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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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