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The PRORAD ATLAS ULTRAPORTABLE Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray unit, flat-panel detector and image acquisition software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.

The PRORAD ATLAS ULTRAPORTABLE X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.

The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS ULTRAPORTABLE PLUS Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray Unit, flat-panel detector and real-time image processing using software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.

The PRORAD ATLAS ULTRAPORTABLE PLUS X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.

The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS X-Ray system includes the ULTRAPORTABLE and ULTRAPORTABLE PLUS, which are portable diagnostic X-ray systems with fixed 70kV and 2mA tube current. These systems are intended to produce anatomical X-rays of the body extremities in both pediatric and adult patients. The PRORAD ATLAS X-Ray system was designed, developed, and manufactured by Prognosys Medical Systems Private Limited. The model numbers are listed below.

The PRORAD ATLAS X-ray system is a sophisticated, battery-powered X-ray generator offered in two versions: PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS. The main distinction between these models lies in their exposure time ranges and target anatomical areas. The ULTRAPORTABLE model provides exposure times ranging from 0.01 to 1.30 seconds, while the ULTRAPORTABLE PLUS model offers an extended exposure range of 0.01 to 2.5 seconds. Both models share identical internal components, software, algorithms, and operational features and are intended for imaging body extremities. The system includes a high-voltage tank with an X-ray tube mounted on an adjustable tripod stand, allowing users to adjust the height to the specific imaging area. Exposure parameters are configured through the X-ray generator's graphical user interface (GUI). After setting the parameters and positioning the patient on the detector, the X-ray is activated via an exposure switch. The detector captures the radiation, converts it into a digital signal, and transmits the data wirelessly to a computer equipped with compatible software. The images are processed and displayed on the computer for diagnostic review. The PRORAD ATLAS system is compatible with several 510(k)-cleared detectors and their associated software, listed below in Table 1. Prognosys includes one detector and its pre-configured software in the package, depending on availability. Fully battery-operated, the system does not support direct power connection but can seamlessly integrate with multiple detectors and compatible software as part of the package.

The provided FDA 510(k) clearance letter and supporting documentation for the PRORAD ATLAS ULTRAPORTABLE X-Ray Systems do not include acceptance criteria or a detailed study that proves the device meets specific performance criteria beyond general safety and effectiveness.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Remex KA6, K212144) rather than presenting a performance study with defined acceptance criteria. The "Summary of non-clinical testing" lists a series of international standards (IEC, ISO) and FDA guidance documents that were followed for design control, risk management, verification, and validation. The "Summary of clinical testing" mentions that clinical images were collected and reviewed by a qualified radiologist, confirming they are "clinically acceptable." However, specific quantitative acceptance criteria for image quality, diagnostic accuracy, or other performance metrics, along with the study design and results against those criteria, are not detailed in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information about sample size, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics, as this information is not present in the provided text.

Based on the available text, here's what can be extracted:

• Overall Conclusion: The device is deemed "safe and effective when the device is used as labelled and is substantially equivalent to the predicate device."

Here's a breakdown of why the requested information cannot be fully provided based on the input:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the document. The document confirms that "Validation of PRORAD ATLAS X-Ray System has demonstrated that the system enables optimal and quality imaging of anatomical structures" and that clinical images are "clinically acceptable," but no specific quantitative criteria or performance metrics are given.

2. Sample size used for the test set and the data provenance: The document states that "Clinical images of body extremities were collected from patients of varying ages, weights, and BMIs." However, the exact sample size and the provenance (e.g., country of origin, retrospective/prospective nature) of this clinical image test set are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document mentions that images were "reviewed by a qualified radiologist." It does not specify the number of radiologists or their specific qualifications (e.g., years of experience, board certification).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method for the clinical image review 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: An MRMC study is not mentioned. The device described is an X-ray system, not an AI software to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is an X-ray system, not an algorithm, and it's intended to be used by trained medical professionals.

