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The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.

The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.

The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.

There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.

The B5 S is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components.

Control Unit Major Component: Viewing monitor (2), Exposure lamp (2), Control monitor (1), Keyboard (1), Footswitch subassembly (1), Printer(optional) (1).

G-Arm Major Component: Image intensifier assembly (2), X-Ray tube assembly (2), Laser light indicator(optional) (2), Steering unit (optional) (1).

The provided document is a 510(k) premarket notification for the MultiScan G-Arm System, which is an Image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device and provides information on non-clinical testing for safety and performance standards. It does not contain information about acceptance criteria for a device's diagnostic performance, a study to prove it meets those criteria, or details regarding ground truth establishment, expert-based evaluation, or AI integration.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be extracted. This document reports on compliance with safety and performance standards relevant to an x-ray system (e.g., electrical safety, EMC, radiation safety), not on diagnostic performance metrics like sensitivity, specificity, or AUC which would typically be associated with acceptance criteria for a device that provides diagnostic interpretations.

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

• Cannot be extracted. This document describes non-clinical testing against standards. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are on the device itself (e.g., electrical measurements, radiation output).

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)

• Cannot be extracted. There is no "ground truth" establishment in the context of diagnostic imaging outcomes mentioned in this document, as it focuses on the engineering and safety performance of the X-ray system.

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

• Cannot be extracted. Not applicable as there is no diagnostic test set or expert evaluation described.

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

• Cannot be extracted. This document describes an X-ray fluoroscopic imaging system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI performance metrics are included.

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

• Cannot be extracted. Not applicable as this is not an AI algorithm.

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

• Cannot be extracted. Not applicable as this document pertains to the physical and electrical performance of an X-ray system, not diagnostic accuracy.

8. The sample size for the training set

• Cannot be extracted. Not applicable as this is not an AI algorithm that requires a training set.

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

• Cannot be extracted. Not applicable as this is not an AI algorithm.

Summary of available information from the document:

The provided document details the non-clinical testing performed on the MultiScan G-Arm System (B5 S) to demonstrate its safety and effectiveness for substantial equivalence to a predicate device (K151280).

Acceptance Criteria and Reported Device Performance (Non-clinical Standards Compliance):

The device was tested for compliance with several accepted safety and performance standards. The "acceptance criteria" in this context are the requirements of these standards, and the "reported device performance" is that the device "Pass"ed all these tests.

Study Description (Non-clinical Testing for Substantial Equivalence):

The study was a non-clinical testing process designed to show conformance to recognized safety and performance standards. This is not a clinical study involving patient data for diagnostic accuracy.

• Sample Size for Test Set / Data Provenance: Not applicable. The "tests" were conducted on the device hardware itself against predefined engineering and safety specifications, not on a set of patient cases.
• Number of Experts / Qualifications / Adjudication: Not applicable. Evaluation was against technical standards, not diagnostic interpretation by human experts.
• MRMC / Standalone / AI: Not applicable. The device is a traditional X-ray fluoroscopic system, not an AI-driven diagnostic tool.
• Ground Truth Type: Not applicable in the diagnostic sense. The "ground truth" for the tests performed is the adherence to the specified technical parameters and safety limits defined by the IEC/AAMI standards.
• Training Set Size / Ground Truth for Training Set: Not applicable. The device is a hardware system, not a machine learning model.

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The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.

The Portable Ultrasound Diagnostic Scanner comprises of a console, a cart, an AC adaptor, and several transducers and printers. The console is a portable ultrasound diagnostic device with an integrated keyboard and LCD display. It is capable of digital acquisition, processing and display. The mobile cart with multiple socket-outlet and extension transducer connector improves the mobility by having all accessories on it.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state quantitative "acceptance criteria" for the device's imaging performance (e.g., specific resolution, penetration depth, or diagnostic accuracy metrics). Instead, it primarily establishes substantial equivalence to a predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System) by demonstrating similar technological characteristics and compliance with relevant safety and performance standards.

The "reported device performance" is implicitly that the device performs equivalently to the predicate device and meets the general safety and performance standards for diagnostic ultrasound systems.

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

The document explicitly states: "Non-clinical testing," and references "results of performance and compliance testing conducted on Portable Ultrasound Diagnostic Scanner." The testing focuses on compliance with international and national safety and performance standards (e.g., IEC 60601, NEMA UD 2, ISO 10993).

