Search Results
Found 10 results
510(k) Data Aggregation
(85 days)
This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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.
These are modified versions of the predicate mobile digital diagnostic x-ray systems. They feature motorized movement and full battery operation. Various Canon digital X-ray panels are supplied with the system. The Mobile X-Ray Unit MOVIX DReamy has a Basic configuration or Advanced configuration. The Mobile X-Ray unit MOVIX DReamy is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on MOVIX DReamy and it is displayed on touch screen. The MOVIX DReamy Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit MOVIX DReamy. This X-Ray generator for MOVIX DReamy Mobile X-Ray Unit has a radiogenic unit mounted on head-assembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit MOVIX DReamy is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES: XRR-3331 insert and E7886 insert. The Manual Beam Limiting Device is from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.
Based on the provided text, the MOVIX DReamy device is a mobile X-ray system. The document does not describe acceptance criteria for an AI/ML device or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification for a mobile X-ray system, establishing substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the given document. The document describes the device, its intended use, comparison to a predicate device, and compliance with various international standards, but it explicitly states that no clinical testing was required to establish substantial equivalence.
The relevant sections for this request (AI/ML acceptance criteria and performance study) are not present in this document because it pertains to a different type of medical device clearance.
Ask a specific question about this device
(55 days)
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.
This is a new generation of Ceiling Suspension Radiographic System. This system is characterized by its simple and functional design. Thanks to its vertical and horizontal displacements, the suspension can cover almost all the room positions in which it is installed allowing all radiographic procedures. The system is modular and supports different configurations, such as radiographic system without radiographic table or without Wall Stand. The X-ray image receptors used in this system are digital detectors. X-ray film and Computed Radiography (CR) image receptors can be used but they rarely are these days. The device software used is the CANON CXDI which is supplied unmodified by CANON (Clearance numbers above). It has a moderate level of concern. The Radiographic System ChallengeX AP is provided with Auto-positioning, Auto-centering and Auto-tracking functions and it is composed of: Ceiling Suspension (OTC), Radiographic Table, Wall Stand, High Voltage X-ray Generator and acquisition image software. Auto-tracking allows the X-ray Tube to follow the Receptor when it changes position or the other way around while the SID remains constant. The "Auto" features were present and validated in the predicate system.
The document provided is a 510(k) premarket notification for a medical device called "Radiographic System Challenge X." This notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study with an AI component.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI-based analysis is not present in the provided text.
The document discusses non-clinical testing for compliance with international standards and FDA guidance for traditional medical device aspects such as safety, electrical compatibility, radiation protection, and software validation. It explicitly states that clinical testing was not required to establish substantial equivalence because the digital x-ray receptor panels already had previous FDA clearance.
Key takeaway from the document regarding studies:
- No AI component or AI-specific acceptance criteria are documented.
- The device is a traditional X-ray system, not an AI-powered diagnostic tool.
- Clinical testing was not performed for this submission. The substantial equivalence was established through non-clinical bench testing and compliance with existing standards and previously cleared components (like the detectors and software).
Ask a specific question about this device
(28 days)
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, 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 Soltus 500 Mobile Digital X-Ray System, Model 10501, ("Mobile X-Ray System") is the same as the predicate mobile PhoeniX with 2 additional features, (i) Distributed Antenna System (DAS), and (ii) Enhanced Work Flow (EWF). The Mobile X-Ray System has motorized movement and full battery operation. It contains a touch screen that operates as a control console. The Mobile X-Ray System supports various Canon flat panel detectors (Digital Radiography CXDI) supplied with the unit.
The provided text is a 510(k) Summary for the Soltus 500 mobile X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove meeting specific acceptance criteria for performance metrics typically associated with AI/CADe devices.
Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, effect size of human readers with AI, ground truth details) are not applicable or findable in this type of submission.
Here's a breakdown based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't present specific performance metrics or acceptance criteria in the typical sense of an AI/CADe device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (equivalent to predicate) | "The results of bench testing indicates that the new device is as safe and effective as the predicate device." |
| "Proper system operation is fully verified upon installation." | |
| "We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination." | |
| "The Soltus 500 Battery Mobile X-Ray Units have been tested to be in compliance with the following International Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, IEC 60601-1-6, IEC 62304." | |
| Technological Characteristics (substantially the same) | See the "Substantial Equivalence Chart" (Page 4-5) which details that most characteristics (Indications for Use, Configuration, X-ray Generator(s), Collimator, Digital X-ray Panel Supplied, Software, Panel Interface, Meets US Performance Standard, Power Source) are "SAME" as the predicate K192011. The differences (Computer, Wireless Antennas) are described as improvements (EWF, DAS) that do not impact safety or effectiveness. |
| Firmware and Cybersecurity Validation | "Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005." |
| "Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014." | |
| Diagnostic Quality Images | "produced diagnostic quality images as good as our predicate generator/panel combination." |
| Compliance with relevant standards | IEC 60601-1:2005+A1:2012 (Edition 3.1) |
| IEC 60601-1-2:2014 (Edition 4.0) | |
| IEC 60601-1-3:2008+A1:2013 (Edition 2.1) | |
| IEC 60601-2-54:2009+A1:2015 (Edition 1.1) | |
| IEC 60601-2-28:2010 (Edition 2.0) | |
| IEC 60601-1-6:2010 + A1:2013 (Edition 3.1) | |
| IEC 62304:2006 + A1:2016 (Edition 1.1) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This device is a mobile X-ray system, not an AI/CADe device that performs diagnostic analysis on images. The evaluation primarily involved bench testing of the hardware and software components, and comparison to the predicate device. Clinical testing was explicitly stated as "not required."