7. The type of ground truth used: The ground truth for the clinical images appears to be "clinical acceptability" as determined by a "qualified radiologist." This aligns with "expert consensus" in a general sense, but no more objective ground truth (e.g., pathology, outcomes data) is mentioned for the image quality assessment.

8. The sample size for the training set: The document does not mention a training set, as it describes an X-ray hardware system, not an AI-driven software that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

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The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.

The GXR Series Diagnostic X-ray System consists of a combination of an x-ray generator, and associated equipment such as tube stand, patient table, and, digital imaging system.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GXR-series diagnostic x-ray system:

It's important to note that the provided document is a 510(k) Summary, which is a regulatory filing for a medical device seeking clearance from the FDA based on substantial equivalence to a predicate device. It typically focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving absolute performance against specific clinical acceptance criteria in a comprehensive clinical study. Therefore, the details provided often lean towards non-clinical testing and comparison with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it relies on demonstrating adherence to recognized safety and performance standards, and comparison of technical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if the device meets these standards and is substantially equivalent to the predicate.

Here's a generalized interpretation based on the document's content, focusing on what would typically be implied performance requirements for an X-ray system:

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

• Test Set Sample Size: The document does not specify a "test set" sample size in terms of clinical images or patient cases for performance evaluation against specific acceptance criteria. The testing discussed is primarily non-clinical, related to hardware and software verification and validation.
• Data Provenance: The document implies that the testing data is generated from laboratory testing and verification during the development and modification of the device. There is no mention of clinical data or patient data being used for the performance evaluation in this 510(k) summary. Given the context of a 510(k), particularly for an X-ray system, the primary focus is on engineering and performance testing against standards, rather than large-scale clinical studies. The data is thus likely prospective in terms of being generated specifically for this submission but is non-clinical in nature.

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

This information is not provided in the document. As the evaluation is non-clinical, there is no mention of "ground truth established by experts" in the context of diagnostic performance evaluation. The "ground truth" for non-clinical testing would typically be the expected technical output or adherence to a standard, rather than expert interpretation of images.

4. Adjudication Method for the Test Set

This information is not provided as the testing described and implied is non-clinical and does not involve expert adjudication of diagnostic findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards, not on proving improved reader performance with or without AI assistance.

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

This is not applicable in the sense of an AI algorithm's standalone performance. The device is a diagnostic X-ray system, which is inherently designed to be used with a human interpreter (a medical professional). While it has image processing software ("RADMAX"), this software enhances images for human diagnosis, not to provide an automated diagnosis itself.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing is adherence to technical specifications and international standards. For example, for radiation output, the ground truth is that the device delivers the specified kVp and mA, and for electrical safety, that it meets the requirements of IEC 60601-1. For image quality, it refers to intrinsic properties like spatial resolution, MTF, and DQE, which are measured objectively, not subjective expert consensus on diagnostic findings.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is an X-ray imaging system, not an AI/ML diagnostic algorithm that requires a training set of medical images in the conventional sense. The "training" for the device would involve calibration and configuration during manufacturing and installation to ensure it meets its technical specifications. The "RADMAX" software has image processing modules, but the document does not suggest these are deep learning models trained on vast datasets.

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

This information is not applicable for the same reasons as #8. If any parameters for the image processing modules are "learned" or optimized, the document does not elaborate on this process or the ground truth used for such optimization.

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The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

"TOPAZ" system is a system providing state-of-the-art image quality, user interface. "TOPAZ" system may be moved quietly and smoothly with motor drive mechanism "TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view. The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique. The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from. The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility.

The provided text is a 510(k) Summary for the TOPAZ Mobile X-ray System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the format typically used for AI/CADe devices. This document describes the device, its intended use, technological characteristics, and differences from the predicate, along with non-clinical testing for safety and EMC standards.

Therefore, the specific information about "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested for AI/CADe devices (including details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details) is not present in this 510(k) Summary.

