(99 days)
The NeuViz Dual Systems (modified) are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
The NeuViz Dual Systems (modified) are whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of 2 slices simultaneously. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.
The provided document is a 510(k) summary for the Neusoft NeuViz Dual Multi-slice CT Scanner System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for new performance claims.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not present in this document. The document primarily attests to the device's adherence to relevant safety and performance standards (IEC/EN 60601-x series) and its substantial equivalence to previously cleared CT scanners.
Based on the information available, here's what can be extracted:
Acceptance Criteria and Device Performance
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are primarily established by the performance and safety characteristics of the predicate devices and adherence to recognized medical device standards. The document doesn't provide specific quantitative performance metrics beyond stating it's a multi-slice CT system.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with 21 CFR 892.1750 (Computed Tomography X-ray System) | Device classified as Class II under this regulation. |
| Compliance with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard) | Stated that the device complies. |
| Compliance with IEC/EN 60601-1, -1-1, -1-2, -1-3, -1-4, -2-28, -2-32, -2-44 | Stated that the device complies with these standards for safety and performance of medical electrical equipment, X-ray source assemblies, associated equipment, and computed tomography. |
| Substantial Equivalence to Predicate Devices (K062451: NeuViz Dual Systems, K033326: Philips Plus CT Scanner) | Stated as substantially equivalent, implying comparable functional performance, safety, and intended use as the predicates. |
| Ability to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data. | Stated as the intended use and a core function of the device described. |
Study Information
The document is a 510(k) summary, which typically does not include detailed study reports with the level of granularity requested. The "study" here is the basis for the substantial equivalence determination, rather than a clinical trial or performance study against specific acceptance criteria for a novel device.
- Sample size used for the test set and the data provenance: Not mentioned. The 510(k) process for a CT scanner typically relies on engineering and phantom testing for physical performance, and comparison to predicate devices, rather than a "test set" of patient data in the way an AI algorithm might have.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not mentioned. Ground truth for a CT scanner's performance would primarily be established through physical measurements, phantom studies, and comparison to established imaging quality metrics of predicate devices.
- Adjudication method for the test set: Not applicable or not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. This is not typically required for a 510(k) for a basic CT imaging device, especially one demonstrating substantial equivalence.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is the imaging hardware and associated software, not a standalone algorithm.
- The type of ground truth used: For a CT scanner, ground truth for performance would be objective physical measurements (e.g., spatial resolution, contrast resolution, noise, dose) against phantoms and established industry standards. The document primarily references compliance with IEC/EN standards for safety and performance, which dictate how such measurements are to be performed and the acceptable limits.
- The sample size for the training set: Not applicable. This is not an AI/ML algorithm that would have a "training set" in the conventional sense. The device is a CT scanner system.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document demonstrates that the Neusoft NeuViz Dual Multi-slice CT Scanner System is substantially equivalent to existing predicate devices (NeuViz Dual Systems K062451 and Philips Plus CT Scanner K033326) and adheres to a comprehensive set of international and federal safety and performance standards. It does not contain the detailed study results one might expect for a novel AI or diagnostic algorithm, as its regulatory pathway relies on demonstrating equivalence and adherence to established norms for CT technology.
§ 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.