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The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages.

The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as:
• Fractures of bones in finger, metacarpus or wrist
• Fractures of foot, ankle or elbow joint
• Arthritis

The Ortho Device is a 3D tomographic X-ray device intended to be used to produce radiological images of a specific cross-sectional plane of the body. The device is comprised of a Flat Panel X-ray source combined with a digital detector within a mounting frame, a control unit and a workstation. It is intended to offer 3D imaging of orthopedic structures by using a panel of X-ray sources that construct a 3D tomosynthesis image with the associated reconstruction software from individual images; it is also possible to create synthetic 2D images of the desired anatomy.

The Ortho Device is a portable system that can be mounted on a stand for tabletop applications or on a trolley cart for added mobility with motorized vertical positioning. The C-Arm and Control Unit components are both designed to be carriable by a single person. To allow for the ideal positioning of the anatomy (hand and weight-bearing foot images) in the beam path and to achieve the desired plane of view, the Ortho Device C-Arm can be manually rotated by up to 90°. The central beam is aligned perpendicularly to the image receptor.

The "Ortho Device" was created to fill a diagnostic niche in orthopedic medicine for cost effective and portable imaging for patients and is used, amongst other applications, for 3D-radiographic diagnostic imaging of hand, elbow and foot in orthopedic and radiological practices as well as in emergency departments of hospitals. The Ortho Device results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decisionmaking on human anatomy.

The Ortho Device system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.31.

The provided text is a K221949 510(k) summary for the ADAPTIX 3D Orthopedic Imaging System ("Ortho Device"). It does not contain information about acceptance criteria, detailed study designs, or reader study results with explicit performance metrics. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone performance details.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• Sample size for the training set.
• How ground truth for the training set was established.

However, based on the section "9. Non-Clinical Performance Data," I can extract the following relevant information regarding performance evaluation, albeit without specific quantitative acceptance criteria or detailed study methodologies:

The study that "proves the device meets the acceptance criteria" in this context refers to a series of non-clinical tests summarized in Section 9. While "acceptance criteria" for specific performance metrics are not explicitly stated with quantitative thresholds, the document implies that these criteria were met by stating "Passed" for each test.

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

Since explicit quantitative acceptance criteria are not provided, the table below lists the performance aspects tested and the reported outcome.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "sample clinical images" being evaluated by radiologists but does not specify the sample size, data provenance, or whether the study was retrospective or prospective for these clinical image evaluations. For other non-clinical tests (e.g., toxicity, electrical safety), the "sample size" would refer to the number of device units or components tested, which is not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document states "Evaluation of sample clinical images by radiologists". It does not specify the number of radiologists, their qualifications, or their experience levels.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method used for the evaluation of clinical images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention an MRMC comparative effectiveness study or any evaluation of human reader performance with or without AI assistance. The device is an imaging system, not explicitly described as having AI for interpretation in this summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the device as an "imaging system" that "results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decision-making." This implies the device provides images for human interpretation, and there is no mention of an algorithm performing standalone diagnoses.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the evaluation of clinical images, "Evaluation of sample clinical images by radiologists to demonstrate that the device is able to image all intended body parts" and "to help clinician for the assessment of bone fracture and arthritis" implies that the ground truth for these evaluations was based on expert assessment/consensus (i.e., the radiologists' judgment). No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set:
Not applicable/not provided. This document describes a medical imaging device, not a machine learning algorithm that requires a separate training set. The "software verification and validation testing" mentioned refers to the device's operational software, not an AI training process.

9. How the ground truth for the training set was established:
Not applicable/not provided, as there is no mention of a training set for an AI algorithm.

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The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to:

• · Querying and retrieving patient information and /or images from other modalities.
• · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements.
• · Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum.
• · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).
• · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy).
• · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction. varicocele).
• · Application of fistula (kidney/bladder).
• · Simple procedures (e.g. urethra, testis, phimonis).
• · Introcorporeal shock wave lithotripsy.
• · Uroflow/urodynamics.
• · Pediatric radiological and therapeutic applications

The Uroview FD II is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient the Uroview FD Skeleton, which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD II X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid.

