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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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This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.

The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability.

The Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM).

The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits:

a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345.

b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components:

•GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus).

· EMD Technologies Epsilon Series generator. (Or generators already on site)

The provided text describes a 510(k) premarket notification for the "Halifax Imaging Kit," a stationary digital x-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (Halifax SR Suite 1.0, K121345).

Based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in this 510(k) summary. The submission focuses on demonstrating "substantial equivalence" rather than proving specific performance metrics of the device itself. The primary "study" to meet acceptance criteria relies on demonstrating that the new device configuration (Halifax Imaging Kit) is as safe and effective as its predicate device and that its components (like digital panels) already have their own 510(k) clearances.

Therefore, the "acceptance criteria" here is primarily about fulfilling the FDA's requirements for substantial equivalence, rather than meeting specific quantifiable performance targets for a diagnostic or AI-driven system.

However, I can extract information related to the closest aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria with quantitative performance metrics for this device as it's not a diagnostic AI system. The acceptance criteria for a 510(k) submission of this nature are generally qualitative and relate to safety, effectiveness, and substantial equivalence to a predicate device.

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

• Test Set Description: The "test set" primarily refers to components, bench tests, and a phantom study.
• Sample Size: Not applicable in the traditional sense of a clinical or image-based test set for an AI/diagnostic algorithm.
  • For the bench testing, no "sample size" of patients or images is mentioned. It refers to testing of the Universal Synchronization Switch (board level functionality, firmware, enclosure wiring) and the Imaging Kit Control Module.
  • For the phantom study (for precision validation per installation), the sample size would be the "small carbon fibre box" used for in vitro precision and accuracy calculation. No specific number of phantom images or measurements is given, but it implies a single phantom setup used for validation.
• Data Provenance: Not explicitly stated for specific data points other than the general context of the company being Halifax Biomedical Inc. (Canada) and the submission to FDA (USA). The phantom study refers to validation at a "[Hospital]" in "[City]" ([Room details]), "[State/Province]", "[Country]" – implying it could be anywhere, but the company is Canadian. The data is prospective in the sense that the bench testing and phantom validation are performed as part of the device development and installation process.

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

• Not applicable. This submission does not involve human expert adjudication of medical images to establish ground truth for a diagnostic algorithm. The "ground truth" for the device's functionality relates to its mechanical/electrical performance, precise synchronization, and ability to perform RSA measurements.
• The "experts" would be the engineers and QA personnel performing the bench tests and the precision validation (phantom study). Their qualifications are typically implied by their roles in medical device development and testing.

4. Adjudication Method for the Test Set

• Not applicable. No human image-reading adjudication method is mentioned as this is not a diagnostic imaging AI system. The "adjudication" of performance is done through objective bench test results and phantom study measurements against expected performance, rather than through consensus of human readers interpreting clinical images.

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. An MRMC study was not done. This device is an X-ray system, not an AI or CAD system intended to assist human readers. The document explicitly states "Clinical testing was not required to establish equivalence because all of the new digital receptor panels already have their own 510(k) clearances."

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

• Not applicable. This is an X-ray imaging system, not a standalone algorithm. While it produces images for Roentgen Stereophotogrammetric Analysis (RSA), the "algorithm" for RSA (RSA-CMS software) is stated to be "Unchanged" from the predicate device and was cleared under K042383. The submission is about the kit that acquires the images, not a new RSA analysis algorithm.

7. The Type of Ground Truth Used

• Engineering specifications and physical measurements (for bench testing and phantom studies).
  • For the Universal Synchronization Switch and Imaging Kit Control Module: Proper Board level functionality, firmware performance, proper enclosure internal wiring assemblies and connections.
  • For the RSA System precision: In vitro precision and accuracy calculated using a phantom study (small carbon fibre box) consistent with common RSA validation techniques. This relies on the known physical properties and movements of the phantom as the "ground truth."
  • For the digital receptor panels: Their own prior 510(k) clearances serve as evidence of their established performance and safety, essentially acting as their "ground truth" for those components.

8. The Sample Size for the Training Set

• Not applicable. This device is an X-ray imaging system, not an AI or machine learning algorithm that requires a training set. The software for RSA analysis (RSA-CMS) is unchanged from the predicate and would have had its own development and validation process earlier, but details are not in this document.

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

• Not applicable. See point 8.

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