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. No clinical ground truth was established as clinical testing was not required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method was used as no clinical test set requiring ground truth was established.
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 was not an AI/CADe device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an X-ray imaging system, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No clinical ground truth was used for evaluation. The "ground truth" for the device's functionality was based on engineering specifications, performance standards, and comparison to the predicate device's established performance, verified through bench testing.
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is a hardware system; there is no training set or ground truth in this context.
Ask a specific question about this device
(45 days)
The DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The CXDI-702C Wireless and CXDI-402C Wireless are solid-state x-ray imagers with approximate imaging areas of 350 x 426 mm and 415 x 426 mm, respectively. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.
The subject of this Special 510(k) submission is a change to the Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless to add the X-ray I/F unit option, update to the CXDI control software, change the IP Level, make changes to the case, and remove Standalone mode. The X-Ray I/F unit synchronizes the timing of the X-ray irradiation with the detector's capture and has been included in other Canon devices (CXDI-701C Wireless (K131106)). The X-Ray I/F Unit is an optional unit that allows the proposed device work together with several older units that use the X-ray I/F Unit instead of the multibox. The IP Level was changed from IPX7 to IP54. The Standalone mode was removed from the proposed devices. The imaging process to sharpen images, Edge Enhancement, was included in the Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless, but adjustments of multiple imaging parameters were required to enhance structured edges. The optional feature, Advanced Edge Enhancement, for CXDI-702C Wireless and CXDI-402C Wireless automatically adjusts the six image processing parameters (Enhancement - Edge Enhancement, Enhancement - Edge Frequency, Enhancement - Contrast Boost, Dynamic Range Adjustment - Dark Region, Dynamic Range Enhancement - Bright Region, and Noise Reduction - Effect) by one button to enhance structures. The CXDI control software has been updated to a new version for functional improvements. The material of the casing of the detector has changed from fiberglass to magnesium alloy. Together, these changes to the Digital Radiography CXDI-710C Wireless and CXDI 410C Wireless make up the Digital Radiography CXDI-702C Wireless and CXDI-402C Wireless.
The provided text describes a 510(k) premarket notification for two digital radiography devices, the CXDI-702C Wireless and CXDI-402C Wireless. This submission is a "Special 510(k)," indicating that the changes made to the devices are minor and fall within established performance specifications, meaning a direct comparative effectiveness study with human readers (MRMC) might not have been the primary focus of the submission for overall device clearance, but rather a demonstration of continued equivalence through specific performance tests and comparative data with predicate devices.
The acceptance criteria and study proving the device meets these criteria can be inferred from the "Summary of Non-Clinical / Test Data" section and the "Comparisons with the predicate devices" table.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to predicate devices (CXDI-710C Wireless and CXDI-410C Wireless) after specific modifications. Therefore, the "acceptance criteria" are primarily that the modified devices maintain performance comparable to the predicate devices and meet relevant safety and performance standards. The "reported device performance" is largely framed as successful verification and validation tests and comparability data.
