Search Results

The VALORY system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adults and pediatric patients.

Applications can be performed with the patient in sitting, standing or lying position.

The system is not intended for use in Mammography applications

VALORY is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiographic images of the human body. VALORY is a ceiling mounted stationary X-Ray system with digital image capture that consists of a tube and operator console with a patient table and/or wall stand. VALORY uses Agfa's NX workstation with MUSICA2 TM image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI) to capture and process the digital image.

The provided text describes the VALORY system, a general radiography X-ray imaging system, and its substantial equivalence to a predicate device (DR 600, K152639). However, it does not detail specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving the device meets these criteria in the way a clinical performance study would.

Instead, the submission focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics.
• Bench testing for image quality and usability.
• Software verification and validation.
• Compliance with electrical safety, EMC, and radiation protection standards.
• Adherence to quality management systems and guidance documents.

Here's an attempt to extract and organize the requested information, noting where specific details are not provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria for image quality or clinical performance metrics (like sensitivity, specificity, or accuracy) in a traditional sense. The performance is assessed relative to the predicate device.

"Additional image quality validation testing for NX 23 was completed in scope of the DX-D Imaging Package with XD Detectors and included a full range of GenRad image processing applications compared to MUSICA 2 image processing using anonymized adult and pediatric phantoms and read by eight internal experts." |
| Usability: Meets safety and workflow requirements. | "Usability evaluations for VALORY were conducted with external radiographers. The usability studies evaluated overall product safety, including workflow functionality for adults and pediatric patients, system movements, information and support for components. The results of the usability tests, fulfillment of the validation acceptance criteria, and assessment of remaining defects support VALORY passing usability validation testing." |
| Software Safety: Acceptable risk profile. | "Software verification testing for NX 23 was completed... For the NX 23 (NX Orion) software there are a total of 535 risks in the broadly acceptable region and 37 risks in the ALARP region with only four of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk." |
| Compliance: Meets relevant electrical, EMC, and radiation standards. | VALORY is compliant to FDA Subchapter J mandated performance standards 21 CFR 1020.30 and 1020.31. Also compliant with IEC 60601 series, ISO 13485, ISO 14971, DICOM, IEC 62366-1, and IEC 62304. |
| Functional Equivalence: Same intended use as predicate. | The VALORY system has indications for use that is consistent with and substantially equivalent to the legally marketed predicate device (K152639). |

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

The "test set" consisted of:

• Anthropomorphic adult and pediatric phantoms.
• No information on the exact number of phantoms or images used in these tests.
• The data provenance is not specified as country of origin, but it is implied to be laboratory-generated phantom data as "No clinical trials were performed in the development of the device. No animal or clinical studies were performed in the development of the new device."
• The studies were retrospective in the sense that they were conducted for submission, but not using existing clinical patient data.

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

• Image Quality Evaluation: "qualified internal experts and external radiographers" evaluated images from phantoms compared to the predicate device. For NX 23 testing, "eight internal experts" read images. Specific qualifications (e.g., years of experience) for these experts are not provided.
• Usability Evaluation: "external radiographers." Specific numbers and qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the expert evaluations, such as 2+1 or 3+1. It states experts "evaluated" and "read" the images, implying their findings were used as the basis for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done.
• The device is a general radiography X-ray imaging system, not explicitly an AI-assisted diagnostic device for specific disease detection. Its image processing (MUSICA/MUSICA2/MUSICA3) is an established technology from the predicate device and other Agfa systems. The study focuses on demonstrating image quality equivalence, not on reader performance improvement with AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The VALORY system itself is an imaging system, not a standalone diagnostic algorithm.
• The software risk assessment for NX 23 (the workstation software) involved evaluating risks without explicit human interaction for every risk listed, focusing on software failure modes. However, this is not a diagnostic "algorithm only without human-in-the-loop performance" in the sense of an AI CAD system. The image processing algorithms within MUSICA are an integral part of the system's image generation, not a separate diagnostic interpretation.

