(192 days)
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
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software verification and validation | All tests passed. | Test samples passed all criteria. |
| Electrical safety (AAMI/ANSI ES60601-1, IEC 60601-1-6) | Compliance with applicable electrical safety standards. | Test samples passed all criteria. |
| Electromagnetic compatibility (IEC 60601-1-2) | Compliance with applicable electromagnetic compatibility standards. | Test samples passed all criteria. |
| Hardware Verification Testing | All hardware functionalities met specifications. | Test samples passed all criteria. |
| Hardware Review | Hardware design and components met specifications. | Test samples passed all criteria. |
| Operational Temperature and Humidity Conditioning | Maintained performance under specified environmental conditions. | Test samples passed all criteria. |
| Stress Cycling Testing | Withstood repetitive stress without failure. | Test samples passed all criteria. |
| Repeated Cleaning and Tablet Stand Cycling Testing | Maintained integrity and functionality after repeated cleaning and cycling. | Test samples passed all criteria. |
| Usability Evaluation (IEC 62366) | Met usability standards. | Test samples passed all criteria. |
| Packaging Validation (ASTM D4332, ASTM 4169) | Compliance with applicable packaging standards. | Test samples passed all criteria. |
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.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).