(199 days)
The OmniTom Elite computed tomography (CT) system is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily the head and neck.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age The CT images can be obtained either with or without contrast.
OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is supported for adult imaging of the head and neck.
The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K223447). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.
The ability to upgrade the OmniTom Elite system with photon counting detector (PCD) remains the same. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.
The provided text describes the OmniTom Elite Computed Tomography (CT) system and its updates, focusing on the Photon Counting Detector (PCD) configuration. However, it does not contain specific numerical acceptance criteria for performance metrics or detailed results from a study that quantifies these criteria. The document states that the device successfully meets "all the image quality criteria that are used for testing" and that images were "confirmed diagnostic quality," but it doesn't provide the actual criteria or the numerical outcomes.
Therefore, many parts of the request cannot be fully answered with the given information.
Here's an attempt to answer based on the provided text, highlighting where information is missing:
Acceptance Criteria and Study Details for OmniTom Elite with PCD
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for image quality metrics. It broadly claims that the device "meets all the image quality criteria that are used for testing" and that images were of "diagnostic quality."
| Metric / Feature | Acceptance Criteria (Not Explicitly Stated as Numerical Value) | Reported Device Performance (Not Explicitly Stated as Numerical Value) |
|---|---|---|
| Noise | Satisfactory for diagnostic quality | Successfully demonstrated comparable image quality to predicate |
| Slice Thickness | Satisfactory for diagnostic quality | Successfully demonstrated comparable image quality to predicate |
| Low Contrast Resolution | Satisfactory for diagnostic quality | Successfully demonstrated comparable image quality to predicate |
| High Contrast Resolution | Satisfactory for diagnostic quality | Successfully demonstrated comparable image quality to predicate |
| Radiation Metrics | Conformance with equipment performance standards & regulations | Successfully demonstrated comparable image quality to predicate |
| Modulation Transfer Function | Satisfactory for diagnostic quality | Successfully demonstrated comparable image quality to predicate |
| Diagnostic Quality of Images (Clinical) | Images confirmed to be of diagnostic quality by radiologists | Confirmed diagnostic quality of images |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: "Volunteers underwent CT scanning for a full head scan, the top of the skull, the midbrain, and through the sinuses." The number of volunteers is not specified.
- Data Provenance: The study involved prospective scanning of volunteers. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "independent board-certified practicing radiologists." The number of radiologists is not specified.
- Qualifications of Experts: "board-certified practicing radiologists."
4. Adjudication method for the test set
The document does not specify an adjudication method (e.g., 2+1, 3+1). It only states that images were "reviewed by independent board-certified practicing radiologists."
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
- MRMC Study Done: No. The study described is a clinical evaluation of the device's image quality, not an MRMC study comparing human reader performance with and without AI assistance. The device itself is a CT system, and while it introduces new image processing features (like MD Plus for bone removal, VNC, ultra-high resolution), it doesn't appear to be an AI-assisted diagnostic tool for humans, but rather an imaging system that produces images that radiologists interpret.
- Effect Size: Not applicable as an MRMC comparative effectiveness study with AI assistance was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, elements of standalone performance were evaluated.
- Bench Testing: Software development and testing in accordance with IEC 62304 and FDA guidance for software functions, including risk management analysis and verification/validation testing, indicate standalone algorithm assessment for software functions.
- Image Quality Evaluation: "Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests." This constitutes standalone testing of the imaging system's output characteristics without human interpretation.
7. The type of ground truth used
- For Image Quality Evaluation: Physical phantom measurements were used to assess image quality metrics.
- For Clinical Evaluation: The "ground truth" for diagnostic quality was established by the consensus or interpretation of "independent board-certified practicing radiologists." This is expert consensus on the diagnostic acceptability of the images. No mention of pathology or outcomes data as ground truth is made.
8. The sample size for the training set
The document does not provide information regarding a training set size or methodology, as the study described is an evaluation of the CT system's performance, not an AI algorithm that requires a distinct training phase. The MD Plus algorithm is mentioned, but its training details are not.
9. How the ground truth for the training set was established
Not applicable/no information provided, as details about a training set for an AI algorithm are not given.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.