7. The Type of Ground Truth Used

• Image Quality: The ground truth for image quality evaluation was based on the performance of the predicate device (DR 600) and other marketed flat-panel detectors, combined with expert evaluation of images from anthropomorphic phantoms. It's a comparative assessment rather than a definitive "ground truth" of a disease state.
• Usability: Ground truth for usability was established through the feedback and performance of external radiographers during usability studies, ensuring the system met workflow and safety requirements.
• Software/Safety: Ground truth for software safety and compliance was against established standards (IEC, ISO, FDA regulations) and internal risk analyses.

8. The Sample Size for the Training Set

The document makes no mention of a "training set" in the context of machine learning or AI models. The device is being cleared based on substantial equivalence to an existing X-ray system, not as a novel AI diagnostic algorithm that requires a distinct training dataset. The "image processing algorithms" mentioned are presented as existing, cleared technologies from previous Agfa devices.

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

Since there is no mention of a distinct training set for an AI model, this information is not applicable and not provided in the document.

Ask a specific question about this device

The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

• · Positioning fluoroscopy procedures
• · Gastro-intestinal examinations
• · Urogenital tract examinations
• · Angiography
• · Digital Subtraction Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.

In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

Agfa's DR 800 with DSA medical device is a fluoroscopic x-ray system that includes digital angiography (product code JAA) intended to capture tomographic, static and dynamic images of the human body. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table. FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.

Here's an analysis of the acceptance criteria and study information for the Agfa DR 800 with DSA, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format for performance metrics. Instead, it describes a more qualitative approach, focusing on equivalence to predicate devices and confirmation through expert evaluation.

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

• Test Set Sample Size: Not explicitly stated in terms of number of images or cases. The document mentions "anthropomorphic phantoms" for clinical image validation.
• Data Provenance: The study used "anthropomorphic phantoms," which are physical models designed to simulate human anatomy for imaging purposes. This indicates a laboratory/phantom study rather than real patient data. The country of origin for the phantom data is not specified, but the submission is from Agfa N.V. (Belgium). It is a prospective study in the sense that the new device was evaluated with these phantoms.

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

• Number of Experts: Not explicitly stated. The document mentions "qualified experts" and "radiographers."
• Qualifications of Experts: Described as "qualified experts" and "radiographers." No specific experience levels (e.g., "10 years of experience") are provided.

4. Adjudication Method for the Test Set

Not specified. The document states "evaluated by qualified experts" and "radiographers evaluated...by comparing overall image quality with the primary predicate A device," implying a comparative evaluation rather than a strict adjudication process for ground truth establishment.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic device; it's a conventional X-ray system with digital image processing and DSA capabilities. The study compared the device's image quality to a predicate device, focusing on equivalence, not human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the "Bench Testing" and "Software Verification and Validation Testing" sections describe standalone performance evaluations of the device's functions and image processing algorithms. The "Clinical image validation" with phantoms also focuses on the device's output (image quality) rather than human interaction with the device in a diagnostic workflow where the human acts as the ultimate decision-maker for the study’s performance outcome.

7. The Type of Ground Truth Used

The "ground truth" for the image quality evaluation was based on expert comparison and qualitative assessment of images produced by the device, specifically assessing "diagnostic confidence for DSA image quality and roadmapping" as "between good and excellent" when compared to a predicate device. This is primarily an expert consensus on image quality rather than pathology, clinical outcomes, or a gold standard.

8. The Sample Size for the Training Set

Not applicable. This device is an X-ray imaging system, not a machine learning or AI algorithm that requires a training set of data. The image processing algorithms are described as being "similar to those previously cleared" or "similar to the primary predicate device."

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

Not applicable, as this device does not utilize a machine learning model that would require a ground truth for a training set.

Ask a specific question about this device

The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

Applications can be performed with the patient in the sitting, standing or lying position.

This system is not intended for mammography applications.

