(178 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate device (Cook Endobronchial Blocker) in materials, safety, efficacy, and lung isolation. | Bench test results support performance characteristics and show equivalence. |
| Design durability | Tested in the laboratory. |
| Performance to design specifications (in a simulated clinical environment) | Verified using animal studies. |
| Durability (in a simulated clinical environment) | Verified using animal studies. |
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.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).