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510(k) Data Aggregation
(24 days)
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(174 days)
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult and pediatric patients for:
- Handheld orthopedic radiographic procedures of the extremities.
- Handheld orthopedic serial radiographic procedures of the extremities, excluding the shoulder, hip, and knee. Handheld serial radiographic imaging is limited to forward holding position only.
- Stand-mounted orthopedic radiographic, serial radiographic, fluoroscopic, and orthopedic interventional procedures of the extremities, inclusive of shoulders and knees.
The device is NOT intended for use during surgery. The device is NOT intended to replace a stationary radiographic or fluoroscopic system, which may be required for optimization of image quality and radiation exposure.
The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
The device is NOT intended to be used in environments with the following characteristics:
- Aseptic or sterile fields, such as in surgery
- Home or residential settings or other settings where qualified operators are not present
- Vehicular and moving environments
- Environments under direct sunlight
- Oxygen-rich environments, such as near an operating oxygenation concentrator
The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of the shoulders to fingertips and knees to toes. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.
The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs.
The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.
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(179 days)
The SKAN C Pulsar, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.
SKAN C Pulsar is not recommended for Cardiac Applications.
SKAN C Pulsar surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.
The SKAN C Pulsar, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.
SKAN C Pulsar is a Mobile fluoroscopy C-Arm consisting of two main units:
a) C-arm main unit
b) A Workstation or Monitor Cart
The C-arm unit is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and a Console. C-arm has provision for mechanical movement of C-arm for Orbital and Yoke Rotation along with vertical and wig-wag movements.
Workstation or Monitor cart is composed of a monitor, keyboard and computing system.
The operating principle of the device is to expose X-ray, which are passed through the human body and falls on the sensor. The intensity of X-ray can be adjusted to required level. Detector follows two step conversion. It converts X-ray into light and Light is converted into electrical signal. Electrical signal is than digitized and stored. This stored information is processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device.
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(235 days)
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
GE HealthCare interventional x-ray systems are designed to perform monoplane fluoroscopic X-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures. Additionally, with an OR table, these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.
Allia™ Moveo is a GE HealthCare interventional X-Ray system product model. It consists of a C-arm positioner, an X-ray table, an X-ray tube assembly, an X-ray power unit with its exposure control unit, an X-ray imaging chain (including a digital detector and an image processing unit).
Allia™ Moveo is a monoplane system (C-arm with mobile AGV gantry), with a square 41cm digital detector and the InnovaIQ table (with an option to make it an OR table).
Allia™ Moveo is an image acquisition system requiring connection to the GE HealthCare Advantage Workstation (AW) for 3D reconstruction. When a 3D acquisition is performed on the Allia™ Moveo system, the acquired 2D images are transferred to the Advantage Workstation (AW) to be processed by 3DXR (reference device K243446) for 3D reconstruction.
The purpose of this Premarket Notification is the introduction of a new C-arm with a modified detector mount.
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(281 days)
The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care, and in Veterinary Medicine.
The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
The Cios Select (VA21F) Mobile X-ray System is designed for the surgical environment. The Cios Select (VA21F) is a modification of the Cios Select (VA21) Flat Panel originally cleared under Premarket Notification K223410 on December 7, 2022.
The Cios Select consists of two major units:
The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station.
The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector, and user controls.
The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Imaging Processing System, user controls and image storage devices (USB).
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(133 days)
The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:
- Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
- Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
- The Azurion series can be used in a hybrid Operating Room.
- The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Patient Population:
All human patients of all ages. Patient weight is limited to the specification of the patient table.
The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:
- Real-time image visualization of patient anatomy during procedures
- Imaging techniques and tools to assist interventional procedures
- Post processing functions after interventional procedures
- Storage of reference/control images for patient records
- Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
- Built in radiation safety controls
This array of functions offers the physician the imaging information and tools needed to perform and document minimally invasive interventional procedures.
The Azurion R3.1 is available in identical models and configurations as the predicate device Azurion R2.1. Configurations are composed of detector type, monoplane (single C-arm) or biplane (dual arm), floor or ceiling mounted geometry, standard or OR table type and available image processing.
Identical to the predicate device, the FlexArm option is available for the 7M20 configuration in Azurion R3.1 to increase flexibility in stand movement.
Additionally, identical to the predicate device, Azurion R3.1 can be used in a hybrid operating room when supplied with a compatible operating room table.