The DR 600 with Tomosynthesis is a tomographic and solid state x-ray system (product codes IZF and MQB) intended to capture tomographic slices and static images of the human body. The DR 600 with Tomosynthesis is a ceiling mounted tomographic and general radiographic system that consists of a tube and operator console with a motorized patient table and/or wall stand. The DR 600 with Tomosynthesis uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

The provided text describes the Agfa DR 600 with Tomosynthesis device and its K193262 510(k) submission. However, it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's meeting of these criteria. The document focuses on showing substantial equivalence to predicate devices primarily through technological characteristics and bench testing, not through comparative clinical effectiveness studies with explicit acceptance criteria for diagnostic performance.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device."

Based on the available information, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (as inferred from the document's approach to substantial equivalence):

Since no specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) are presented, the "acceptance criteria" for this 510(k) appear to be primarily focused on demonstrating substantial equivalence to predicate devices through technical specifications, image quality evaluations (bench testing), and compliance with various electrical safety, EMC, and software standards.

- Communications (DICOM)
- Flat Panel Detectors (type, material, sizes, pixel size, dynamic range)
- Operator Workstation (Agfa NX)
- Image Processing (MUSICA DTS, MUSICA2, MUSICA3/3+)
- Operating System (Windows 7, 8, 8.1, 10)
- Display System (Separately cleared medical display)
- Power Supply
- Generators

2. Indication for Use statement is consistent/identical to predicates.

3. Performance/Functionality as Intended:
- Confirmed functions and performs as intended.
- Supports a tomographic workflow and Smart Dr visualization (including adult and pediatric patients).

4. Image Quality Equivalent to Predicate:
- For both adult and pediatric patients.

5. Software Validation:
- Verification and validation plans confirmed.
- Risk assessment shows no unacceptable risks.

6. Electrical Safety and EMC Compliance:
- Adherence to specified IEC standards (60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54).
- Compliance with FDA Subchapter J mandated performance standard 21 CFR 1020.30 and 1020.31.

7. Quality Management System Compliance:
- Adherence to ISO 13485:2015, ISO 14971:2012, ACR/NEMA PS3.1-3.20 (DICOM). | 1. Technological Characteristics:
- Communications: Same as both predicates (DICOM).
- Flat Panel Detectors: Same as both predicates (Flat Panel Detectors, GOS/CsI Scintillator, various sizes 17x17, 14x17, 10x10 in., 148 µm pixel size in primary predicate, 139 µm in other, 16 bit dynamic range in primary predicate, 14 bit in other). The new device shares characteristics with both, indicating equivalence.
- Operator Workstation: Same as both predicates (Agfa NX).
- Image Processing: MUSICA DTS, MUSICA2, MUSICA3/3+. The addition of tomographic image processing is identical to the DR 800 (K183275) primary predicate device.
- Operating System: Same as predicate K183275 (Windows 7, 8, 8.1, 10).
- Display System: Same as both predicates (Separately cleared medical display K051901).
- Power Supply: Same as predicate K152639 (50-60 Hz, 380/400/415/440/480V + 10%).
- Generators: Same as predicate K183275 (Choice of three models: 50, 65KW, 80 KW).
- Overall: "Principles of operation and technological characteristics of the new and predicate devices are the same."

2. Indication for Use: "The DR 600 system is a General Radiography X-ray imaging system... In addition, the system provides the Agfa tomosynthesis option... Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep." This is stated to be "virtually identical" to K152639 with the tomosynthesis addition from K183275.

3. Performance/Functionality:
- "Technical and acceptance testing was completed on the DR 600 in order to confirm the medical device functions and performs as intended. All deviations or variances are documented... All design input requirements have been tested and passed."
- "Functionality evaluations were conducted with three qualified radiographers. Usability and TBD. The results of these tests fell within the acceptance criteria for the DR 600; therefore, the DR 600 supports a tomographic workflow and Smart Dr visualization including adult and pediatric patients."

4. Image Quality: "Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 600 and the primary predicate device, DR 800 (K183275) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients."

5. Software Validation: "Verification and validation testing confirmed the device meets performance, safety, usability and security requirements... For the NX22 (NX Nomad) software there are a total of 342 risks in the broadly acceptable region and 27 risks in the ALARP region with only one of these risks identified. Zero risks were identified in the Not Acceptable Region."

