(12 days)
Agfa's Computed Radiography Systems with NX 2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton "in luding skull, spinal column and extremities) chest, abdomen and other body parts.
When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.
When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskelelal regions of adult or pediatric patients.
Agfa's Computed Radiography Systems with NX 2.X software are not indicated for use in mammography.
The predicate and new devices are nearly identical computed radiography imaging systems. NX 2.X systems (new devices) have:
- . An improved image processing package, Musica2 Platinum (optional). provides improved image processing of the thorax, abdomen or musculoskeletal images for adult or pediatric patients.
- . An auto-stitch function that allows users to automatically combine subimages of large patient anatomies (a leg or spine, for example) into a single image.
- The ability to designate one workstation as the central workstation that . has the ability to view exams on all connected workstations.
The basic principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.
The provided 510(k) summary for K071162, "Premarket Notification: Computed Radiography Systems With NX 2.X Workstations" from Agfa HealthCare Corporation, does not contain a detailed study with acceptance criteria and reported device performance as typically expected for demonstrating substantial equivalence for significant changes or novel devices.
Instead, this submission primarily focuses on demonstrating substantial equivalence to a predicate device (Agfa's Computed Radiography Systems with NX1.0 workstations, K053634) based on the similarity of technological characteristics and intended use, with minor improvements in image processing (Musica2 Platinum) and workflow features (auto-stitch, central workstation viewing).
Here's a breakdown of the requested information based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, resolution, signal-to-noise ratio) are explicitly stated for the NX 2.X system or Musica2 Platinum image processing in the provided document. | No specific quantitative performance data is reported to demonstrate meeting any acceptance criteria. The document broadly states that "Agfa's Computed Radiography (CR) Systems with NX 2.X Workstations have been tested for proper performance to specifications through various in-house and imaging performance tests" and "Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2." However, these are general statements about safety and electrical standards, not specific clinical performance metrics related to diagnostic quality or image processing efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not mentioned. The submission relies on "diagnostic quality images to aid the physician with diagnosis," implying a continued reliance on human interpretation, but no specific study design involving expert readers for a test set is described.
4. Adjudication Method for the Test Set
- Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study demonstrating the effectiveness of the improved image processing (Musica2 Platinum) compared to the base system or predicate is not described. The submission focuses on the similarity of algorithms and adjusted parameters rather than a comparative effectiveness study.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted or reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No detailed standalone performance study is described. The "improved image processing package, Musica2 Platinum" is a component of a CR system that aids human diagnosis, not a standalone diagnostic algorithm. The claim is about image quality improvement, not automated diagnosis.
7. The Type of Ground Truth Used
- Not explicitly defined or mentioned as part of a formal study to establish ground truth for image processing performance. The "diagnostic quality images" implicitly suggest that the images are intended to be interpreted by medical professionals for clinical diagnosis, but how image quality improvements were objectively measured against a ground truth is not detailed.
8. The Sample Size for the Training Set
- Not mentioned. The document states that Musica2 Platinum "operates with algorithm parameters that are adjusted slightly to match images normally encountered in certain clinical applications." This implies some form of optimization or "training," but the data used for this is not quantified.
9. How the Ground Truth for the Training Set Was Established
- Not mentioned.
Summary of the Submission's Approach:
The 510(k) K071162 relies on a "predicate device" substantial equivalence pathway, meaning it asserts that the new device is as safe and effective as a legally marketed device (Agfa's CR Systems with NX1.0, K053634). The key arguments for substantial equivalence are:
- Same Indications for Use: The new system has essentially the same intended use.
- Similar Technological Characteristics: Both systems use the same fundamental X-ray to digital image conversion process.
- Minor Enhancements: The NX 2.X system offers an "improved image processing package" (Musica2 Platinum), an "auto-stitch function," and a "central workstation" viewing capability. The image processing improvement is described as "similar algorithms" with "slightly adjusted parameters" for specific clinical applications (thorax, abdomen, musculoskeletal).
- Safety and Performance Testing: General statements about in-house and imaging performance tests, and compliance with EN 60601-1-1 and EN 60601-1-2 standards (electrical and safety).
In conclusion, this 510(k) submission does not present a detailed clinical study with quantitative acceptance criteria and performance metrics for the reasons requested. It relies on demonstrating that the changes are minor enough that the new device remains substantially equivalent to the predicate, with general safety and performance testing supporting its functionality.
§ 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.