(242 days)
The Lung Volume Analysis can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D segmentation & isolation of subcompartments, volumetric analysis) and reporting tools are combined with a dedicated workflow. This software application can be used with standard non-contrast-enhanced chest volume acquisitions.
When used by a qualified physician, a potential application is to determine the course of treatment.
The CSLV-001A, Lung Volume Analysis is a post-processing software that provides work flow enhancements by providing automated measurement and extraction capabilities to the clinician. This software employs image data sets from thoracic studies to perform its functions, no additional radiation exposure is required.
The provided text does not contain specific acceptance criteria or a detailed study report with the requested metrics. It primarily focuses on the device's administrative details, regulatory classification, intended use, and a general statement about testing.
However, based on the limited information, here's what can be extracted and what is explicitly not mentioned:
1. A table of acceptance criteria and the reported device performance:
The document states: "Statements related to the accuracy of the software are contained in the user information based upon this testing." However, the actual acceptance criteria (e.g., a specific percentage of accuracy, precision, or segmentation overlap) and the corresponding reported device performance values are not provided in this 510(k) summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "image data sets of the chest" but does not quantify them.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The summary only states that the device can be used "When used by a qualified physician," but it does not detail how ground truth was established for testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
A MRMC study comparing human readers with and without AI assistance is not mentioned in this summary. The device is described as a "post-processing software that provides work flow enhancements by providing automated measurement and extraction capabilities to the clinician," implying it's an assistance tool, but no comparative effectiveness study results are given.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone performance evaluation (without human interaction) of the algorithm's accuracy for segmentation or volumetric analysis is implied by the testing description ("Summary of Testing: This device was tested using an electronic phantom, LungMan Phantom™, and image data sets of the chest."), but specific metrics for standalone performance are not provided. The focus seems to be on the accuracy inherent in the software's measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document mentions "an electronic phantom, LungMan Phantom™," which would have known ground truth values. For "image data sets of the chest," the type of ground truth used (e.g., expert annotations, pathology, clinical outcomes) is not specified.
8. The sample size for the training set:
The sample size for the training set is not mentioned at all. The document only discusses "testing."
9. How the ground truth for the training set was established:
Since details about a training set are not provided, how its ground truth was established is also not mentioned.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.