(170 days)
The TOPAZ Mobile DR System, is a mobile X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy.
This device is not intended for mammography, bone density, fluoroscopy and angiography applications.
The TOPAZ Mobile DR System. (TOPAZ), is a mobile x-ray system. There are 2 models for TOPAZ: TOPAZ-32D (32KW) and TOPAZ-40D (40KW). TOPAZ, may be moved quietly and smoothly with a motor drive mechanism.
The core part of x-ray source is a tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD based x-ray control console provides a user-friendly interface and technique selection. The Collimator supports high accuracy for selected x-ray field size over any SID. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique. Direct radiography via a flat panel detector improves workflow, exam speed and user comfort with efficiency. Digital flat panel detector with Csl screen provides good spatial resolution, MTF, DQE and stability based on a fine pixel pitch. The digital detector type used in TOPAZ is "VARIAN PacScan4336W" or "VARIAN PacScan4336W_V4 which was cleared as part of the Nexus DR™ Digital X-ray Imaging System (with PaxScan 4336Wv4), K161459.
The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the workstation and saved in a DICOM file for review on the device or on a Picture Archiving & Communication System (PACS) workstation Image Management features and functions are:
- ROI: Default 13 ROI support .
- MARK: Unlimited support (User preset support) ●
- Horizontal Flip ●
- Vertical Flip .
- Rotate Clockwise (CW) ●
- . Rotate Counter Clockwise (CCW)
- Inverse (Black or White) .
- . Text Annotation
- Caliper / Ruler: Distance tool
- Angle: Angle measurement tool
- Zoom: Image zoom in/out ●
- . Magnify: Image magnify glass window
- . Pan: Image panning
The provided text does not describe acceptance criteria for a device's performance that is proven by a study. Instead, it is a 510(k) summary for the TOPAZ Mobile DR System, which is a mobile X-ray imaging system. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market.
Therefore, many of the requested points cannot be directly extracted from this document as it focuses on regulatory equivalence rather than specific performance acceptance criteria from a clinical or standalone study.
However, I can extract information related to the non-clinical testing performed to establish safety and effectiveness in comparison to the predicate device.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity). Instead, it refers to fulfilling predetermined testing criteria based on regulatory standards for X-ray systems.
| Acceptance Criteria Type | Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, -2-54, -1-3, -2-28, -1-2 | "TOPAZ Mobile DR System has met all the requirements listed in the Standards" (except for inapplicable requirements). "Passed all predetermined testing criteria." |
| Software Life Cycle | Compliance with ANSI AAMI IEC 62304 | Met requirements. |
| Usability | Compliance with IEC 60601-1-6 | Met requirements. |
| Radiation Protection | Compliance with IEC 60601-1-3, IEC 62494-1 | Met requirements. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Met requirements. |
| Digital Imaging & Communications | Compliance with NEMA PS 3.1 - 3.20 (DICOM) | Met requirements. |
| Image Compression | Compliance with JPEG Standard IEC/ISO10918-1 | Met requirements. |
| Risk Management | Compliance with ANSI AAMI ISO 14971 | Met requirements. |
| Labeling Symbols | Compliance with ISO 15223-1 | Met requirements. |
| General System Functionality | "Validation Test Plan was designed to evaluate all input functions, and actions performed by TOPAZ" | "Validation testing indicated that... results demonstrated that the predetermined acceptance criteria were met." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of diagnostic performance. The testing mentioned is non-clinical, focusing on compliance with safety and performance standards of the physical device and its software.
- Data Provenance: Not applicable. The testing was conducted at the factory and by "Standards testing facilities."
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)
- Not applicable as this document details non-clinical testing for substantial equivalence, not a study evaluating diagnostic performance against a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The "test set" here refers to the system itself being tested against regulatory standards, not image data being adjudicated.
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. A MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical testing is not necessary for the TOPAZ Mobile DR system in order to demonstrate substantial equivalence to the predicate device." This device is a basic X-ray system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an X-ray imaging system, not an algorithm, and its performance is evaluated in the context of its function to acquire images, not analyze them.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For the non-clinical testing, the "ground truth" was the specifications and requirements outlined by the various recognized international and national standards (e.g., IEC, ANSI AAMI, NEMA, ISO).
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI/algorithmic device.
9. How the ground truth for the training set was established
- Not applicable.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.