(14 days)
The Cardiac Function Analysis (CFA) is a software package that can be used in conjunction with CT cardiac images to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic volumes, stroke volume, LV ejection fraction to include peak filling and ejection rates, Myocardial Mass calculations, regional wall motion display and analysis. When interpreted by a trained physician, the software aids in the assessment and in determination of cardiovascular disease diagnosis and management.
The Cardiac Function Analysis software is used to post-process cardiac CT images on the display console of the CT system. Using these post-processed images various measurements can be initiated by the user to obtain clinically relevant information pertaining to the heart. Additionally this information can be used in the detection of cardiovascular disease diagnosis and risk management. Support functions are:
- Generation of Multi-Planar Reconstructed images based upon ECG gated data.
- Manual or semi-automatic contour detection of the ventricular heartwalls.
- Measure and display ventricular wall motions, wall thickness, myocardium mass, ventricle volume and ejection fraction.
- Various data outputs can be selected by the user to generate reports of the above measurements.
The provided 510(k) summary for the Toshiba CT Cardiac Function Analysis Software (CSCF-001A, CSCF-001B) does not contain specific acceptance criteria or details of a study proving the device meets those criteria.
However, I can extract information related to the device and its intended use, and then explain why the requested study details are absent.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria. The document describes the device's functions but does not provide quantitative results of its accuracy, precision, or reliability.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Explanation: As no specific study details are provided, information about the test set's sample size or provenance is absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Explanation: No information is given regarding the establishment of ground truth for any testing, as a detailed performance study is not presented.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified.
Explanation: Since no test set or ground truth establishment process is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- MRMC Study: Not mentioned as performed.
- Effect Size: Not applicable.
Explanation: The document does not describe any MRMC study comparing human reader performance with or without AI assistance. This type of study is more common for AI-driven diagnostic aids that directly impact reader decision-making in a comparative setting. The device described is a post-processing tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Standalone Study: Not mentioned as performed.
Explanation: The 510(k) summary does not present a standalone performance study of the algorithm's accuracy for its various functions (e.g., contour detection, volume calculation) against a gold standard.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not specified.
Explanation: As no specific performance study is detailed, the type of ground truth used for such a study is not mentioned.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/Not specified.
Explanation: This device, introduced in 2002, predates the widespread use of deep learning and large-scale training datasets for medical image analysis as we understand them today. The software likely uses rule-based algorithms or traditional image processing techniques rather than a training set in the modern AI sense. Therefore, a "training set" as defined for contemporary AI devices is unlikely to have been used or reported.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable/Not specified.
Explanation: For the reasons stated above (predates common AI training methodologies), information on how a training set's ground truth was established is not provided.
Summary of the Device and Submission Context:
The Toshiba CT Cardiac Function Analysis Software (CSCF-001A, CSCF-001B) is a post-processing software package for cardiac CT images. Its purpose is to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters (e.g., End Systolic/Diastolic volumes, stroke volume, LV ejection fraction, myocardial mass, regional wall motion). This information is intended to aid trained physicians in the assessment and diagnosis/management of cardiovascular disease.
The submission is a 510(k) for a "new device (software package)" where the primary goal is to demonstrate substantial equivalence to an already legally marketed predicate device (General Electric CardIQ Function [K013422]). The basis for substantial equivalence is that both devices are post-processing analysis software packages providing clinically relevant anatomical and functional information from cardiac CT images.
Key takeaway for this specific 510(k): For medical devices submitted via the 510(k) pathway, especially older submissions, the focus is often on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness concerns, rather than providing extensive de novo performance studies with detailed acceptance criteria and expert validation, unless the device presents novel technology or significant differences from predicates. The document explicitly states: "This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results." This implies that the method might be different, but the resulting output and clinical utility are considered equivalent to the predicate.
§ 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.