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These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).

The AMADEO M-DR mini Portable X-Ray is a fully digital X-ray system for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The AMADEO M-DR mini is used for wireless digital X-ray imaging. The device represents the straightforward combination of 510(k) exempt devices (x-ray generator, code IZO and collimator, code IZX) and already cleared digital panels and imaging software. Two different models of digital image acquisition panels are offered: PerkinElmer XRpad2 4336 or CareView 1500CW. Both of the panels and the associated software have been previously cleared by FDA (K161966 or K150929). Integration with the portable system was straightforward.

The provided text is a 510(k) summary for the AMADEO M-DR mini and AMADEO M-AX mini mobile X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance or clinical studies.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not present in this document.

Here's a breakdown of what can be extracted and what is missing:

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

The document doesn't provide a table of formal acceptance criteria with numerical performance targets for the device. Instead, it asserts equivalence to the predicate device based on meeting recognized standards and similar characteristics.

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

• Sample Size: Not specified. The document mentions "test images" were obtained, but no specific number of images or patients is provided.
• Data Provenance: Not specified. As clinical testing was not required, there is no mention of country of origin or whether data was retrospective or prospective.

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

This information is not provided. Since the submission states clinical testing was "Not required because the proposed digital panels have prior FDA clearance," it implies that new ground truth establishment by experts for image interpretation was not part of this specific submission.

4. Adjudication method for the test set:

Not applicable, as no formal clinical test set or adjudication by experts is described.

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 mobile X-ray system, not an AI-powered diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed or mentioned.

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

Not applicable. This device is an imaging system, not a standalone algorithm.

7. The type of ground truth used:

The concept of "ground truth" in the context of diagnostic accuracy from expert consensus or pathology is not directly applicable to this submission. The "ground truth" for this device's performance relies on its ability to produce diagnostic radiographic exposures that are comparable to those of the predicate device and meet established safety and performance standards. This is evaluated through:

• Compliance with DHHS Radiation Safety Performance Standard.
• Compliance with electrical safety and EMC standards (IEC-60601 series).
• Test images demonstrating total system functionality.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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The dicomPACS® DX-R with flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

The dicomPACS®DX-R with flat panel digital imaging system consists of two components, the dicomPACS®DX-R software for viewing captured images on a Windows based computer, and one of three solid state X-ray imaging devices: Thales Pixium Portable 2430 EZ (wireless), Thales Pixium Portable 3543 EZ (wireless), or the Perkin Elmer 4336 XRpad (also wireless). The system will display high quality images in less than five seconds over a wide range of X-ray dose settings. The software has the following characteristics: The dicomPACS® DX-R software runs on an off-the shelf PC which forms the operator console. Images captured with the flat panel digital detector are communicated to the operator console via LAN or WLAN connection, depending on the model and the user's choice. dicomPACS®DX-R software uses the software API of the panel manufacturers to control the flat panels and to receive and to calibrate image data. The dicomPACS® DX-R software is an independent product for the acquisition, processing and optimization of X-ray images (raw images) provided by flat panel (DR) systems or CR systems. In general, such software is also called "console software" as it is installed on the so-called "console PC" of the imaging device. dicomPACS® DX-R carries out the image processing of the raw images provided by the particular device and provides the radiographer / X-ray assistant with optimum workflow for their work. The key difference between the modified device and our predicate device is the panels are wireless, Wi-Fi.

The provided text describes the dicomPACS DX-R with flat panel digital imaging system. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding device performance metrics. Instead, it relies on a qualitative assessment against predicate devices and standard performance measurements.

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

The document states: "Images from all three panels were reviewed by a US Board Certified Radiologist." It does not specify the exact sample size (number of images or patients) used for this clinical review of the test set.

Data Provenance: The document does not explicitly state 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 Qualifications

Number of Experts: One.
Qualifications: "US Board Certified Radiologist." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The review was conducted by a single radiologist.

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

No, an MRMC comparative effectiveness study is not explicitly mentioned for comparing human readers with and without AI assistance. The study described focuses on the standalone performance of the imaging system and its equivalence to predicate devices.

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

The study described is essentially a standalone performance evaluation of the dicomPACS DX-R system with flat panels. It assesses the basic imaging capabilities (image quality, technical metrics) of the device itself rather than its performance in conjunction with an AI algorithm for diagnosis. The "software" referred to in the description is "console software" for image acquisition, processing, and optimization, not an AI diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical image review was established by expert consensus (in this case, by a single US Board Certified Radiologist who determined clinical acceptability, resolution, and comparability to predicate devices). It's based on the radiologist's interpretation and judgment of the images.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device described is an imaging system and associated software, not an AI diagnostic algorithm that requires a separate training phase. The "software" mentioned (dicomPACS DX-R) handles image acquisition, processing, and optimization, not diagnostic interpretation based on learned patterns.

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

Not applicable, as no training set for an AI algorithm is mentioned in this document.

