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The OTC 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 straight arm tube stand we be supplying an overhead tube crane. The imaging components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The OTC 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-rav generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The ULTRA software was most recently cleared in K214012 and has not been changed from the cleared version

The provided document does not contain an acceptance criteria table or a detailed study proving the device meets specific acceptance criteria in the way typically found in a clinical performance study for an AI/ML medical device. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics and indications for use.

Therefore, many of your specific questions cannot be answered from this content.

Here's what can be extracted and inferred from the document:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the "OTC DDR performs the same functions as the predicate using the same technological methods to produce diagnostic x-ray images." The "reported device performance" is essentially that it functions similarly to the predicate device and meets relevant safety and electromagnetic compatibility (EMC) standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a performance study on a test set of medical cases.

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)

Not applicable. No test set requiring expert ground truth was used for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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. No MRMC study was conducted or reported. The device is an X-ray system, not an AI-assisted diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an X-ray imaging system, not a standalone AI algorithm. It's a device that produces images for human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" here is primarily based on meeting engineering and safety standards, as well as functional equivalence to the cleared predicate device.

8. The sample size for the training set

Not applicable. This submission doesn't describe an AI training process or dataset.

9. How the ground truth for the training set was established

Not applicable.

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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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EXA™ is a software device that receives digital images and data from various sources (i.e. CT scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

EXA™ is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities and offer an interface that users find to be quite intuitive after some initial learning. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ PACS suite.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document is a 510(k) summary for a medical image management and processing system called EXA™. It focuses on demonstrating substantial equivalence to a predicate device (EXA™ - K142919) by comparing their characteristics and stating that software validations after each version update confirm the new version is as safe and effective.

While it mentions software validations, it does not provide specific performance metrics or the details of these validation studies that would be necessary to populate the requested table and answer the subsequent questions.

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The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography 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, chest, abdomen, 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).

The proposed System is a digital radiography diagnostic system that has the capability of obtaining two modes (static mode and dynamic modes) of radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Images may be obtained with the patient sitting, standing, or lying in the prone or supine position. It is not intended for mammographic use. The system is configurable in two options. Both are exactly the same with the exception of the option to select one of two flat panel detectors. One configuration, referred to as KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel and the other configuration, referred to as KDR™ AU System Advanced U-Arm with Static Digital Radiography a HQ/KDR panel. The technological feature of each flat panel detector is described below.

The proposed system is a compact, floor and wall mounted radiographic system with proprietary ULTRA software and DICOM 3 connectivity.

The system consists of a combination of several components. The System's hardware consists of the 3 kev components:

1. A floor and wall-mounted Positioner (also referred to as a stand)
2. A generator
3. An off-the-shelf computer with proprietary software (also referred to as an acquisition workstation)

The positioner has a swivel arm that has several rotating and linear movements, and movement controls including an information screen. Mounted on the positioner are:
a) A collimator,
b) An X-ray tube
c) An Automatic Exposure Control (AEC)
d) A flat panel detector (There are 2 configurations available for the end user to select. The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel detector capable of obtaining both static and dynamic images and the KDR™ AU System Advanced U-Arm with Static Digital Radiography, which contains the HQ/KDR flat panel detector capable of obtaining static images only.

Hardware accessories include:

1. A mobile patient table
2. Stitching stand
3. Weight bearing stand

Optional Hardware accessories include:

1. Motorized height adjustable table
2. 3 knob collimator
3. Dose area product meter
4. Advanced weight bearing stand

The proposed system has a proprietary ULTRA software as the central interface of the system. The software for the proposed system enables users to acquire static and dynamic images.

There are two modes within the software package of the proposed system, "static mode," which may be used to generate, a single frame of radiographic images captured at a single time and "dynamic mode" (or "Dynamic Digital Radiography," abbreviated "DDR,") which generates multiple frames in a single series, presenting the physician with a diagnostic view of dynamic density and anatomic motion without using fluoroscopy or cine. The number of images acquired with the proposed system are limited to 300 compared with flouroscopy or cine, which do not limit the number of images (Note: only the configuration with the HD/FNB flat panel detector is capable of obtaining both static and dynamic images. The other configuration may only obtain static images).

The system is also capable of quickly assuming a preprogrammed position when a new exam is selected, saving time when positioning the equipment. This is referred to as "auto positioning," and made possible by the positioner and image processing software working together.

The provided document is a 510(k) summary for the Konica Minolta Healthcare Americas KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography.

This document describes the device and its substantial equivalence to predicate devices, focusing on regulatory compliance and technical specifications rather than specific clinical performance data for AI/software components. The primary performance data discussed refers to compliance with safety and performance standards for X-ray systems, not an AI-driven diagnostic or assistive feature.

Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI component) are not present in this document. The document primarily addresses the safety and effectiveness of the X-ray system hardware and its software for image acquisition, not an AI-based diagnostic tool.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific performance metrics for an AI component. Instead, it refers to compliance with various electrical, safety, and imaging standards for the overall X-ray system.

2. Sample size used for the test set and the data provenance:

• Not explicitly stated in the provided document. The document discusses compliance with technical standards for an X-ray system, not the performance of an AI algorithm on a specific medical image dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / not stated. This document focuses on the technical and safety performance of an X-ray imaging system, not on a machine learning model requiring expert-annotated ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / not stated. The context of this document does not involve diagnostic interpretations requiring adjudication.

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 done / not stated. The device described is an X-ray acquisition system; it does not present itself as an AI-assistive diagnostic tool for human readers in the context of this 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable / not stated. The device is an X-ray system, which includes software for image acquisition ("proprietary ULTRA software"), but the document does not describe a standalone AI algorithm for diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / not stated. Ground truth, in the context of diagnostic AI models, is not relevant to the compliance testing of an X-ray imaging system described here.

8. The sample size for the training set:

• Not applicable / not stated. The document describes an X-ray system, and there's no mention of a machine learning component requiring a training set in this context.

9. How the ground truth for the training set was established:

• Not applicable / not stated. As no training set is mentioned for an AI algorithm, ground truth establishment is not relevant to the information provided.

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