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The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital.

The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.

The equipment is used for total patient population.

The equipment is NOT intended to be used for Mammography screening.

The equipment is NOT intended to be used for interventional procedure.

The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations.

Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

The Tomosynthesis option for the SONIAL VISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications.

The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube.

The acceptance criteria and study proving device performance are described below for the Shimadzu X-ray TV System SonialVision G4 with the Tomosynthesis option (K142341). This device is intended to add the "Tomosynthesis technique" to its indications for use.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Discovery XR656 with VolumeRad) for the tomosynthesis capability. The reported performance is summarized as follows:

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

• Non-clinical Performance Testing (Tomosynthesis): The document mentions "phantom images" and "accuracy of tomographic acquisition of two devices was measured." It does not specify the exact number of phantom images or measurements, but it refers to a comparative evaluation.
• Clinical Performance Testing (Tomosynthesis): "Multiple clinical images taken by tomosynthesis technique were compared on several different anatomies." The exact number of clinical cases or images is not specified.
  • Data Provenance: The document does not explicitly state the country of origin but mentions a "U.S. certified Radiologist" for the clinical study, implying the clinical data was likely collected or reviewed in the U.S.
  • Retrospective or Prospective: Not specified, but the nature of a clinical comparison study often leans towards retrospective analysis of collected images for initial clearance.

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

• Clinical Performance Testing: "concurrence clinical study was executed by an U.S. certified Radiologist."
  • Number of Experts: One (1) U.S. certified Radiologist.
  • Qualifications: "U.S. certified Radiologist." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

• The document states that a "concurrence clinical study was executed by an U.S. certified Radiologist" and involved an "overall clinical review." This suggests a single reader's judgment was used for comparison, rather than a multi-reader adjudication process (e.g., 2+1, 3+1). No explicit adjudication method is described beyond the single expert's review.

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

• No, an MRMC comparative effectiveness study is not explicitly mentioned for this submission. The clinical review was conducted by a single U.S. certified Radiologist comparing images from the new device and the predicate. Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance, as the primary goal was to show equivalence of the tomosynthesis capability itself, not human performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

• While the tomosynthesis technique is "enabled by additional software option," the evaluation focuses on the performance of the overall device implementing the technique (i.e., the integrated system), rather than just the isolated algorithm performance. The non-clinical and clinical tests compare the complete device's tomosynthesis output and diagnostic capability against a predicate device. So, not a standalone algorithm-only study in the typical sense of evaluating AI performance in isolation.

7. Type of Ground Truth Used

• Non-clinical Performance: Phantom images with known characteristics were used to assess the "accuracy of tomographic acquisition."
• Clinical Performance: The "diagnostic capability" was assessed through comparison of "multiple clinical images" by a "U.S. certified Radiologist" against images from the predicate device. This implies the ground truth for diagnostic capability was established by expert consensus/opinion (from the single radiologist) in comparison to a known clinically accepted device. No mention of pathology or outcomes data is made for the purpose of establishing ground truth for the device's performance.

8. Sample Size for the Training Set

• The document does not specify a sample size for any training set. The submission focuses on verification and validation of the tomosynthesis feature, primarily through comparison with a predicate device, rather than the development and training of a new AI/machine learning model whose training data would need to be described.

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

• As no training set is discussed or implied for a new AI/machine learning model, the method for establishing its ground truth is not applicable and not provided in the document. The tomosynthesis option is described as an "additional software option" that enables the technique rather than a newly trained AI system.

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• -The SONIALVISION G4 is intended to be used for the fluoroscopy/radiography diagnosis in hospital.
• The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.
• The system is used for total patient population.
• This system is NOT intended to be used for Mammography screening.
• This system is NOT intended to be used for interventional procedure.
• This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
• Stored images in this system can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic and angiographic techniques. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube.

