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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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