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(136 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
αEvolve Imaging is an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).
The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging, is an interventional X-ray system with a floor mounted C-arm as its main configuration. An optional ceiling mounted C-arm is available to provide a bi-plane configuration where required. Additional units include a patient table, X-ray high-voltage generator and a digital radiography system. The C-arms can be configured with designated X-ray detectors and supporting hardware (e.g. X-ray tube and diagnostic X-ray beam limiting device). The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging includes αEvolve Imaging, an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided FDA 510(k) summary:
Overview of the Device and its New Feature:
The device is the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging. It's an interventional X-ray system. The new feature, αEvolve Imaging, includes Artificial Intelligence Denoising (AID) to reduce noise in real-time fluoroscopic images and a signal enhancement algorithm, Multi Frequency Processing (MFP). The primary claim appears to be improved image quality (noise reduction, sharpness, contrast, etc.) compared to the previous version's (V9.5) "super noise reduction filter (SNRF)."
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes various performance evaluations and their successful outcomes. For the clinical study, the success criteria are clearly defined.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Bench Testing (Image Quality) | |
| 1. Change in Image Level, Noise & Structure: AID to be better at preserving mean image intensity, improved denoising, and image structure preservation compared to SNRF. | AID determined to be better at preserving mean image intensity and suggested to have improved denoising and image structure preservation (using student's t-test). |
| 2. Signal-to-Variance Ratio (SVR) and Signal-to-Noise Ratio (SNR): AID to show improved ability to preserve image signal while decreasing image noise compared to SNRF. | AID determined to have improved ability to preserve image signal while decreasing image noise (using student's t-test). |
| 3. Modulation Transfer Function (MTF): Improved performance for low-to-mid frequencies and similar high-frequency region compared to SNRF. | Results showed improved performance for low-to-mid frequencies in all test cases, and high-frequency region of MTF curve was similar for AID and SNRF in majority of cases (using student's t-test). |
| 4. Robustness to Detector Defects: Detector defects to be sufficiently obvious to inform clinician of service need, and image quality outside the defect area to remain visually unaffected, facilitating procedure completion. | Detector defects were sufficiently obvious, and image quality outside the area of the detector defect remained visually unaffected, facilitating sufficient image quality to finish the procedure. |
| 5. Normalized Noise Power Spectrum (NNPS): AID to have smaller noise magnitude in the frequency range of ~0.1 cycles/mm to 1.4 cycles/mm, with negligible differences above 1.4 cycles/mm. | AID had a smaller noise magnitude in the frequency range of ~0.1 cycles/mm to 1.4 cycles/mm. Noise magnitudes above 1.4 cycles/mm were very small and differences considered negligible. |
| 6. Image Lag Measurement: AID to perform better in reducing image lag compared to SNRF. | AID determined to perform better in reducing image lag (using student's t-test). |
| 7. Contrast-to-Noise Ratio (CNR) of Low Contrast Object: AID to show significantly higher CNR for low-contrast elements compared to SNRF. | AID had a significantly higher CNR than images processed with SNRF for all elements and test cases (using student's t-test). |
| 8. Contrast-to-Noise Ratio (CNR) of High Contrast Object: AID to show significantly higher CNR for high-contrast objects (guidewire, vessels) compared to SNRF. | AID had a significantly higher vessel and guidewire CNR than images processed with SNRF for all test cases (using student's t-test). |
| Clinical Study (Reader Study) | |
| Overall Preference (Binomial Test): Image sequences denoised by AID chosen significantly more than 50% of the time over SNRF. | The Binomial test found that image sequences denoised by AID were chosen significantly more than 50% of the time (indicating overall preference). |
| Individual Image Quality Metrics (Wilcoxon Signed Rank Test): Mean score of AID images significantly higher than SNRF for sharpness, contrast, confidence, noise, and absence of image artifacts. | The mean score of AID imaging chain images was significantly higher than that of the SNRF imaging chain for sharpness, contrast, confidence, noise, and the absence of image artifacts. |
| Generalizability: Algorithm to demonstrate equivalent or improved performance compared to the predicate with diverse clinical data. | Concluded that the subject algorithm demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary provides the following information about the clinical test set:
- Clinical Dataset Source: Patient image sequences were acquired from three hospitals:
- Memorial Hermann Hospital (Houston, Texas, USA)
- Waikato Hospital (Hamilton, New Zealand)
- Saiseikai Kumamoto Hospital (Kumamoto, Japan)
- Data Provenance: The study used retrospective "patient image sequences" for side-by-side comparison. The summary does not specify if the acquisition itself was prospective or retrospective, but the evaluation of pre-existing sequences makes it a retrospective study for the purpose of algorithm evaluation.