This document primarily asserts that the "TOPAZ Mobile X-ray System" is substantially equivalent to the predicate device "TOPAZ Mobile DR System (K201124)" based on:

• Identical intended use.
• Similar technological characteristics, with modifications thoroughly tested for safety and effectiveness against international standards.
• Nonclinical testing results provided in the 510(k) demonstrating that predetermined acceptance criteria were met for safety (electrical safety, EMC, radiation protection) and software validation.

The "study that proves the device meets the acceptance criteria" in this context refers to the nonclinical testing against various recognized international and FDA standards, not a clinical performance study with human readers or pathology, as would be expected for AI/CADe systems.

Here's a summary of the available information regarding acceptance criteria and testing, tailored to what is provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria and reported device performance in the typical format for clinical accuracy for AI/CADe. Instead, it states that the device was assessed, tested, and passed predetermined testing criteria during validation testing, aligning with the risk analysis. It also confirms that the device meets "all the requirements listed in the Standards" (see the Standards table below). The "device performance" reported is its conformance to these standards and its substantial equivalence to the predicate.

Nonclinical Standards Met (acting as acceptance criteria for safety and effectiveness):

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

• Not Applicable/Not Provided. The document describes non-clinical engineering and software validation testing against standards, not a clinical study involving a "test set" of patient data for diagnostic performance. The focus is on the device's hardware, software (RADMAX), and new flat panel detectors meeting safety and electrical 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):

• Not Applicable/Not Provided. Ground truth establishment by experts is relevant for clinical performance studies, which this document does not describe.

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

• Not Applicable/Not Provided. This is relevant for clinical performance studies.

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 document describes a 510(k) for an X-ray system, not an AI/CADe system. No MRMC study was performed or is mentioned.

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

• Not Applicable/No. The device itself is an X-ray system, not an algorithm, and its performance is assessed in terms of meeting engineering and regulatory standards, not standalone diagnostic performance. The imaging software (RADMAX) is mentioned as identical to the predicate and has a "Basic Documentation Level" of concern, implying human interpretation of images.

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

• Not Applicable/Not Provided. For the non-clinical testing described, "ground truth" would relate to the correct functioning of the hardware and software according to specifications and standards, not clinical diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable/Not Provided. This is relevant for AI/ML models. While the device contains software, it is not described as an AI/ML diagnostic algorithm needing a training set. The software changes are primarily GUI and image processing module updates, verified for impact on safety and effectiveness (not AI training).

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

• Not Applicable/Not Provided. As above, this is not an AI/ML submission requiring a training set.

In summary, the provided 510(k) document is for a mobile X-ray system and demonstrates substantial equivalence through nonclinical testing against recognized performance, safety, and EMC standards, rather than a clinical performance study with acceptance criteria related to diagnostic accuracy, which would be typical for AI-powered diagnostic devices.

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Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

This device is not intended for mammography and pediatric patients.

This Digital Radiography System (ManntiX K) is a portable digital device developed, designed and manufactured by Shenzhen Browiner Tech Co., Ltd. A detailed comparison table with an equivalent device are in 510(k) summary. The device consists of the following major components: portable X-ray Assembly, X-ray Protective Device, Mobile Stand, Digital Detector, image processing system. The difference between ManntiX B and ManntiX K are as below.

Note:

• 1. ManntiX B and ManntiX K are delivered with one of CareView1500Cwe, Mars1717X and Luna 1012X, or two of them, or three of them.
• 2. A computer system, necessary for image viewing and manipulation, is not part of the device.

The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation.

Portable X-ray assembly including collimator and tube, produces X-rays at the clinically required dose; X-ray protective device is used to protect the human body during diagnostic radiography; mobile stand is used to support or hang X-ray source components; digital detector receives X-ray signals and converts them into visible light, which is converted into electrical signals by photoelectric elements and then converted into digital signals by analog-to-digital conversion before being transmitted to the computer; image processing system has multiple functions. including new patient registration, image acquisition and processing, data transmitting, etc; image acquisition workstation is used in addition to the image processing system to adjust exposure parameters, check the status of the entire machine, and view logs.