The Uroview FD II X-ray system includes the following major components:

• . Uroview FD Skeleton (urological table incl. tilting table)
• High Frequency RF X-ray generator
• X-ray tube incl. housing
• Collimator
• . Measuring chamber
• . Grid
• Dynamic flat panel detector
• Digital imaging workstation
• . Video monitors
• Accessories

The Uroview FD II is considered as an update to the model Uroview FD with some new components as part of the continuous X-ray system evolution. Major X-ray components are identical to the Uroview FD and new components use FDA-cleared or FDA-registered X-ray components. Therefore the Uroview FD II is considered similar by properties and technological characteristics.

The Uroview FD II system is designed to meet the requirements in accordance with relevant sections of 21 CFR 1020.30-1020.33.

The provided text is a 510(k) premarket notification for a medical device called Uroview FD II. It extensively details the device's characteristics and compares it to a predicate device, Uroview FD. However, it explicitly states:

"There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop performance with AI assistance. The focus is solely on non-clinical performance and demonstrating substantial equivalence to a predicate device through technical specifications and compliance with standards.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

Since no clinical study based on explicit acceptance criteria for diagnostic performance is described, a table like this cannot be created from the provided text. The performance reported relates to compliance with engineering and safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable as no clinical test set was used for a clinical performance study. The "test set" here refers to the physical device and its components undergoing non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as no human interpretation or "ground truth" establishment by experts was part of the non-clinical testing for performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no human-based assessment requiring adjudication was conducted.

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. The document explicitly states "There was no human clinical testing required." This device is an X-ray system, and the submission focuses on its hardware and software compliance, not on AI assistance to human readers.

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

Not applicable, as the device is a fluoroscopic X-ray system, not an AI algorithm. Its performance is inherent to its physical operation and image quality, not an independent algorithmic output.

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

Not applicable. For the non-clinical tests conducted, the "ground truth" was established by engineering specifications, validated test methods, and industry standards (e.g., whether the device passed a given electrical safety test).

8. The sample size for the training set:

Not applicable. The device is hardware and software for image acquisition and processing, not a machine learning model that requires a training set in the typical sense.

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

Not applicable as per point 8.

Summary of available information regarding compliance and "acceptance criteria" from the document:

The primary "acceptance criteria" for the Uroview FD II, as demonstrated in this 510(k) submission, revolve around its non-clinical performance and compliance with relevant national and international standards, and substantial equivalence to a legally marketed predicate device (Uroview FD).

Here's a table summarizing the reported device performance against these non-clinical acceptance criteria (which are essentially compliance with standards):

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets these non-clinical acceptance criteria is the comprehensive non-clinical performance testing program conducted by Pausch Medical GmbH. This is detailed in Section 9 of the 510(k) submission, "Non-Clinical Performance Data."

• Sample size: Not applicable in the traditional sense for these engineering and safety tests. The "sample" is the manufactured device (Uroview FD II) and its components.
• Data provenance: Not specified in terms of country of origin for the test results, but the submission is from Pausch Medical GmbH in Germany. The tests are "non-clinical," meaning they were conducted in a lab environment or on the device itself, not on human subjects.
• Experts/Ground Truth/Adjudication: For these non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the standards (e.g., maximum radiation leakage, acceptable temperature range, etc.). Expertise lies in the engineers performing the tests and interpreting the results against these established quantitative and qualitative criteria. There's no "adjudication" in the sense of reconciling human interpretations.

In essence, the device's acceptance is based on demonstrating that its technical specifications and physical performance meet established safety and performance standards for X-ray systems, and that any differences from its predicate device do not raise new safety or effectiveness concerns. No new clinical performance claims, particularly those involving AI or human reader improvement, are made or substantiated.