- Sample Size: The exact number of patient image sequences or cases used in the clinical test set is not specified in the provided document. It only mentions that the sequences were split into four BMI subgroups.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states the clinical comparison was "reviewed by United States board-certified interventional cardiologists." The exact number of cardiologists is not specified.
- Qualifications: "United States board-certified interventional cardiologists." No mention of years of experience or other specific qualifications is provided.
4. Adjudication Method for the Test Set
The document describes a "side-by-side comparison" reviewed by experts in the clinical performance testing section. For the overall preference and individual image quality metrics, statistical tests (Wilcoxon signed rank test and Binomial test) were used. This implies that the experts rated or expressed preference for both AID and SNRF images, and these individual ratings/preferences were then aggregated and analyzed.
The exact adjudication method (e.g., 2+1, 3+1 consensus) for establishing a ground truth or a final decision on image quality aspects is not explicitly stated. It seems each expert provided their assessment, and these assessments were then statistically analyzed for superiority rather than reaching a consensus for each image pair.
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
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MRMC Study: Yes, a type of MRMC comparative study was conducted. The clinical performance testing involved multiple readers (US board-certified interventional cardiologists) evaluating multiple cases (patient image sequences).
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Effect Size of Human Readers' Improvement with AI Assistance: The study directly compared AID-processed images to SNRF-processed images in a side-by-side fashion. It doesn't measure how much humans improve with AI assistance in a diagnostic task (e.g., how much their accuracy or confidence improves when using AI vs. not using AI). Instead, it measures the perceived improvement in image quality of the AI-processed images when evaluated by human readers.
- The study determined: "the mean score of the AID imaging chain images was significantly higher than that of the SNRF imaging chain with regard to sharpness, contrast, confidence, noise, and the absence of image artifacts."
- And for overall preference, "the Binomial test found that the image sequences denoised by AID were chosen significantly more than 50% of the time."
This indicates a statistically significant preference for and higher perceived image quality in AID-processed images by readers. However, it does not quantify diagnostic performance improvement with AI assistance, as it wasn't a study of diagnostic accuracy but rather image quality assessment. The "confidence" metric might hint at improved reader confidence using AID images, but it's not a direct measure of diagnostic effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, extensive standalone performance testing of the AID algorithm was conducted through "Performance Testing – Bench" and "Image Quality Evaluations." This involved objective metrics and phantom studies without human subjective assessment.
Examples include:
- Change in Image Level, Noise and Structure
- Signal-to-Variance Ratio (SVR) and Signal-to-Noise Ratio (SNR)
- Modulation Transfer Function (MTF)
- Robustness to Detector Defects (visual comparison, but the algorithm's output is purely standalone)
- Normalizes Noise Power Spectrum (NNPS)
- Image Lag Measurement
- Contrast-to-Noise Ratio of a Low Contrast Object
- Contrast-to-Noise Ratio of a High Contrast Object
7. The Type of Ground Truth Used
- For Bench Testing: The ground truth for bench tests was primarily established through physical phantoms and objective image quality metrics. For example, the anthropomorphic chest phantom, low-contrast phantom, and flat field fluoroscopic images provided known characteristics against which AID and SNRF performance were measured using statistical tests.
- For Clinical Study: The ground truth for the clinical reader study was established by expert opinion/subjective evaluation (preference and scores for sharpness, contrast, noise, confidence, absence of artifacts) from "United States board-certified interventional cardiologists." There is no mention of a more objective ground truth like pathology or outcomes data for the clinical image evaluation.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set of the Artificial Intelligence Denoising (AID) algorithm.
9. How the Ground Truth for the Training Set was Established
The document does not provide any information about how the ground truth for the training set was established. It describes the AID as "Artificial Intelligence Denoising (AID) designed to reduce noise," implying a machine learning approach, but details on its training are missing from this summary.
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(74 days)
The Cios Spin is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patients during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients.