6. Electrical Safety and EMC Compliance: Document states compliance with all listed IEC standards and FDA performance standards.

7. Quality Management System Compliance: Document states adherence to all listed ISO and other standards. |

Study Details (Based on the provided text):

1. Sample sizes used for the test set and the data provenance:

   • Test Set: No specific numerical sample size is mentioned for image quality evaluations beyond "anthropomorphic adult and pediatric images." The document mentions "functionality evaluations were conducted with three qualified radiographers," but this refers to human user testing of workflow and usability, not diagnostic image performance.
   • Data Provenance: Not explicitly stated, but likely retrospective as it refers to comparisons of images taken with the new device and a predicate device. The comparison of anthropomorphic phantom images suggests a controlled laboratory setting.

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

   • The document states "Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates." It also mentions "clinical image quality evaluations for adults and pediatric patients" and "functionality evaluations were conducted with three qualified radiographers."
   • Number of Experts: At least "three qualified radiographers" for functionality, and "internal and independent specialists" for image quality, but exact numbers or specific qualifications (e.g., years of experience, board certification) are not detailed.
   • Qualifications: "Qualified radiographers" and "internal and independent specialists."

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

   • No adjudication method is described for the image quality evaluations or other performance tests. The comparison to predicates implies direct visual or quantitative comparison by specialists.

4. 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:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device."
   • Therefore, no effect size of human readers improving with AI assistance is provided as this type of study was not conducted. The device in question is an imaging system, not an AI-based diagnostic assistance tool.

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

   • The "performance data including clinical image quality evaluations for adults and pediatric patients" involved the system's output. The "image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients." This implies an evaluation of the algorithm's output (image quality) without necessarily focusing on a human-in-the-loop diagnostic task. So, in essence, standalone image quality performance was evaluated against a predicate.

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

   • The "ground truth" for image quality evaluation appears to be comparison to a cleared predicate device's image quality, as judged by "internal and independent specialists," using anthropomorphic phantoms. There is no mention of pathological confirmation or patient outcomes for establishing ground truth, as it was not a clinical trial.

7. The sample size for the training set:

   • This device is an X-ray system with image processing, not a machine learning/AI algorithm that requires a "training set" in the traditional sense of AI development. The software capabilities (MUSICA DTS, MUSICA2, MUSICA3/3+) are described as being identical to previously cleared versions in predicate devices. Therefore, a "training set" for a new AI model is not applicable here.

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

   • Not applicable, as no new AI model training set is described. The image processing algorithms are identical to those previously cleared.

Ask a specific question about this device

The DR 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by radiographers and radiologists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

Applications can be performed with the patient in the sitting, standing or lying position.

This device is not intended for mammography applications.

Agfa's DR 100s is a mobile x-ray system, a direct radiography system (product code ILL) intended to capture images of the human body. The device is an integrated mobile digital radiography x-ray system. The complete DR 100s systems consists of the mobile x-ray unit with integrated x-ray generator and NX software and one or more DR detectors. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital image capture. It is compatible with Agfa's computed radiography systems as well.

This submission is to add another mobile unit to Agfa's direct radiography portfolio.

The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DX-D 100 (K103597) and other devices in Agfa's radiography portfolio today, which includes DR 600 (K152639), DR 400 (K141192) and DR 800 (K183275).

Significant dose reduction can be achieved using the DR 100s with patented Agfa's MUSICA imaging processing and CsI flat-panel detectors. Testing with board certified radiologists determined that Cesium Bromide (CR) and Cesium Iodine (DR) detectors when used with MUSICA imaging processing can provide dose reduction between 50-60% for adult patients and up to 60% for pediatric and neonatal patients when compared to traditional Barium Fluoro Bromide CR systems (K141602).

Principles of operation and technological characteristics of the new and predicate device are the same. The new device is virtually identical to Agfa's DX-D 100(K103597) with the exception that it has a telescopic column and ergonomic design. It uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.