| Acceptance Criteria (Inferred from submission purpose and tests) | Reported Device Performance (Summary) |
|---|---|
| Maintain fundamental scientific technology | The fundamental scientific technology of the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless has not been modified. |
| Mitigate risks and hazardous impacts of device modifications (e.g., FMEA) | Risks and hazardous impacts of the device modification were analyzed by FMEA methodology. Specific risk control and protective measures were reviewed and implemented. Overall assessment concluded all identified risks and hazardous conditions were successfully mitigated and accepted. |
| Maintain "safe and effective" performance comparable to predicate devices | Tests performed demonstrated that the devices are safe and effective, perform comparably to the predicate devices, and are substantially equivalent to the predicate devices. |
| Meet internal functional specifications (including software) | Verification/validation testing to internal functional specifications (including software) was conducted and results were provided. |
| Produce non-clinical image quality comparable to predicate devices | Non-clinical image comparisons involving flat panel display images taken by the new device and the predicate devices were performed. |
| Usability of new features (e.g., Advanced Edge Enhancement) | Interviews were conducted with experienced clinicians on the usability of the advanced edge enhancement. |
| Compliance with FDA requirements for software (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC) | Documentation was provided demonstrating compliance, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. |
| Compliance with other relevant FDA guidance (e.g., Radio Frequency Wireless Technology in Medical Devices, Cybersecurity) | Other FDA guidance documents used in development include Radio Frequency Wireless Technology in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Documentation provided confirmed changes do not impact compliance with FDA requirements for Solid State X-ray Imaging Devices. |
| Compliance with U.S. Performance Standard for radiographic equipment and voluntary safety standards (IEC 60601 series) | Testing confirmed that the CXDI-702C Wireless and CXDI-402C Wireless comply with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-6, and 60601-2-54. |
| Biocompatibility (ISO 10993 series) | Biocompatibility evaluation confirmed that the changes did not impact safety and that the devices comply with ISO 10993-1, 10993-5, and 10993-10. |
| No new questions regarding safety or effectiveness | Verification/validation activities successfully demonstrated that the device continues to meet standards for areas impacted by modifications and raises no new questions regarding either safety or effectiveness when compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a numerical sample size for the "non-clinical image comparisons" or "interviews with experienced clinicians." It refers to "tests performed on the models" and "non-clinical image comparisons." For a 510(k) Special submission, the focus is often on demonstrating that the modifications do not adversely affect performance, rather than a large-scale clinical trial.
- Data Provenance: Not explicitly stated. Given that it's a submission for products by Canon, Inc. (Japan), the non-clinical tests would typically be performed internally or by contracted labs. The "interviews with experienced clinicians" likely involved healthcare professionals in a relevant market, but the specific country is not detailed. The data is retrospective in the sense that it evaluates the modified device against known performance of the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated for image evaluation.
- Qualifications of Experts: The document mentions "experienced clinicians" for interviews regarding the usability of the Advanced Edge Enhancement feature. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed. For the image comparisons, it implies internal testing and comparison to established predicate performance rather than requiring independent expert reads to establish ground truth in the same way a diagnostic AI would.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. For non-clinical image comparisons demonstrating comparability, a formal adjudication process like 2+1 or 3+1 by multiple readers is not typically detailed in this type of 510(k) submission. It's more about objective image quality metrics and visual comparison against predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, the document does not indicate that a formal MRMC comparative effectiveness study was conducted. This type of study is more common for novel diagnostic AI devices where the primary claim is an improvement in human reader performance with AI assistance. For a Special 510(k) of a digital X-ray detector with minor modifications, the focus is on maintaining equivalence rather than demonstrating improvement over human readers.
- Effect Size: Not applicable, as an MRMC study was not described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of a digital X-ray detector. The device itself (the detector) processes images and provides them for display, but it doesn't have a diagnostic "algorithm" that operates independently to provide outputs like disease detection that would require a standalone performance evaluation in the same way a diagnostic AI software would. The "Advanced Edge Enhancement" is an image processing feature, not a diagnostic algorithm. The document explicitly states the "Standalone mode was removed from the proposed devices" for how the detector operates, meaning it always communicates with an operator console (human-in-the-loop for image review).
7. The Type of Ground Truth Used
- Ground Truth: For the non-clinical image comparisons, the "ground truth" would be established by comparing the images from the modified device against the known and accepted image quality and characteristics of the legally marketed predicate devices. This isn't "expert consensus" or "pathology" in the diagnostic sense, but rather a technical comparison of image properties (e.g., resolution, contrast, noise, and the visual appearance of anatomical structures) to ensure the modifications did not degrade quality. The "usability" of the Advanced Edge Enhancement was evaluated through clinician interviews, where their feedback implicitly serves as a form of ground truth for user experience.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not describe a "training set" because the device is a digital X-ray detector, not an AI algorithm that learns from data. The "Advanced Edge Enhancement" is likely a rule-based or engineered image processing algorithm, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm.
Ask a specific question about this device
(58 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatic subjects for taking diagnostic radiographic exposures of the skull, spinal column, 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
These are redesigned versions of our predicate mobile digital diagnostic xray systems. They feature motorized movement and full battery operation. Various Canon digital Xray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit PhoeniX has a Basic configuration or Advanced configuration. Advanced configurations include:
- Second screen on head assembly.
- Smooth movements of head assembly.
- Telescopic arm in four steps instead three steps for basic configuration.
The Mobile X-Ray unit is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on Mobile X-ray unit and it is displayed on touch screen. It is the user interface and compatible digital detectors are listed above. All have FDA Clearance. The Advanced configuration has a second Touch Screen Monitor located on head-assembly.
