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EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.

Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine

(※ This device is not intended for mammography applications.)

EXTRON Series are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.

The EXTRON Series are composed of a C-arm main body and a monitor cart. The C-arm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.

The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.

X-rays can penetrate into the human body through a two-step conversion process.

X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.

Here's a breakdown of the acceptance criteria and the study information for the DRTECH Corporation EXTRON Series, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) summary, which often emphasizes equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for a new device's performance. The "performance" here refers to demonstrating equivalence to the predicate, primarily through non-clinical testing and image quality assessment.

Acceptance Criteria and Device Performance for DRTECH Corporation EXTRON Series

Based on the provided 510(k) summary, the device's "acceptance criteria" are implied by its demonstration of substantial equivalence to predicate devices through compliance with established international and FDA-recognized consensus standards and a comparison of technological characteristics. The study primarily relies on non-clinical performance and a qualitative assessment of image quality.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for a "test set" in the traditional sense of a clinical trial. Instead, it states: "Sample clinical images using anthropomorphic phantoms representative of the indicated anatomies and populations have been taken for both the proposed devices (EXTRON 3/5/7) and the predicate devices (Veradius Unity and OEC 9900 ELITE)."
• Data Provenance: The data primarily comes from non-clinical testing using anthropomorphic phantoms. There is no mention of human subject data (clinical images from patients). The provenance of the phantoms themselves (e.g., manufacturer) or the exact location where these phantom images were acquired is not stated, but the manufacturer is based in South Korea. The study is retrospective in the sense that the comparison is made against existing predicate devices, but the image acquisition for the subject device is new. It is explicitly stated that "Clinical studies were not performed."

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

• Number of Experts: The document states: "These images have been reviewed and compared by qualified clinical experts." The exact number of experts is not specified.
• Qualifications of Experts: The experts are described as "qualified clinical experts." No specific qualifications (e.g., radiologist with X years of experience, board certification) are provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: The document states that the phantom images "have been reviewed and compared by qualified clinical experts." It does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It appears to be a comparative review rather than a ground truth establishment process requiring formal adjudication for diagnostic accuracy.

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. This device is an X-ray imaging system, not an AI software intended to assist human readers in diagnosis. The study focused on demonstrating the image quality equivalence of the X-ray system itself. Therefore, the question about human reader improvement with/without AI assistance is not applicable.

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

• Not applicable. This device is an X-ray system, not an algorithm. The "standalone performance" implicitly refers to the performance of the X-ray system in producing images, which was assessed through non-clinical tests and qualitative image comparisons with predicate devices.

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

• For the image quality comparison, the "ground truth" for the phantom images is the inherent physical properties of the anthropomorphic phantoms themselves, as imaged by both the subject and predicate devices. The "qualified clinical experts" then assessed if the images produced by the subject device were "clinically comparable" to those from the predicate devices. There is no mention of pathology, outcomes data, or a formal expert consensus to establish a diagnostic ground truth in the traditional sense, as these were phantom images, not patient images.

8. The Sample Size for the Training Set

• Not applicable. This device is an X-ray imaging hardware system, not an AI/machine learning model that requires a training set.

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

• Not applicable, as there is no training set for an AI/machine learning model.

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The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider Spinal System.

The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image y systems.

The provided text describes a 510(k) premarket notification for the Remi Robotic Navigation System (K223350). The submission focuses on demonstrating substantial equivalence to its predicate devices, particularly an earlier version of the Remi Robotic Navigation System (K223070) and the EXCELSIUS GPS (K171651). The key change in the subject device is the addition of compatibility with 2D fluoroscopic imaging systems for pedicle screw placement in the posterior lumbar region (L1-S1).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the tested device. It broadly states that "The testing shows that the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems." and that the device "continues to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use."

However, the "POSITIONING ACCURACY (BENCH)" for the Primary Predicate Device is listed as: 0.74 ± 0.36 mm (worst case); 95% CI: 1.46mm (worst case). Since the subject device "Same as Primary Predicate" for this characteristic and the testing was done to demonstrate equivalence, it can be inferred that the acceptance criterion for accuracy for the new functionality is to maintain this level of accuracy or be equivalent to it.

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

The document mentions "Performance Testing - Bench" was conducted, including "Navigation Accuracy Verification," "System Accuracy Validation," "Software System Test," "ASTM F2554 Accuracy Test," and "Software Unit and Integration Tests." However, specific sample sizes for these tests (e.g., number of cases, images, or measurements) are not provided.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that it is bench testing, it is likely that the data was generated in a controlled laboratory or testing environment rather than being derived from patient cases.

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

This information is not provided. The document describes bench testing, which typically uses defined physical standards or simulated scenarios to establish ground truth rather than expert consensus on clinical images/data.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of clinical data and subsequent consensus determination. Since the testing described is bench testing, such an adjudication method is unlikely to apply.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through bench testing, verifying that the added 2D fluoroscopy functionality maintains the device's accuracy and safety profiles compared to its predicate with 3D imaging. There is no information regarding human readers improving with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance study was done. The performance testing described (Navigation Accuracy Verification, System Accuracy Validation, Software System Test, ASTM F2554 Accuracy Test, Software Unit and Integration Tests) are all characteristics of a standalone performance evaluation, focusing on the device's technical capabilities without human interaction determining performance outcomes within the tests themselves. The stated purpose was "to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained," specifically concerning "the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems."