The provided text describes the DR 100s mobile X-ray system and its substantial equivalence to a predicate device, the DX-D 100. However, it does not contain specific acceptance criteria or a detailed clinical study proving the device meets these criteria in the manner requested.

The document states that the DR 100s uses the same image processing algorithms and flat-panel detectors as previously cleared devices, and that "Clinical image validation was conducted during testing in support for the 510(k) clearances for the flat-panel detectors (K161368 and K172784) and MUSICA software (K183275) in a previous submission." It also mentions that "Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 100s and the predicate device, DX-D 100 (K103597) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 100s passed the acceptance criteria."

This means the primary method for demonstrating equivalence and meeting acceptance criteria was through bench testing and referencing prior clearances for components. There's no detailed mention of a specific, standalone clinical study with human patients for the DR 100s itself, nor a multi-reader multi-case (MRMC) study.

Therefore, many of the requested details about a clinical study's methodology (sample size, data provenance, expert numbers, adjudication, MRMC results, ground truth types) cannot be extracted from this document directly for the DR 100s.

Here's an attempt to answer the questions based only on the provided text, acknowledging where information is missing:

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

The document does not explicitly list quantitative acceptance criteria in a table format for image quality or specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it states:

• "The test results indicated the image processing of the DR 100s passed the acceptance criteria." (for image quality bench tests)
• "All design input requirements have been tested and passed." (for technical and acceptance testing)
• "The results of these tests fell within the acceptance criteria for the DR 100s X-ray system therefore, the DR 100s supports a General radiographic workflow including adult and pediatric patients." (for usability and functionality)

Without specific numerical criteria, a performance table cannot be constructed. The main "performance" metrics provided are technical specifications of the flat-panel detectors (DQE, MTF, pixel size, etc.) which are compared to predicate devices but don't represent acceptance criteria for a clinical study proving diagnostic performance.

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

• Sample Size: Not specified for the image quality bench tests. The document only mentions "anthropomorphic adult and pediatric images."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are described as "bench tests" using anthropomorphic phantoms, not real patient data directly for the DR 100s itself. The "clinical image validation" mentioned refers to prior 510(k) clearances for components (detectors and software), not this specific device submission.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: It vaguely mentions "internal experts" for usability and functionality evaluations. For the "clinical image validation" of previously cleared components, it references validation conducted with "board certified radiologists" for dose reduction testing (K141602), but this is for a different aspect (dose reduction with MUSICA and CsI detectors) and potentially not the core image quality comparison for equivalence of the total system.

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

• Adjudication Method: Not specified.

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

• MRMC Study: No MRMC study is explicitly mentioned for the DR 100s. The document states "No clinical trials were performed in the development of the device. No animal or clinical studies were performed in the development of the new device."
• Effect Size: Not applicable, as no MRMC study was performed.

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

• The device is a mobile X-ray system and image processor, not an AI algorithm for diagnosis. Its performance is inherent in the image acquisition and processing. The "image processing of the DR 100s passed the acceptance criteria" refers to the system's ability to produce images comparable to the predicate. Therefore, the "standalone" performance is the image quality produced directly by the system.

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

• For the image quality bench tests, the "ground truth" was likely established through objective phantom measurements and comparison to the predicate device, rather than clinical ground truth (expert consensus, pathology, or outcomes data). The document refers to "anthropomorphic adult and pediatric images" meaning images of phantoms designed to mimic human anatomy.

8. The sample size for the training set

• Training Set for DR 100s: The DR 100s system itself is a hardware device with integrated software for image processing (MUSICA). It's not an AI model that undergoes a "training" phase in the conventional sense (e.g., deep learning). The MUSICA image processing algorithms are stated to be "identical to those previously cleared" in other Agfa devices (K103597, K152639, K141192, K183275). Therefore, any "training" (algorithm development/tuning) would have occurred for these prior versions/devices, and no specific training set for the DR 100s is mentioned.

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

• Not applicable/Not specified as the DR 100s itself does not undergo a "training" phase like a new AI algorithm. The MUSICA algorithms were previously developed and cleared.