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The dicomPACS® DX-R with flat panel digital imaging system is intended for use in generating radiographic images of human antomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

The dicomPACS®DX-R with flat panel digital imaging system consists of two components, the dicomPACS®DX-R software for viewing captured images on a Windows based computer, and one of three solid state X-ray imaging devices: Toshiba FDX4343R, Toshiba FDX3543RP, or Konica Minolta AeroDR P-11 (1417HQ). The system will display high quality images in less than five seconds over a wide range of X-ray dose settings. The software has the following characteristics: The dicomPACS® DX-R software runs on an off-the shelf PC which forms the operator console. Images captured with the flat panel digital detector are communicated to the operator console via LAN or WLAN connection, depending on the model and the user's choice. dicomPACS®DX-R software uses the software API of the panel manufacturers to control the flat panels and to receive and to calibrate image data. The dicomPACS® DX-R software is an independent product for the acquisition, processing and optimisation of X-ray images (raw images) provided by flat panel (DR) systems or CR systems. In general, such software is also called „console software" as it is installed on the so-called „console PC" of the imaging device. dicomPACS® DX-R carries out the image processing of the raw images provided by the particular device and provides the radiographer / X-ray assistant with an optimum workflow for their work.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "Images are clinically acceptable; quality, resolution comparable to or better than predicate devices.",
    "Reported Device Performance": "The panels produce images that are clinically acceptable. The images are of excellent quality, high resolution and are comparable to or better than the images from the predicate devices."
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The text only mentions \"Images from all three panels were reviewed\". A specific sample size for the test set is not provided. The data provenance is not explicitly stated, but the reviewer is a US Board Certified Radiologist, suggesting the evaluation was relevant to US clinical standards.",
  "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)": "One US Board Certified Radiologist was used to review the images and establish clinical acceptability.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "No specific adjudication method is described, as only one radiologist reviewed the 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 MRMC comparative effectiveness study was done. The study conducted was a review of images by a single radiologist to confirm clinical acceptability and comparability to predicate devices, as described in the FDA Guidance Document for Solid State X-ray Imaging Devices.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The study was not a standalone (algorithm only) performance study. It involved a human reviewer (radiologist) assessing the output of the device (images).",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Expert consensus by a single US Board Certified Radiologist on the clinical acceptability, quality, and resolution of the images.",
  "8. The sample size for the training set": "Not applicable. This device is a digital X-ray imaging system, not an AI/ML algorithm that requires a training set in the conventional sense. The performance evaluation focuses on the image quality produced by the system.",
  "9. How the ground truth for the training set was established": "Not applicable, as this is not an AI/ML device requiring a training set."
}

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dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators.

The software comes in two varieties - as dicomPACS® 5.2. and as dicomPACS® DX-R 1.6. While dicomPACS® DX-R 1.6 provides some functionality like generator control, CR/DR acquisition and raw data processing, dicomPACS® does not have these functions.

The provided text is a 510(k) summary for the dicomPACS® 5.2 and dicomPACS® DX-R 1.6 devices. It describes modifications made to the device and asserts substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on:

• Administrative information about the submission.
• Indications for Use for the updated devices.
• A functional comparison table highlighting new features in the updated versions.
• Identification of "significant changes" to the device (Multiplanar Reconstruction, CR/DR acquisition, and Raw data processing).
• A "Substantial Equivalence Conclusion" stating that the modifications do not alter the Indications for Use, fundamental scientific technology, or introduce new safety/effectiveness questions.
• The FDA's letter of substantial equivalence.

Therefore, I cannot provide the requested information from the provided text. The document is an application for market clearance based on substantial equivalence, not a performance study report.

No information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets is present in the provided text.

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dicomPACS® is a software system for the administration, archiving, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® also provides services for administering the data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using dicomPACS® are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® is a Picture Archiving and Communications System (PACS), as are the two Predicate Devices HIPAX and eFilm. All of them have been developed to acquire, store, communicate, display and process medical images, for example X-ray, CR, CT, MRI, and ultrasound images etc. They offer features (e.g. window levelling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.

dicomPACS® has a modular system architecture. It consists of the basic application dicomPACS-Viewer for image viewing and processing, the dicomControlCenter as application for image storage and communication and a number of other modules for database management, image acquisition, printing etc.

dicomPACS® conforms to the DICOM (Digital Imaging and Communications in Medicine) standard.

dicomPACS® is an autonomous software and involves no hardware.

The provided text is a 510(k) summary for the dicomPACS® device, a Picture Archiving and Communications System (PACS). While it describes the device's intended use and comparison to predicate devices, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or detailed performance metrics like sensitivity, specificity, or AUC.

The document states: "dicomPACS® has been tested according to the specifications documented in this notification (Section 14 g). It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement." However, "Section 14 g" and the DICOM Conformance Statement are not provided in this extract, nor are any performance results from such testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The information primarily focuses on:

• Device identification: Trade name, common name, applicant details, regulation number, classification.
• Device description: Functionality (acquire, store, communicate, display, process medical images), modular architecture, DICOM conformance.
• Predicate devices: HIPAX (K052411) and eFilm Workstation (K020995) are identified as comparable devices.
• Intended use: Acquisition, storage, communication, and viewing of medical images from various modalities, with tools for viewing (zoom, filters, measurements) and exchange. It also mentions integration with RIS/KIS.
• Technological characteristics: Software-only, runs on specific MS Windows operating systems, does not control life-sustaining devices, and requires interpretation by qualified specialists.
• Conclusion: Stating substantial equivalence to predicate devices.
• FDA Communication: A letter from the FDA stating the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Further detailing the device's use for administration, archiving, improvement, and compression of medical image data for diagnosis, emphasizing requirements for mammographic images.

In summary, the provided text does not contain the specific performance study information requested.

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