The provided text describes a 510(k) submission for the SHIMADZU SONIALVISION G4, an X-ray TV system. The submission focuses on demonstrating substantial equivalence to a predicate device (DAR-8000F, K052500) rather than establishing novel acceptance criteria for a new device's performance against specific metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define distinct "acceptance criteria" in the format of specific numerical thresholds for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

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

• Sample size for test set: The text mentions a "concurrence study of clinical images" but does not specify the number of clinical images or patients included in this study.
• Data provenance: Not explicitly stated, however, the study was reviewed by a "U.S. radiologist," suggesting the clinical images might have been relevant to a U.S. clinical context, though their origin (country, etc.) is not specified. The study was conducted for the purpose of a 510(k) submission to the FDA.
• Retrospective or prospective: Not explicitly stated. The description "concurrence study of clinical images" could imply either.

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

• Number of experts: The text states the concurrence study "was reviewed by an U.S. radiologist." This implies one expert was primarily responsible for the review reported in the submission.
• Qualifications of experts: "an U.S. radiologist." No further details on years of experience, subspecialty, Board Certification, etc., are provided.

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

• Adjudication method: Not specified. Since only one radiologist is mentioned as reviewing the study, it suggests an adjudication method for multiple readers was likely none or not applicable in the way implied by "2+1" or "3+1". The review seemed to be a direct comparison by a single radiologist.

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, especially one involving AI assistance, was not performed. The study was a "concurrence study of clinical images between subject device and its predicate device" reviewed by a single radiologist to confirm substantial equivalence in diagnostic capability, not to assess reader improvement with AI. This product is an X-ray system, not an AI-powered diagnostic tool.

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

• Standalone algorithm performance: Not applicable. The SONIALVISION G4 is an X-ray imaging system, not an AI algorithm. Its performance is evaluated as an imaging device.

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

• Type of ground truth: Not explicitly defined as a formal "ground truth" establishment process. The "concurrence study of clinical images" involved a U.S. radiologist reviewing the images from both the subject and predicate devices to determine diagnostic capability. This implies that the accepted clinical interpretation by that radiologist served as the basis for comparison, which could be considered a form of expert interpretation/clinical judgment in the context of demonstrating equivalence. It is not explicitly stated if this was compared against a separate, independent "ground truth" such as pathology or long-term outcomes.

8. The sample size for the training set

• Sample size for training set: Not applicable/Not mentioned. This submission describes an X-ray imaging system, not an AI algorithm that undergoes a "training set" phase. Device development involved "verification and validation testing as well as phantom testing," but not a "training set" in the context of machine learning.

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

• Ground truth for training set: Not applicable/Not mentioned. As this is not an AI device, there is no "training set" or corresponding "ground truth" to establish in that context.

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This device is intended to be used in radiology. This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area. This device is for diagnostic use.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.

The provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Corporation regarding their R-300 device, a diagnostic x-ray beam-limiting device (collimator).

This document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, it's a letter stating that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market without requiring new clinical trials or extensive performance studies.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this document does not contain that level of detail. The information presented is focused on regulatory approval based on substantial equivalence to existing devices, not on de novo performance testing against specific acceptance criteria.

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This device is intended to be used in radiology.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.

This device is for diagnostic use.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.

The provided document is an FDA 510(k) clearance letter for the R-201 device, which is a diagnostic x-ray beam-limiting device (collimator).

Unfortunately, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.

The letter primarily provides:

• Confirmation of substantial equivalence to predicate devices.
• The device's regulation number, name, and product code.
• Indications for use.
• General regulatory information and requirements for marketing the device.

It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or ground truth establishment for any studies.
3. Information on expert qualifications, adjudication methods, or MRMC studies.
4. Data on standalone algorithm performance.
5. Training set details.

To answer these questions, one would need to review the original 510(k) submission (K101036) document, which would contain the performance data and testing methodology used to demonstrate substantial equivalence. The provided FDA letter is merely the agency's response to that submission.

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The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the R-30H. The document is an FDA 510(k) clearance letter for the R-30H, an angiographic x-ray system. It states that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail any performance studies, acceptance criteria, or specific metrics.

