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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.

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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.

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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.

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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.

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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.

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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 for adult, pediatric and neonatal examinations. The DX-D Imaging Package may be used wherever conventional screen-film systems, CR or DR systems may be used.

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

The device is a direct radiography imaging system of similar design and construction to the original (predicate) version of the device. Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2™ image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and directly digitize x-ray images without a separate digitizer. This new version includes optional image processing algorithms for adult, pediatric and neonatal images that were previously cleared for use in Agfa's computed radiography systems.

The device uses a direct conversion process to convert x-rays into a digital signal. X-rays incident on the scintillator layer of the detector generate light that is absorbed by photo-detectors, converted to a digital signal and sent to the workstation the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.

Principles of operation and technological characteristics of the new and predicate devices are the same.

While the provided text mentions that "Performance data including laboratory image quality measurements and image comparison studies by independent radiologists are adequate to ensure equivalence," it does not provide specific acceptance criteria or detailed results of these studies. Therefore, a table of acceptance criteria and reported device performance cannot be generated with the given information.

Here's an analysis of what can be extracted and what is missing:

Acceptance Criteria and Study Details (Based on Provided Text)

The document states that the performance data from "laboratory image quality measurements" and "image comparison studies by independent radiologists" were "adequate to ensure equivalence." However, no specific metrics, targets, or results for these studies are provided.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified.
• Data Provenance: The document mentions "In-hospital image quality comparisons," implying diagnostic images from a clinical setting. It does not specify the country of origin.
• Retrospective/Prospective: Not specified.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. The document mentions "independent radiologists."
• Qualifications of Experts: The document states "qualified independent radiologists." Specific experience (e.g., "10 years of experience") is not provided.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified.

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

• Was it done?: Not explicitly stated as an MRMC study in the standard terminology, but the document mentions "image comparison studies by independent radiologists" and "In-hospital image quality comparisons have been conducted with qualified independent radiologists." This suggests a human reader component. However, it's unclear if this was a comparative effectiveness study involving AI assistance.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as the document doesn't describe AI-assisted reading or its effect size. The new version includes "optional image processing algorithms," but the study described is for the device's imaging quality, not human-in-the-loop performance with new algorithms.

6. Standalone (Algorithm Only) Performance Study

• Was it done?: No. The document describes the device as an imaging system, not a standalone AI algorithm for interpretation. The "optional image processing algorithms" are part of the overall imaging package, and the performance validation is for the "complete system," not the algorithm in isolation for diagnostic accuracy.

7. Type of Ground Truth Used

• Type of Ground Truth: Implied to be expert consensus/radiologist interpretation. The document refers to "image comparison studies by independent radiologists" and "in-hospital image quality comparisons." Pathology or outcomes data are not mentioned.

8. Sample Size for Training Set

• Sample Size: Not applicable. This device is an X-ray imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense for diagnostic image analysis. The "new version includes optional image processing algorithms for adult, pediatric and neonatal images that were previously cleared." These algorithms would have been developed and validated, but the document doesn't provide details on their training data.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable (see point 8).

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Agfa's DX-D FLFS is indicated for acquiring images for measurements in the orthopedic field (skeleton).

Agfa's DX-D FLFS is a direct radiography accessory, similar to the predicate. The device allows the user to stitch multiple acquired images of long patient anatomies (like a full leg or full spine) into a single patient image. This is particularly useful for making measurements during orthopedic examinations. The DX-D FLFS includes an optional software license for its NX workstation (for image processing) and a patient stand with grid.

The Agfa DX-D FLFS is an accessory for direct radiography systems that allows stitching multiple images of long patient anatomies (like a full leg or full spine) into a single image, useful for orthopedic measurements.