The PhoeniX Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode, that is, operating without mains being present or unplugged from mains. The unit is connected to mains to charge the batteries; New rating: the input voltage range goes from 100 V~ to 240 V~, 1 phase, 1.1 kVA. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit PhoeniX. This new X-Ray generator for PhoeniX Mobile X-Ray Unit has a radiogenic unit mounted on headassembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit PhoeniX is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES:
- New: XRR-3331 insert.
- New: E7886 insert.
New: Manual Beam Limiting Device from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.
The provided text describes a 510(k) premarket notification for a mobile X-ray system named PhoeniX. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for novel acceptance criteria.
Therefore, many of the requested items (acceptance criteria, specific study details with sample sizes, expert involvement, and ground truth information) are not directly addressed in the provided FDA submission as they would be for a de novo marketing authorization or a more extensive clinical study. The submission relies heavily on non-clinical testing and the prior clearance of its components and predicate devices.
However, I can extract information related to the device's technical specifications and the basis for its substantial equivalence, which implicitly acts as its "acceptance criteria" for regulatory clearance.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The device is considered acceptable if its performance and specifications are substantially equivalent to the predicate device and meet relevant international standards. The "reported device performance" in this context refers to its technical specifications and compliance with safety standards, rather than clinical performance metrics like sensitivity or specificity.
| Acceptance Criteria (Implicitly based on Predicate & Standards) | Reported Device Performance (PhoeniX) |
|---|---|
| Indications for Use: | 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. (SAME as Predicate) |
| Configuration: | Mobile System with digital x-ray panel and image acquisition computer. (SAME as Predicate) |
| kW Rating: | 20 kW, 32 kW, 40 kW and 50 kW. (Predicate: 40 kW only) |
| kV Range: | From 40 kV to 150 kV in 1 kV steps. (SAME as Predicate) |
| mA Range: | From 10 mA to 630 mA / 640 mA / 650 mA. (Predicate: From 10 mA to 500 mA) |
| Collimator: | Ralco R108F (Two versions: Basic and Advanced). (Predicate: Ralco R221 DHHS) |
| Digital X-ray Panels Supplied: | CANON CXDI-401C Wireless, CANON CXDI-701C Wireless, CANON CXDI-801C Wireless. (SAME as Predicate). Plus: CANON CXDI-710C Wireless, CANON CXDI-810C Wireless, CANON CXDI-410C Wireless. (New panels, but all previously FDA cleared). |
| Software: | Canon control software CXDI-NE. (SAME as Predicate, updated in K190368) |
| Panel Interface: | Ethernet or Wi-Fi wireless. (SAME as Predicate) |
| Meets US Performance Standard: | YES 21 CFR 1020.30. (SAME as Predicate) |
| Power Source: | Universal power supply, from 100 V~ to 240 V~. 1 phase, 1.1 kVA. (Predicate: Input transformer with 7 input voltage taps; AC 20 amp and Batteries) |
| Safety and Effectiveness: | "The results of bench testing indicate that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination." |
| Compliance with International Standards: | IEC 60601-1:2005+A1:2012 (Edition 3.1), IEC 60601-1-2:2014 (Edition 4.0), IEC 60601-1-3:2008+A1:2013 (Edition 2.1), IEC 60601-2-54:2009+A1:2015 (Edition 1.1), IEC 60601-2-28:2010 (Edition 2.0), IEC 60601-1-6:2010 + A1:2013 (Edition 3.1), IEC 62304:2006 + A1:2016 (Edition 1.1). (Compliance affirmed through non-clinical testing) |
Regarding the Study Proving Acceptance Criteria:
The "study" in this submission is primarily a non-clinical bench testing and comparative analysis to establish substantial equivalence to a legally marketed predicate device (K161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of number of images or patients. The non-clinical testing involved "Systems covering all generator/panel combinations were assembled and tested." This suggests testing of device configurations rather than a "test set" of medical images or patient data in the typical sense of an AI/CAD device.
- Data Provenance: Not applicable in the context of clinical data for a "test set." The testing是在实验室环境中，使用设备进行物理和功能验证。
3. Number of Experts and Qualifications to Establish Ground Truth:
- Not applicable as this was a non-clinical submission for substantial equivalence based on technical specifications and functionality. Clinical trials requiring expert reads for ground truth were not performed.
4. Adjudication Method:
- Not applicable as there was no clinical reading study or consensus required for ground truth determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document states: "Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." This device is a mobile X-ray system, not an AI or CAD software that assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:
- Not applicable. This device is an X-ray imaging system, not an algorithm that performs a diagnostic task independently. Its performance is related to image quality, radiation output, mechanical safety, and electrical safety.
