(136 days)
The SCENARIA Phase 2 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 2 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
The SCENARIA Phase 2 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
The SCENARIA Phase 2 system consists of a Gantry, Operator's Workstation, Patient Table, high-Frequency X-ray Generator, and accessories.
The provided text describes the 510(k) summary for the SCENARIA Phase 2 Whole-body X-ray CT System. However, it does not detail specific acceptance criteria or a study that proves the device meets those criteria in the typical sense of a clinical performance study with defined metrics (e.g., sensitivity, specificity, or accuracy compared to a ground truth) and corresponding acceptance thresholds for a new device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (SCENARIA Whole-body X-ray CT System, K101888) through performance comparisons and compliance with relevant standards.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present quantitative acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the primary "acceptance criterion" is implicit: the SCENARIA Phase 2 system must be comparable to and substantially equivalent to the predicate device (SCENARIA K101888) in terms of physical, performance, and technological characteristics.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Clinical Performance Equivalence to Predicate Device | A clinical evaluation comparison was conducted. The results found the SCENARIA Phase 2 system to be substantially equivalent to the original SCENARIA System (K101888). |
| Bench Performance Equivalence to Predicate Device | Evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index. The results confirm the performance characteristics of the SCENARIA Phase 2 are comparable to the predicate device and support the conclusion of substantial equivalence. |
| Technological Equivalence to Predicate Device | Gantry, X-ray Tube, X-ray Generator, Patient Table specifications are the same as the predicate. Helical Scanning, Image Processing, Display, Image Storage, and Performance features are equivalent. Dose-related features are also included. The system is technologically equivalent in concept, function, and performance to the predicate device. |
| Compliance with Safety Standards | Designed and manufactured under Quality System Regulations (21 CFR § 820). In conformance with applicable parts of IEC 60601 series standards (IEC 60601-1, -1-1, -1-2, -1-3, -2-32, -2-44). |
| Safety and Effectiveness (Overall Conclusion) | Developed and validated according to applicable standards. Testing has proven the system is safe and effective for the indicated use. Risk and hazard analysis shows no new safety issues compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical evaluation comparison was conducted," but does not provide details on the sample size (number of patients/cases) used for this clinical evaluation.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information about experts used, the number of experts, or their qualifications for establishing ground truth in the clinical evaluation. Given that it's a comparison to a predicate device, the "ground truth" implicitly refers to the predicate device's performance being the established benchmark.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not mentioned or implied. The clinical evaluation was a "comparison" with the predicate device, but its methodology is not detailed enough to suggest an MRMC study or an effect size for human readers with/without AI assistance. This device is a CT scanner, not an AI-assisted diagnostic tool, so an MRMC study in this context would be unusual.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of an algorithm is not applicable here, as the device is a CT imaging system, not an AI algorithm. The performance evaluation focuses on the imaging system's physical and image quality characteristics.
7. Type of Ground Truth Used
Based on the available text, the "ground truth" for the performance claims appears to be:
- Predicate Device Performance: The primary "ground truth" is the established performance of the legally marketed predicate device (SCENARIA K101888). The new device's performance is compared against this standard.
- Bench Test Standards: For specific technical parameters (dose profile, image noise, MTF, etc.), the ground truth would be established by physical measurements and engineering specifications, often against industry-standard phantoms or test objects.
- Compliance with International Standards: Compliance with IEC 60601 series standards serves as a ground truth for safety and general electrical/radiation performance.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a CT imaging system and not a machine learning or artificial intelligence algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As no training set is relevant, this question is not applicable.
In summary: The submission for the SCENARIA Phase 2 CT system demonstrates substantial equivalence to its predicate device through a combination of clinical comparison and bench testing that evaluated physical and performance characteristics. It adheres to applicable safety and quality standards. Specific quantitative acceptance criteria for clinical performance (like sensitivity/specificity), detailed test set sizes, expert qualifications, or adjudication methods typically found in AI/CAD device submissions are not provided, as this is a medical imaging device and not an AI-powered diagnostic algorithm.
§ 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.