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This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)

Mobile x-ray system

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Medical Systems regarding their MobileDaRt Evolution device. This document confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, or ground truth establishment. The letter is purely an administrative communication confirming market clearance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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/ This device is intended to be used in the diagnosis of circulatory vascular system.

/ This device is operated and used by the physicians and X-ray technologist.

As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-9400f is the same as that of predicate device of BRANSIST safire (K062360) and DAR-8000f (K052500).

Consequently, the indications for use of DAR-9400f are also the same as that of BRANSIST safire (K062360) and DAR-8000f (K052500) and there are no additional indications.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device named DAR-9400f, an angiographic x-ray system. The letter states that the device is "substantially equivalent" to legally marketed predicate devices.

However, this letter does not contain any information about the acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications that would allow me to answer your specific questions. The letter is an administrative document confirming regulatory clearance based on substantial equivalence, rather than a summary of performance studies.

Therefore, I cannot provide the requested table or answer most of the questions based on the information given. The document does not describe a study that "proves the device meets the acceptance criteria" in the way you're asking, as 510(k) clearance for this type of device often relies on demonstrating equivalence to a predicate device rather than extensive new clinical trials with specific performance metrics and acceptance criteria.

To elaborate on why most of your questions cannot be answered from this document:

1. Acceptance criteria and reported device performance: Not present. The letter only states the device is substantially equivalent to predicates.
2. Sample size and data provenance: No study details are provided.
3. Number of experts and qualifications: No study details are provided.
4. Adjudication method: No study details are provided.
5. MRMC comparative effectiveness study: No information about such a study is present. This is an X-ray system, not typically an AI-driven interpretive device, so "human readers improve with AI vs without AI assistance" is likely not applicable in the context of this device's 2007 clearance.
6. Standalone performance study (algorithm only): Not applicable for an angiographic x-ray system in this context.
7. Type of ground truth used: Not applicable, as no performance study details are given.
8. Sample size for training set: Not applicable, as this is a hardware system, not an algorithm being trained.
9. How ground truth for training set was established: Not applicable.

The "Indications for Use" section (page 21 of the original submission, page 2 of the provided text snippet) briefly mentions:

• "This device is intended to be used in the diagnosis of circulatory vascular system."
• "This device is operated and used by the physicians and X-ray technologist."

It then states that the intended use and indications for use are the same as two predicate devices (BRANSIST safire K062360 and DAR-8000f K052500). This reinforces that the clearance is based on equivalence, not new performance data against specific acceptance criteria.

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This device is intended to be used for generating fluoroscopic images of human anatomy for the diagnostic, surgical and interventional angiography and cardiology procedures of circulatory vascular system.

Not Found

The provided documents are a 510(k) submission and the FDA's acknowledgement letter for the Shimadzu GE OEC Altitude Angiographic X-ray System. These documents confirm the device's classification, intended use, and substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML-based device.

The GE OEC Altitude is an Angiographic X-ray System, a hardware medical device used for generating fluoroscopic images. The 510(k) refers to its physical components (MH-100 and DAR-2400-15B/30B from the predicate device Shimadzu Angiosigma NEO) and its functionality as an imaging system, not an AI/ML diagnostic or assistive tool.

Therefore, I cannot provide the requested information because the provided input does not describe an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML. The 510(k) process for this type of device typically focuses on technical specifications, safety, and performance characteristics like radiation dose, image quality (spatial resolution, contrast), and mechanical integrity, rather than diagnostic accuracy metrics produced by an AI.

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This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices.

This device is an angiographic X-ray system, as described in 21 CFR 892.1600.

This document is a 510(k) clearance letter from the FDA for the BRANSIST Safire angiographic X-ray system. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter primarily addresses the device's substantial equivalence to predicate devices, its regulatory classification, and general marketing requirements. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth information.

Therefore, I cannot provide the requested information from the provided text.

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