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The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

The Allegro Imaging System is a Positron Emission Tomography (PET) system, a nuclear medical imaging system with capabilities to acquire, process, and display clinical images that can be utilized in both conventional, fixed installations or mobile environments. It is intended to produce attenuation and non-attenuation corrected images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel. The system allows the reconstruction of high-resolution, three-dimensional, static, gated, and dynamic images of biochemical and metabolic processes.

The provided text describes information about the Allegro Imaging System. However, it does not contain specific details about acceptance criteria and a study proving the device meets those criteria in the format requested in the prompt.

The document indicates:

• Device Performance: "The device performance was measured in accordance with NEMA-NU2 standard." This suggests the NEMA-NU2 standard likely serves as a reference for performance, but no specific metrics or thresholds are provided.
• Comparison to Predicate Device: The conclusion states that the device is "substantially equivalent to the predicate device based upon similar intended use, technological comparison, and system performance." This implies that the performance of the new device aligns with that of the predicate device (Allegro Imaging System K003434).

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for a specific study. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Missing Information:

• A specific table of acceptance criteria and reported device performance.
• The sample size used for any test set.
• The data provenance (country of origin, retrospective/prospective).
• The number of experts and their qualifications used to establish ground truth.
• The adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether standalone performance was evaluated.
• The type of ground truth used (e.g., pathology, outcomes).
• The sample size for the training set.
• How the ground truth for the training set was established.

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