Ask a specific question about this device

The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

• Positioning fluoroscopy procedures
• Gastro-intestinal examinations
• Urogenital tract examinations
• Angiography
  It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.
  In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
  The DR 800 is not intended for mammography applications.

Agfa's DR 800 with Tomosynthesis a tomographic and fluoroscopic x-ray system (product codes IZF and JAA) intended to capture tomographic slices of the human body. The DR 800 is a floormounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital and wide dynamic range capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

The Agfa DR 800 with Tomosynthesis underwent bench testing and software verification and validation to demonstrate substantial equivalence to its predicate devices, the GE Medical System's Discover XR656 with VolumeRAD (K132261) and Agfa's previous version of the DR 800 with MUSICA Dynamic (K180589). The primary focus of the testing for this submission was on the new Digital TomoSynthesis (DTS) software and its performance in generating tomographic slices.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical count of cases/images. The testing involved "anthropomorphic phantoms" for image quality evaluation, including both adult and pediatric phantoms. The pediatric phantom testing analyzed "five tomographic slices at 5x the dose and five tomographic slices at 10x the dose."
• Data Provenance: The data provenance is from bench testing using anonymized anthropomorphic phantoms. This indicates that the data is prospective in the sense that the phantoms were specifically used for this testing, but it is not from human patients. The country of origin of the data is not specified, but the manufacturer is Agfa N.V. (Belgium).

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

• Number of Experts: "Qualified independent radiographers and internal experts" were used for usability, functionality, and image quality evaluations. The exact number of each group is not specified.
• Qualifications of Experts: They are described as "qualified independent radiographers and internal experts" and "qualified radiologists" (in the "Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence" section). Specific details like years of experience or subspecialty are not provided.

4. Adjudication Method for the Test Set

• The document implies that the "qualified independent radiographers and internal experts" evaluated the images and that the results "fell within the acceptance criteria" or "passed the acceptance criteria," suggesting a consensus or individual assessment against predefined criteria. However, a specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

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

• No MRMC comparative effectiveness study was done. The study design described is a bench test comparison of the device against a predicate device's reference images using phantoms, with evaluation by human experts, rather than an assessment of human reader performance with or without AI assistance. The device itself is an imaging system, not an AI-powered diagnostic tool for interpretation assistance in the sense of comparing human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone evaluation of the algorithm's output was done, as part of the image quality validation. The "reconstruction software of the image processing for Digital TomoSynthesis (DTS)" was evaluated to ensure the generated tomographic images were suitable for diagnosis. This is an assessment of the algorithm's output (the tomographic slices) without direct human intervention in the image generation process, beyond setting up the acquisition parameters.

7. The Type of Ground Truth Used

• The ground truth for the image quality evaluation was based on comparison to reference images from the primary predicate device (GE Discovery XR656 with VolumeRAD - K132261) using anthropomorphic phantoms, and expert assessment by "qualified independent radiographers and internal experts" confirming the images were "suitable for diagnosis" and "clinically sufficient." It is not pathology, or outcomes data.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set for the MUSICA DTS software. It mentions that "The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with MUSICA Dynamic (K180589) and other devices in Agfa's radiography portfolio today... The addition of the tomographic image processing is similar to the predicate device (K132261)." This suggests leveraging existing, previously trained algorithms or development methodologies, rather than describing a specific new training dataset for this submission.

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

• This information is not provided in the document. As noted above, the submission emphasizes similarity to existing, cleared technologies, rather than detailing the unique training of a novel algorithm from scratch.

Ask a specific question about this device

The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

• · Positioning fluoroscopy procedures
• · Gastro-intestinal examinations
• · Urogenital tract examinations
• · Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.

The DR 800 is not intended for manimography applications.

