(26 days)
The purpose of Visaris Vision® is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X-ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X-ray panels. Visaris Avanse®, the software component, is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detector technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements. These models are available: Vision C: A universal digital system employing an Overhead Tube Crane, a table, and a wall stand. Vision U: A universal U-Arm system Vision V: A floor mounted tube system Vision X: A universal straight Arm system All of these come with the previously cleared Visaris 360, the integrated digital radiology workflow system. (Visaris Avance, K150725)
This document describes a 510(k) premarket notification for the "Visaris Vision" digital X-ray system. This system is a collection of components, including X-ray tubes, generators, collimators, tables, and digital X-ray panels, controlled by the Visaris Avanse® PACS software. The submission seeks to demonstrate substantial equivalence to a predicate device, the Siemens Multix Fusion (K121513).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly present a dedicated table of "acceptance criteria" for the Visaris Vision system in the way one might expect for a specific performance metric (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to the predicate device and compliance with recognized standards.
The "Comparison Table" in Section 4 (Page 5) compares the technological characteristics of the Visaris Vision with the predicate device (Siemens Multix Fusion K12113). While not framed as "acceptance criteria," these represent the benchmarks the device must meet to be considered substantially equivalent.
| Comparable Properties | Acceptance Criteria (Implicit from Predicate Device) | Reported Device Performance (Visaris Vision) | Comparison Results |
|---|---|---|---|
| Indications for use | The Multix Fusion is a radiographic system used in hospitals, clinics, and medical practices. Enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities for pediatric, adult, and bariatric patients. Can be used for intravenous, small interventions, and emergency applications. Not for mammography. Uses digital detector for diagnostic images. | Acquires, stores, communicates, displays, and processes medical X-ray images. Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use. | Equivalent |
| Tube crane/Tube stand | Overhead tube crane with manual or automated x-ray tube assembly movement. | Equivalent model: Vision C | Equivalent Functionality |
| Wall stand | Manual vertical movable wall stand, tiltable tray. | Motorized | Equivalent Functionality |
| Table | Free-floating and height-adjustable, maximum patient weight 660 lbs., working table height 20-5/16 inch to 37-5/8 inch. | Same. | Equivalent Functionality |
| X-ray tube | 150 kVp, 0.6 mm & 1 mm focal spots. | 150 kVp 0.6/1.2mm focal spots | Equivalent Functionality |
| Collimator | Siemens. | Claymount, X-Alliance, or Ralco (All CFR Certified) | Equivalent Functionality |
| X-ray Generator | 55, 65, or 80 kW Siemens brand | Various Models available: (All HF) Claymount, (up to 63 kW) CPI, (32kW to 100kW) EMD, (45 kW, to 80 kW) POSKOM (32 kW to 50 kW) Sedecal (40, 50, 65, or 80 kW) (All CFR Certified) | Equivalent Functionality |
| Wireless detector | 14" x 17" | 14" x 17" Uses FDA cleared detector and software. Pixium 3543 EZ C (Other previously cleared models available, see table above) | Equivalent Functionality |
| Fixed detector | 17" x 17" | 17"x17". Uses FDA cleared detector and software. Pixium 4343RC (Other previously cleared models available) | Equivalent Functionality |
| Conventional film/screen systems or CR cassettes | Film/Screen or CR Cassettes. | Comes with FDA cleared digital x-ray panels. Conventional film and CR cassettes can still be used. | Similar Functionality |
| Operator console | GUI-based | Same | Similar Functionality |
| Power Source | AC LINE | SAME | Same |
| Standards | 60601-1:2005; 60601-1-2:2014; 60601-2-54 Edition 1.0; PS 3.1 - 3.20 (2011) 21CFR1020 (Implicit: Compliance with these standards is expected for safety and performance) | Tested successfully according to: IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-54 Edition 1.0, NEMA PS 3.1 - 3.20 (2011) (DICOM), and 21CFR1020. All components certified to comply with the standard by their respective manufacturers. | SAME (Compliance is reported) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "clinical evaluation" was performed. However, it does not specify a distinct "test set" with a given sample size for this evaluation in terms of patient numbers or image counts, nor does it provide details on data provenance (country of origin, retrospective/prospective). The clinical evaluation's primary objective seems to be system verification and risk assessment rather than a quantitative performance evaluation of a specific diagnostic output.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for a test set. The clinical evaluation focused on "verification in the normal working conditions" and "determination of all adverse effects," implying system functionality and safety checks rather than a diagnostic accuracy study requiring expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned as a "test set" for diagnostic performance was not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such MRMC comparative effectiveness study is mentioned. This device is an X-ray system, not an AI-powered diagnostic algorithm designed to assist human readers. The software component, Visaris Avanse®, is described as "a digital radiography imaging, control and management software... provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export." This suggests image acquisition and management, not AI-driven interpretation assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance for an algorithm is not applicable here as the device is an X-ray imaging system, not a diagnostic algorithm that provides standalone interpretations. The system's "performance" is tied to its ability to acquire, store, and process medical X-ray images, as demonstrated by non-clinical testing against standards and successful integration of components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that no diagnostic accuracy study is described, there's no mention of ground truth established through expert consensus, pathology, or outcomes data. The "clinical evaluation" appears to focus on verifying the device's functional specifications and safety in a real-world setting.
8. The sample size for the training set
This information is not provided and is not applicable in the context of this 510(k) submission, which is for an X-ray imaging system, not a machine learning or AI algorithm requiring a training set in the typical sense. The software component (Visaris Avanse) was "used unmodified from our clearance obtained in K150725," implying that any development/training specific to that software would have been addressed in its prior submission.
9. How the ground truth for the training set was established
As there's no described training set for a diagnostic algorithm, this information is not provided.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.