7. Type of Ground Truth Used

The ground truth for the bench testing would likely involve engineered physical phantoms, precisely manufactured test fixtures, and controlled experimental setups with known geometric parameters and validated measurements. For example, for "Navigation Accuracy Verification" and "System Accuracy Validation," physical measurements against a known standard or calibrated instruments would establish the ground truth. For "Software System Test" and "Software Unit and Integration Tests," the ground truth would be defined by the software's specified functional requirements and expected outputs.

8. Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The submission is for a modification to an existing cleared device, specifically adding 2D fluoroscopic image compatibility. While the software was updated to support this, including an algorithm correcting distortion, the text implies that the evaluation focused on the performance of the system with the new capability rather than the development of a completely new AI algorithm requiring extensive training data. If machine learning was used for the distortion correction, details about its training would typically be in a separate section not provided here.

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

As no training set is explicitly mentioned, this information is not provided.

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The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

Here's a breakdown of the acceptance criteria and study information for the ControlRad™ Trace Model 9, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes various performance tests conducted by ControlRad to demonstrate the safety and effectiveness of the ControlRad™ Trace Model 9. However, it does not detail specific study methodologies with the level of granularity requested for some fields (e.g., exact sample sizes for test sets, data provenance, ground truth establishment for training data, MRMC studies). The tests described are primarily bench tests and clinical simulations rather than large-scale clinical trials with human readers.

Here's what can be extracted:

• Sample size used for the test set and the data provenance: Not explicitly stated for each test. The studies appear to be retrospective in the sense that they are engineering performance tests and simulations rather than prospective patient studies. The data provenance is implied to be from testing conducted by ControlRad, Inc.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For image quality evaluations, the text mentions "clinically simulated image" and "ability of the filtered image outside the ROI to provide image context to the ROI", implying expert review, but the number and qualifications are not specified.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
• 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 comparative effectiveness study involving human readers and AI assistance is described. The image quality tests are comparative to the OEC 9900 Elite alone, not comparing human performance with and without the device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The described tests are largely standalone performance evaluations of the device's capabilities (e.g., DAP reduction accuracy, attenuation, filter motion). The "Image Quality Clinical Simulations" also assessed algorithm performance in generating the filtered image and its ability to provide context.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • For DAP measurements: Measured DAP values (using a dosimeter or similar equipment)
  • For image quality: Likely expert visual assessment against the baseline OEC 9900 Elite images. The term "clinically simulated image" suggests a controlled environment for evaluation.
  • For touchscreen and filter motion: Functional verification against expected operational behavior.
• The sample size for the training set: Not applicable and not mentioned. This device is an X-ray system enhancement with a filter and image processing, not a machine learning model that requires a "training set" in the conventional sense for image interpretation. The device's software is based on algorithms that modify X-ray output and image display.
• How the ground truth for the training set was established: Not applicable, as there's no mention of a traditional machine learning training set.

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The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III Lithotripter is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk Image Processing.

The provided document is a 510(k) summary for the Dornier Delta III Lithotripter, detailing its substantial equivalence to predicate devices. It mentions a retrospective confirmatory clinical study, but it does not provide specific acceptance criteria or the study's detailed results in a format that allows for a table of acceptance criteria vs. device performance.

Here's an analysis of the information available and what is not present in the document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A retrospective confirmatory clinical study was performed using the Delta III Lithotripter. As compared to the currently cleared Dornier Lithotripters, the overall treatment results were comparable for the subject device. The complication rate was extremely low."

However, specific numerical acceptance criteria (e.g., stone-free rate, fragmentation rate, complication rate thresholds) and precise reported device performance metrics against those criteria are not provided in this 510(k) summary. The summary only gives a qualitative statement of comparability and low complication rates.

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

The document does not specify the sample size for the retrospective confirmatory clinical study. It is stated to be a "retrospective confirmatory clinical study." The country of origin of the data is not specified.

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

This information is not provided in the document. The type of ground truth used (e.g., imaging, clinical outcomes) is also not detailed for the clinical study.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The clinical study described is a "retrospective confirmatory clinical study" to compare overall treatment results and complication rates, not specifically to evaluate human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device is an extracorporeal shock wave lithotripter, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable and not mentioned. The performance data section refers to compliance with standards for acoustic output, electrical safety, and electromagnetic compatibility for the hardware device itself.

7. Type of Ground Truth Used

For the retrospective clinical study, the document broadly refers to "overall treatment results" and "complication rate." It does not explicitly state the method by which ground truth for treatment success or stone fragmentation was established (e.g., follow-up imaging, clinical assessment, pathology).

8. Sample Size for the Training Set

The Delta III Lithotripter is a hardware device for lithotripsy, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, this concept is not applicable and not provided. The device development involved design and verification testing, and compliance with standards.

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

As above, the concept of a "training set" for an AI algorithm is not applicable to this device.

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