7. Type of Ground Truth Used:
- Technical Specifications and Compliance with Standards: The "ground truth" for this submission are the established performance characteristics of the predicate device and the specified requirements of relevant international safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30). The "truth" is that the device meets these engineering and regulatory benchmarks.
- The document mentions that the modified combination of components "produced diagnostic quality images as good as our predicate generator/panel combination," implying an internal assessment of image quality, but no explicit detailed ground truth generation method is described for clinical image interpretation.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set of data. The device's components (X-ray generator, panels, software) are either updates to existing technology or previously cleared devices.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML algorithm.
Ask a specific question about this device
(35 days)
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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 ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.
The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.
Here's an analysis of the acceptance criteria and study information for the ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems, based on the provided text:
Acceptance Criteria and Device Performance Table:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting and reporting specific performance metrics with acceptance criteria in a comparative table for novel device features. The "Comparable Properties" table (pages 6-8) is used to show alignment with predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit from Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (K150816, K153119) for diagnostic radiographic exposures of various body parts in adults and pediatrics, excluding mammography. | "Equivalent" to predicate devices. |
| Configuration of Digital Panels | Battery or AC operated wireless IEEE 802.11n or Wired Ethernet. | "Same" as predicate devices. |
| Digital Panel Models and their Clearance Numbers | Utilize previously cleared FDA digital flat panel detectors (specific K numbers listed in Note 1). | "Similar functionality" to predicate devices (Note 1 states the subject device uses different flat panel detectors that are previously FDA cleared, and testing demonstrates no increased safety concern or effect on effectiveness). |
| Image Acquisition Panel Specifications | Comparable pixel resolution and size range (e.g., 3,320 x 3,408 Pixels 125 µm, 3,072 x 3,072 Pixels 139 µm, etc.). | "Similar functionality" to predicate devices (Note 1). |
| DICOM Compliance | DICOM 3 compliant. | "Same" as predicate devices. |
| WiFi Wireless (if applicable) | Functionality similar to predicate wireless detectors. | "Similar functionality" to predicate devices (specific Canon, Varex, PerkinElmer, and DRTECH wireless detectors listed). |
| Image Acquisition Software | Utilize previously cleared FDA image processing software (specific K numbers listed in Note 2). | "Similar functionality" to predicate devices (Note 2 states Prognosys uses previously cleared FDA software and does not modify it). |
| Power Source | AC Line, various voltages available. | "Same" as predicate devices. |
| X-ray Generator | Range of power ratings (e.g., 32 kW to 80 kW, 125 kV/150 kV). | "Same or similar functionality" to predicate devices (Note 3 states the subject device uses similar X-ray generators with different power ratings and that these generators have been used in previously cleared 510(k) devices). |
| X-ray Tubes | Range of kV, focal spot sizes, and heat units (e.g., Toshiba E7239FX, Varex RAD14, etc.). | "Similar functionality" to predicate devices (Note 4 states both configurations provide similar imaging resolution and these tubes have been used in previously cleared 510(k) devices). |
| Collimator | Adequate inherent filtration. | "Similar functionality" to predicate devices (Note 5 states the inherent filtration is different but does not affect safety and effectiveness). |
| Performance Standard Compliance | Compliance with FDA 21 CFR 1020.30-31 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components). | "Same" as predicate devices. |
| Electrical Safety | Compliance with IEC 60601-1. | "Same" as predicate devices. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Device complies with this standard. |
| Radiation Protection | Compliance with IEC 60601-1-3. | Device complies with this standard. |
| Specific Safety/Performance for X-ray Equipment | Compliance with IEC 60601-2-54. | Device complies with this standard. |
| Usability | Compliance with IEC 60601-1-6. | Device complies with this standard. |
| Risk Management | Compliance with ISO 14971. | Device complies with this standard. |
| Cybersecurity | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" guidance for device labeling. | Cybersecurity concerns were addressed based on the US FDA Guidance document. |
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" for a dedicated algorithm performance study. Instead, compliance is demonstrated through testing of the integrated system and reliance on previous FDA clearances for individual components.
- Data Provenance: Not applicable in the context of an algorithm performance test set. The clinical images reviewed by a radiologist were "acquired by the device," but the origin (e.g., country, prospective/retrospective status) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One radiologist.
- Qualifications of Experts: Only "a radiologist" is mentioned. Specific qualifications (e.g., years of experience, board certification) are not detailed.
3. Adjudication method for the test set:
- Adjudication method: Not applicable. The radiologist's review was a single assessment, not a consensus or adjudication process among multiple readers.
4. 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. The document explicitly states: "Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document." The clinical image review was supplementary.
