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D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

As compared to the predicate system, we have added a newly compatible Digital Dynamic X-ray receptor panel, model: Pixium RF 4343 FL (Model 4). This panel has already received FDA clearance (reference device above). The original Canon panels remain available. The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the Xrays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. Panel information: Based on a flat-panel digital detector with the largest field-of-view in the market, the Pixium RF 4343 FL (Model 4) is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an alldigital real-time system, generating high-quality images for both routine dynamic applications and high-end static ones. Digital technology facilitates the work of X-ray technicians and speeds up the process, allowing medical centers to optimize patient throughput. Universal: a single detector for both Radiography or Fluoroscopy. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.

The provided text is a 510(k) summary for the D2RS & D2RS9090 Digital Dynamic Remote System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective.

The document primarily focuses on explaining that the device is a modified fluoroscopic x-ray system, specifically incorporating a new digital x-ray detector (Pixium RF 4343 FL Model 4) that had already received FDA clearance as a reference device (K202235). The key arguments for substantial equivalence are based on:

1. Technological characteristics: The new panel has similar or better characteristics (e.g., DQE, MTF, pixel pitch, matrix size) compared to the original panel in the predicate device.
2. Bench/Performance Testing: Systems covering all generator/panel combinations were assembled and tested for proper operation. Software was validated, and cybersecurity recommendations were observed. The physical components also comply with various IEC standards.
3. Clinical Evaluation: It explicitly states that clinical studies were NOT required because the added compatible digital x-ray receptor panel had previously received FDA clearance (as a reference device, K202235). This means there was no new clinical study specifically demonstrating the performance of this integrated system in terms of diagnostic accuracy or a comparison with human readers.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/algorithm because the document does not describe the device as having an AI/algorithmic component that processes or interprets images for diagnostic purposes. The device is a fluoroscopic imaging system, and the "performance" described relates to its image quality and safety as an imaging modality, not to an AI's diagnostic performance.

To directly answer your request based on the provided text, while acknowledging its limitations for an AI/algorithm context:

There is no mention of acceptance criteria or a study proving an AI/algorithm meets those criteria because the device described is an X-ray imaging system, not an AI-powered diagnostic tool. The "performance" assessment is based on physical characteristics and compliance with standards for X-ray devices.

Here's what can be extracted, interpreted, or explicitly stated as "not present" based on your specific questions, assuming for a moment you were expecting details on a diagnostic AI:

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

   • Acceptance Criteria (Interpreted for a Hardware Device): The acceptance criteria are implicit in the comparison table (pages 5-6) and the compliance with international standards (pages 6-7). The core criterion for substantial equivalence in this context is that the new panel's characteristics (e.g., DQE, MTF, pixel pitch, matrix) are "equal to or better than the predicate device" and that the system complies with safety and performance standards.
   • Reported Device Performance:

     Characteristic	Acceptance Criteria (Predicate / K213479)	Reported Performance (New Device / K221335)
     Name	Canon CXDI-RF Wireless B1	Pixium RF 4343 FL (Model 4)
     Dimension	480 x 460 mm	500 x 490 mm
     Useful Area	42 x 43 cm	43 x 43 cm
     Scintillator	Csl	Csl
     Pixel pitch	160 µm	148 µm
     Matrix	2592 × 2656 pixels	2874 x 2840 pixels
     AD conversion	16 bits	16 bits
     DQE	60% (0.5 lp/mm)	73% typ (0 lp/mm) (Similar performance)
     MTF	38% (2 lp/mm)	35% typ. (2 lp/mm) (Similar performance)
     Fps Max	30 fps	30 fps
     Interface	Ethernet/Wireless WiFi	Ethernet
     DICOM 3	YES	YES
     Operating temperature	15-40°C	15-40°C

2. Sample size used for the test set and the data provenance: Not applicable/not provided. This type of information would be relevant for a study validating an AI/diagnostic algorithm using a test dataset of patient cases. This document describes a new hardware component (detector) being integrated into an existing system, and its performance validation is through bench testing and comparison of physical specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is for diagnostic AI models, not for an X-ray imaging system's hardware performance.

4. Adjudication method for the test set: Not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done, as the device is not an AI assistance tool for human readers. Clinical studies were explicitly stated as "not required" because the new panel component had already received clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. The device is a system that produces images for human interpretation.

7. The type of ground truth used: For this device, the "ground truth" for its performance is derived from physical measurements (e.g., DQE, MTF), compliance with established industry standards (IEC, FDA guidance documents), and proper functioning during bench testing.

8. The sample size for the training set: Not applicable/not provided. This information is relevant for AI models, not for the manufacturing and testing of an X-ray imaging system.

