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510(k) Data Aggregation
(14 days)
This software package has been designed to evaluate the perfusion of organs and turnors.
The software allows for the calculation of blood flow, blood volume and permeability from sets pf images reconstructed from dynamic CT data acquired after the injection of a contrast bolus.
The package also allows for the independent calculation of arterial and portal venous component of hepatic perfusion. It supports the evaluation of regions of interest and the visual inspection of time density curves.
The CSBP-001A is post-processing software that does not affect the operation of the parent CT System. This software provides analysis tools that are used on a series of dynamic images (images collected over time) to provide numerical values related to tissue perfusion of organs, tumors lesions, etc. Additionally, this software will allow for the display of perfusion maps.
The provided text does not contain detailed acceptance criteria for the Toshiba CSBP-001A Body Organ Perfusion System, nor does it describe a specific study that proves the device meets such criteria in terms of performance metrics.
The document is a 510(k) summary for a new device, focusing on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a dedicated study.
However, based on the information provided, we can infer some details related to the device and the nature of its submission to the FDA.
Here's an attempt to structure the answer based on the available text, with explanations for what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The FDA 510(k) process for this device focuses on "substantial equivalence" to predicate devices. This typically means the new device functions similarly and is as safe and effective as existing legally marketed devices, rather than meeting specific quantitative performance thresholds. | The document states: "This software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner that is similar to the predicate devices, or in a manner that is a combination of the predicate devices." It further states that "Bench test data is provided in the submission to provide evidence of the safety and effectiveness of this device," but no specific performance metrics or acceptance criteria are detailed in this public summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document refers to "Bench test data" being provided in the submission, but it does not specify the sample size of this test set.
- Data Provenance: Not mentioned. The submission does not specify the country of origin of any data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not mentioned. There is no information provided about the establishment of a "ground truth" using experts for any test set. The submission focuses on demonstrating substantial equivalence, which often relies on comparison to existing clinically validated methods or predicate devices rather than an independent expert-derived ground truth.
4. Adjudication Method for the Test Set
- Not mentioned. Since no specific test set or expert involvement in establishing ground truth is described, no adjudication method is provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No evidence of an MRMC study. The document does not mention an MRMC comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The device is described as "post-processing software" for analysis and display, not necessarily an AI-assisted diagnostic tool in the sense of an MRMC study comparing human performance with and without its aid.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Implied standalone performance for software functions. The device is described as "post-processing software that does not affect the operation of the parent CT System." It "provides analysis tools" and "allows for the display of perfusion maps." While not explicitly termed a "standalone study" in the modern sense of AI algorithm evaluation, the "bench test data" would inherently evaluate the software's ability to calculate and display perfusion parameters from dynamic CT data, which is essentially its standalone function. No human-in-the-loop performance is described or evaluated in this summary.
7. The Type of Ground Truth Used
- Not explicitly stated. Given the nature of a perfusion system, the "ground truth" for evaluating its calculations (blood flow, blood volume, permeability) would typically involve comparison to established quantitative methods, phantom studies, or other clinically accepted perfusion imaging techniques and their derived values. However, the document does not specify how the ground truth was established for the "bench test data."
8. The Sample Size for the Training Set
- Not applicable / Not mentioned. The document describes the CSBP-001A as "post-processing software" that "provides analysis tools." This phrasing suggests a rule-based or model-based approach to calculating perfusion parameters rather than a machine learning or AI model requiring a "training set" in the contemporary sense. Therefore, a training set sample size is not relevant or mentioned.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a training set is not mentioned, the method for establishing its ground truth is also not.
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