- Effect size of human reader improvement with AI: Not applicable, as no MRMC study or AI assistance evaluation was conducted. The device is an imaging system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This device is a diagnostic X-ray system, which intrinsically requires a human (a qualified doctor or technician) in the loop for operation and interpretation. The performance of individual cleared components (digital panels, software) was relied upon.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the supplementary review, the "ground truth" was the radiologist's assessment that the images were "acceptable and allowed the radiologist to make an accurate diagnosis." This is a form of expert opinion on image quality and diagnostic utility, rather than an objective "truth" like pathology or outcomes.
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The device is a conventional X-ray system composed of cleared components.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no machine learning algorithm described.
Ask a specific question about this device
(16 days)
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.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Summary of how criteria are met) |
|---|---|
| Equivalence in Intended Use | "This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography." - Unchanged from predicate. |
| Equivalence in Technological Characteristics (Components) | New kit integrates FDA cleared/certified X-Ray components. Compared in a "Substantial Equivalence Chart" (Page 5-6) showing similar or equivalent components (Generator, Maximum output, Stand, Image Acquisition, Digital Panel, Digital Resolution, Software, Acquisition Software, Collimator, Safety). |
| Equivalence in Safety | "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis has been performed." |
| "UL listed and EMC tested power supply used in the Imaging Kit." | |
| Equivalence in Effectiveness | "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device." |
| "Every installation undergoes a precision validation test... a phantom study was undertaken using a small carbon fibre box. Phantom studies, commonly used for RSA validation, are a technique used to calculate in vitro precision and accuracy of an RSA System." | |
| No New Indications for Use | "has no new indications for use" |
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.
Ask a specific question about this device
(53 days)
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, 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.
This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.
The provided text does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of diagnostic accuracy or clinical outcomes. The document is a 510(k) premarket notification for a mobile X-ray system (MDR17 Mobile Direct Radiographic System), focusing on proving substantial equivalence to a predicate device (RadPRO® Mobile 40kW).
The "Performance Testing" section primarily discusses bench testing for electrical safety, mechanical safety, EMC, and software, and clarifies that clinical testing was not required for a determination of substantial equivalence because the digital X-ray receptor panel had already received FDA clearance.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study details related to device performance in the context of diagnostic accuracy, human reader improvement, or standalone algorithm performance, as this information is explicitly stated as not being required or performed in this submission.
However, I can extract the information provided about the testing that was conducted:
Here's the relevant information based on the provided text, focusing on the evaluations performed for K173018, even though it highlights the absence of clinical performance studies:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission relying on bench testing for safety and electrical/mechanical performance, and not a clinical performance study measuring diagnostic accuracy, there are no specific "acceptance criteria" presented in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) for the device itself. Instead, the "acceptance criteria" are implied by adherence to recognized consensus standards for safety and electrical characteristics.
| Acceptance Criteria (Implied by Standards Conformance) | Reported Device Performance |
|---|---|
| Conformance to AAMI ES60601-1 (Electrical Safety) | Conforms |
| Conformance to IEC 60601-1-2 (EMC) | Conforms |
| Conformance to IEC 60601-1-3 (Radiation Protection) | Conforms |
| Conformance to IEC 60601-1-6 (Usability) | Conforms |
| Conformance to IEC 60601-2-54 (X-Ray Equipment) | Conforms |
| Conformance to IEC 62366 (Usability Engineering) | Conforms |
| Conformance to FDA Guidance for Software in Medical Devices (Moderate Level of Concern) | Conforms (Testing for verification found acceptable) |
| Mitigation of EMC, mechanical, and electrical hazards | Mitigated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as no clinical performance study or test set for diagnostic accuracy was conducted or required. The testing referred to is bench testing against engineering 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)
This information is not provided as no clinical performance study requiring expert ground truth establishment was conducted or required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical performance study requiring adjudication was conducted or required.
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 comparative effectiveness study was not done. The submission explicitly states, "Clinical testing is not required for a determination of substantial equivalence." This device is a mobile X-ray system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done. This device is a hardware X-ray system, not an algorithm, and clinical testing was not required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as no clinical performance study requiring ground truth was conducted. For the bench testing, the "ground truth" was adherence to the specifications of the referenced international and national consensus standards.
8. The sample size for the training set
This information is not applicable as this submission is for a hardware medical device (X-ray system), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this submission is for a hardware medical device (X-ray system), not a machine learning or AI algorithm.
Ask a specific question about this device
(138 days)
The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.
Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.
The ModelOne mobile X-ray system is a diagnostic mobile x-ray system utilizing digital radiography technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The ModelOne system incorporates a flat-panel(s) detector that can be used wirelessly for exams as in-bed projections. The system is intended to be marketed with two options with flat-panel digital images from Canon and Konica Minolta.
Based on the provided text, the device is an X-ray system, and the "study" described is a non-clinical performance evaluation rather than a traditional clinical study with human patients. The information provided is for regulatory clearance (510(k) summary) rather than a comprehensive research paper on AI performance.
