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The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatic patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/ supine position.

The DigiX FDX System is not meant for mammography.

The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaqing.

The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.

The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to predicate devices rather than defining specific quantitative performance metrics as "acceptance criteria" for a new AI/software feature in the way clinical performance studies usually do. Instead, the "acceptance criteria" are implied to be that the modifications do not negatively impact safety or effectiveness, and that the device performs comparably to the predicate devices and meets relevant safety standards.

For the new features explicitly mentioned (Automatic Stitching and Dual Energy Subtraction), the document states they add functionality without affecting patient safety or effectiveness. For the other components, the criteria are often "Same" or "Similar functionality with same imaging results" or "doesn't affect the safety or effectiveness."

To represent this in a table, we'll extract performance comparisons from the "Functional and Specification Differences" table (Table 4) and the "Justification for Differences" (Table 5).

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

The document states:

• "Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing."
• "Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission."
• "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system."

The document does NOT specify a sample size for any test set (clinical or otherwise) in terms of patient data or images used for validation of the radiographic system itself, nor does it mention data provenance (country of origin, retrospective/prospective). It primarily relies on hardware and software equivalence, and compliance with industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document explicitly states "Clinical testing is not applicable." Therefore, there was no clinical study conducted that would necessitate expert readers to establish ground truth for a test set. The evaluation focuses on technical performance and equivalence to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring expert adjudication was performed, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study was done. The document states "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system." Therefore, there is no information on how much human readers improve with or without AI assistance. The new software features (Automatic Stitching, Dual Energy Subtraction) are presented as additional functionalities that don't affect safety or effectiveness, not as AI-assisted diagnostic tools requiring a comparative effectiveness study.

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

Not applicable. The device is a radiographic system, not an AI algorithm intended for standalone diagnostic performance. While it includes new software features (Automatic Stitching, Dual Energy Subtraction), these are integrated functionalities of the imaging system and not described as standalone diagnostic algorithms requiring independent performance evaluation without human interaction.

7. Type of Ground Truth Used

The "ground truth" for the evaluation is primarily based on:

• Compliance with technical specifications and design requirements: Functional testing, image performance testing.
• Adherence to safety and performance standards: IEC 60601 series, EN ISO 14971, IEC 62366-1, IEC 62304, 21 CFR 1020.30, 21 CFR 1020.31.
• Substantial equivalence to predicate devices: Demonstration that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Software documentation assessment: For the software components, including the new features, documentation was provided for a "Moderate Level of Concern" software as per FDA guidance.

No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used or required given the nature of this submission.

8. Sample Size for the Training Set

Not applicable. The document describes an X-ray imaging system, not an AI/ML device that requires a training set of data. The new software features (Automatic Stitching, Dual Energy Subtraction) are described as functionalities, not adaptive algorithms that learn from data.

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

Not applicable. As there was no training set, there was no ground truth to establish for it.

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The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

The DigiX FDX system is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging. The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted x-ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, x-ray generator, x-ray tube, beam limiting device, and a solid-state image receptor. The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.

Here's a summary of the acceptance criteria and the study information for the Allengers Medical Systems Limited DigiX FDX device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on substantial equivalence to a predicate device (Siemens Ysio K081722) rather than defining explicit, quantitative acceptance criteria for clinical performance. The "acceptance criteria" can be inferred as meeting or being sufficiently similar to the predicate device in terms of functionality and safety, as well as complying with relevant standards.

