(90 days)
Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Vertex Ultra is a gantry (ring type) device designed for single- or dual-detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, two detectors, a collimator storage cabinet with acquisition computer unit, a patient imaging table, and a remote hand controller. The Vertex Ultra gantry is an "open" frame permitting easier access for imaging of standing, seated, and supine patients. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies; or the pallet may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys.
Vertex Ultra is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in relative 90° or relative 180° positions (as study appropriate), static, dynamic, gated, total body and ECT studies (circular orbit), non-circular orbital ECT, coincidence imaging, and gated SPECT (circular and non-circular orbit) imaging studies can be performed with or without a previously cleared ADAC attenuation correction option. In addition, Vertex Ultra acquisition software can be programmed to complete multiple imaging studies called protocol strings, which involve a combination of several imaging studies collected for use in customized clinical procedures.
The provided text describes the Vertex Ultra Gamma Camera System (K982911), which is a device intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific performance against clinical acceptance criteria with detailed studies and ground truth. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions that you requested is not explicitly present in the provided document.
However, based on the Testing section, we can infer the types of tests performed and the general nature of what would constitute "acceptance."
Here's an attempt to structure the information based on the provided text, while acknowledging its limitations for filling out all requested fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Acceptable field uniformity (visual inspection). | Flood phantom images were produced to demonstrate acceptable field uniformity. |
| Proper alignment (e.g., within established tolerances). | Center of rotation (COR) testing was performed to verify proper alignment. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document only mentions "Flood phantom images" and "center of rotation (COR) testing," implying the use of phantom data, not patient data for acceptance.
- Data Provenance: The 'data' (flood phantom images, COR test results) would be generated internally during the device's manufacturing and testing phases by ADAC Laboratories. It is not patient data from a specific country or collected retrospectively/prospectively in a clinical trial sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of the provided document. The "ground truth" for technical performance tests like field uniformity and COR alignment is determined by the physical properties of the phantom and the known geometric parameters of the system, not by clinical experts.
4. Adjudication method for the test set
Not applicable. Technical tests like field uniformity and COR alignment do not typically involve adjudication by multiple experts. The assessment is based on measured values and visual inspection against predetermined specifications.
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
No MRMC comparative effectiveness study was done. The device described is a gamma camera system, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a hardware system for image acquisition, not an algorithm.
7. The type of ground truth used
For the described tests:
- Flood phantom images: The ground truth for field uniformity is the expected uniform distribution of radioactivity across the detector field, which is a physical characteristic of the phantom.
- Center of rotation (COR) testing: The ground truth for alignment is the known mechanical axis of rotation of the gantry and detector, used to verify the imaging system's accuracy in identifying this center.
8. The sample size for the training set
Not applicable. This device is a gamma camera hardware system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable (as above).
§ 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.