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The SceptreP3 system is intended to be used:

• 1. to produce cross-sectional images of the hunan body that measure the distribution of positron emitting radiopharmaceuticals within the imaged area,
• tadiopliatinaccunears within the things a suy produced by x-ray transmission from the same axial plane 2) taken at different angles,
• taken at different angles,
  to create attenuation maps from the x-ray data to correct the PET images, and 3)
• to creat anchuation maps from the A tay images after reconstruction to produce images with both 4) anatomical and physiological data.

The system processes, displays, and stores the reconstructed images. The device output can aid to diagnosis when used by a qualified physician.

The SceptreP3 combines the technologies of a multi-slice x-ray computed tomography system, rne Socker 3 comments on computed tomography scanner, and a DICOM compliant image workstation into an integrated system that uses the PET and CT data to produce cross-sectional images of the body at various angles.

The system is made up of 4 discrete sub-systems that are independently marketed under unique 510(k) clearances. The sub-system models are:
CT - Presto
PET - ECAT ART-LSO PET System
Workstation - Sceptre-VS (AVIA)
Patient Table - PET/CT Patient Handling System (PHS)

The SceptreP3 system consisting of a CT gantry, a PET gantry, operator's workstation, patient handling system (table), high-frequency x-ray generator, and accessories. The system performance is identical to the predicate devices.

The provided text is a 510(k) summary for the SceptreP3 PET/CT system. It does not include a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a novel AI device would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices, meaning its performance is considered comparable because it uses established technologies.

Here's a breakdown of the information that can be extracted or inferred from the document, and where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity, specificity, or image quality metrics) in the way one would see for a new diagnostic algorithm. The primary "acceptance criteria" here is substantial equivalence to predicate devices.
• Reported Device Performance: The document explicitly states: "The system performance is identical to the predicate devices." and "The evaluation results of the SceptreP3 are comparable to the predicate devices and support our conclusion that the Sceptre PET/CT system is substantially equivalent."

Since the device is a combination of existing, already cleared sub-systems, its performance is considered a direct reflection of those predicate devices. There are no new performance metrics reported for the combined system beyond its functionality for image acquisition, reconstruction, display, and fusion.

Table (based on the provided text's approach):

Information Not Present in the Document:

The following requested items are typically associated with performance studies for novel devices or AI algorithms. Since this submission relies on substantial equivalence of combined, previously cleared components, these details are not provided:

2. Sample size used for the test set and the data provenance: Not applicable/Provided. No specific "test set" for performance evaluation of the combined system is described beyond the inherent performance of the predicate devices. The submission does not detail data provenance for such a test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. There is no mention of a test set requiring expert ground truth establishment for novel performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/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 applicable/Provided. This device is an imaging system, not an AI-assisted diagnostic tool in the modern sense.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Provided. This is an integrated hardware/software system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Provided.

8. The sample size for the training set: Not applicable/Provided. This device is not an AI/ML algorithm that undergoes a "training" phase in the context of the submission provided.

9. How the ground truth for the training set was established: Not applicable/Provided.

Summary of Study (Based on 510(k) Substantial Equivalence):

The "study" for the SceptreP3 system, as described in the 510(k) summary, is a demonstration of substantial equivalence to existing, legally marketed predicate devices.

• Methodology: The manufacturer combined four independently cleared sub-systems (CT, PET, Workstation, Patient Table). The core argument is that each sub-system retains its original performance and technological characteristics, and the integration introduces no new questions of safety or effectiveness. Minimal software changes were made to allow for integrated control and data transfer.
• Proof: "Testing has proven that the system is safe and effective for the indicated use. Risk and hazard analysis shows that there are no new safety issues associated with this system as compared with the predicate devices." This implies internal testing and analysis confirmed the integrated system operates as expected without introducing new hazards, primarily by verifying the functionality of the interface and combined operation to ensure it aligns with the performance of its cleared components. The specific details of this "testing" are not provided in this summary but would have been part of the full 510(k) submission.

In essence, the "study" is a regulatory comparison rather than a performance efficacy study against clinical ground truth, typical for devices building upon pre-existing technologies.

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