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The CPS LSO PET/CT HiRez Series Scanners are combined positron emission tomography (PET) and X-ray computed tomography (CT) scannesr. The 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 prounds sion 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 CPS LSO PET/CT Hi-Rez series of scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology syotome are a signiture registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the and anatomic informanner and the Siemens Somatom CT (either Emotion or Sensation depending on the specific model).

The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT oncology maonine mans, quiet attenuation correction for PET studies as well as oomponont provided farmer through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

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serviceability as well as to deal with parts obsolescence. (RUC) The City Serviceability as well as to deal with parts esset Handling System (PHS). The CT
limited to the PET gantry as well as the Patient Handling System (PHS). The CT illined to the F LT gamry as well as the reviously commercially available systems.

The provided text describes a 510(k) premarket notification for the "LSO PET/CT HiRez Series" and predominantly focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.

While the document details the device's purpose and indications for use, it does not contain information on acceptance criteria or a study proving the device meets acceptance criteria in the way one would expect for a performance evaluation study. The submission is for a new iteration of an already market-cleared device, emphasizing cost reduction and minor physical changes. Therefore, the core of the submission isn't to prove new performance claims against acceptance criteria, but to show that the modified device remains substantially equivalent to its predicates.

Given this, I cannot extract the specific information requested in the prompt, such as:

• A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to predicates based on general safety and effectiveness, not specific quantitative performance metrics against predefined criteria.
• Sample size used for the test set and the data provenance: No performance test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance study is detailed.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical imaging device, not an AI algorithm.
• The type of ground truth used: Not applicable as no specific performance study is detailed.
• The sample size for the training set: Not applicable as this is not an AI/algorithm-based device in the context of the 510(k) summary.
• How the ground truth for the training set was established: Not applicable.

The document states: "Changes incorporated in this system are the result of a cost reduction effort combined with changes that allow the 'look' of the gantry to be modified easily. Additional changes were incorporated to improve reliability and serviceability as well as to deal with parts obsolescence. These changes were limited to the PET gantry as well as the Patient Handling System (PHS). The CT component of the system remained identical to previously commercially available systems." This indicates that the core imaging performance, particularly for the CT component, was considered unchanged and therefore, not a subject of new performance evaluations for this 510(k) submission.

Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving those criteria were met.

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