(114 days)
GE PET/CT systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The systems are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions in patients of all ages. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning.
The systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.
The Discovery™ PET/CT 710 Clarity Edition consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. Due to the overall length of the PET/CT. the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.
Discovery™ PET/CT 710 Clarity Edition systems have a quantitation reconstruction method option called Q.Clear. This method iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality,
The provided text is a 510(k) Summary for the GE Discovery PET/CT 710 Clarity Edition, which is a submission to the FDA. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.
This document does not describe a study involving acceptance criteria and device performance in the way a clinical trial or algorithm performance study would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Discovery PET/CT 690) by comparing design, materials, energy sources, operating principles, technology, and compliance with standards.
Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not present in this type of submission.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence rather than presenting specific quantitative performance metrics against predefined acceptance criteria for the new "Clarity Edition" feature (Q.Clear). It states that the "Discovery Clarity Edition performs as well as currently marketed devices," but without specific metrics.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable or not provided. This 510(k) does not detail a "test set" in the context of an algorithm performance study. The substantial equivalence argument relies on comparing the device's technological characteristics and overall safety and effectiveness with the predicate, rather than a clinical study with a specific test dataset for a new feature like Q.Clear.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable or not provided. Ground truth establishment for a test set is specific to performance studies involving diagnostic accuracy or image quality assessment by human readers. This document does not describe such a study.
4. Adjudication Method for the Test Set:
Not applicable or not 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 or not provided. An MRMC study is not mentioned. The device's new feature, Q.Clear, is an iterative reconstruction method, but its impact on human reader performance is not quantified in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not explicitly detailed as a standalone performance study. The document describes the Q.Clear method as a "quantitation reconstruction method option" that "iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality." This implies an assessment of image quality, but no specific standalone algorithm performance metrics (e.g., SNR, contrast, resolution) or the study demonstrating them are provided in this summary.
7. The Type of Ground Truth Used:
Not applicable or not provided.
8. The Sample Size for the Training Set:
Not applicable or not provided. The Q.Clear method is a reconstruction algorithm, not a machine learning algorithm in the typical sense that would require a "training set." While such algorithms are developed and optimized using various datasets, this 510(k) summary does not provide details of such development.
9. How the Ground Truth for the Training Set was Established:
Not applicable or not provided.
Summary of available information regarding the "study" (in the context of substantial equivalence):
The submission acts as the "study" by comparing the new device, Discovery PET/CT 710 Clarity Edition, to its predicate, Discovery PET/CT 690.
- Acceptance Criteria (Implied for Substantial Equivalence): The implicit acceptance criteria for this 510(k) submission is that the new device, including its Q.Clear feature, performs "as well as currently marketed devices" and introduces "no significant change in safety or effectiveness" compared to the predicate device.
- Reported Device Performance:
- The new device "employs the same design, construction, materials, energy source, operating principles, and technology" as the predicate.
- The Q.Clear method is "similar to existing iterative reconstruction methods except it is able to continue iterations to full convergence while maintaining image quality by using noise reduction."
- Both systems are "compliant with the same IEC, NEMA and related safety and performance standards."
- Both systems "use the same acquisition methods and attenuation correction methods."
- "Discovery Clarity Edition performs as well as currently marketed devices."
In conclusion, this 510(k) summary provides a regulatory argument for substantial equivalence rather than a detailed scientific study with specific performance metrics against acceptance criteria for the new Q.Clear feature. The "study" is the comparison itself, aiming to show that the new device is as safe and effective as the predicate.
§ 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.