The Cios Spin (VA31A) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
a. The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
b. The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The following modifications were made to the Predicate Device the Cios Spin Mobile X-ray System cleared under Premarket Notification K210054 on February 5, 2021. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device Cios Spin (VA31A). The following modification is incorporated in the Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance:
- Software updated from VA30 to VA31A to support the below software features
A. Updated Retina 3D for optional enlarged 3D Volume of 25cm x 25cm x 16cm
B. Introduction of NaviLink 3D Lite
C. Universal Navigation Interface (UNI)
D. Updated InstantLink with Extended NXS Interface - Updated Collimator
- Updated FLC Imaging system PC with new PC hardware Updated AppHost PC with High Performance Graphic Card
- New Eaton UPS 5P 850i G2 as successor of UPS 5P 850i due to obsolescense
Based on the provided FDA 510(k) clearance letter for the Siemens Cios Spin (VA31A), here's an analysis of the acceptance criteria and the study proving the device meets them:
Important Note: The provided document is a 510(k) summary, which often summarizes testing without providing granular details on study design, sample sizes, and ground truth establishment to the same extent as a full clinical study report. Therefore, some information requested (e.g., specific number of experts for ground truth, adjudication methods) may not be explicitly stated in this summary. The focus of this 510(k) is primarily on demonstrating substantial equivalence to a predicate device, especially for software and hardware modifications, rather than a de novo effectiveness study.
Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating that the modifications to the Cios Spin (VA31A) do not introduce new safety or effectiveness concerns compared to its predicate device (Cios Spin VA30) and a reference device (CIARTIC Move VB10A) that incorporates some of the new features. The acceptance criteria are implicitly tied to meeting various industry standards and demonstrating functionality and safety through non-clinical performance testing.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from Text) | Reported Device Performance / Evidence |
|---|---|---|
| Software Functionality | Software specifications met acceptance criteria as stated in test plans. | "All test results met all acceptance criteria." |
| Enlarged Volume Field of View (Retina 3D) | Functionality and performance of new 25cm x 25cm x 16cm 3D volume. | "A non-clinical test 'Enlarged Volume Field of View' testing were conducted." The feature was cleared in the CIARTIC Move (K233748), implying its performance was previously validated. |
| NaviLink 3D Lite Functions | Functionality and performance of the new navigation interface. | Part of software updates VA31A; "All test results met all acceptance criteria." |
| Universal Navigation Interface (UNI) | Functionality and performance of UNI. | Part of software updates VA31A; "All test results met all acceptance criteria." UNI was present in the reference device CIARTIC Move (K233748). |
| InstantLink with Extended NXS Interface | Functionality and performance of updated interface. | Part of software updates VA31A; "All test results met all acceptance criteria." |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-43, IEC 60601-2-54. | "The system complies with the IEC 60601-1, IEC 60601-2-43, and IEC 60601-2-54 standards for safety." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | "The system complies with... the IEC 60601-1-2 standard for EMC." |
| Human Factors/Usability | Device is safe and effective for intended users, uses, and environments. Human factors addressed. | "The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer reports and feedback forms." |
| Risk Mitigation | Identified hazards are controlled; risk analysis completed. | "The Risk analysis was completed, and risk control was implemented to mitigate identified hazards." |
| Overall Safety & Effectiveness | No new issues of safety or effectiveness introduced by modifications. | "Results of all conducted testing and clinical assessments were found acceptable and do not raise any new issues of safety or effectiveness." |
| Compliance with Standards/Regulations | Adherence to various 21 CFR regulations and standards (e.g., ISO 14971, IEC 62304). | Extensive list of complied standards, including 21 CFR sections 1020.30, 1020.32, and specific IEC/ISO standards mentioned in Section 9. |
Study Details Proving Device Meets Acceptance Criteria
The study described is primarily a non-clinical performance testing and software verification and validation effort rather than a traditional clinical trial.
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients or images for performance evaluation. The testing described is "Unit, Subsystem, and System Integration testing" and "software verification and regression testing." This type of testing uses a diverse set of test cases designed to cover functionality, performance, and safety requirements. For the "Enlarged Volume Field of View," it's a non-clinical test, likely using phantoms or simulated data.
- Data Provenance: Not applicable in terms of patient data provenance for the non-clinical and software testing described. This is bench testing and software validation. Customer reports and feedback forms are mentioned for human factors, but specific details on their origin (country, etc.) are not provided. The manufacturing site is Kemnath, Germany.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not explicitly stated. For non-clinical performance and software testing, "ground truth" is typically established by engineering specifications, known correct outputs for given inputs, and compliance with industry standards. If clinical use tests involved subjective evaluation, the number and qualifications of experts are not detailed, but they are implied to be "healthcare professionals" (operators are "adequately trained").
