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Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information.

The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment.

It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.

The new device is nearly identical to the Agfa predicate (OT-3000). It includes tools for performing common hip, knee and spine measurements, and provides access to orthopedic device manufacturers electronic templates. The measurements and tools enable planning of orthopedic procedures, monitoring patient progress and patient communications.

The orthopedic application is compatible with multiple workstations and Impax® software versions. User may purchase a complete set of tools or individual modules depending on their needs.

The basic principles of operation of the new and predicate devices are the same.

This 510(k) summary (K071972) indicates that the "Agfa Orthopedic Software for Impax Workstations" is nearly identical to a previously cleared device (OT-3000, K050751) with the addition of a spine-planning module, which is present in another predicate device (Cedara Software Corporation's I-SoftView Orthopedic Tools Set, K022881). The submission does not contain detailed acceptance criteria or a dedicated study report that explicitly proves the device meets specific performance metrics in a quantitative way. Instead, the focus is on demonstrating substantial equivalence based on technological characteristics and intended use.

However, based on the provided text, we can infer the acceptance criteria and the "study" that supports it:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "medical images" were used for testing the new spinal measurements, but does not specify the sample size (number of images or cases) or the data provenance (e.g., country of origin, retrospective or prospective nature) for this testing.

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

The document mentions "medical images" and "laboratory testing" for confirming the correct operation of spinal measurements, but does not specify the number of experts involved or their qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth for any test set.

4. Adjudication Method for the Test Set:

The document provides no information about an adjudication method (e.g., 2+1, 3+1, none) for any test set. The confirmation of correct operation appears to be based on internal "laboratory testing."

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

No, the document does not indicate that an MRMC comparative effectiveness study was done. The focus is on demonstrating substantial equivalence to predicate devices, not on quantifying improvement in human reader performance with or without AI assistance.

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

The testing mentioned for the new spinal measurements ("Correct operation...has been confirmed with medical images in laboratory testing") likely refers to a standalone assessment of the algorithm's functionality. However, the document does not explicitly state it as a "standalone" study in the context of comparing it to human performance. The device itself is a software application intended to be used by physicians, so its performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used:

The document refers to the "correct operation" of spinal measurements being confirmed. This implies that some form of expert knowledge or established anatomical/mathematical correctness was used as the ground truth against which the software's measurements were compared. However, the specific method of establishing this ground truth (e.g., expert consensus, pathology, other validated measurements) is not detailed. It's likely that clinicians or technical experts verified the accuracy of the software's calculated measurements against expected values or manual measurements on the "medical images."

8. The Sample Size for the Training Set:

The submission does not mention a training set or its sample size. This is common for software that is largely a re-implementation or slight modification of existing functional tools, rather than a novel algorithm requiring extensive machine learning training data. The device's operation is based on identifying physiological landmarks and calculating measurements, which implies programmed rules rather than a learned model from a large training dataset.

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

Since a training set is not mentioned, the method for establishing its ground truth is not applicable.

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The system is indicated for the storage, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from any DICOM device by healthcare professionals, including radiologists, physicians, technologists and clinicians.

• With the Teleradiology option it can be used to consult and share information with remote users.
• With the Mammography option it can be used for screening and diagnosis (with MG, "For presentation" images only) from FDA approved modalities in softcopy and printed formats.
• With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine (Coxometry, Gonometry, Lipman Cobb).
• With the Slice Imaging option it can be used to process basic 3D rendering: MIP, MPR or series synchronization.
• With the Quality Assurance option it can be used by PACS administrators or technologists to perform quality control activities related to patient images and data.

The new device is a multifunction PACS workstation for displaying and interpretation of medical images. It includes functions similar to the predicates. It can be used as a general radiography or orthopedic workstation. It displays "for presentation" (MG) mammography images. Image processing is handled by the mammography modalities. It can also display 3D images acquired from CT and MR modalities. It provides user teleradiology functionalities to share information and consult with remote users and can be used to perform quality control activities related to patient images and data.

This 510(k) submission for the Impax SE SigmaCom Client (PACS Medical Imaging Display Workstation) does not contain detailed acceptance criteria or a specific study demonstrating its performance against those criteria in the way a clinical validation study for an AI-powered diagnostic device would.

Instead, this submission is centered on demonstrating substantial equivalence to existing legally marketed predicate devices. The "testing" section states: "Agfa's Impax SE SigmaCom Client (PACS Medical Imaging Display Workstation) has been tested for conformance to specifications." This typically refers to internal engineering and software validation testing, rather than a clinical multi-reader, multi-case study or a standalone algorithm performance study.

Therefore, many of the requested sections cannot be filled as the information is not present in the provided document.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The submission refers to "testing for conformance to specifications," which implies internal validation, but no specific test set or clinical data set size is mentioned.
• Data Provenance: Not specified.