Agfa HealthCare's DR 800 is an image-intensified fluoroscopic x-ray system (product code JAA) intended to capture images of the human body. The DR 800 is a floor-mounted R/F system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA Dynamic™ image processing and flat-panel detectors for digital and wide dynamic range image capture. It is capable of replacing other direct radiography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify exact numerical sample sizes for the test sets used in the various evaluations (usability, FLFS, dose control, image quality). It mentions the use of "anthropomorphic phantoms" for image quality testing.
• Data Provenance: The data is described as "Laboratory data" and "image quality evaluations conducted with independent radiologists."
  • Country of Origin: Not explicitly stated, but the company is Agfa HealthCare N.V. (Belgium), and the submission is to the FDA (USA), implying development might be international but for the US market. The use of "DIN-norm" suggests European origin or influence for some standards.
  • Retrospective or Prospective: Not explicitly stated. The nature of the "bench testing" and "clinical image quality evaluations" using phantoms suggests a controlled, prospective testing environment rather than retrospective analysis of patient data. "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld." confirms prospective, non-clinical study design.

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

• Number of Experts:
  • Usability and Functionality: "qualified independent radiographers and internal experts." (Number not specified)
  • FLFS Clinical Validation: "qualified internal radiographer." (One identified)
  • FLFS Comparison Test: "several qualified internal experts." (Number not specified, but more than one)
  • Dose Control Validation: "qualified internal expert." (One identified)
  • Image Quality Validation: "qualified independent radiographers and internal experts." (Number not specified)
• Qualifications of Experts: The experts are consistently referred to as "qualified independent radiographers" or "qualified internal experts" (or radiographer). Specific years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies among expert opinions. Evaluations often involved "qualified independent radiographers and internal experts," implying consensus or individual assessment, but a specific arbitration process is not detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as being performed to compare human readers with and without AI assistance.
• The study focused on showing equivalence or improvement of the new device (DR 800 with MUSICA Dynamic) compared to reference images and predicate devices/software, and its ability to meet acceptance criteria for performance, not on AI-assisted human reading performance. The "MUSICA Dynamic" is described as software for image processing, not necessarily an AI for diagnostic assistance to human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are primarily standalone evaluations of the device's technical performance and image quality. These evaluations assessed the output of the DR 800 system with MUSICA Dynamic processing (which is an algorithm) directly, using phantoms and comparing its output to reference images and predicate devices. There is no indication of a human-in-the-loop performance study where the algorithm's output is then interpreted by a human and compared to human interpretation without the algorithm.

7. Type of Ground Truth Used

The ground truth used appears to be:

• Expert Consensus/Opinion: For image quality, usability, and FLFS validation, the assessments by "qualified independent radiographers and internal experts" served as the ground truth for determining acceptability.
• Technical Standards/Benchmarks: For dose control, "DIN-norm" and "dose limit curve" served as the objective ground truth.
• Reference Images/Predicate Device Performance: For image quality validation, comparisons were made to "reference images using anonymized phantoms" and against predicate device performance, implying these served as a comparative ground truth.
• Pre-defined Requirements: For usability and functionality, the 'acceptance criteria' themselves served as the ground truth of what the device needed to achieve.

There is no mention of pathology or long-term outcomes data as ground truth.

8. Sample Size for the Training Set

• The document does not provide information on the sample size for a training set. This is likely because the device is an X-ray imaging system with image processing software (MUSICA Dynamic), and the focus of the 510(k) submission is on demonstrating substantial equivalence and validation of its performance, not on a machine learning model that would require a distinct training set. The "MUSICA Dynamic" algorithms are described as "similar to those previously cleared" or "identical to the predicate device" in terms of dynamic image processing.

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

• As no training set is explicitly mentioned or detailed for a machine learning model, there is no information on how its ground truth would have been established. The image processing algorithms are likely based on established signal processing techniques, rather than learned directly from a labeled dataset in the way a modern AI model might be.

Ask a specific question about this device

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.

Agfa's DX-D Imaging Package is not indicated for use in mammography.

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors.

This submission is to add the DR10s and DR14s Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only.

Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similatorphotodetector flat panel detectors to capture and digitize the images as predicate K142184.