• G1092: 0.6mm/1.2mm focal spot (Predicate: 0.6mm/1.0mm), 1 MHU (Predicate: 783 kHU), 108 mm target diameter (Predicate: 100 mm).
  G292: 0.6mm/1.2mm focal spot (Predicate: 0.6mm/1.0mm), 600 KHU (Same), 12° target angle (Predicate: 16°), 102 mm target diameter (Predicate: 100 mm). | Similar, providing essentially same imaging resolution and higher loading for some G1092 models. Different target angle for G292 provides full coverage at 40" SID. Differences in heat units and target diameter also noted as "similar" or providing higher loading/instantaneous focal spot loading. |
  | Beam Limiting Device: Construction, compliance with CFR 21 1020.31, automatic feature. | Matches predicate. | Same. |
  | Solid State X-ray Image Detectors: Panel type, active area, pixel pitch, pixel matrix, input scintillator, limiting resolution. | Detectors (e.g., P-E XRPAD 4343F vs. Trixell Pixium 4600):
• Active area: 432x432mm (Predicate: 429x429mm).
• Pixel pitch: 100 µm (Predicate: 143 µm).
• Pixel matrix: 4318x4320 (Predicate: 3001x3001).
• Limiting resolution: 5 lp/mm (Predicate: 3.57 lp/mm).
  Similar differences for other detector models listed. | Essentially the same imaging area. Provides higher resolution for pixel pitch, pixel matrix, and limiting resolution in most cases, which is considered an improvement and not negatively affecting safety or effectiveness. |
  | Viewing Monitors: Size, resolution. | Matches predicate. | Same. |
  | Software Features: DICOM 3.0 compatibility, operating system, user interaction, multi-user, image import/export, acquisition device, image interferences, organization, search, storage, database, viewing, measurement, annotation, operations, security, generator control. | Matches predicate for all listed software features. Also uses previously cleared image processing software. | Same. |
  | Safety Standards Compliance: | Complies with 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601-1, EN 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, EN ISO 14971, EN 62366, EN 62304. | All applicable standards met. |
  | Functional Performance: All system motions, image performance. | All functions met design requirements. Image performance criteria satisfactorily met (details in Section 18 of the original submission, not provided in this extract). | Confirmed. |
  | Software/Firmware Functionality: All functions between DROC software and IntegraX firmware. | All functions passed testing criteria. | Confirmed. |

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

The document explicitly states: "It was determined that clinical evaluation was not required as all imaging devices have been previously cleared by the FDA."
Therefore, there was no clinical test set used for this specific 510(k) submission. The evaluation was based on non-clinical testing and substantial equivalence to previously cleared devices.

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

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is a diagnostic X-ray system, not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

Not applicable. The device is a diagnostic X-ray system, not an algorithm, and its performance is evaluated as a system used by a human operator.

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

Not applicable for clinical ground truth, as no clinical evaluation was performed. For non-clinical performance (image quality, functional testing, safety), the "ground truth" was compliance with design specifications and relevant international standards.

8. The sample size for the training set:

The document does not describe the use of machine learning or AI models that would require a "training set" in the traditional sense. The device is a traditional X-ray system. The component parts, such as solid-state detectors and image processing software, are stated to have been "previously cleared by the FDA" or "tested and evaluated per Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." Therefore, any implicit training (e.g., for image processing algorithms) would have occurred as part of the development and clearance of those component devices, but details are not provided here for the system submission.

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

Not applicable, as no training set for an AI/ML model is described for this device.

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The Varian Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. I mage processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varian Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Varian Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Varian Nexus DR™ Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, Varian PaxScan 4336Wv4, computer, monitor, and the digital imaging software.

The provided document is a 510(k) premarket notification for the Nexus DR 100 Digital X-ray Imaging System (with PaxScan 4336Wv4). It focuses on establishing substantial equivalence to existing predicate devices.

Based on the provided text, the document primarily discusses non-clinical testing and general validation, rather than a specific study designed to meet predetermined acceptance criteria for a new AI or diagnostic algorithm's performance. The information requested in the prompt is highly relevant for studies proving the performance of AI/CADe/CADx devices. This submission, however, is for a digital X-ray imaging system, which is a hardware and software system for image acquisition and display, and not explicitly an AI-driven diagnostic tool in the sense of the prompt's questions.

Therefore, many of the questions regarding specific acceptance criteria for diagnostic performance, sample sizes for test sets, experts for ground truth, adjudication methods, MRMC studies, and training set details are not fully addressable from this document as it does not describe such a study for the device's diagnostic performance.

However, I can extract information related to the technological characteristics comparison which serves as a form of "acceptance criteria" for substantial equivalence.