Here's an analysis of its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Design verification tests confirm the device meets specifications" and "Performance of the complete system has been validated," but it does not provide quantities for test sets or details on the images used.
• Data Provenance: Not specified. There is no information provided about the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication Method: Not specified. The document does not describe any expert review or adjudication process for establishing ground truth for the test set.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed in the development of the DX-D FLFS." This device is more about image processing and stitching rather than an AI diagnostic aid requiring reader performance comparison.

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

• Standalone Study: Yes, in essence, the testing conducted was a standalone performance evaluation of the stitching algorithms and system. "Stitching algorithms operate as planned with expected measurement accuracy. Performance of the complete system has been validated." The device's primary function is automated image stitching, so these tests evaluate the algorithm performs its intended function independently.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for the performance claim of "expected measurement accuracy" is implied to be based on engineering specifications and potentially phantoms or simulated data designed to test the stitching and measurement capabilities. No independent expert review, pathology, or outcomes data is mentioned as ground truth.

8. The sample size for the training set:

• Sample Size: Not specified. The document does not provide details on any training data used for the stitching algorithms.

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

• Ground Truth Establishment: Not specified. Given the absence of clinical testing and the focus on engineering validation, it's likely the algorithms were developed and refined based on internal technical metrics and potentially synthetic or standardized images, rather than a formally established clinical ground truth for training.

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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.

The device is a direct radiography imaging system of similar design and construction to the predicate. Agfa's DX-D Imaging Package uses the company's familiar NX workstation with MUSICA2 TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium lodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and directly digitize x-ray images without a separate digitizer common to computed radiography systems. This new version uses a previously cleared detector with wireless communication capability.

The device uses a direct conversion process to convert x-rays into a digital signal. X-rays incident on the scintillator layer of the detector generate light that is absorbed by photo-detectors, converted to a digital signal and sent to the workstation the data is processed by Agfa's MUSICA image processing software. The acronym MUSICA stands for Multi-Stage-Image-Contrast-Amplification. MUSICA-acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts.

The provided 510(k) summary does not contain specific acceptance criteria for device performance, nor does it detail a study proving the device meets particular quantitative metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not specify quantitative acceptance criteria or performance metrics in the way your request implies (e.g., sensitivity, specificity, accuracy). The evaluation is based on comparison to a predicate device and adherence to industry standards for safety and image quality.

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

• Sample Size: Not specified. The document mentions "Image quality measurements have been completed" and "Image quality comparisons between the new and predicate devices have been performed as well. Sample images have been provided." This implies a set of images was used for comparison, but the size is not disclosed.
• Data Provenance: Not specified. Given the nature of a 510(k) demonstrating substantial equivalence for an imaging system, these would likely be technical image quality test images (e.g., phantoms) rather than clinical patient data. The summary states, "No clinical testing was performed in the development of the DX-D Imaging Package."

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

This information is not provided in the 510(k) summary. Since "No clinical testing was performed," it is unlikely that human experts were involved in establishing ground truth for a clinical test set from patient data. The "ground truth" for technical image quality assessments would be derived from the known properties of the phantoms used and objective image quality metrics.

4. Adjudication Method for the Test Set

This information is not provided. Given the lack of clinical testing and expert involvement, an adjudication method for a clinical test set is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed in the development of the DX-D Imaging Package." Therefore, no effect size of AI assistance could be reported.

6. If a Standalone (algorithm only without human-in-the-loop performance) Study was Done

The device is an imaging system (hardware and software for image acquisition and processing), not an AI algorithm intended for diagnostic interpretation. Therefore, a "standalone algorithm only" performance study in the context of interpretation accuracy (e.g., sensitivity/specificity for disease detection) is not applicable as it's outside the scope of this device's intended use or claim. The "performance" assessment focuses on image quality and system functionality.

