Search Results

For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.

The AnyScan-S is a Single- or Dual-Detector Gamma Camera System that rne Anyolanar static, dynamic as well as SPECT and whole body imaging applications with high patient throughput requirements.

The provided text describes the 510(k) Premarket Notification for the AnyScan-S SPECT Imaging System. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "Clinical images were obtained using the AnyScan-S in human subjects." However, it does not specify the exact number of human subjects or the sample size of the clinical images used for the test set.
• Data Provenance: The document implies that the clinical images were obtained from human subjects directly during the testing of the AnyScan-S device, suggesting a prospective nature for this specific part of the evaluation. The country of origin of the data is not specified.

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

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

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

This document describes a SPECT Imaging System, which is a medical imaging device. It does not involve an AI component or human-in-the-loop performance evaluation, therefore, an MRMC comparative effectiveness study regarding AI assistance would not be applicable and was not performed.

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

The device itself is a standalone SPECT imaging system. The performance testing described (NEMA phantoms, clinical image quality) reflects the standalone performance of the device's imaging capabilities without human intervention in image acquisition or processing beyond standard operational procedures. There is no explicit "algorithm only" component mentioned as distinct from the device's overall function.

7. The Type of Ground Truth Used

• For the NEMA phantom testing, the "ground truth" is established by the physical properties and known measurements of the NEMA NU1 phantoms, according to NEMA Standard test protocols.
• For clinical images in human subjects, the document states "Tomographic image quality was at least equal to images produced by reference predicate devices." This implies a comparison to a clinical standard established by existing, legally marketed predicate devices, rather than a singular, independently established "ground truth" like pathology or outcomes data specifically for this study. The implication is that if the images are "at least equal," they meet the clinically acceptable standard.

8. The Sample Size for the Training Set

The document does not mention a training set for an algorithm, as the device is a hardware imaging system and not primarily an AI algorithm. Its performance is based on the physical characteristics and design of the SPECT system.

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

As no training set for an algorithm is mentioned or implied, this question is not applicable.

Ask a specific question about this device

The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesons, turnors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The innages produced by the system can also be used by the physician to aid in radiotherapy to atmont planning and interventional radiology procedures.

SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopns with energies up to 588keV

CT: The CT component 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.

SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT PERT CT and other imaging modalities.

The Siemens Symbia® system is combined X-Rav Computed Tomography (CT) and Emission Computed Tomography (SPECT) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces 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. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for SPECT studies and precise anatomical reference for the fused SPECT and CT images.

The system maintains independent functionality of the CT and SPECT devices, allowing for single modality CT and / or SPECT diagnostic imaging.

The Symbia E and Symbia S series are gamma cameras used to view and analyze images of the human body and the distribution of administered radionuclides.

The Symbia T series have an additional CT system designed to produce crosssectional 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. The Symbia T series allows healthcare facilities to carry out SPECT and CT studies using the same instrument.

The MI Workplace is a software workstation for use with nuclear medicine applications. The MI Applications software functions as the primary user interface for acquiring, viewing, manipulating, post-processing and archiving images from the Siemens family of dedicated SPECT, PET and SPECT/CT and PET/CT systems.

Enhancements in Symbia 4.0 include:

• 1. New optional acquisition method IQ•SPECT* for cardiac imaging
  • SMARTZOOM* collimator .
  • Cardio-centric acquisition .
  • IQ.SPECT reconstruction. .
• 2. New optional accessories; pediatric pallet, scintimamography pallet and radiation therapy pallet.
• 3. Single detector configuration of the commercially available Symbia E (K072567) gamma camera, Symbia E Single
• 4. Upgraded version of the MI Applications software (2009A)

The provided 510(k) summary for the Symbia 4.0 does not include a detailed study or acceptance criteria table typically found in performance testing sections. This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's indications for use and safety measures.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific study is not available within this document.

The document states:

• "Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product."
• "Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechnanical and radiation hazards."
• "Siemens considers that the proposed systems do not introduce new safety concerns, and is substantially the same in design, materials, energy sources and technology as the currently marketed systems. Siemens believes that the Symbia 4.0 systems are substantially equivalent to the predicate devices."

This indicates that Siemens is relying on its adherence to established standards and the substantial equivalence argument, rather than presenting a performance study with specific acceptance criteria in this summary.

In summary, the detailed study information requested is not present in the provided 510(k) summary.

Ask a specific question about this device