• Sample Size: Not specified in terms of patient or imaging data. The testing appears to be primarily device-centric (e.g., electrical safety, acoustic output, biocompatibility) rather than a clinical performance study using patient data.
• Data Provenance: The nature of the "non-clinical test results" suggests they are derived from laboratory and engineering tests of the device itself. There is no indication of patient data being used for the "test set" in the context of clinical performance. The manufacturer is "Beijing East Whale Imaging Technology Co., Ltd." in CHINA.

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

This information is not provided because the testing described is non-clinical and related to device compliance with engineering and safety standards, not a clinical performance study requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as the document describes non-clinical engineering and safety compliance testing, not a clinical study involving human readers and adjudicated ground truth.

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

Not applicable. The device described is an ultrasound diagnostic scanner, and the submission is for its substantial equivalence to a predicate ultrasound system based on technological similarities and compliance with standards. It is not an AI-powered diagnostic device, nor does the document mention any MRMC studies or AI assistance for human readers.

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

Not applicable. This is not an algorithm-only device. It's a complete ultrasound diagnostic scanner intended for use by a physician.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced standards (e.g., maximum acoustic output levels, electrical impedance, biocompatibility test results). There is no clinical "ground truth" (like pathology or expert consensus on diagnoses) discussed in this document.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound scanner, not an AI/machine learning model that requires a training set of data.

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 discussed in this document.

Summary of the Study (as described in the 510(k) Summary):

The study described is a non-clinical performance and compliance testing program. It aims to demonstrate that the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner (and its various probe configurations) is substantially equivalent to a legally marketed predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System).

The primary evidence presented for this substantial equivalence is:

• Compliance with recognized safety and performance standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, ISO 10993-5, and ISO 10993-10.
• Similar intended use: The indications for use broadly overlap with the predicate device across various anatomical regions and clinical applications.
• Similar technological characteristics: The document details a side-by-side comparison (table on pages 11-12) showing that the proposed device shares the same classification, product codes, regulation numbers, panel, class, probe types (though specific model names differ, the general categories are similar), acoustic track, imaging modes, power supply, acoustic output limits, electrical safety, EMC, performance standards, biocompatibility standards, software level of concern, and design with the predicate.

The conclusion is that "the differences between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the proposed device. And no new risk is raised regarding to effectiveness and safety. The proposed device is substantial with the predicated device." This means the "study" effectively demonstrates that the device functions within established safety parameters and has similar capabilities to an already-approved device, thus meeting the requirements for 510(k) clearance by proving substantial equivalence.

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The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures.
There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.

The provided document, a 510(k) Summary of Safety and Effectiveness for the DigiArc 100AU G-Arm MultiScan System, offers limited information regarding specific acceptance criteria and detailed study results for device performance. It primarily focuses on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and general clinical imaging evaluation.

Here's an attempt to extract and infer the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. It states that the device "meets the requirement of intended use and clinical use" and "is as safe and effective as the predicate devices." The primary method of demonstrating compliance is through adherence to relevant IEC standards for X-ray medical electrical equipment and a general assessment of clinical images.

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

The document mentions "Clinical images evaluation was performed," but it does not specify the sample size for this clinical image evaluation (test set). It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the manufacturer's location in Beijing, China, it is plausible the data originated from China, but this is not explicitly 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 "images assessment for simultaneous imaging have been done by the manufacturer" and "Clinical images evaluation was performed." However, it does not specify the number of experts involved in establishing ground truth, nor does it provide any details about their qualifications (e.g., radiologists, years of experience).

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 test set. It simply mentions "images assessment" and "Clinical images evaluation," implying an assessment was made but without detailing the process for resolving discrepancies or establishing a definitive ground truth from multiple readers.

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 describe an MRMC comparative effectiveness study. The device is an imaging system (fluoroscope), not an AI-assisted diagnostic tool. Therefore, the question of human readers improving with AI assistance is not applicable in this context. The study described focuses on the device's technical performance and image quality compared to predicate devices and standards.

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

This refers to a standalone algorithm performance. Since the device is a medical imaging system (fluoroscope) and not an AI algorithm, a standalone algorithm performance study is not applicable here. The performance evaluated is that of the hardware and integrated software in generating diagnostic images.

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

The document does not explicitly state the type of ground truth used. Given that it involves "Clinical images evaluation," it is most likely that the "ground truth" was established by expert assessment or clinical diagnosis based on a variety of available clinical information, but this is not detailed. There is no mention of pathology or outcomes data being used as ground truth for the imaging system's performance.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is expected as the DigiArc 100AU is a conventional X-ray fluoroscopy system, not a machine learning or AI-driven device that typically requires a training set.

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

As there is no mention of a training set, there is no information on how its ground truth was established.

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