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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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