(74 days)
This digital radiographic system is 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, extremitics, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 K V or 40 - 150 k V with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and cciling suspension. The digital subsystem is the SmartRad (CMT Medical Technologies) K003438.
This 510(k) summary (K082604) for the Viztek DR Series Digital Diagnostic Digital X-Ray Systems (Multiple Models) is a submission for substantial equivalence to predicate devices, not a study presenting novel performance data. Therefore, many of the requested elements regarding acceptance criteria and study details are not directly applicable.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it is a submission for substantial equivalence, not a direct performance study against a predefined clinical benchmark. The acceptance criteria essentially revolve around demonstrating equivalence to legally marketed predicate devices in terms of technical characteristics and intended use.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as URS LP Digital, Millennium, Radpro (Sedecal) K042876 | "SAME" - Intended for diagnostic radiographic exposures of skull, spine, chest, abdomen, extremities, and other body parts in adults and pediatrics, with patient sitting, standing, or lying prone/supine. |
| Configuration | U-Arm mount or Ceiling Suspension (same as predicate) | "SAME" - U-Arm mount or Ceiling Suspension. |
| Performance Standard | Compliance with 21 CFR 1020.30 (same as predicate) | "SAME" - Compliance with 21 CFR 1020.30. |
| Generator | High frequency made by Sedecal (same as predicate) | "Uses same generator made by Sedecal". |
| Electrical Safety | Electrical Safety per IEC-60601, UL listed (same as predicate) | "SAME" - Electrical Safety per IEC-60601, UL listed. |
| Safety and Effectiveness | Bench and laboratory test results indicate safety and effectiveness comparable to predicate devices. | "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices." |
Note on "Digital Panel" and "Number of panels": While these are present in the comparison chart, they highlight differences rather than direct "acceptance criteria" for performance. The Viztek device uses a Pixium 4600 panel and can have one or two panels, while the predicate uses a CANON CXDI 50G and has one. The implication is that these differences do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for substantial equivalence, not a clinical study involving a test set of patient data for performance evaluation. The "tests" mentioned are bench and laboratory tests, not clinical evaluations with a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical ground truth establishment or expert review of a test set of images is described for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is 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
Not applicable. This device is a digital X-ray system, not an AI-powered diagnostic tool, and no MRMC study is described. The submission focuses on the hardware and its equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a digital X-ray system, and there is no "algorithm only" performance reported in this context. The device's primary function is to acquire X-ray images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. The "ground truth" for this submission is adherence to recognized performance standards (e.g., 21 CFR 1020.30, IEC-60601 for electrical safety), and the technical specifications and intended use of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.