The provided document is a 510(k) summary for a Digital Radiography System (ManntiX B, ManntiX K). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving that the device meets those criteria, especially in the context of an AI/ML-driven device's performance.

The document primarily focuses on:

• Regulatory information: FDA review, regulations, and contact details.
• Device description: Components, technical specifications (generator, detector, image processing), and intended use.
• Comparison to a predicate device: Highlighting similarities in intended use, technology, and functionality to establish substantial equivalence.
• Non-clinical performance tests: Listing compliance with various IEC and ISO standards related to electrical safety, electromagnetic compatibility, radiation protection, software lifecycle, and usability.
• Biocompatibility: Statement of evaluation according to ISO 10993-1.

There is no mention of:

• Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) beyond general safety and electrical performance standards.
• A study proving the device meets such acceptance criteria.
• Sample sizes for test sets, data provenance, expert ground truth adjudication (for AI/ML performance evaluation), MRMC studies, standalone performance, type of ground truth used (pathology, outcomes), or training set details.

This type of 510(k) submission primarily demonstrates that the proposed device is as safe and effective as a legally marketed predicate device, often through a comparison of technical specifications and adherence to recognized standards. It does not typically involve the detailed clinical or AI/ML performance evaluation aspects you've asked about unless the device incorporates novel AI/ML components that significantly alter its diagnostic output or workflow. In this case, the device is a Digital Radiography System, which is an imaging modality, and the details provided relate to the hardware and image acquisition/processing capabilities rather than an AI/ML diagnostic aid.

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Intended for use by a qualified/trained doctor or technician on adult 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 Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.

Based on the provided text, the device in question is a Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H). The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating substantial equivalence to a predicate device, the MX40 Mobile Digital X-ray System (K181874), rather than proving a specific, quantitative performance metric for a clinical application (like detection of a disease).

The documentation primarily discusses non-clinical performance tests related to electrical safety, electromagnetic compatibility, radiation protection, software validation, and usability. There is no mention of a clinical study to assess diagnostic performance (e.g., accuracy in detecting specific conditions).

Therefore, the following information is extracted and where information is not provided in the text, it is explicitly stated as "Not provided in the text."

Acceptance Criteria and Device Performance for Digital Radiography System

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness, primarily through compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable/Not provided. The summary describes non-clinical engineering and performance testing against standards, not a clinical test set with patient data for diagnostic performance.
• Data provenance: Not applicable/Not provided. The testing described is type testing and verification against standards, not clinical data collection.

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

• Not applicable/Not provided. Ground truth in a diagnostic sense (e.g., for disease detection) was not established as part of this submission's described testing, which is focused on technical performance and safety.

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

• Not applicable/Not provided. No clinical test set requiring adjudication of ground truth 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

• No. An MRMC study was not done. This device is a mobile X-ray system, not an AI-powered diagnostic software.

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

• Not applicable. This is a hardware device (X-ray system), not a standalone algorithm.

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

• Not applicable for diagnostic performance. For the described non-clinical performance tests (e.g., electrical safety, radiation output), the "ground truth" is defined by the requirements and specifications of the relevant international and FDA performance standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).

8. The sample size for the training set

• Not applicable/Not provided. This document describes a traditional medical device (X-ray system) and its non-clinical testing, not an AI/ML product that would require a training set.

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

• Not applicable/Not provided. (See point 8).

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This product is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. This device is not intended for mammographic applications.

The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs.

The FDA 510(k) summary for the Definium Pace Select, a Digital Radiographic System, indicates that clinical studies were not required to support substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria in terms of clinical performance (like sensitivity, specificity, or reader improvement with AI assistance) or a detailed clinical acceptance criteria table for such measures is not provided in this document.

The submission focuses primarily on demonstrating substantial equivalence to its predicate device (Discovery XR656 HD) based on non-clinical tests, technological characteristics, and safety/effectiveness data. The device's safety and effectiveness were confirmed through design verification and validation testing.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical studies were not deemed necessary for this 510(k) submission, there isn't a table presenting clinical acceptance criteria (e.g., sensitivity, specificity) and corresponding device performance metrics in the document. The acceptance criteria focused on compliance with voluntary standards and successful completion of verification and validation testing.

• ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012
• IEC 60601-1-2:2014[Including AMD 1:2021]
• IEC 60601-1-3: 2021
• IEC 60601-1-6: 2020
• IEC 60601-2-54: 2018
• IEC 62366: 2015 + AMD1:2020
• ISO 10993-1: 2018
• ISO 10993-5: 2009/(R)2014
• ISO 10993-10: 2010/(R)2014
• ISO 10993-18 Second edition 2020-01
• PS 3.1 - 3.20: 2022d (DICOM set) |
  | Quality Assurance Measures | Applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit level testing (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation). |
  | Risk Mitigation | Risks for new floor mounted positioners and image chain were evaluated, mitigated with design controls and labeling. Mitigations were verified and validated with acceptable results. |
  | Design Verification & Validation | Performed to confirm safety and effectiveness; test plans and results were executed with acceptable results. |

2. Sample Size for Test Set and Data Provenance:

No distinct "test set" in the context of clinical performance evaluation (e.g., images for diagnostic accuracy assessment) is mentioned because clinical studies were not required. The "testing" referred to in the document pertains to design verification and validation, which would involve hardware and software testing, rather than a clinical image dataset.

3. Number of Experts for Ground Truth and Qualifications:

Not applicable, as no clinical study requiring expert ground truth establishment for diagnostic accuracy was conducted for this submission.

4. Adjudication Method:

Not applicable, as no clinical study requiring adjudication of expert interpretations was conducted.

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

No MRMC study was conducted. The device is a digital radiographic system, and the submission emphasizes its substantial equivalence based on technological characteristics and safety, not on AI assistance to human readers.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed in terms of a standalone diagnostic performance study, as the device itself is an imaging system, not a standalone diagnostic algorithm. The "image processing with same algorithm" as the predicate device suggests the algorithms are part of the overall system functionality, not a separate AI diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical tests and design verification/validation, the "ground truth" would be established through engineering specifications, regulatory compliance standards, and functional requirements. For example, for radiation output, the ground truth would be the expected range defined by standards and the device's design. There is no mention of clinical ground truth (e.g., pathology, outcomes data) being used for this 510(k) submission.

8. Sample Size for Training Set:

Not applicable, as this device submission is for a digital radiographic system, not an AI/ML algorithm that typically requires a training set of data for development. The reference to "same algorithm" for image processing as the predicate implies existing, validated algorithms rather than newly trained ones.

9. How Ground Truth for Training Set Was Established:

Not applicable, as this device is not presented as an AI/ML system requiring a training set with established ground truth.

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Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configurations for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the Acculvue software cleared in our predicate K210919.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. Specifically, the document is a 510(k) summary for a medical device (AcuityDR G4) and focuses on demonstrating substantial equivalence to a predicate device.

The document discusses performance characteristics of the digital panels (DQE, MTF, resolution) and indicates that clinical image evaluation was performed on the proposed panels by a Board Certified Radiologist who found the images to be of excellent quality. However, it does not provide explicit acceptance criteria, a structured study design with specific metrics, or details about patient data, expert qualifications, or ground truth establishment in the way requested.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

1. Table of acceptance criteria and reported device performance: While performance characteristics like DQE and MTF values are reported, these are not presented as acceptance criteria in the context of a specific study to prove the device meets them. There's no clear threshold or target defined that the device needs to achieve to be considered "acceptable" in a formal study sense.

2. Sample size used for the test set and data provenance: The document mentions "clinical image evaluation" was performed but does not specify the sample size of images or patients used. It also doesn't provide details on the data's origin (country, retrospective/prospective).

3. Number of experts used to establish the ground truth and qualifications: It states "a Board Certified Radiologist" performed clinical image evaluation, implying one expert. However, their specific qualifications (e.g., years of experience, specific sub-specialty) are not provided beyond being "Board Certified." The method for establishing "ground truth" (if any beyond the radiologist's assessment) is not described.

