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The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez scanners are 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 LSO PET/CT HiRez is a family of combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. These dual modality tomographs are modified versions of the ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518) and will utilize the same Siemens SOMATOM CT scanner components as their respective predicate PET/CT scanners. However, on this new family of CPS PET/CT HiRez systems, the ACCEL PET scanner electronics has been modified to appreciably increase PET count rate capability, with front-end acquisition electronics processing speed being significantly improved. The modified ACCEL PET scanner component will also incorporate a new version block detector utilizing a 13 by 13 LSO crystal matrix in place of the previously used 8 by 8 LSO crystal matrix which will provide a significant improvement in the spatial resolution of PET images. As with the predicate systems, 2D PET acquisition septa and PET transmission sources are not included in the modified LSO PET/CT HiRez systems. PET emission data are acquired only in 3D and PET attenuation correction map data are obtained from the CT. The PET and CT components of each system are contained within a unified housing similar to the predicate ECAT LSO PET/CT and ECAT LSO PET/CT 16 scanners to create an integrated PET, CT and combined PET/CT, tomographic imaging system.

The outward appearance of this family of modified PET/CT HiRez systems remains the same as the similarly configured preceding models. The LSO PET/CT HiRez gantry structure, patient handling system (PHS), advanced computational system (ACS 3) and workstation will be the same as those used with the LSO PET/CT and ECAT LSO PET/CT 16 systems. Software used in these scanners will be the most recent version of the previously used PET/syngo software with minor changes to accommodate the revised PET acquisition electronics and modified crystal configuration detectors. User operating instructions have been revised accordingly.

The LSO PET/CT HiRez scanners are intended for use primarily as clinical, whole-body oncology machines with medium to high-end spiral CT performance and fast patient-throughput clinical PET performance. As on the predicate systems, the CT component will also enhance PET scans by allowing fast, essentially noise-free attenuation correction for PET studies, and by providing precise anatomical reference through fused PET and CT images. In addition, the LSO PET/CT HiRez scanners will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on these PET/CT systems.

The purpose of introducing this family of modified LSO PET/CT HiRez tomographic systems is to offer a series of PET/CT scanners having a varied range of CT performance combined with the fast patient throughput of the modified ACCEL PET, as an even higher performance alternative to the presently distributed ECAT LSO PET/CT and ECAT LSO PET/CT 16 PET/CT systems.

The provided text is a 510(k) summary for the LSO PET/CT HiRez and LSO PET/CT 16 HiRez systems. It describes the device, claims substantial equivalence to predicate devices, and outlines its intended use. However, it does not contain detailed information about acceptance criteria or a specific study proving the device meets said criteria in the format requested.

The document states: "The combined PET/CT system has been tested by CPS and found to meet its predetermined performance requirements." but does not elaborate on what these requirements are, how they were tested, or the specifics of the study.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While the manufacturer is US-based (Knoxville, TN), the origin of any test data is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Not mentioned. The document focuses on the technical modifications and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
• Effect size of human readers with vs. without AI: Not applicable, as no MRMC study or AI assistance is discussed for improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Not explicitly stated as a "standalone study" in the context of an algorithm. The text refers to the "combined PET/CT system... tested by CPS and found to meet its predetermined performance requirements," which implies performance testing of the device itself. However, it's not a standalone algorithm performance in the modern sense of AI evaluating images without human intervention, as this is a medical imaging device for human interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical imaging device (hardware and associated software), not an AI algorithm trained on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

• How Ground Truth Was Established: Not applicable (see point 8).

Summary of what the document does provide regarding "acceptance criteria" indirectly:

The document primarily proves "substantial equivalence" to existing predicate devices (ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518)). This is the primary "acceptance criterion" for 510(k) clearance. The study that proves this is the comparison made within the 510(k) submission itself, where the new device's design, material, composition, energy source, radiation safety, and performance characteristics are shown to be similar to legally marketed devices.

The key modifications and performance improvements mentioned are:

• Increased PET count rate capability: Due to modified ACCEL PET scanner electronics with significantly improved front-end acquisition electronics processing speed.
• Improved spatial resolution of PET images: Due to a new version block detector utilizing a 13 by 13 LSO crystal matrix (vs. the previously used 8 by 8 LSO crystal matrix).

While these are stated as improvements, the specific quantitative acceptance criteria and the detailed study data that verified these improvements are not provided in this summary. The text indicates that these improvements lead to "even higher performance" as an alternative to the predicate systems, implying that performance was assessed and deemed superior or equivalent in relevant aspects.

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