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The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and Xray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) 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 2) 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.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient. }

The ECAT LSO PET/CT is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT PET/CT (K002715) and will utilize the same CT component from the Siemens SOMATOM EMOTION (CT) Scanner. However, in place of the PET component that uses 288 BGO crystal block detectors, the ECAT LSO PET/CT will be configured with the CPS ECAT ACCEL PET (K002584) using 144 LSO crystal block detectors, in combination with the Siemens Somatom EMOTION CT. As with the predicate system, 2D PET acquisition and the PET transmission sources are not included in the modified ECAT LSO PET/CT. PET acquisition data is acquired only in 3D and PET attenuation correction map data is obtained from the CT. The PET and CT components will be integrated as in the original ECAT PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system.

The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), and workstations will remain essentially the same as the ECAT PET/CT system with only minor modifications to accommodate the different PET detectors. In addition, the ECAT LSO PET/CT as well as the HR+ based ECAT PET/CT will also be offered with either the Siemens single slice EMOTION CT (K991764) or the dual slice EMOTION MS CT (K003074), for the CT component of the system. The EMOTION MS CT with two rows of X-ray detectors does not otherwise affect performance of the ECAT LSO PET/CT.

This is a 510(k) premarket notification for the ECAT LSO PET/CT Scanner, a combined Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner. This is a medical device, and the documentation provided describes its intended use and a comparison to a predicate device. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance metrics.

The document is a US FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting detailed performance studies with acceptance criteria in the way a clinical trial or a robust standalone performance study would.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about clinicians establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone performance study details.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

The provided text only includes:

1. Device Proprietary Name: ECAT LSO PET/CT Scanner
2. Common Name: Combination Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT)
3. Classification Name: Emission Computed Tomography System per 21 CFR 892.1200
4. Predicate Device: ECAT PET/CT from CTI PET Systems (CPS), 510(k) Number K002715
5. Device Description: It's a modified version of the ECAT PET/CT (K002715), utilizing the same CT component (Siemens SOMATOM EMOTION) from a predicate CT scanner (K002713, K991764, K003017 for single/dual slice versions) but replacing the 288 BGO PET crystal block detectors with 144 LSO crystal block detectors from the Siemens ECAT ACCEL PET (K002584). It integrates PET, CT, and combined PET/CT imaging.
6. Intended Use/Indications for Use:
   • To image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for determining metabolic and physiologic functions.
   • To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (from axial or spiral planes).
   • The PET and CT functions can be used in combination for high-resolution, noise-free CT attenuation correction maps for PET images, and to produce fused CT and PET images for detailed anatomic and metabolic function information.

Conclusion:

This document is a regulatory submission demonstrating substantial equivalence, not a performance study report. It states that "The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), workstations will remain essentially the same as the ECAT PET/CT system (ACS 3), with only minor modifications to accommodate the different PET detectors." This implies that the performance characteristics are expected to be similar to the predicate device due to the nature of the modification (a change in detector type within the PET component, while other major systems remain the same or are sourced from predicate devices). However, specific performance criteria and studies demonstrating their fulfillment are not detailed in this 510(k) summary.

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