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Adjudication method for the test set:
- Not applicable/Not explicitly stated. For software and bench testing, adjudication usually refers to a process of resolving discrepancies in ratings or measurements. Given the nature of this submission (software/hardware modifications and non-clinical testing), formal clinical adjudication methods (like 2+1, 3+1 for image reviews) are not described as part of the primary evidence. Acceptance is based on test cases meeting predefined engineering requirements.
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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 conducted. This 510(k) is for a mobile X-ray system with software and hardware updates, not an AI-assisted diagnostic device where evaluating human reader performance with and without AI would be relevant. The "AI" mentioned (Retina 3D, NaviLink 3D) refers to advanced imaging/navigation features, not machine learning for diagnostic interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "non-clinical test 'Enlarged Volume Field of View' testing" and other "Unit, Subsystem, and System Integration testing" for functionality and performance are essentially standalone tests of the device's components and software without immediate human interpretation in a diagnostic loop. The acceptance criteria for these tests refer to technical performance endpoints, not diagnostic accuracy.
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The type of ground truth used:
- Engineering Specifications and Standard Compliance: For the performance and safety testing, the "ground truth" is adherence to predefined engineering requirements (e.g., image dimensions, system response times, electrical safety limits) and compliance with national and international industry standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1).
- For the Human Factors Usability Validation, "customer reports and feedback forms" serve as a form of "ground truth" regarding user experience and usability.
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The sample size for the training set:
- Not applicable. This submission describes modifications to an X-ray imaging system, not the development of a machine learning algorithm that requires a separate training set. The existing software (VA30) was updated to VA31A. The "training" for the software itself would have occurred during its initial development, not for this specific 510(k) submission.
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How the ground truth for the training set was established:
- Not applicable. As above, this information is not relevant to this specific 510(k) submission, as it focuses on modifications to an existing device rather than the development of a new AI/ML algorithm requiring a training set and its associated ground truth.
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(259 days)
The software supports image guidance by overlaying vessel anatomy onto live fluoroscopic images in order to navigate guidewires, catheters, stents and other endovascular devices.
The device is indicated for use by physicians for patients undergoing endovascular PAD interventions of the lower limbs including iliac vessels.
The device is intended to be used in adults.
There is no other demographic, ethnic or cultural limitation for patients.
The information provided by the software or system is in no way intended to substitute for, in whole or in part, the physician's judgment and analysis of the patient's condition.
The Subject Device is a standalone medical device software supporting image guidance in endovascular procedures of peripheral artery disease (PAD) in the lower limbs, including the iliac vessels. Running on a suitable platform and connected to an angiographic system, the Subject Device receives and displays the images acquired with the angiographic system as a video stream. It provides the ability to save and process single images out of that video stream and is able to create a vessel tree consisting of angiographic images. This allows to enrich the video stream with the saved vessel tree to continuously localize endovascular devices with respect to the vessel anatomy.
The medical device is intended for use with compatible hardware and software and must be connected to a compatible angiographic system via video connection.
Here's a breakdown of the acceptance criteria and study information for the Vascular Navigation PAD 2.0, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance for Vascular Navigation PAD 2.0
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Video Latency (Added) | $\le$ 250 ms | $\le$ 250 ms (for Ziehm Vision RFD 3D, Siemens Cios Spin, and combined) |
| Capture Process Timespan (initiation to animation start) | $\le$ 1s | Successfully passed |
| Stitching Timespan (entering stitching to calculation result) | $\le$ 10s | Successfully passed |
| Roadmap/Overlay Display Timespan (manual initiation / selection / realignment to updated display) | $\le$ 10s | Successfully passed |
| System Stability (Stress and Load, Anti-Virus) | No crashes, responsive application (no significant waiting periods), no significant latencies of touch interaction/animations, normal interaction possible. | Successfully passed |
| Level Selection and Overlay Alignment (True-Positive Rate for suggested alignments) | Not explicitly stated as a number, but implied to be high for acceptance. | 95.71 % |
| Level Selection and Overlay Alignment (Average Registration Accuracy for proposed alignments) | Not explicitly stated (but the stated "2D deviation for roadmapping $\le$ 5 mm" likely applies here as an overall accuracy goal). | 1.49 $\pm$ 2.51 mm |
| Level Selection Algorithm Failures | No failures | No failures during the test |
| Modality Detection (Prediction Rate in determining image modality) | Not explicitly stated ("consequently, no images were misidentified" implies 100% accuracy) | 99.25 % |
| Modality Detection (Accuracy for each possible modality) | Not explicitly stated (but 100% for acceptance) | 100 % |
| Roadmapping Accuracy (Overall Accuracy) | $\le$ 5 mm | 1.57 $\pm$ 0.85 mm |
| Stitching Algorithm (True-Positive Rate for suggested alignments) | $\ge$ 75 % | 95 % |
| Stitching Algorithm (False-Positive Rate for incorrect proposal of stitching) | $\le$ 25 % | 6.4 % |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number.
