(233 days)
The Philips Ingenuity Digital PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical crosssections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.
The device is a hybrid diagnostic imaging system that combines Positron Emission tomography and X-ray computed tomography scanners that can be utilized in fixed installations. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET) scanner, X-ray Computed Tomography (CT) scanner, Patient Table
This Philips 510(k) Premarket Notification Submission for the Ingenuity Digital PET/CT System does not contain the detailed acceptance criteria and study results in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K052640, Gemini Raptor). It states:
- Determination of Substantial Equivalence: "The Ingenuity Digital PET/CT System has comparable indications for use as its predicate device."
- Summary of Nonclinical Tests: "In accordance with "Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems", system performance is provided using NEMA NU-2. Safety evidence is provided using IEC 60601 series of standards."
- Summary of Clinical Tests: "In accordance with "Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems", clinical images are included."
These statements indicate that the submission referenced existing guidance documents (NEMA NU-2 and IEC 60601 for nonclinical, and a general guidance for clinical images) for performance and safety testing. However, it does not provide the specific acceptance criteria or the reported device performance in a table, nor does it detail the specifics of any studies (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies).
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, experts, and adjudication methods from the provided text. The document confirms that clinical images were included in the submission, but it doesn't describe a specific clinical study with detailed results for a new device's performance against defined acceptance criteria. It relies on the concept of substantial equivalence by meeting regulatory guidance and having similar indications for use to a previously cleared device.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.