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510(k) Data Aggregation
(198 days)
The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily 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 only supported for adult axial imaging for head and neck.
The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K211711). 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.
Here's a breakdown of the acceptance criteria and study details based on the provided text, formatted to answer your specific questions:
Acceptance Criteria and Device Performance Study
The NeuroLogica OmniTom Elite CT system, particularly with its Photon Counting Detector (PCD) configuration, underwent various tests to demonstrate its safety, effectiveness, and substantial equivalence to its predicate device. The primary focus of the new features described is the multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific, quantified table of "acceptance criteria" for the new multi-energy CT functionality in terms of specific performance metrics tied to a pass/fail threshold. Instead, it describes various tests and their successful outcomes, demonstrating that the device performs as intended and is comparable to the predicate. The overall acceptance criterion is inferred to be that the new features do not raise new questions of safety or effectiveness and provide diagnostically acceptable images, similar to the predicate device.
| Category | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Material Decomposition | Ability to accurately decompose basic materials (water, iodine, calcium) and represent them in maps. | "For material decomposition, the multi-energy CT phantom was scanned, where three basic materials, water, iodine and calcium were decomposed. The materials were well represented in the respective decomposition maps, for example; iodine of varying densities highlighted on the iodine map." |
| Virtual Monoenergetic Images (VMI) | Ability to generate VMI. (Implicitly accepted if material decomposition works and images are diagnostic) | VMI capability is listed as a feature and implied by the success of material decomposition and diagnostic image quality. |
| Image Quality (PCD) | Comparable image quality to the predicate device, meeting existing criteria for noise, slice thickness, low/high contrast resolution, radiation metrics, and MTF. | "Imaging metrics successfully demonstrated that the proposed device with PCD has comparable image quality with its previous version, predicate device (K211711) and meets all the image quality criteria that are used for testing." "PCD capabilities were tested to demonstrate properties of PCD in count mode and multi-energy mode... Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning." |
| Diagnostic Acceptability | Clinical scans produced by the PCD configuration must be diagnostically acceptable and equivalent to images from the predicate device (EID). | "The clinical scans indicate the ability of the PCD configuration of the OmniTom Elite device to generate diagnostically acceptable images, which are equivalent to those produced by the OmniTom Elite with EID." "Multi-energy studies demonstrate the PCD's ability not only to produce diagnostically acceptable images but also to ability to decompose images using different basis materials such as iodine and calcium." |
| Safety and Compliance | Adherence to recognized safety standards (e.g., IEC 60601 series, ISO 14971) and FDA regulations. | Device is "in conformance with all applicable parts of the following FDA recognized consensus standards" and has passed "Electrical Safety and Electromagnetic Compatibility testing and proved to be in compliance with IEC 60601-1-2, and IEC 60601-2-44." Risks were controlled and mitigated. |
| Software Functionality | All software requirements are met, and the new features do not negative affect existing functionality. | "Software verification and software validation testing was executed to confirm all software requirements were met. The proposed OmniTom Elite device was shown to meet all requirements and to not have any impact on imaging." |
| Overall Performance | Device operates in accordance with specifications, meets user needs, and performs as well as similar CT devices. | "The results of the performance testing and conformance to the harmonized standards demonstrate that the subject device operates in accordance with specifications and meets user needs and intended use. The proposed OmniTom Elite CT system performs as well in its intended use as similar CT devices currently on the market." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a numerical sample size (e.g., number of patients/scans) for the clinical evaluation (test set). It states, "Volunteers underwent CT scanning for a full head scan, from the upper jaw to the top of the skull to aid in generation of comparative images." The provenance is described as "Comparative study was conducted under an IRB" using "Volunteers." It implies a prospective study, but the geographic origin (country) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The clinical images "were reviewed by three independent board-certified practicing radiologists." No specific number of years of experience is provided, but 'board-certified' is a standard qualification.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated beyond "reviewed by three independent board-certified practicing radiologists." It's unclear if consensus was required, if a majority rule was applied for disagreement, or if all three had to independently confirm diagnostic quality without formal adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader study was conducted to compare OmniTom Elite with PCD and OmniTom Elite with EID (existing detector technology). However, this was not a comparative effectiveness study designed to quantify how much human readers improve with AI vs. without AI assistance. The study's purpose was to confirm the diagnostic quality and equivalence of the images from the new PCD system compared to the existing EID system, verifying that the new technology does not compromise diagnostic utility. Therefore, an effect size of human improvement with AI assistance is not provided, as that was not the study's objective.
6. Standalone (Algorithm Only) Performance
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for the diagnostic interpretation of images. The performance data is primarily focused on the system's ability to generate diagnostically acceptable images, perform material decomposition, and adhere to image quality metrics. The "clinical evaluation" always refers to images being reviewed by radiologists. The material decomposition phantom study could be considered a form of standalone performance for that specific function.
7. Type of Ground Truth Used for the Test Set
The ground truth for the clinical evaluation test set was established by expert consensus/review of the images. "Three independent board-certified practicing radiologists" confirmed the "diagnostic quality of the images." For the material decomposition functionality, the ground truth was based on a manufactured "multi-energy CT phantom, where three basic materials, water, iodine and calcium were decomposed." This phantom represents a known, measurable composition.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set (if any machine learning components were involved in the new features). Given that the submission focuses on hardware and software feature upgrades rather than a new AI diagnostic algorithm, a distinct "training set" may not be applicable in the traditional sense of machine learning model development. This is more of a system validation rather than an AI model clearance.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the document, there is no information on how its ground truth was established.
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