(311 days)
SURESubtraction Lung software is intended to aid in the visualization of lung parenchyma enhancement by subtracting a non-contrast enhanced volume from a contrast enhanced volume.
The SURESubtraction Lung, CSSL-001A, is a post-processing software that subtracts image information by comparison of two data sets, one of which is contrast enhanced. Registration software is used to match the two independent studies.
The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or most of the requested quantitative metrics (sample sizes, number of experts, adjudication methods, MRMC study, standalone performance, training set data).
However, it does offer some general insights into the device validation process. Here's a breakdown of what can be extracted and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document generally focuses on the device's ability to create subtraction images that "aid in the visualization of lung parenchyma enhancement" and "aid in the visualization of abnormal blood perfusion correlating to thromboembolic disease such as pulmonary embolism." | "This data concluded that the software aids in the visualization of contrast enhancement." |
| "Subtraction images produced by the software can be used in the visualization of abnormal blood perfusion correlating to thromboembolic disease such as pulmonary embolism." | "SURESubtraction Lung, CSSL-001A, performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis." |
Missing Information: Specific quantitative or qualitative metrics for acceptance criteria (e.g., sensitivity, specificity, image quality scores, agreement rates) are not provided in the document.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states "clinical data."
- Data Provenance: "clinical data at an investigational site." Country of origin is not specified, but it's likely related to either the submitting company (Toshiba Medical Systems Corporation, Japan) or Toshiba America Medical Systems, Inc., which has an office in Tustin, CA. The document does not explicitly state if the data was 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 in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the document.
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
- An MRMC study is not explicitly mentioned. The document states that the software "aids in the visualization," implying assistance to a human reader, but does not quantify the improvement or describe a comparative effectiveness study design.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the device as "intended to aid in the visualization" and for "post-processing," which suggests it's designed to be used with a human-in-the-loop. A standalone performance evaluation is not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies that the ground truth for "abnormal blood perfusion correlating to thromboembolic disease such as pulmonary embolism" was used to assess the visualization capability. However, the specific method for establishing this ground truth (e.g., expert consensus on other imaging modalities, pathology, follow-up outcomes) is not detailed.
8. The sample size for the training set
- This information is not provided in the document. The document refers to "testing was conducted" but doesn't differentiate between training and test sets.
9. How the ground truth for the training set was established
- This information is not provided in the document, as the training set itself is 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.