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

• Not applicable/Not specified. This type of submission relies on demonstrating functional equivalence to existing devices rather than performance against a clinical ground truth established by experts.

4. Adjudication method for the test set

• Not applicable/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

• No. This is not an AI-powered device, and no MRMC study is mentioned. The device is a PACS workstation for displaying and interpreting medical images.

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

• Not applicable/Not specified. This is a workstation that aids human interpretation, not a standalone diagnostic algorithm.

7. The type of ground truth used

• Not applicable/Not specified. The "ground truth" for this device's validation appears to be its ability to perform functions as intended and to be comparable to predicate devices, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable/Not specified. This is a PACS workstation, not an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable/Not specified.

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Agfa's Computed Radiography Systems with NX 2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton "in luding skull, spinal column and extremities) chest, abdomen and other body parts.

When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.

When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskelelal regions of adult or pediatric patients.

Agfa's Computed Radiography Systems with NX 2.X software are not indicated for use in mammography.

The predicate and new devices are nearly identical computed radiography imaging systems. NX 2.X systems (new devices) have:

• . An improved image processing package, Musica2 Platinum (optional). provides improved image processing of the thorax, abdomen or musculoskeletal images for adult or pediatric patients.
• . An auto-stitch function that allows users to automatically combine subimages of large patient anatomies (a leg or spine, for example) into a single image.
• The ability to designate one workstation as the central workstation that . has the ability to view exams on all connected workstations.

The basic principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.

The provided 510(k) summary for K071162, "Premarket Notification: Computed Radiography Systems With NX 2.X Workstations" from Agfa HealthCare Corporation, does not contain a detailed study with acceptance criteria and reported device performance as typically expected for demonstrating substantial equivalence for significant changes or novel devices.

Instead, this submission primarily focuses on demonstrating substantial equivalence to a predicate device (Agfa's Computed Radiography Systems with NX1.0 workstations, K053634) based on the similarity of technological characteristics and intended use, with minor improvements in image processing (Musica2 Platinum) and workflow features (auto-stitch, central workstation viewing).

Here's a breakdown of the requested information based on the provided text, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned.

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

• Not mentioned. The submission relies on "diagnostic quality images to aid the physician with diagnosis," implying a continued reliance on human interpretation, but no specific study design involving expert readers for a test set is described.

4. Adjudication Method for the Test Set

• Not mentioned.

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

• No. An MRMC study demonstrating the effectiveness of the improved image processing (Musica2 Platinum) compared to the base system or predicate is not described. The submission focuses on the similarity of algorithms and adjusted parameters rather than a comparative effectiveness study.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted or reported.

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

• No detailed standalone performance study is described. The "improved image processing package, Musica2 Platinum" is a component of a CR system that aids human diagnosis, not a standalone diagnostic algorithm. The claim is about image quality improvement, not automated diagnosis.

7. The Type of Ground Truth Used

• Not explicitly defined or mentioned as part of a formal study to establish ground truth for image processing performance. The "diagnostic quality images" implicitly suggest that the images are intended to be interpreted by medical professionals for clinical diagnosis, but how image quality improvements were objectively measured against a ground truth is not detailed.

8. The Sample Size for the Training Set

• Not mentioned. The document states that Musica2 Platinum "operates with algorithm parameters that are adjusted slightly to match images normally encountered in certain clinical applications." This implies some form of optimization or "training," but the data used for this is not quantified.

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

• Not mentioned.

Summary of the Submission's Approach:

The 510(k) K071162 relies on a "predicate device" substantial equivalence pathway, meaning it asserts that the new device is as safe and effective as a legally marketed device (Agfa's CR Systems with NX1.0, K053634). The key arguments for substantial equivalence are:

• Same Indications for Use: The new system has essentially the same intended use.
• Similar Technological Characteristics: Both systems use the same fundamental X-ray to digital image conversion process.
• Minor Enhancements: The NX 2.X system offers an "improved image processing package" (Musica2 Platinum), an "auto-stitch function," and a "central workstation" viewing capability. The image processing improvement is described as "similar algorithms" with "slightly adjusted parameters" for specific clinical applications (thorax, abdomen, musculoskeletal).
• Safety and Performance Testing: General statements about in-house and imaging performance tests, and compliance with EN 60601-1-1 and EN 60601-1-2 standards (electrical and safety).

In conclusion, this 510(k) submission does not present a detailed clinical study with quantitative acceptance criteria and performance metrics for the reasons requested. It relies on demonstrating that the changes are minor enough that the new device remains substantially equivalent to the predicate, with general safety and performance testing supporting its functionality.

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