Therefore, many of the typical acceptance criteria and study details for an AI/ML device (e.g., ground truth establishment for a test set, MRMC studies, standalone AI performance) are not applicable or not provided in this document. The device is a mobile X-ray system, not an AI-powered diagnostic tool. The focus is on the safety and performance of the hardware and integrated previously-cleared digital imagers, demonstrating substantial equivalence to a predicate device.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent or not relevant for this type of device:
Acceptance Criteria and Device Performance (Non-AI X-ray System)
The document describes performance tests for a mobile X-ray system, NOT an AI/ML device. The acceptance criteria are implicit in the performance tests verifying the functionality and safety of the hardware. The "reported device performance" refers to the successful completion of these non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Usability | Acceptance test on customer site | "Performance tests confirm that the device is as effective and performs as well as or better than the predicate device." (Implies meeting usability expectations) |
| Performance test at hospital by professional personnel | "Performance tests confirm that the device is as effective and performs as well as or better than the predicate device." (Implies meeting usability expectations) | |
| Battery Performance | Beginning of life/end of life test | "Performance tests confirm that the device is as effective and performs as well as or better than the predicate device." (Implies battery life meets operational needs) |
| Mobility | Driving distance test (full to empty battery) | "The driving distance test was performed to verify maximum distance of driving from full to empty battery." (Implies meeting or exceeding required driving distance for mobile operation) |
| Generator Performance | Comparison of exposure time with competitors | "The aim of generator performance test was to compare the time of exposure of !M1 and its competitors." (Implies competitive or equivalent exposure times, contributing to "performs as well as or better than the predicate device.") |
| System Integration | Integration test with previously cleared flat-panel imagers | "Integration test was performed on the previously cleared flat-panel digital imagers in order to demonstrate that all components of the device function in a reproductive way according to the design specifications." (Confirms successful integration and functional operation of the complete system) |
| Software Risk | Software risk classification | "The software risk is classified as moderate level of concern device according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Acceptance is compliance with software risk guidelines, not a performance metric in this context, but a regulatory requirement met) |
| Safety | Overall safety assessment | "Technological differences do not raise questions of safety and the device is as safe as legally marketed DRX-Revolution by Carestream." (Overall safety acceptance based on non-clinical tests and comparison to predicate) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of "cases" or "patients" as this is a device performance test, not a clinical study on diagnostic accuracy. The tests involve the device itself and its components.
- Data Provenance: The tests are "non-clinical testing" and performed on the device hardware. Usability tests involved "professional personal" at a "hospital," but this is for evaluating the device's operation in a real-world setting, not an evaluation of diagnostic output. It's a "retrospective" view of testing results provided to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. This document describes a mobile X-ray system, not an AI/ML diagnostic algorithm that requires expert-established ground truth for image interpretation. The "ground truth" here is the device's functional performance against its design specifications and compared to a predicate, not clinical diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not Applicable / None. No adjudication method is mentioned as this is not a study assessing human or AI diagnostic performance based on image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. "No clinical testing was performed on the subject device." Therefore, no MRMC study was conducted to evaluate human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Not Applicable / No. The device itself is an X-ray imaging system. It produces images, but the document does not describe a new AI algorithm for interpreting those images. The "software" mentioned is for acquiring and displaying images, and its risk is classified. The post-processing is defined by protocols from previously cleared Canon and Konica Minolta image software.
7. Type of Ground Truth Used
- Functional Performance Specifications and Predicate Comparison. The "ground truth" for this regulatory submission is that the device functions according to its design specifications (e.g., battery life, driving distance, exposure time) and performs "as well as or better than the predicate device" in non-clinical settings.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no AI/ML training set is mentioned or implied.
Ask a specific question about this device
(54 days)
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, 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.
RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.
This document is a 510(k) premarket notification for the RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR, a mobile X-ray system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in response to your request:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sedecal Mobile Digital Diagnostic X-Ray Systems, K101517) through technical and safety comparisons, and by showing that the device is as safe and effective. The performance is assessed through compliance with relevant standards and successful integration of previously cleared components.