7. The Type of Ground Truth Used

Based on "No clinical testing was performed," the ground truth for any image quality measurements would likely be based on physical phantom measurements and objective image quality metrics (e.g., spatial resolution, contrast-to-noise ratio, modulation transfer function, detective quantum efficiency) rather than expert consensus, pathology, or outcomes data from human subjects.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an X-ray imaging system with image processing (MUSICA2). While MUSICA2 is an image processing algorithm, the document describes it as enhancing contrast rather than performing diagnostic interpretation based on a trained model in the current AI sense. There is no mention of a "training set" for a machine learning model. The focus is on the physics of image acquisition and standard image processing.

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

This information is not applicable/not provided for the same reasons as #8. If MUSICA2 involves learned parameters, their derivation is not disclosed, but it's unlikely to involve a "ground truth" in the diagnostic context.

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The DX-D 600 system is indicated to make static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts.

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

This device is not intended for use in mammography.

The device is a conventional x-ray system with digital image capture equipment. The device is a combination of conventional x-ray system with and/or wall stand. The new device is a ceiling mounted tube and operator workstation with MUSICA 2TM image processing. The DX-D 600 uses Agfa's digital flat panel detectors of the scintillator-photodetector type (Cesium Iodide on Gadolinium Oxysulfide). It is compatible with Agfa's computed radiography systems as well.

The Agfa DX-D 600 is a stationary X-ray system. The 510(k) summary states that "An image quality evaluation has been conducted comparing images from the new device to the predicated [sic]." and "Performance of the complete system has been validated." However, no specific quantitative acceptance criteria or detailed study results are provided in the document.

Here's an overview based on the provided text, highlighting the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide details on the sample size used for any image quality evaluation or system performance validation. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. The comparison focuses on the new device's images against those from a predicate device, which usually implies an engineering or technical comparison rather than a human reader study.

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

The device is an X-ray system, not an AI algorithm for image analysis. Therefore, a standalone algorithm performance study, as typically understood in the context of AI, would not be applicable here. The "image processing" mentioned is MUSICA 2™ which is an established image processing technology for optimizing image quality, not a diagnostic AI algorithm.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any evaluations. Given the comparison is to a "predicated" [sic] device, the implicit ground truth for image quality likely relates to the accepted image quality standards or diagnostic utility achievable with the predicate device. It's not clear if this involved expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The device is a conventional X-ray system with digital image capture and image processing. It is not an AI-based diagnostic device that typically requires a "training set" in the machine learning sense. The image processing (MUSICA 2™) is a pre-existing technology.

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

As above, the concept of a "training set" and associated ground truth establishment is not applicable to the Agfa DX-D 600 as described in this 510(k) summary.

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Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

The new device is a combination of a conventional mobile x-ray system with digital image capture equipment. The new device is essentially a modification of the predicate mobile x-ray system, Sedecal Easy Moving Plus (K090322). In this case, the digital detector available with the predicate has been replaced with Agfa's system, its previously cleared DX-D Imaging Package (K092669). The DX-D 100 uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium Iodide or Gadolinium Oxysulfide).

The provided document is a 510(k) summary for the Agfa DX-D 100 mobile x-ray system. The information provided focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and conformity to product and management standards. It explicitly states, "No clinical testing was performed in the development of the DX-D 100." Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies of the device meeting those criteria through a clinical validation or similar study involving ground truth and expert readers.

It only describes the device and its equivalence to legally marketed predicate devices, with testing limited to product standards and management standards (e.g., electrical safety, DICOM compliance, risk management, quality management).

Thus, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria derived from a clinical performance evaluation.

Reason for Not Providing Information on Acceptance Criteria and Performance Study:

The document states:

• "Performance of the complete system has been validated. Sample images have been provided." (This refers to technical validation, not clinical performance against acceptance criteria in humans)
• "No clinical testing was performed in the development of the DX-D 100."

This explicitly indicates that the type of study detailed in the request (involving ground truth, human readers, sample sizes, and expert adjudication) was not conducted or, at least, not submitted as part of this 510(k) premarket notification. The 510(k) relied on demonstrating substantial equivalence through technological comparison and adherence to safety and performance standards for an x-ray system, rather than clinical performance data.

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