(27 days)
The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system out would also be used by the plysician for staging of tumors, planning, guiding, and monitoring theram on the CE Discovery NMCT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, in inded to produce:
NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Wolle body scanning) and tomographic mode (SPECT, Gated SPECT) The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contractions
CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, nordiac and vascular X-Ray Computed Tomography applications
NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion),
The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used fors pationts of all ages.
The Discovery NM/CT 670 system is a hybrid SPECT-CT system for performing nuclear cardiology medicine studies, CT studies or SPECT-CT hybrid studies wherein the SPECT and CT studies may be registered and displayed in a fused form on processing and review Workstation. The Discovery NM/CT 670 system is intended to allow healthcare facilities to carry out SPECT and CT studies using the same instrument Major parts of the hybrid system include the following parts : new NM Gantry with Dual detector heads , CT Gantry (same as BrightSpeed Elite (BSD16) gantry), new common patient table , Integrated operation Console including BSD16 operation console and NM operation console & BSD16 Power Distribution Unit .
The provided 510(k) summary for the Discovery NM/CT 670 system explicitly states that "The Discovery NM/CT 670 did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these were not conducted or reported for this submission.
Instead, the submission for the Discovery NM/CT 670 relies on demonstrating substantial equivalence to predicate devices (K022960- INFINIA and K082816- GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM) by showing that it employs the same fundamental scientific technology and complies with voluntary standards.
Here's a breakdown of the available information regarding how the device meets acceptance criteria, based on the provided text:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Verification Activities)
Since no clinical studies were performed, the "acceptance criteria" discussed are related to manufacturing, design, and regulatory compliance rather than clinical performance metrics like sensitivity, specificity, or reader agreement. The "reported device performance" refers to the successful completion of these internal verification and validation activities.
| Acceptance Criterion Type | Reported Device Performance/Method |
|---|---|
| Regulatory Compliance & Standards | The Discovery NM/CT 670 and its applications are designed to comply with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission. |
| Risk Management | Risk Analysis was performed. |
| Design Control & Verification | Requirements Reviews: Conducted. |
| Design Reviews: Conducted. | |
| Testing on unit level (Module verification): Performed. | |
| Integration testing (System verification): Performed. | |
| Performance testing (Verification): Performed. | |
| Safety testing (Verification): Performed. | |
| Final Validation (System Level) | Final acceptance testing (Validation): Performed. |
| Technical Equivalence to Predicates | The Discovery NM/CT 670 employs the same fundamental scientific technology as its predicate devices. |
- CT part: Identical to predicate device K082816 (16 slices, BSD16), with a new equivalent patient table (meets NM attenuation requirements or less) and minor software modifications.
- NM part: Improved modification of predicate device K022960- Infinia (new NM Gantry with Dual detector heads). |
Additional Information Not Applicable or Not Provided in the Document:
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with expert ground truth was used.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set with expert adjudication was used.
- 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. The device is not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI, but a hybrid imaging system. No human reader studies with or without AI assistance were conducted or reported.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a medical imaging system, not a standalone algorithm. Its "performance" is assessed through engineering verification and validation against its design specifications and equivalence to predicate devices, not through standalone diagnostic accuracy studies.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the internal verification and validation activities, the "ground truth" would be the engineering specifications and established performance benchmarks of the predicate devices. No clinical outcomes, pathology, or expert consensus ground truth was established from clinical studies.
- The sample size for the training set: Not applicable as no machine learning algorithm requiring a training set is discussed or implied to be part of the substantial equivalence determination process for this device's regulatory review. The device is a hardware imaging system with associated software.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the K093514 submission specifically states that clinical studies were not required to support substantial equivalence. The device's acceptance relied on demonstrating technical equivalence to predicate devices and adherence to internal quality assurance measures and voluntary standards.
§ 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.