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The GE Road Warrior PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitation of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.

The GE Road Warrior PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.

The provided documentation for the GE Road Warrior PET CT System (K022812) does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria through a clinical evaluation involving human readers or ground truth analysis.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE Discovery LS CT-PET System) based on:

• Similar technological characteristics.
• Comparable safety and effectiveness features.
• Same basic design, construction, and materials.
• Same intended uses.
• Conformance with electrical and radiation safety standards.
• Compliance with quality systems (21 CFR 820, ISO 9001, EN 46001).

Here's a breakdown of why the requested information cannot be fully provided based on the input:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states, "Clinical Tests: None required." and relies on substantial equivalence to the predicate device and compliance with safety standards rather than specific performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Cannot be provided. No clinical test set data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Cannot be provided. No clinical test set and thus no ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Cannot be provided. No clinical test set is mentioned.

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 / Cannot be provided. This device is an imaging system, not an AI-powered diagnostic tool. No MRMC studies or AI involvement are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Cannot be provided. This is an imaging system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Cannot be provided. No clinical test set and thus no ground truth is described.

8. The sample size for the training set

• Not applicable / Cannot be provided. No training set for an algorithm is mentioned as this is a hardware imaging system, not an AI model.

9. How the ground truth for the training set was established

• Not applicable / Cannot be provided. No training set is mentioned.

Summary of what is present in the document regarding "acceptance criteria" and "proof":

• Acceptance Criteria (Implied):
  • Substantial equivalence to the GE Discovery LS CT-PET System in technological characteristics, safety, effectiveness, design, construction, materials, and intended uses.
  • Conformance with applicable medical device safety standards (electrical, radiation).
  • Compliance with 21 CFR 820, ISO 9001, and EN 46001 quality systems.
• Study Proving Acceptance Criteria (Implied):
  • A "Summary of Studies" section generally states: "The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards."
  • The "Conclusion" states: "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance."
  • The primary "proof" is the argument for substantial equivalence to the predicate device, which inherently suggests the device meets the established safety and effectiveness profile of that predicate without requiring new clinical performance studies. The FDA's 510(k) clearance letter (K022872) validates this substantial equivalence determination.

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