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The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM™ Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.

The LumaGEM™ Molecular Breast Imaging System is a scintillation camera system, which uses Cadmium Zinc Telluride (CZT) detectors to create an image of radionuclide distribution. The LumaGEM™ Molecular Breast Imaging System is available in a dualhead or single-head configuration and can be used to help identify suspected lesions in breast tissue as an adjunct to standard mammography. The LumaGEM™ Molecular Breast Imaging System is provided with a customized gantry, which allows flexible positioning to facilitate accurate breast imaging, and a workstation to enable image acquisition and analysis functions.

The provided text describes the LumaGEM™ Molecular Breast Imaging System, its indications for use, and a summary of testing conducted to support substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study proving the device meets these criteria, or most of the requested information regarding study design elements such as sample sizes, expert qualifications, or ground truth establishment for either training or test sets.

The document primarily focuses on:

• Administrative details: Applicant, contact person, dates, classification, product codes.
• Device description: How it works (CZT detectors, dual/single head, gantry, workstation).
• Indications for Use: What the device is intended for (aid in evaluation of breast lesions, adjunct to mammography, planar scintigraphy).
• Predicate devices: List of substantially equivalent devices.
• Testing for substantial equivalence: A general list of tests performed (Gamma camera verification, System verification, Electrical and mechanical safety, Electromagnetic compatibility) without details of methodologies, results, or acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the text:

1. Table of acceptance criteria and the reported device performance:

• Not available in the provided text. The document only lists general categories of testing performed (e.g., "Gamma camera verification testing") but does not provide specific acceptance criteria (e.g., minimum spatial resolution, sensitivity) or the corresponding performance results.

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

• Not available in the provided text. The document does not describe any clinical test sets, patient data, or their origin. The testing mentioned is bench testing.

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

• Not available in the provided text. Since no clinical test set is described, there's no mention of experts or ground truth establishment for such a set.

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

• Not available in the provided text. No clinical test set details are provided.

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 available in the provided text. The device is a "Scintillation (gamma) camera" (imaging device), not an AI-assisted diagnostic tool described with human-in-the-loop performance. The document only mentions that "resultant images are intended to be viewed by qualified medical professionals."

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

• Not applicable/Not available. This is a medical imaging device, not an algorithm. The performance of the imaging system itself is implied to be evaluated by the "Gamma camera verification testing" and "System verification testing," but no specific performance metrics or "standalone" study details are provided.

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

• Not available. The document does not describe any ground truth for clinical performance, as only bench testing is explicitly mentioned. For bench testing, the "ground truth" would be the known properties of the phantoms or test objects used, but these details are not provided.

8. The sample size for the training set:

• Not applicable/Not available. This is an imaging device, not a machine learning algorithm that requires a training set in the typical sense.

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

• Not applicable/Not available. As above, no training set for an algorithm is mentioned or implied.

In conclusion, the provided text describes the regulatory submission for an imaging device but lacks the detailed performance study information typically associated with establishing acceptance criteria against a defined clinical or algorithm performance benchmark. The "TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION" section only lists categories of bench testing rather than clinical efficacy studies.

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The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.

The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily describes a 510(k) premarket notification for the Molecular Breast Imaging Software, focusing on its intended use, product description, and substantial equivalence to predicate devices. The "Testing in Support of Substantial Equivalence Determination" section only broadly mentions "Software verification and validation" and "Direct comparison testing between the subject device and the original application" without providing any specific criteria, methods, or results of these tests.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Key takeaway from the provided text: The submission relies on demonstrating substantial equivalence to predicate devices, and the "testing" mentioned is not detailed enough to provide the requested information.

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The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.

The principles of operation and technology incorporated in the LumaGEM™ are equivalent to scintillation gamma cameras which use a combination of a scintillator with photomultiplier tubes as a photon radiation detector. The LumaGEM™ gamma camera includes signal analysis and display equipment, equipment supports and accessories.

The provided text describes a 510(k) summary for the "LumaGEM™ Scintillation Camera" but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

• Identifying the device and its manufacturer.
• Stating its intended use (measuring and imaging the distribution of radionuclides in the human body).
• Claiming substantial equivalence to predicate devices (ADAC S315, Elscint APEX SPX-4, DIGIRAD Notebook Imager, Siemens Orbiter, and SCINTICOR System Seventy Five).
• Highlighting the main difference: the LumaGEM™ camera uses position-sensitive photomultiplier tubes, which are stated to improve spatial resolution and potentially decrease risk due to reduced detector weight.
• Indicating the energy range for planar imaging (30-300 keV).
• A letter from the FDA confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information as it is not present in the given text. The document is a regulatory submission for premarket notification, not a detailed technical report or clinical study outlining performance metrics against acceptance criteria.

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