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Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all pediatric patients (birth to 21 years) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications

The Virtual C DRF-NEO system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as photo-spot and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF-NEO System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient.

The provided text describes a 510(k) premarket notification for the "Virtual C DRF-NEO Digital Imaging System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and summaries of non-clinical testing. It explicitly states that "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."

Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting. The submission relies on establishing substantial equivalence to a predicate device, and thus, does not include information on acceptance criteria based on clinical performance metrics or studies involving human readers or ground truth.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific clinical acceptance criteria for the "Virtual C DRF-NEO Digital Imaging System" or present a study comparing its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications.

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

Not applicable. No clinical test set was used, as "No clinical data is necessary to evaluate safety or effectiveness." The assessment was based on non-clinical bench testing and comparison to technical specifications of a predicate device.

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

Not applicable. No clinical test set was used, and therefore, no experts were involved in establishing ground truth for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. No MRMC comparative effectiveness study was conducted. The device is a digital imaging system, not an AI-assisted diagnostic tool that would typically involve a multi-reader study to evaluate improvement with AI.

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

Not applicable. No standalone performance study was conducted. The assessment was based on demonstrating substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

Not applicable. For the purpose of this 510(k) submission, the ground truth was effectively the technical specifications and validated performance of the predicate device and the digital panel component (DRTECH EVS 2430W with K171137 clearance), against which the proposed device's characteristics were compared for substantial equivalence. No clinical ground truth (e.g., pathology, outcomes data) was used for evaluating the new device's performance in a clinical context.

8. The Sample Size for the Training Set

Not applicable. No training set was involved, as this submission is not for an AI/ML algorithm requiring a training phase.

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

Not applicable. No training set was used.

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Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications

The Virtual C DRF system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as multi-rad and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient. As compared to our predicate device, there are three main changes: The digital receptor panel become a DRTECH brand panel, the generator changes from Sedecal to Source-ray, and and the collimator is changed from Colimar to a PortaVision "Machine Vision" collimator. An initial report was submitted for that collimator.

The provided document is a 510(k) Premarket Notification for the "Virtual C DRF Digital Imaging System." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with an AI algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered device, a study proving it meets these criteria, or details about expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily discusses non-clinical testing (bench testing, electrical safety, EMC, software validation, cybersecurity) and a comparison of the new device's technical specifications and intended use against a predicate device. It explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."

In summary, none of the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance) for an AI-powered device is present in this medical device submission.

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Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pedian the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)

The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.

This document is a 510(k) Premarket Notification from Portavision Medical LLC for their MobileRay Pulse SE Digital Imaging System, demonstrating its substantial equivalence to a predicate device. The information provided heavily focuses on describing the device, comparing its technical specifications to a predicate, and detailing non-clinical bench testing for safety and effectiveness.

Crucially, the document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification." This means that the device's acceptance criteria and the proof of meeting them are not based on human reader studies, ground truth establishment, or clinical performance metrics discussed in an MRMC or standalone study. Instead, the acceptance criteria are met through demonstrating equivalence in technical specifications and successful completion of robust non-clinical bench testing.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding an AI component, MRMC study, ground truth, and expert adjudication, is not applicable to this specific 510(k) submission. This submission is for a conventional X-ray and fluoroscopy system, not an AI-powered diagnostic device.

However, I can extract information related to the device's performance based on the technical comparison and bench testing described. It's important to frame this within the context of technical equivalence rather than AI-driven performance metrics.

Acceptance Criteria and Device Performance (Based on Technical Equivalence and Bench Testing):

Since no clinical or AI-specific performance study was conducted or presented, the "acceptance criteria" here refer to the demonstration of technical equivalence and adherence to safety and performance standards for an X-ray imaging system. The "reported device performance" is a comparison of its technical specifications and safety/EMC test results against established predicate device characteristics and regulatory standards.

Regarding the specific questions about an AI study (which are NOT applicable to this submission):

1. Sample size for the test set and data provenance: No test set of clinical images used for performance evaluation (AI or human reader) was mentioned. The "test set" in this context would be the device itself undergoing bench testing.
2. Number of experts used to establish ground truth & qualifications: Not applicable. No clinical ground truth was established for performance evaluation.
3. Adjudication method for the test set: Not applicable. No clinical test set to adjudicate.
4. MRMC comparative effectiveness study: Not applicable. No MRMC study was done, as this is a traditional imaging device, not an AI-assisted one. The document explicitly states "No clinical data is necessary."
5. Standalone performance: Not applicable in the context of AI. The device's "standalone" performance is its technical capability to produce X-ray images, which was assessed through bench testing and comparison to predicate technical specifications.
6. Type of ground truth used: Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used for performance evaluation.
7. Sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The "study" described in this 510(k) submission is a non-clinical bench testing and technical comparison study.

• Objective: To demonstrate the substantial equivalence of the MobileRay Pulse SE Digital Imaging System to a legally marketed predicate device (EcoTron AnyView 500R Fluoroscopic Mobile X-ray System, K160279) and compliance with relevant safety and performance standards.
• Methodology:
  • Technical Comparison: Direct comparison of features, specifications (e.g., KV/mA ranges, generator type, software functions), and indications for use between the proposed device and the predicate.
  • Bench Testing: Electrical safety and Electromagnetic Compatibility (EMC) testing according to international standards (e.g., EN 60601-1-2, IEC 60601-1). Thermal stability testing for the X-ray generator to ensure safe operation during fluoroscopy. Validation of software according to FDA guidance. Cybersecurity assessment.
• Data Provenance: The data primarily comes from internal company testing and accredited lab testing for standard compliance. This is "prospective" bench testing data rather than retrospective or prospective clinical data. The country of origin for the data generation would be where the manufacturer and testing labs are located (not specified, but implied to be within typical regulatory testing frameworks).
• Conclusion: The submission concludes that the MobileRay Pulse SE is as safe and effective as the predicate device due to similar indications for use, similar technological characteristics, and successful non-clinical bench testing demonstrating compliance with safety and performance standards. The key difference is the use of digital panels versus an image intensifier, and a unique source-to-image receptor alignment technology, but these are deemed "insignificant technological differences" that do not raise new questions of safety or effectiveness.

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This device is intended for use in generating radiographic images of neonatal anatomy. It is intended to replace radiographic film/ screen or CR systems in neonatal general-purpose diagnostic procedures. This device is not intended for mammography applications.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the Pvmed ddr 2430t. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily focuses on:

• The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Information related to regulatory compliance for the device.
• Indications for Use: Generating radiographic images of neonatal anatomy, replacing film/screen or CR systems in neonatal general-purpose diagnostic procedures, and specifically stating it is not for mammography applications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and the study details as this information is not present in the provided text.

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The NeoRay DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy, it is specifically optimized to operate within the Neonatal environment. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

The NeoRay DDR 2520 Digital Imaging System is a portable X-Ray system comprised of a portable digital radiographic imaging system, an X-Ray generator/collimator system, and a mobile stand.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it is a 510(k) summary for the NeoRay DDR 2520 Digital Imaging System, describing its intended use, technological characteristics, and substantial equivalence to predicate devices.

The document states:

• "There are no significant differences between the NeoRay DDR 2520 Digital Imaging System and the predicate devices and therefore, the NeoRay DDR 2520 Digital Imaging System does not raise any questions regarding safety and effectiveness."
• "The NeoRay DDR 2520 Digital Imaging System, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."
• The "technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. The only difference is the size."

This indicates that the device's acceptance was based on showing substantial equivalence to existing, legally marketed devices, rather than through a performance study against specific acceptance criteria for a new type of functionality. Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not available in this type of submission.

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