(57 days)
The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The CRystalView T-Series is not indicated for use in mammography.
The CRystal View T-Series System is an electrostatic X-ray imaging system that employs storage phosphor plates in place of conventional X-ray film for radiographic imaging applications. The system provides image data that must then be viewed with an external computer and appropriate software. The CRystal View T-Series System is comprised of the following functional components: Reusable storage phosphor plates, multiple sizes; Plate carousels, corresponding to reusable storage phosphor plate size; The CRystal View T-Series Scanner, an image reader /digitizer. The CRystal View T-Series Scanner / Communications Interface, USB 2.0; Optional Integrated phosphor plate eraser; CRystal View T-Series control software and a user or distribution channel-supplied computer system. Image data is sent via a dedicated connection from the CRystalView T-Series Scanner to the computer system, where it is processed and displayed for review.
The provided text is a 510(k) summary for the Alara CRystalView® T-Series Computed Radiography System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance. It lacks the quantitative data and detailed methodology typically found in such a study.
Here's an analysis based only on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria nor reported device performance metrics in a comparative format. It makes a general claim:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance characteristics equivalent to predicate device | "Alara's laboratory and V&V testing demonstrate that the CRystal View T-Series performance characteristics and diagnostic capabilities are equivalent to the predicate." |
| Diagnostic capabilities equivalent to predicate device | "Alara's laboratory and V&V testing demonstrate that the CRystal View T-Series performance characteristics and diagnostic capabilities are equivalent to the predicate." |
| Substantial equivalence to predicate(s) | "The CRystalView T-Series' performance is substantially equivalent to the DenOptix Imaging System and the FCR ClearView using the ST-VI imaging plates." |
Missing: Specific, measurable acceptance criteria (e.g., spatial resolution, DQE, contrast resolution, noise levels, etc.) and quantitative data demonstrating how the CRystalView T-Series met these criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any information regarding the sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). It only refers to "Alara's laboratory and V&V testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study. The device itself is a Computed Radiography System, implying it produces images for human interpretation, rather than an AI algorithm for diagnosis.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. Given that this is a CR acquisition system and not an AI-based diagnostic algorithm, a "training set" in the context of machine learning is not applicable here. The device produces images, and the "training" involved would be for the internal algorithms responsible for image processing and reconstruction, which are typically developed using engineering and physics principles rather than a labeled medical image training set.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the document does not describe how ground truth for a training set was established.
Summary of what is available from the text:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the CRystalView T-Series Computed Radiography System to previously cleared predicate devices (K042023: Fuji Computed Radiography (FCR) ClearView CS Image Reader and K955643; DenOptix ALARA Imaging System). The claims of equivalence are based on "Alara's laboratory and V&V testing," which are stated to show that the performance characteristics and diagnostic capabilities are equivalent. However, without the underlying test reports, the specific acceptance criteria, quantitative results, and methodological details (like sample sizes, expert involvement, and ground truth establishment) cannot be extracted from this document. This level of detail is typically found in the full 510(k) submission and supporting validation documentation, not usually in the public summary.
§ 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.