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

For this 510(k) submission, "acceptance criteria" are not framed in terms of diagnostic performance metrics like sensitivity or specificity for a specific condition. Instead, the device's performance is compared against predicate devices based on technological characteristics and physical image quality parameters to demonstrate substantial equivalence. The "acceptance" is that these characteristics are equivalent or better than the predicates.

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

The document primarily describes non-clinical tests and a technological characteristics comparison to establish substantial equivalence. It refers to "Validation Protocols" and "predetermined test methods and corresponding acceptance criteria" but does not detail a specific "test set" of clinical images or patients in the sense of a diagnostic performance study. The data presented is characteristic measurements of the detector and system, not image data from patients for a diagnostic evaluation.

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

Not applicable. The document does not describe a clinical study where experts established ground truth for diagnostic decisions.

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

Not applicable. This type of adjudication method is used in diagnostic performance studies, which are not detailed in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a digital X-ray imaging system, not an AI-assisted diagnostic device, and thus no MRMC study for AI assistance is described.

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

Not applicable, as this device is an imaging system and not primarily a standalone diagnostic algorithm.

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

Not applicable in the context of a diagnostic performance study. The "ground truth" for the non-clinical tests would be the measured physical properties of the system and detector according to standard testing methodologies (e.g., those detailed in the referenced FDA guidance for solid-state X-ray imaging devices).

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML component with a "training set" for diagnostic performance. The device involves image processing algorithms, but these are typically deterministic or rule-based for image enhancement, not machine learning algorithms trained on large datasets for diagnostic classification.

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

Not applicable, as there is no mention of a training set for a diagnostic AI/ML algorithm.

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These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.

The Amrad Systems are permanently-installed diagnostic x-ray systems for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. They are intended to produce diagnostic x-ray images of human anatomy. The Amrad Systems enable radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography. The Amrad Systems typically include a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator. An FDA cleared digital imaging system is included.

The Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are intended for general diagnostic x-rays and compared for substantial equivalence to the Siemens Multix Fusion (K121513). The document does not provide a table of acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device and adherence to recognized industry standards for safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, resolution, dose). Instead, it states that "EMC, mechanical safety, and electrical safety were evaluated according to various FDA recognized consensus standards," and "the identified risk of EMC, mechanical, and electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness."

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

No specific test set or sample size for evaluating clinical performance is mentioned. The document states: "Clinical testing is not required for a determination of substantial equivalence because the imaging components supplied have already received FDA clearance. Furthermore, the intended operators of the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, and radiation hazards, Summit Industries LLC adheres to recognized and established industry practice, and all equipment is subject to final performance testing. All components bear the UL or ETL certification labels."

The document also mentions: "We did collect and evaluate digital images using standardized phantoms." However, details on the sample size of these phantom images, their provenance, or how they relate to a "test set" are not provided.

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

Not applicable, as no clinical test set requiring expert-established ground truth is described. The device's substantial equivalence is based on physical and technological characteristics compared to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

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

No MRMC comparative effectiveness study was done. The document focuses on substantial equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.

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

Not applicable. This device is a digital radiography system, not an AI algorithm for image interpretation. Its performance is inherent in its ability to produce diagnostic x-ray images.

7. Type of Ground Truth Used:

The primary "ground truth" for the clearance is indirect:

• Substantial equivalence to the predicate device (Siemens Multix Fusion K121513): This implies that the predicate device's established safety and effectiveness serve as the ground truth for the new device.
• FDA-cleared imaging components: The digital panels and software (PaxScan 4343R and 4336R) used in the Amrad Systems were previously cleared by the FDA in K093066 and K130318. Their prior clearance acts as a form of ground truth for their performance.
• Standardized phantoms: The document mentions evaluating "digital images using standardized phantoms." This type of testing uses known physical properties of the phantoms as ground truth for image quality measurements (e.g., spatial resolution, contrast-to-noise ratio), but no details of such measurements or acceptance criteria are provided.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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