(160 days)
The NeuSight PET/CT Scanner System can be used for the functional and anatomical imaging of human bodies and organs. The device is intended for whole body or regional tumor examination, cardiac examination and head examination. The device can assist in radiotherapy planning and be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. Trained doctors can read useful diagnostic information from the image generated.
The NeuSight PET/CT Scanner System is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. It uses CT images to correct for non-uniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. NeuSight System has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated graphical user interface. The product provide some reconstruct methods, such as FBP、3DRP、OSEM、 ClearView (cleared in K133373) , and some advance algorithms based on OSEM. These advance algorithms can improve the image quality.
The NeuSight PET/CT Scanner System consists of two variants:
- NeuSight PET/CT 64
- NeuSight PET/CT 16
NeuSight PET/CT 16 is designed based on NeuSight PET/CT 64 and has the same hardware configuration with NeuSight PET/CT 64. Their hardware of CT part is the same as NeuViz64 (K121792). In the performance parameters, NeuSight PET/CT 16 only limits the optional scope of partial scan parameters by software in order to different from NeuSight PET/CT 64. There's no essential technological difference between the two types of PET/CT and the safety and effectiveness of these products could be ensured through verification, validation and difference assessment.
The provided text describes the 510(k) summary for the NeuSight PET/CT 64 and NeuSight PET/CT 16 systems. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative form for device performance. Instead, it relies on substantial equivalence to a predicate device (GE Discover VCT System, K050559) and compliance with various international standards for safety and performance. The performance claim is that the device "performs as intended" and its image quality was "evaluated in a blind state by a certified radiologist."
While specific quantitative acceptance criteria are not provided in this summary, the general performance claims are:
| Metric / Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantially equivalent to the predicate device (GE Discover VCT System, K050559) in indications for use, operating principle, and scientific technology. Compliant with numerous international standards for safety and performance (e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 14971, NEMA NU2, NEMA PS 3.1 - 3.20, NEMA XR 25, NEMA XR 28). | "The results of these tests demonstrate that the subject device performs as intended." "The result of all conducted testing was found acceptable to support the claim of substantial equivalence." |
| Image Quality | Implicitly, image quality should be sufficient for diagnostic purposes, comparable to the predicate device, and acceptable to a certified radiologist. Compliance with NEMA NU2:2012 (Performance Measurements of Positron Emission Tomographs) and IEC 61223-3-5:2004 (Acceptance tests - Imaging performance of computed tomography X-ray equipment) implies adherence to established image quality standards. | "Sample clinical images were provided within the submission. The image quality has been evaluated in blind state by a certified radiologist." (No quantitative metrics are provided in this summary, only qualitative expert evaluation). |
| Safety and Harm | Compliant with Good Manufacturing Practices (GMP) 21CFR 820, ISO 13485:2003, and multiple safety-related standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60825-1). Risk management process (ISO 14971) implemented to minimize electrical, mechanical, and radiation hazards. Compliance with radiation safety performance standards (21 CFR §1010 and §1020). | "The safety and effectiveness of the NeuSight PET/CT Scanner System was assured by adherence to Good Manufacturing Practices(GMP) 21CFR 820 and to International Standards ISO 13485:2003." "Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled during product development, and verification and validation testing." |
| Software Performance | Compliant with IEC 62304:2006 (Medical device software - Software life-cycle processes) and FDA guidance for software in medical devices (Moderate Level of Concern). | "Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements if demonstrated via testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Sample clinical images were provided within the submission."
- Sample size: Not specified. It only mentions "sample clinical images."
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of experts: Singular, "a certified radiologist."
- Qualifications of experts: "certified radiologist." No further details like years of experience are provided in this summary.
4. Adjudication Method for the Test Set
The document states: "The image quality has been evaluated in blind state by a certified radiologist." This suggests a single reader evaluation. There is no mention of consensus or multi-reader adjudication methods (like 2+1 or 3+1).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not explicitly mentioned in this document. The evaluation of image quality was performed by a single certified radiologist. There is no information provided regarding human readers improving with AI vs. without AI assistance, as this is a PET/CT scanner system, not specifically an AI-driven image analysis tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This is a hardware device (PET/CT scanner) with integrated software for image reconstruction and display. The intent is "Trained doctors can read useful diagnostic information from the image generated." Therefore, the entire system is designed for human-in-the-loop performance. While the device contains "advance algorithms based on OSEM" that "can improve the image quality," the performance evaluation mentioned focuses on the output images read by a human. A standalone algorithm only performance, in the sense of an AI diagnostic tool without human review, is not described for this device.
7. The Type of Ground Truth Used
For the sample clinical images, the "ground truth" for evaluating image quality appears to be the expert opinion of a certified radiologist. There is no mention of pathology, outcome data, or expert consensus serving as ground truth for the image quality evaluation described.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This summary pertains to the regulatory submission for a PET/CT scanner system, not typically a machine learning algorithm that requires an explicit training set for its primary function. While it mentions "advance algorithms based on OSEM" that improve image quality, it does not describe their development or training data in this context.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is also not applicable/provided in this document.
§ 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.