(107 days)
These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions.
DR Vision Neo is flat panel state-of-art digital imaging suite, driving significant improvements in productivity and quality. The streamlined efficiency of the DR Vision Neo enhance the entire radiographic operation, improving workflow by delivering diagnostic images instantly, and allowing users to move x-ray images clectronically to remote workstations, image archives, and printers. The DR Vision Neo is a Trixell Pixium 4600 flat panel detector based direct digital radiography system with ceiling suspended design. These are essentially standard diagnostic x-ray systems which have added to them a digital x-ray acquisition panel. The DR Vision Neo has a single panel while the DR Vision Duo has two panels, one in a wall stand and one in the patient table. Features are:
- Flat panel detector: Amorphous silicon panel with cesium iodide scintillator offers exceptional DQE 17" x 17" size eliminates the need to rotate the panel for transverse views l 43 x 143 micron pixels in matrix of 3121 x 3121 x 14 bits. * High-precision 9 million pixel resolution. * 14-bit digital data conversion with 16.000 grayscales. * Motorized detector panel movements with auto-tracking with ceiling suspended tube stand. Battery operated mobile elevating table for radiological applications with 4-way floating table top allows easy and quick patient positioning. * IHE/HL-7/DICOM Standard
The provided text is a 510(k) summary for the DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems, which focuses on establishing substantial equivalence to a predicate device. It does not contain detailed information about a clinical study with acceptance criteria and specific device performance metrics in the way a traditional performance study would.
Instead, the submission for these diagnostic X-ray systems relies on demonstrating substantial equivalence to a legally marketed predicate device (K061054 Siemens Axiom Aristos FX Plus Digital Radiography System). This is a common pathway for medical devices that are similar in technology and intended use to existing devices.
The "acceptance criteria" in this context are not performance thresholds for a disease detection task, but rather the criteria for demonstrating substantial equivalence to the predicate device. The "study" proving this is a comparison of technical characteristics and safety/effectiveness claims.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance/Comparison (DR Vision Neo/Duo vs. Predicate) |
|---|---|
| Intended Use: Device performs radiographic X-ray examinations of the whole body (excluding mammography) in various patient positions. | Meets: Identical stated Indications for Use. |
| Performance Standard: Compliance with 21 CFR 1020.30. | Meets: States "SAME" as predicate device for 21 CFR 1020.30. |
| Power Range: Comparable X-ray generator power. | Meets: DR Vision Pro/Duo: 32-80 Kw vs. Predicate: 50 Kw or 80 Kw (within comparable range). |
| Digital Panel: Utilizes a similar or identical digital detector. | Meets: States "Identical" Trixell 4600 digital panel as the predicate device. |
| Electrical Safety: Compliance with IEC-60601 and UL listing. | Meets: States "SAME" as predicate device for electrical safety per IEC-60601 and UL listed. |
| Safety and Effectiveness: Bench, test laboratory, and clinical testing indicate the new device is as safe and effective as predicate. | Meets: "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices." (General statement, no specific performance metrics provided in this summary). |
| Technological Differences: Few technological differences, no new indications for use. | Meets: "few technological differences, and has no new indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
- The document mentions "bench, test laboratory and clinical testing," but does not specify a sample size for any test set or clinical study.
- Data Provenance: Not specified. There is no information on the country of origin of the data or if it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish ground truth or their qualifications. The evaluation for substantial equivalence relies on comparing technical specifications and general safety/effectiveness, rather than expert-derived ground truth for diagnostic accuracy in a specific condition.
4. Adjudication Method
- Not applicable/Not specified. Since a specific clinical study with detailed diagnostic outcomes is not described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe a MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. This device is a diagnostic X-ray system, not an AI-powered diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
- No. The document does not describe a standalone performance study. This is an X-ray imaging system, not an algorithm being evaluated for standalone performance.
7. Type of Ground Truth Used
- Not applicable in the context of diagnostic accuracy. The "ground truth" here is effectively the accepted technical specifications and safety profile of the predicate device, which the new device is compared against for substantial equivalence. There's no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic performance of the device in a clinical setting in this summary.
8. Sample Size for the Training Set
- Not applicable/Not specified. This document does not describe an AI or machine learning model that would require a "training set." It is related to the hardware and basic functionality of a digital X-ray system.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not specified. As there is no training set mentioned, there is no information on how its ground truth would be established.
Conclusion from the document:
The regulatory submission for the DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems establishes substantial equivalence by demonstrating that they have the same intended use, comply with the same performance and safety standards, have comparable power ranges, and utilize the identical digital panel as the legally marketed Siemens Axiom Aristos FX Plus Digital Radiography System. The conclusion is that the new devices are as safe and effective as the predicate, with few technological differences and no new indications for use.
§ 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.