The table below summarizes the comparison between the new device and the predicate, highlighting the "performance" implicitly defined by these comparisons:
| Characteristic | Acceptance Criteria (Implied by Predicate Performance / Standard Compliance) | Reported Device Performance (RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR) |
|---|---|---|
| Intended Use | Capable of taking diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts on adult and pediatric subjects, with the patient sitting, standing, or lying in prone or supine position. Not for mammography. (Matching K101517 with added mammography exclusion) | SAME, with added FDA requested language: Not for mammography. |
| Configuration | Battery or line-operated mobile X-ray unit. | SAME, now with telescopic tube mount (FLEX PLUS) to enhance visibility. |
| Performance Standard Compliance | Compliance with 21 CFR 1020.30 (Federal Safety Performance Standard for Diagnostic X-ray Systems). | SAME. Product is UL listed. |
| Generator | High frequency generator made by Sedecal. | SAME. |
| Generator Power Level | Capable of at least 40 KW power output. (Predicate offered 20, 32, 40, 50 KW) | 40 kW (One power level offered). (Meets or exceeds 40KW of predicate options) |
| Collimator | Ralco R221 DHHS Manual Collimator | SAME. |
| Image Acquisition | Use of FDA-cleared digital flat panel detectors for image acquisition, with documented pixel sizes. (Predicate used Trixell 3543pR or Varian 4336R) | Canon CXDI 401C Wireless (K133693), Canon CXDI 701C Wireless (K131106), Canon CXDI 801C Wireless (K131106). All Canon panels are previously FDA cleared. Pixel sizes: 125 μm. |
| Software | Functional image acquisition and control software. (Predicate used dicomPACS®DXR) | Canon control software CXDI-NE. |
| Connection | Ethernet or Wireless Wi-Fi functionality. | SAME. |
| DICOM Compliance | YES | YES. |
| Workflow | Basic X-ray system functionality (predicate's 'Not applicable' implies basic). | Enhanced Work Flow via second PC (provides additional functionality beyond predicate). |
| Power Source | AC Line or Rechargeable Battery operation. | SAME. |
| Electrical Safety & EMC | Compliance with IEC-60601, IEC-60601-1-2, IEC 60601-1-3, IEC 60601-2-54. | SAME. |
| Other Standards | Wi-Fi 802.11b/g connectivity. | Wi-Fi 802.11b/g and additional compliance with: FCC Rules and Regulations 47 CFR Chapter I Part 15 Subpart B; Part 18 Subpart C ICES-003 ISSUE 5 (2012) & ICES-001 ISSUE 4 (2014) & ANSI C63.4-2009. |
| Wi-Fi Communication with Detectors | Functional Wi-Fi communication with detectors (predicate used one single antenna). | "DAS" distributed Wi-Fi antenna system (enhances range and sensitivity for accompanying detectors, using 4 sector antennas). |
| Overall Safety and Effectiveness | "As safe and effective as the predicate devices." (Implied acceptance criterion for substantial equivalence). | "Bench, test laboratory results, and clinical image comparisons indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified." "After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Sedecal SA that the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices." |
Study Proving Acceptance Criteria (Substantial Equivalence):
The study proving the device meets the acceptance criteria (i.e., is substantially equivalent to the predicate) is primarily a non-clinical bench and laboratory testing study, complemented by the fact that core components (digital panels) were previously FDA cleared.
1. A table of acceptance criteria and the reported device performance:
See the table above.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of patient cases or images for testing the entire device system's imaging performance beyond general statements about "test images." However, the digital panels themselves (Canon CXDI series) were previously cleared by the FDA (K131106 and K133693), implying their performance was assessed in their respective submissions.
- Data Provenance: Not explicitly stated for specific images. The testing was conducted by SEDECAL SA in Algete, Madrid, España (Spain). The nature of the testing described (laboratory, bench, test images, clinical image comparisons) suggests some data would be internally generated or acquired during testing. Given it's a 510(k) for an X-ray system, the "data" is primarily technical specifications, compliance with standards, and image quality demonstrations rather than a large clinical dataset for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Sample images were verified by a Board Certified Radiologist." This indicates at least one expert.
- Qualifications: "Board Certified Radiologist." No details on years of experience.
4. Adjudication method for the test set:
- Not specified. Given only one expert is mentioned for image verification, a formal adjudication method (like 2+1 or 3+1) is unlikely to have been employed for the specific "sample images." The primary method appears to be comparison against accepted standards and the predicate device's performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of the hardware system, not on evaluating human reader performance with or without AI assistance. The device is a mobile X-ray system, not an AI-powered diagnostic algorithm in the typical sense of needing MRMC studies to assess reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable to this device in the context of a diagnostic AI algorithm. The device itself is a standalone X-ray imaging system. The submission details its performance, safety, and effectiveness without reliance on a human-in-the-loop performance for its core function of image acquisition. The "Enhanced Work Flow" is a separate software capability for facilitating client software, not an AI algorithm for interpreting images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "sample images" mentioned, the ground truth was expert verification by a Board Certified Radiologist. The overall "ground truth" for the device's main function comes from compliance with established technical standards (e.g., electrical safety, radiation performance, image acquisition parameters) and the performance of the legally marketed predicate device.
8. The sample size for the training set:
- This device is a hardware X-ray system, not an AI algorithm trained on a dataset of images. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- N/A, as there is no training set for an AI algorithm.
Ask a specific question about this device
Page 1 of 1