- For Latency Tests: Data from Siemens Cios Spin and Ziehm Vision RFD 3D.
- For Level Selection and Overlay Alignment: Images acquired with Siemens Cios Spin, Ziehm Vision RFD 3D, and GE OEC Elite CFD.
- For Modality Detection: Image data from Siemens Cios Spin, GE OEC Elite CFD, Philips Zenition, and Ziehm Vision RFD 3D.
- For Roadmapping Accuracy: Image data from Siemens Cios Spin.
- For Stitching Algorithm: Image data from Philips Azurion, Siemens Cios Spin, GE OEC Elite CFD, and Ziehm Vision RFD 3D.
- Data Provenance:
- Retrospective/Prospective: Not explicitly stated for all tests. However, the Level Selection and Overlay Alignment and Roadmapping Accuracy tests mention using "cadaveric image data" which implies a controlled, likely prospective, acquisition for testing purposes rather than retrospective clinical data. Other tests reference "independent image data" or data "acquired using" specific devices, suggesting a dedicated test set acquisition.
- Country of Origin: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document mentions "manually achieved gold standard registrations" for Level Selection and Overlay Alignment and "manually comparing achieved gold standard (GS) stitches" for the Stitching Algorithm, implying human expert involvement in establishing ground truth, but specific details on the number or qualifications of these "manual" reviewers are absent. The phrase "if a human would consider the image pairs matchable" in the stitching section further supports human-determined ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The ground truth seems to be established through "manually achieved gold standard" or "manual comparison," implying a single expert or a common understanding rather than a formal adjudication process between multiple conflicting expert opinions (e.g., 2+1 or 3+1).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The submission focuses on standalone technical performance measures and accuracy metrics of the algorithm rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
- Was it done? Yes. The entire "Performance Data" section details the algorithm's performance in various standalone tests, such as latency, stress/load, level selection and overlay alignment, modality detection, roadmapping accuracy, and stitching algorithm performance. The results are quantitative metrics of the device itself.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Expert Consensus / Manual Gold Standard: For Level Selection and Overlay Alignment ("manually achieved gold standard registrations") and for the Stitching Algorithm ("manually comparing achieved gold standard (GS) stitches"). This implies human experts defined the correct alignment or stitch.
- Technical Metrics: For Latency, Capture Process, Stitching Timespan, Roadmap/Overlay Display Timespan, and System Stability, the ground truth is based on objective technical measurements against defined criteria.
- True Modality: For Modality Detection, the ground truth is simply the actual modality of the image (fluoroscopy vs. angiography) as known during test data creation or acquisition.
8. Sample Size for the Training Set
- Sample Size: Not provided. The submission focuses solely on the performance characteristics of the tested device and its algorithms, without detailing the training data or methods used to develop those algorithms.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not provided. As with the training set size, the information about the training process and ground truth for training is outside the scope of the clearance letter's performance data section.
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LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.
LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.
The LUMINOS Q.namix T is an under-table fluoroscopy system and the LUMINOS Q.namix R is an over-table fluoroscopy system. Both systems are multifunctional, general R/F systems, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. They are designed as modular systems with components such as main fluoro table including fixed fluoroscopy detector and X-ray tube, a ceiling suspension with X-ray tube, Bucky wall stand, X-ray generator, monitors, a bucky tray in the table as well as portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
This FDA 510(k) clearance letter and summary discuss the LUMINOS Q.namix T and LUMINOS Q.namix R X-ray systems. The provided documentation does not include specific acceptance criteria (e.g., numerical thresholds for image quality, diagnostic accuracy, or performance metrics) in the same way an AI/ML device often would. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.
