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This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.

This document describes the regulatory submission for the Universal DR 1748, an upgrade kit for digital X-ray systems. It asserts substantial equivalence to a predicate device, the Konica Minolta SKR 3000 (K210619). The primary difference is the digital X-ray panel and associated software.

However, the provided text does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and the detailed study that proves the device meets those criteria for the AI/Software component (Ultra software).

The mention of the "Ultra" software suggests it is a crucial component of the new system, having been previously cleared (K212291). The relevant part states: "The digital panel software employed was used unmodified from clearance obtained from FDA. The software has been validated as a control for CPI and Sedecal diagnostic x-ray generators."

This means that the software's performance and validation were established in its prior clearance (K212291) and are not re-evaluated in detail within this specific K214030 submission summary. The current submission focuses on the integration of this pre-cleared software with new hardware components (the Venu1748V digital panel).

Therefore, based solely on the provided text, I cannot extract the specific details about the acceptance criteria and the study proving the software's performance. The document only confirms that the software was "unmodified" from a previously cleared version and "validated as a control" for certain generators.

To provide the requested information, one would need to access the K212291 submission for the "Ultra" software, as that is where its performance studies would have been detailed.

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The Straight Arm DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).

This submission is for a MODIFICATION to our predicate device. Instead of supplying a "U-shaped" arm we will be supplying a "Straight" arm. The other components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The Straight Arm DDR features the latest developments in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube, positioner, automatic exposure control, collimator, X-ray generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The straight arm assembly was originally cleared in K062335. The ULTRA software was most recently cleared in K212291 and has not been changed from the cleared version.

The provided text describes a 510(k) premarket notification for a medical device called "Straight Arm DDR." This is a modification to an existing predicate device (KDR™ AU-DDR System) where the only change is the physical arm configuration from a "U-shaped" arm to a "Straight" arm. The software (ULTRA) and other core components remain unchanged.

Given this context, the acceptance criteria and study described will focus on demonstrating that this mechanical modification does not negatively impact the safety and effectiveness of the device as an X-ray system. This is not a submission for an AI/ML medical device, so the detailed criteria typically associated with AI/ML algorithm performance (e.g., sensitivity, specificity, MRMC studies) are not applicable here.

Here's an interpretation based on the provided information, focusing on the demonstrated substantial equivalence for a modified X-ray system:

Acceptance Criteria and Device Performance for Straight Arm DDR (K214012)

For this type of device modification (physical change to an existing X-ray system), the acceptance criteria primarily revolve around demonstrating that the modified device remains safe, effective, and performs equivalently to the predicate device, especially in terms of image quality and adherence to relevant safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Nature: This submission primarily relies on non-clinical engineering and performance testing of the device components and the integrated system, rather than a clinical "test set" of patient data like an AI/ML algorithm would use.
• Sample Size: Not applicable in the sense of patient data. The "sample" is the physical device itself, prototypes, or test configurations.
• Data Provenance: Not applicable as it's not a data-driven AI/ML study. The testing is conducted on the manufactured device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Ground Truth Establishment: Not applicable for establishing "ground truth" in the diagnostic sense (e.g., disease presence). The "ground truth" here is adherence to engineering standards and functional performance.
• Expert Oversight: The testing described would be supervised by qualified design, quality, and regulatory engineers within Konica Minolta Healthcare Americas, Inc., and assessed by regulatory bodies like the FDA. Their qualifications would be in medical device engineering, quality assurance, regulatory affairs, and X-ray system design/functionality.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring reader adjudication of medical images. Performance is measured against engineering specifications and regulatory standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC study was not done.
• Reason: This submission is for a physical modification of an X-ray system, not an AI/ML algorithm intended to assist human readers in diagnosis. Clinical performance was deemed "Not required for a determination of substantial equivalence" because the core imaging technology and software remained unchanged from the previously cleared predicate, and the physical modification ("Straight Arm" vs "U-Arm") was considered to have equivalent performance for image acquisition.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Not applicable. This is a medical imaging hardware system with integrated control software, not an AI/ML algorithm whose performance would be assessed in isolation. The software component ("ULTRA") was previously cleared and is used unmodified.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is primarily engineering specifications, international performance standards (e.g., IEC standards), and functional requirements for X-ray systems.
  • For safety and performance, the ground truth is defined by the passing criteria of the listed IEC standards (e.g., "satisfactory results" for IEC60601-1 and IEC60601-1-2).
  • For image quality, the ground truth would be comparison to the expected output from the predicate device and the quality deemed acceptable for diagnostic imaging.
  • For functionality, the ground truth is the successful operation of all components and the system as a whole.

8. The Sample Size for the Training Set

• Training Set: Not applicable. This is not an AI/ML device that requires a training set of data. The "training" for this device's development comes from established engineering principles and past validated designs.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable. See point 8.

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