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

In summary, the provided document is a 510(k) summary for a hardware modification to a medical imaging device. It is not a study that proves an AI/algorithm meets acceptance criteria, and therefore, most of your specific questions regarding AI validation studies cannot be answered from this text.

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D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.

The provided text describes a 510(k) premarket notification for a medical device called D2RS & D2RS9090 Digital Dynamic Remote System. The submission aims to establish substantial equivalence to a predicate device (D2RF Digital Dynamic Remote System). Here's a breakdown of the requested information based on the provided text, with notes where information is not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be "as safe and effective as the predicate device" and compliance with relevant IEC standards and FDA guidances. The performance is assessed against these implicit criteria and through a comparison of technological characteristics.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "both static and moving images" were reviewed, but doesn't quantify the number of images or cases.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: "A board certified radiologist" (singular) was used.
• Qualifications: "board certified radiologist." Specific experience level (e.g., years of experience) is not mentioned.

4. Adjudication method for the test set

• Adjudication Method: "A board certified radiologist reviewed... and found them to be of excellent diagnostic quality." This implies a single-reader review rather than an adjudication process involving multiple experts. No formal adjudication method (like 2+1 or 3+1) is mentioned.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly done. The study described is a single-reader review for diagnostic image quality, comparing the device's output to an implicit standard of "excellent diagnostic quality," likely in comparison to the predicate device's expected performance. This submission is for an imaging system, not an AI-assisted diagnostic tool.
• Effect Size: Not applicable, as no MRMC study with AI assistance was performed.

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

• Standalone Performance: Not applicable in the context of this submission. The device is an X-ray imaging system, where human interpretation of the images is inherent to its use. The "algorithm" here refers to the system's image acquisition and processing capabilities, not an AI for diagnosis. The clinical evaluation focuses on the quality of the images produced for human interpretation.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the clinical evaluation was based on the subjective assessment of a "board certified radiologist" who determined the images to be of "excellent diagnostic quality." This is an expert opinion/consensus implicitly benchmarked against diagnostic standards. It is not pathology, or outcomes data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The device described is an X-ray imaging system, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" of such a system involves engineering and calibration to produce high-quality images according to technical specifications and clinical needs, rather than learning from a dataset.

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

• Ground Truth for Training Set: Not applicable. As mentioned above, this is an X-ray imaging system, not an AI/ML algorithm that generates a "ground truth" during a training phase.

In summary, the submission focuses on demonstrating substantial equivalence primarily through technological comparison to a predicate device, adherence to relevant technical standards, and a qualitative assessment of image quality by a radiologist. It is not an AI-based diagnostic device; therefore, many of the questions related to AI studies (MRMC, training sets, etc.) are not directly applicable.

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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.

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The D-RS AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It Is intended to replace fluoroscopic images obtained through image intensionaly. Not intended for mammography applications.

The D2RS AT Digital Dynamic Remote System is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Trixell Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. Panel information: Based on a flat-panel digital detector with the largest field-of-view in the market, the Pixium RF 4343 FL is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an all-digital real-time system, generating high-quality images for both routine dynamic applications and high-end static ones. Digital technology facilitates the work of X-ray technicians and speeds up the process, allowing medical centers to optimize patient throughput. Universal: a single detector for both Radiography and Fluoroscopy. An optional static panel may be added to the system: Trixell Pixium 3543EZ. The 3543EZ panel has already been cleared in various 510(k)s including K131314 and K141440. That panel is not mounted and can be moved around by the technician. The system must always have either the Pixium RF 4343, Pixium RF 4343FL for the system to be able to perform fluoroscopy. These fluoroscopic panels were not to our knowledge previously cleared by FDA, so complete performance information as requested by the FDA guidance document on solid state x-ray panels has been provided.

This document describes the D²RS_AT Digital Dynamic Remote System, an image-intensified fluoroscopic x-ray system seeking 510(k) clearance. The provided text outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through comparison to a predicate device (Stephanix D²RF K102529) and adherence to various standards and guidance documents. Explicit quantitative acceptance criteria are not provided as a list with pass/fail thresholds. Instead, performance metrics are presented for both the new device's panels and the predicate device's panel, and the conclusion states that the new device performs "comparably to and is substantially equivalent to the predicate device."

Study Proving Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is detailed under "Bench/Performance Testing/Data" and "Clinical Evaluation."

