provided. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

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

This information is not applicable and therefore not provided. This device is a catheter, not an algorithm.

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

This information is not applicable and therefore not provided. This 510(k) is not about establishing ground truth for a diagnostic condition but rather confirming equivalence of the modified catheter to its predicate.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is a physical medical device (catheter), not a machine learning algorithm that requires a training set.

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

This information is not applicable and therefore not provided. As above, this is a physical device, not an AI/ML algorithm requiring a training set with established ground truth.

In summary, for K111522 Chartis Catheter (a Special 510(k)):

The core of this submission is demonstrating that minor changes to materials, packaging, and shelf-life of the Chartis Catheter do not raise new types of safety or effectiveness questions and that the modified device remains substantially equivalent to its predicate. The "performance data" refers to verification and validation tests for these modifications, not a clinical study to establish diagnostic accuracy or clinical effectiveness against a "ground truth" in the way an AI/ML device would. The detailed specifications of these tests (e.g., sample size, specific criteria, methodologies) are not included in this summary document but would have been part of the full 510(k) submission.

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The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

The Chartis Catheter consists of two components which are pouched separately and provided to the user in a single shelf carton with the Instructions for Use. These two components are the Chartis Catheter and the Connector Set. The Catheter is the patient contact component while the Connector Set acts to connect the Chartis Catheter to the Chartis Console (which is documented in a concurrent 510(k) submission). The system is designed to be used by experienced bronchoscopists during a diagnostic bronchoscopy in a hospital bronchoscopy suite for functional assessment of air pressures and flows in isolated lung compartments.

The provided text describes the Chartis Catheter, a medical device for assessing lung function, and its 510(k) summary for FDA clearance. However, it explicitly states that "Bench test results support the performance characteristics of the device and show equivalence to the currently marketed predicate device. Design durability was tested in the laboratory and animal studies were used to validate performance of the system in a simulated clinical environment, as well as verify the performance to design specifications and the durability of the device."

This indicates that the clearance was based on bench testing and animal studies to demonstrate equivalence to a predicate device, rather than a clinical study with acceptance criteria, ground truth, and human reader performance metrics as requested in the prompt. Therefore, much of the requested information cannot be extracted from the provided text.

Here is what can be inferred or directly stated from the document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or similar performance metrics typically associated with AI/diagnostic device studies. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Study Details (as far as can be determined from the text)

1. Sample sized used for the test set and the data provenance:

• Test Set Sample Size: Not specified. The studies mentioned are "bench tests" and "animal studies."
• Data Provenance: The studies were conducted in a "laboratory" and using "animal studies." No information on country of origin or whether it was retrospective/prospective in a human context is provided.

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

• Not applicable as the studies were "bench tests" and "animal studies," not clinical studies requiring human expert ground truth for interpretation of results.

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

• Not applicable.

4. 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 mentioned. The device itself is a Catheter and Console system for measuring pressure and flow, not an AI or imaging diagnostic tool that would typically involve human readers interpreting results in an MRMC study.

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

• The Chartis Catheter and Console system is an instrument for measurement, not an algorithm in the traditional sense of AI. Its performance would inherently be "standalone" in terms of its mechanical and functional characteristics, but it is operated by a "bronchoscopist" who interprets the displays. The document doesn't detail an algorithm's performance.

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

• For bench tests, ground truth would likely be based on engineering specifications and validated measurement techniques (e.g., using calibrated instruments for pressure and flow).
• For animal studies, ground truth would be based on physiological measurements within the animal model designed to simulate clinical conditions.

7. The sample size for the training set:

• Not applicable. The development process described involves traditional engineering testing and animal studies, not machine learning with distinct training and test sets.

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

• Not applicable.

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The Pulmonx Visualized Endotracheal Tube (VETT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation, for oral and nasal intubations.

The VETT System is indicated for viewing during difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.

The Pulmonx Visualized Endotracheal Tube (VETT) with Cuff utilizes the fiberoptic components of a bronchoscope and integrates them into the wall of a standard endotracheal tube. Real-time endoscopic visualization from the distal end of the tracheal tube is possible on a continuous or intermittent basis without disconnecting the patient from the mechanical ventilator.

The VETT is made with biocompatible materials. The device is supplied with a preformed arc, pre-cut to length and with depth markings and a full length radiopaque stripe. The distal tip is a hooded bevel with a Murphy's eye. The cuff is a low pressure-high volume cuff. The inflation system has a self sealing valve. The airway connector is a standard 15mm connector. The device is sterilized by ethylene oxide and is designed for single use. The sizes are 7.0, 7.5 and 8.0 mm ID.

The VETT works in conjunction with the Pulmonx Compact Video System which includes a 5 inch LCD display, an integral Light Source and a Remote Handpiece and Cable. A Head Mounted Display is provided as a supplement to the primary display.

The Pulmonx Visualized Endotracheal Tube System (VETT) was evaluated for substantial equivalence to predicate devices. The study did not involve AI, human readers, or a multi-reader multi-case design.

Here's a breakdown of the acceptance criteria and performance based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state specific sample sizes for each test. Instead, it refers to "all samples" for the fiberoptic system testing. The provenance of the data is not specified; it is assumed to be internal testing conducted by Pulmonx, Inc. and not from clinical trials involving human subjects or external data sources. The study is a retrospective comparison against existing product specifications and performance characteristics of predicate devices.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device utilizes objective physical and performance measurements (e.g., force, patency, ASTM standards) rather than expert interpretation of images or clinical data for establishing ground truth.

4. Adjudication Method

Not applicable. The evaluation is based on objective measurements and comparisons to established standards or predicate device specifications, not on subjective expert opinions requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device, not an AI or imaging diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The document describes various tests performed on the VETT cannula, cuff, and fiberoptic system to demonstrate its safety and effectiveness. These tests were conducted on the device itself (e.g., measuring forces, lumen patency, cuff properties, image quality, light output).

7. Type of Ground Truth Used

The ground truth used is primarily based on:

• Established Standards: ASTM1242 for lumen patency, cuff leak resistance, symmetry, herniation, and compliance.
• Predicate Device Specifications/Performance: Performance benchmarks set by the Mallinckrodt Medical Hi-Lo Tracheal Tube for cannula flexibility, minimum tracheal sealing pressure, fatigue, and burst performance, and by the Olympus LF1/LF2, American Optical LS-6A/LS-7, Welch Allyn Hi-Lux, and UroHealth END-101 for the fiberoptic and video system characteristics.
• Objective Measurements: Internal testing to quantify properties like image quality, light output, and force.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the conventional sense. The development of the device would have involved internal testing and iteration, but this is not reported as a formal training set for algorithm development.

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

Not applicable, as there is no "training set" for an algorithm. The design and performance targets for the VETT were established based on the characteristics of existing predicate devices and relevant industry standards.

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