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The Uroview FD is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/ urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to: · Querying and retrieving patient information and /or images from other modalities. · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements. · Ultrasound examinations(in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum. · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement , penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction, varicocele). - · Application of fistula (kidney/bladder). - · Simple procedures (e.g. urethra, testis, phimonis). - · Introcorporeal shock wave lithotripsy. - Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications.

The "Uroview FD" is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient table called the "Uroview FD Skeleton", which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid. The Uroview FD X-ray system includes the following major components: - . Uroview FD skeleton (urological table incl. tilting table) - . High Frequency RF X-ray generator - X-ray tube incl. housing - . Collimator - . Measuring chamber - . Grid - . Dynamic flat panel detector (Pixium RF4343 FL, originally cleared under K080859) - . Digital imaging workstation - Video monitors - . Accessories The Uroview FD X-ray System includes the following two software programs: HIRIS RF43 and Uroview FD software; these are explained briefly. The Hiris RF43 software controls the digital imaging system in fluoroscopy and radiography modes using the flat panel detector. The software is specifically designed for remote controlled fluoroscopy and radiography and emergency equipment and performs real-time X-ray diagnostics of the gastro-intestinal tract and the urogenital system. The Uroview FD software controls the patient table Uroview FD (Skeleton) and does not interact with the HIRIS RF43 software. It allows the user comprehensive control of the patient table via hand control and foot switch allowing operator to activate movement of the Uroview FD. The Uroview FD system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.33.

It appears there's a misunderstanding in the prompt's request for acceptance criteria and study details for an AI/Software as a Medical Device (SaMD). The provided text is a 510(k) summary for a physical medical device, the Uroview FD, which is an X-ray fluoroscopic system.

This document does not describe an AI/SaMD product or a clinical study evaluating its performance with respect to specific acceptance criteria in the way typically required for AI/SaMD. Instead, it focuses on demonstrating substantial equivalence of the Uroview FD X-ray system to a predicate physical device (UROSKOP Omnia) based on technological characteristics and non-clinical performance data.

Therefore, most of the requested information regarding AI/SaMD acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI model cannot be extracted from this document, as it pertains to a different type of device and different regulatory pathway.

The document explicitly states:

• "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
• The software mentioned (HIRIS RF43 and Uroview FD software) controls the digital imaging system and patient table, respectively, and is verified at a "Moderate Level of Concern" for functionality, compatibility, risk analysis, and user interface. This is standard software validation for a hardware device, not an AI algorithm performing diagnosis or detection.

Given this, I cannot provide the requested table and study details as they are framed for an AI/SaMD. I can, however, summarize the non-clinical performance acceptance criteria and proof of adherence as outlined in the document for the physical Uroview FD X-ray system:

Summary of Acceptance Criteria and Performance for the Uroview FD X-ray System (Non-AI/SaMD)

The Uroview FD is a physical X-ray fluoroscopic system, not an AI/SaMD. Its acceptance criteria and performance demonstration are based on non-clinical testing to prove substantial equivalence to a legally marketed predicate device (UROSKOP Omnia).

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of AI/SaMD performance evaluation. The data for these tests are derived from laboratory and engineering tests of the physical device and its components, not from patient data or clinical imaging test sets.

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

Not applicable. Ground truth as typically understood for AI models (e.g., diagnostic labels on medical images) is not relevant here. The "ground truth" for these tests refers to the engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication process involving multiple human reviewers for these non-clinical engineering and electrical tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This study type is for evaluating the impact of AI on human reader performance, which isn't relevant for this physical X-ray system.

6. If a Standalone (Algorithm Only) Performance was done

No, a standalone algorithm performance study was not done. The software components are for controlling the hardware and imaging process, not for performing diagnostic tasks independently.

7. The Type of Ground Truth Used

The ground truth for this device's performance demonstration is based on engineering specifications, recognized national and international standards (e.g., IEC, ISO), and validated internal test procedures. This is typical for a hardware medical device seeking substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" for an algorithm.

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

Not applicable, as there is no training set for an AI algorithm.

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