(67 days)
The Supria True64 system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria 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 Supria True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
The Supria True64 system uses 64-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
The Supria True64 system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This submission is a 510(k) premarket notification for a new version of an existing device (Supria True64 CT system). The primary goal of a 510(k) is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not necessarily to establish novel clinical efficacy or new performance benchmarks against a specific disease. Therefore, the "acceptance criteria" here are largely focused on maintaining equivalent performance to the predicate and adhering to relevant standards for CT systems. The studies are primarily to confirm this equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or target-based fashion for all parameters. Instead, it relies heavily on demonstrating that the Supria True64's performance is "similar to" or "comparable to" the predicate device (HITACHI SUPRIA Whole-body X-ray CT System Phase 3, K163528) and complies with relevant industry standards.
Here's a table summarizing the implicit acceptance criteria and reported performance, derived from the "Performance Comparison" and "Technological Characteristic Differences" sections:
| Testing Type / Characteristic | Implicit Acceptance Criteria | Reported Device Performance (Supria True64) |
|---|---|---|
| Bench Validation Testing | No change / Substantial equivalence to predicate for specified parameters | "No change about the following performance: Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT dose index." |
| Dose Profile | Equivalent to predicate | Equivalent to predicate (implied, as "no change") |
| Noise | Equivalent to predicate | Equivalent to predicate |
| Mean CT number & Uniformity | Equivalent to predicate | Equivalent to predicate |
| Spatial Resolution | Equivalent to predicate; 0.35 mm (high-contrast) | 0.35 mm (high-contrast); Equivalent to predicate |
| Tomographic Section Thickness | Equivalent to predicate | Equivalent to predicate |
| Sensitivity Profile | Equivalent to predicate | Equivalent to predicate |
| Tomographic Plane Location | Equivalent to predicate | Equivalent to predicate |
| CT dose index | Equivalent to predicate | Equivalent to predicate |
| Low-contrast resolution | 2.5 mm @ 0.25% at |
§ 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.