4. Adjudication method: Not mentioned.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and typically not required for substantial equivalence claims for this type of device (an X-ray system). The evaluation described is a qualitative assessment of image quality by a radiologist. There is no mention of comparing human readers with and without AI assistance.

6. Standalone (algorithm only) performance: Not applicable here as the device is an X-ray system, not an AI algorithm performing diagnostic tasks independently. The software provided is for controlling the X-ray generator and image acquisition, not for diagnostic interpretation.

7. Type of ground truth used: The text indicates a "Board Certified Radiologist" evaluated image quality. This suggests expert consensus (though with only one expert mentioned) on image quality, but not pathology or outcomes data.

8. Sample size for the training set: Not applicable and not mentioned, as this device itself is not a machine learning algorithm requiring a training set for diagnostic classification.

9. How the ground truth for the training set was established: Not applicable.

The document mainly focuses on comparing the AcuityDR G4 system's technological characteristics (like detector DQE, MTF, and resolution) and indications for use to its predicate device (AcuityDRe, K210919) and other reference devices, concluding that the new device is substantially equivalent. The image quality evaluation by the radiologist appears to be a supportive qualitative assessment rather than a structured quantitative study with predefined acceptance criteria.

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Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

PRIMO S is an image acquisition and processing software application, in radiography mode for Flat Panel detectors. The software is specifically designed for integration with production equipment of the SEDECAL group. The PRIMO S application will be used on different types of Sedecal equipment / systems:

• mobile units
• fixed installations.

The PRIMO S VP application provides the following functions:

• User login: the device is usable only by authenticated users
• Management of the operator interface GUIs and setup of the application itself
• The operator interface GUI must reserve a space on the monitor for the Sedecal equipment/system GUI (choice of examination (APR), X-ray generator commands, collimator, stand, etc.)
• Management of patient data through manual entry and reception from the DICOM WORKLIST service
• Management of image processing algorithms for each type of examination
• Management of the automatic advancement procedures of the operations during the study.
• Image acquisition and processing
• Saving in Hard Disk of the acquired images
• Automatic and manual image stitching procedure
• Off-line image editing and optimization using process and graphic functions
• Documentation of images and study data using DICOM services of STORE, PRINT, CDROM, MPPS, RDSR, STORAGE COMMITMENT
• Application configuration setup
• Export and automatic saving of images on external support (USB key)

The application communicates with the Sedecal equipment through software modules (DLL) for:

• The choice of the examination, made by the operator through a GUI defined by Sedecal (APR)
• Send the exposure parameters foreseen by the selected exam (kV, mA, mAs, ms, collimator aperture, stand position, ...)
• Receive the system status parameters and the exposure result

While the provided text describes the PRIMO S device and its 510(k) submission, it explicitly states:

"6. Clinical testing. Not required for a determination of substantial equivalence."

This indicates that a clinical study with detailed acceptance criteria and performance metrics, as requested in your prompt, was not performed or required for the FDA clearance of this specific device. The clearance was based on substantial equivalence to a predicate device, supported by non-clinical testing and adherence to various standards.

Therefore, I cannot provide the specific information you requested regarding validation studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set, as such a study was not conducted or reported in this document.

The document primarily focuses on:

• Device Description: What PRIMO S is and what it does.
• Indications for Use: The medical conditions and body parts it's intended for.
• Technological Characteristics Comparison: How it compares to its predicate device (Sedecal SA K130883) in terms of X-ray generator, digital detectors, panel sizes, operating system, etc.
• Non-Clinical Testing: A list of standards (IEC 62304, EN/IEC 62366-1, ISO 14971, NEMA DICOM, ISO 15223-1) that were employed in development, and mention of software validation based on FDA guidance and cybersecurity considerations.

Since there's no clinical trial data, I cannot populate the table or answer the specific questions about the study design that would prove the device meets acceptance criteria based on clinical performance.

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