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

• Test Set Sample Size: Not explicitly stated. The "Clinical Evaluation" mentions a "board certified radiologist reviewed both static and moving images." This implies a qualitative assessment of some images, but the number of images or cases reviewed is not specified.
• Data Provenance: The document does not specify country of origin for the data or whether it was retrospective or prospective. Given that the device is manufactured in France (Rue Jean Moulin - ZI du Bayon La Ricamarie - FRANCE), it's plausible testing was conducted there or in another location appropriate for device evaluation. The context of a 510(k) submission typically involves data collected specifically for the regulatory submission, making it akin to a prospective study for that purpose, even if the cases themselves might be simulated or representative.

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

• Number of Experts: "a board certified radiologist reviewed..." indicates one radiologist.
• Qualifications of Experts: "board certified radiologist." Specific experience (e.g., "10 years of experience") is not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable or "none" for multiple readers. Since only one radiologist is mentioned as reviewing the images, there was no multi-reader consensus or adjudication process described. The single radiologist's assessment served as the "truth" for the clinical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not explicitly described. The "Clinical Evaluation" section mentions a single board-certified radiologist reviewing images but does not present a comparison of human reader performance with and without AI assistance, nor does it quantify an effect size of improvement. The study focuses on the device's image quality for diagnostic purposes rather than the reader's comparative performance with different aids.

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

• Yes, a standalone study (or rather, non-human-in-the-loop performance evaluation) was done as part of the bench testing. The "Bench/Performance Testing/Data" section discusses objective metrics like MTF, DQE, spatial resolution, and pixel pitch. These are measurements of the device's inherent image quality characteristics, independent of a human observer's interpretation.

7. The Type of Ground Truth Used:

• For Bench/Performance Testing: The ground truth is objective physical measurements of the system's performance characteristics (e.g., specific X-ray phantom designs for MTF/DQE, calibrated measurement tools for spatial resolution, etc.).
• For Clinical Evaluation: The "ground truth" was established by the subjective assessment of "good diagnostic quality" by a single board certified radiologist. This is an expert opinion-based ground truth.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This device is an X-ray imaging system, not an AI / machine learning algorithm that typically requires a training set of data. The document describes a physical medical imaging device and its components (flat panel detectors). Therefore, no "training set" in the context of machine learning is applicable or mentioned.

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

• Not Applicable / Not Provided. As there is no mention of an AI/ML component requiring a training set, the establishment of ground truth for such a set is not relevant to this submission.

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The D'RF Digital Dynamic Remote System Is indicated for use in generating fluoroscopic Images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

D'RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray Images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital Images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table.

The provided document is a 510(k) summary for a Digital Fluoroscopic X-Ray System (D'RF Digital Dynamic Remote System). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the manner requested.

Here's a breakdown of the information that can be extracted and what is explicitly not mentioned in the summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table of acceptance criteria with specific quantitative metrics or reported device performance data in the way a clinical study would.
Instead, it broadly states:

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

This information is not provided in the 510(k) summary. The document mentions "Performance testing" but does not detail the size or nature of any test set (e.g., number of patients, images, or phantom studies). There is no mention of data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission for fundamental X-ray technology, a clinical study involving expert ground truth might not be a primary requirement for this type of device.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

An MRMC study is not mentioned in the 510(k) summary. The focus is on demonstrating equivalence to the predicate, not necessarily comparative effectiveness with human readers.

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

This concept is not applicable in the context of this device. The D'RF Digital Dynamic Remote System is a physical X-ray imaging system, not an AI algorithm. Its "performance" refers to the quality of the images it generates and its operational characteristics, which are ultimately interpreted by a human.

7. The type of ground truth used

This information is not provided as there is no detailed study described. For X-ray imaging systems, "ground truth" often relates to image quality metrics (e.g., spatial resolution, contrast-to-noise ratio) measured using phantoms, rather than clinical outcomes or pathology from patient data for a diagnostic algorithm.

8. The Sample Size for the Training Set

This information is not applicable as the D'RF Digital Dynamic Remote System is a physical X-ray imaging system, not a machine learning model that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

In summary:

The provided 510(k) summary for the D'RF Digital Dynamic Remote System focuses on demonstrating substantial equivalence to a predicate device (Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System K093688). It broadly states that the device's technological characteristics are "equal to or better than" the predicate and that it is "safe and effective."

The document does not contain the detailed clinical study information, specific acceptance criteria with quantitative metrics, sample sizes, expert ground truth details, or MRMC study results that your request is looking for. These types of detailed performance studies are more common for novel diagnostic algorithms or devices with highly specific quantitative performance claims, rather than for a new iteration of a well-established imaging modality like an X-ray system seeking substantial equivalence. The "performance testing" mentioned likely refers to engineering and quality control tests to ensure the system meets its specifications and regulatory standards, rather than a clinical trial with patient ground truth.

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