(18 days)
The Definium™ 5000 X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.
The provided text is a 510(k) summary for the Definium™ 5000 X-Ray System (K063283). This document aims to demonstrate substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications are not present in the provided text. The document focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.
Here's an attempt to answer the questions based only on the provided information:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state quantitative acceptance criteria for image quality or clinical performance as it would in a de novo submission or a detailed clinical study report. Instead, it attests to "state of the art image quality" and that "the new device is as safe and effective as the predicate devices" based on "bench, user, and standards testing."
The "Substantial Equivalence Chart" compares technical characteristics rather than performance metrics against acceptance criteria.
| Characteristic | Acceptance Criteria (Not explicitly defined, but inferred as "equivalent to predicate") | Reported Device Performance (as presented in the "This Submission" column) |
|---|---|---|
| Intended Use | General purpose diagnostic X-ray unit | SAME (General purpose diagnostic X-ray unit) |
| Image Acquisition | Digital: CANON CXDI-50G, K031447 (from predicate K042876) | Digital: GE Tethered Portable Digital Radiographic Detector K041922 |
| Digital Panel Size | Up to 14" x 17" active area (from predicate K042876) | 16" x 16" active area |
| Digital Resolution | 160 x 160 microns pixel pitch, with approximately 6 million pixels (from predicate K042876) | 200 x 200 micron pixel pitch, approximately 4 million pixels |
| Maximum Output | Depends on model of generator (from predicate K042876) | 64 Kw model only |
| User Interface | Depends on Control Console option (from predicate K042876) | Software Driven Touch Panel LCD, + remote control unit + remote console |
| Method of Control | Dedicated push button controls (from predicate K042876) | Software Driven Touch Panel LCD, + IR remote control unit and control room interface box |
| Collimator | Manual R302/A (from predicate K042876) | Automatic Collimator Hewitt 150 |
Note: The differences in "Digital Panel Size" and "Digital Resolution" are noted in the submission but are deemed not to raise new questions of safety or effectiveness, as the overall system is considered substantially equivalent. The performance "criteria" are implicitly met if the device is deemed substantially equivalent.
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 "bench, user, and standards testing" but does not provide any details on sample sizes, whether the data was retrospective or prospective, or the country of origin.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This device is an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The document is about the physical X-ray system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an AI algorithm's performance. As the device is an X-ray system and not an AI algorithm, this type of standalone performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document refers to "bench, user, and standards testing" leading to a conclusion of safety and effectiveness, but it does not specify the type of ground truth used. For an X-ray system, ground truth for image quality might involve physical phantoms, dose measurements, or qualitative expert assessment of image clarity, but these details are not provided.
8. The sample size for the training set
This refers to AI algorithm training. As the device is an X-ray system and not an AI algorithm, a "training set" as commonly referred to in AI/ML is not applicable.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.