The study presented focuses primarily on image quality evaluation for the new detectors (X.fluoro and X.wi-D24) for diagnostic acceptability, rather than establishing acceptance criteria for the entire system's overall performance.
Here's an attempt to extract and present the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria for the overall device performance are not stated in the provided 510(k) summary, this section will reflect the available qualitative performance assessment for the new detectors. The primary "acceptance criterion" implied for the overall device is substantial equivalence to predicate devices and acceptability for diagnostic use.
| Feature/Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (LUMINOS Q.namix T/R with new detectors) |
|---|---|---|
| Overall Device Equivalence | Substantially equivalent to predicate devices (Luminos Agile Max, Luminos dRF Max) in indications for use, design, material, functionality, technology, and energy source. | Systems are comparable and substantially equivalent to predicate devices. Test results show comparability. |
| New Detector Image Quality (X.fluoro, X.wi-D24) | Acceptable for diagnostic use in radiography & fluoroscopy. | Evaluated images and fluorography studies from different body regions were qualified for proper diagnosis by a US board-certified radiologist and by expert evaluations. |
| Compliance with Standards | Compliance with relevant medical electrical safety, performance, and software standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, DICOM). | The LUMINOS Q.namix T/LUMINOS Q.namix R systems were tested and comply with the listed voluntary standards. |
| Risk Management | Application of risk management process (per ISO 14971). | Risk Analysis was applied. |
| Software Life Cycle | Application of software life cycle processes (per IEC 62304). | IEC 62304 (Medical device software - Software life cycle processes) was applied. |
| Usability | Compliance with usability engineering standards (per IEC 60601-1-6, IEC 62366-1). | IEC 60601-1-6 and IEC 62366-1 were applied. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: "expert evaluations" for the new detectors X.fluoro and X.wi-D24.
- Sample Size: The exact number of images or fluorography studies evaluated is not specified. The document mentions "multiple images and fluorography studies from different body regions" for the US board-certified radiologist's evaluation.
- Data Provenance:
- Countries of Origin: Germany (University Hospital Augsburg, Klinikum rechts der Isar Munich, Herz-Jesu-Krankenhaus Münster/Hiltrup) and Belgium (ZAS Jan Palfijn Hospital of Merksem).
- Retrospective or Prospective: Not explicitly stated, but clinical image quality evaluations often involve prospective data collection or a mix with retrospective cases. Given they are evaluating "new detectors" and "clinical image quality evaluation", it implies real or simulated clinical scenarios.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts:
- Initial Evaluations: Multiple "expert evaluations" (implies more than one) were conducted across the listed hospitals. The exact number of individual experts is not specified.
- Specific Evaluation: One "US board-certified radiologist" performed a dedicated clinical image quality evaluation.
- Qualifications of Experts:
- For the general "expert evaluations": Not specified beyond being "experts."
- For the specific evaluation: "US board-certified radiologist." No mention of years of experience is provided.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1 consensus voting) for establishing ground truth or evaluating the image quality. The evaluations appear to be individual or group assessments leading to a conclusion of "acceptability for diagnostic use."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? The document does not describe a formal MRMC comparative effectiveness study designed to quantify the improvement of human readers with AI vs. without AI assistance.
- Effect Size of Human Reader Improvement: Therefore, no effect size is reported.
- Note: While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the study described is an evaluation of the detectors' image quality and the overall system's substantial equivalence, not the clinical impact of these specific AI features on human reader performance.
6. Standalone Performance Study (Algorithm Only)
- The document primarily describes an evaluation of the new detectors within the LUMINOS Q.namix T/R systems and the overall system's substantial equivalence.
- While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the document does not report on a standalone performance study specifically for these AI algorithms in isolation from the human-in-the-loop system. The AI features are listed as technological characteristics that contribute to the device's overall updated design.
7. Type of Ground Truth Used
For the detector image quality evaluation, the ground truth was based on expert assessment ("qualified for proper diagnosis"). This falls under expert consensus or expert judgment regarding diagnostic acceptability.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set for any AI components. The focus of this 510(k) summary is on substantiating equivalence and safety/effectiveness of the entire X-ray system, not on the development of individual AI algorithms within it.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, the method for establishing its ground truth is not mentioned in the document.
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