This document describes the 510(k) summary for Agfa's DX-D Imaging Package, focusing on the newly added DR10s and DR14s Flat Panel Detectors. The submission aims to demonstrate substantial equivalence to a predicate device (K142184).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, the acceptance criteria are implied to be equivalence to the predicate device (K142184) and performance falling within expected parameters for radiographic systems. The reported device performance is presented through comparison with other Agfa flat-panel detectors on the market, including the predicate.

Below is a table summarizing the performance characteristics of the new detectors (DR 10s, DR 14s) and the predicate (represented by DX-D 10, DX-D 20, DX-D 40 from the comparison table, as the predicate K142184's individual detector specs aren't explicitly broken out separately):

The overall acceptance criteria for the study is "Substantial Equivalence" to the predicate device (K142184), demonstrated through:

• Identical Indications for Use.
• Same principles of operation and technological characteristics (despite some hardware differences).
• Performance data (laboratory and clinical evaluations) ensuring equivalence.

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

• Test Set Sample Size:
  • For laboratory image quality (DQE, MTF) comparisons and grid evaluation: The document does not specify a numerical sample size in terms of images or measurements. It states "equivalent test protocols as used for the cleared detectors" were used and the results "confirmed that the DX-D Imaging Package with DR 10sC, DR14sC, and DR14sG flat-panel detectors was equivalent to other flat-panel detectors Agfa currently markets including the predicate (K142184)."
  • For usability and functionality evaluations: Not specified.
  • For Image Quality Validation testing (using anthropomorphic phantoms): Not specified.
  • For in-hospital image quality comparisons ("clinical evaluations"): "anonymized" patient images were utilized, but the number of images or cases is not specified.
• Data Provenance: The data appears to be retrospective (for human image data, implied from "anonymized to remove all identifying patient information" and "No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.") and laboratory-generated (for DQE, MTF, grid, usability, and phantom studies). The country of origin is not explicitly stated.

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

• For laboratory image quality, grid evaluation, usability/functionality:
  • "qualified individuals employed by the sponsor" conducted these evaluations.
  • "qualified independent radiographers" conducted usability and functionality evaluations.
  • "a qualified internal radiographer" conducted the grid evaluation.
  • "qualified independent radiographers" evaluated anthropomorphic phantoms.
• For in-hospital image quality comparisons:
  • "qualified independent radiologists" conducted these comparisons.
• Qualifications: "Qualified independent radiographers" and "qualified independent radiologists" are mentioned. Specific experience levels (e.g., "10 years of experience") are not provided. The term "qualified" implies they possess the necessary expertise for the task.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical evaluations" and "in-hospital image quality comparisons" mention "qualified independent radiologists" in plural, suggesting a consensus or comparison approach among them, but details are not provided.

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

• No MRMC comparative effectiveness study was done in the sense of measuring human reader improvement with vs. without AI assistance.
• The studies conducted were focused on demonstrating that the new device's image quality and performance were equivalent to the predicate device and other established systems, meaning human readers would perform similarly with the new device as with the predicate.

6. Standalone (Algorithm Only) Performance Study

• No standalone algorithm performance (AI-only) study was done for diagnostic interpretation. The device is an imaging package (hardware detectors and workstation) for capturing and displaying images, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

• For laboratory image quality (DQE, MTF, grid): The "ground truth" is based on physical measurements and standardized test protocols.
• For usability and functionality: The "ground truth" is based on expert assessment by radiographers against pre-defined workflow and compatibility requirements.
• For image quality validation (phantoms): The "ground truth" is based on expert assessment by radiographers of the generated images, likely comparing features to expected phantom characteristics and established image quality standards.
• For in-hospital image quality comparisons: The "ground truth" is implicitly based on radiological expert consensus (potentially with existing patient reports as a reference, though this is not specified), primarily for qualitative comparison against images produced by predicate devices.

8. Sample Size for the Training Set

The document does not mention a training set, as this device (an X-ray imaging package) is not an AI diagnostic device that requires a training set in the typical machine learning sense. The "software validation testing" refers to verification and validation of the software components against predefined requirements, not training a machine learning model.

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

Not applicable, as no training set for an AI algorithm is mentioned or implied.

Ask a specific question about this device