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The NeuViz 64 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

The NeuViz 64 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

Here's a breakdown of the acceptance criteria and study information for the Neusoft NeuViz 64 Multi-Slice CT Scanner System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria for image quality or clinical performance. Instead, it relies on a qualitative assessment and substantial equivalence to a predicate device.

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

• Sample Size: 260 subjects
• Data Provenance: Obtained from 2 sites. The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

• Number of Experts: Radiologist (singular, implying at least one, but the exact number is not specified).
• Qualifications: "Radiologist" - no further specific qualifications (e.g., years of experience, subspecialty) are mentioned.

4. Adjudication Method for the Test Set:

• The document states that a "Radiologist assessed the diagnostic quality of the images." It does not provide details on an adjudication method (e.g., 2+1, 3+1, none) if multiple radiologists were involved. Given the singular "Radiologist," it's possible a single reader assessed the images.

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

• No, an MRMC comparative effectiveness study is not mentioned. The study described is a clinical image assessment, not a comparative study with and without AI assistance or a comparison among multiple readers using the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• This device is a CT scanner, a hardware device that acquires and reconstructs images. It is not an AI algorithm intended for standalone diagnostic interpretation. Therefore, a "standalone algorithm only" study, as typically understood for AI, is not applicable or described. The study focuses on the diagnostic quality of the images produced by the scanner, which are then interpreted by a human radiologist.

7. Type of Ground Truth Used:

• Expert Consensus: The diagnostic quality of the images was assessed by a "Radiologist," which represents expert opinion. There is no mention of pathology, outcomes data, or other objective ground truth measures being used to validate the radiologist's assessment in this context.

8. Sample Size for the Training Set:

• The document describes a clinical evaluation of the scanner's output and its substantial equivalence to a predicate device. There is no mention of an "AI" or machine learning component that would require a separate training set. Therefore, this question is not applicable to the information provided.

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

• As there is no mention of a training set for an AI algorithm, this question is not applicable.

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The SOMATOM Definition AS/ ASt is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Definition AS/ AST is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM Definition AS/AS+ system produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run such post processing applications optionally.

This 510(k) summary for the SIEMENS SOMATOM Definition AS/AS+ Computed Tomography X-ray System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices already on the market. It covers:

• Contact Information: Details of the submitting company and regulatory contact.
• Device Name and Classification: Product name, proprietary trade name, classification name, panel, CFR section, device class, and product code.
• Substantial Equivalence: Identification of predicate devices (Siemens SOMATOM Sensation 64 and Toshiba Aquilion 64) with their FDA clearance numbers and dates.
• Device Description: A general description of the SOMATOM Definition AS/AS+ as a CT X-ray system, its function, software, and output format (DICOM).
• Indications for Use: The intended purpose of the device to produce cross-sectional images of the body.
• General Safety and Effectiveness Concerns: A statement that labeling provides instructions, cautions, and warnings, and that risk management (hazard analysis) is performed to minimize hazards.
• FDA Clearance Letter: Official correspondence from the FDA confirming the substantial equivalence determination.

Therefore, I cannot provide the requested information regarding acceptance criteria or the study that proves the device meets those criteria, as it is not present in the provided text.

If this information were available, it would typically be found in a separate section detailing performance testing, clinical validation, or engineering specifications. For a device like a CT scanner, acceptance criteria would likely relate to image quality parameters (e.g., spatial resolution, contrast resolution, noise, dose efficiency), dose limits, system reliability, and electrical/mechanical safety standards. The study proving these criteria would involve specific tests and measurements.

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The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 64 and 40 are intended to be utilized by appropriately trained health care professionals to:

• Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
• Produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
  The Biograph 64 and 40 PET/CTs provide registration and fusion of highresolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

The Biograph 64 and Biograph 40 are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology examinations. The Biograph systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO HiRez PET scanner and the Siemens Somatom Sensation 64 or 40 CT.
The combined PET/CT scanner is intended for use as a clinical, whole-body machine with high-end spiral CT and PET performance. The CT component provides attenuation correction for PET studies as well as precise anatomical reference through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

The provided text is a 510(k) summary for the Biograph 64 and Biograph 40 PET/CT systems. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared devices.

Based on the content, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert involvement, adjudication methods, or ground truth establishment. The document is primarily a regulatory submission for premarket notification, focusing on equivalence to existing devices rather than a detailed performance study against defined acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions about standalone performance, MRMC studies, sample sizes, or ground truth establishment for a performance study. This type of information is typically found in detailed validation reports, not in a 510(k) summary.

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