(229 days)
The Intelli-C is indicated for use as a multipurpose diagnostic X-ray system for universal radioscopic and fluoroscopic studies. With its C-arm and digital flat detector, it can perform a range of applications including interventional procedures, vascular procedures, specialized applications including angiographic studies of the entire body on adults and paediatrics.
The Intelli-C system is only indicated for use by trained professionals. The Intelli-C is not intended for mammography studies.
The Intelli-C device that we wish to bring to market is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies.
This type of device is typically used in departments with a single fluoroscopy installation that benefit from the versatility of multi-purpose systems that allow a wider range of examinations than a standard fluoroscopy unit. In larger departments such systems can provide backup for other fluoroscopy installations, for example in case of breakdown.
As with most multi-purpose systems, the Intelli-C has the patient tabletop and C-arm assembly supported on a main column from which the complete unit can be elevated and tilted. The tabletop is supported only at the foot end providing good, all round access to the patient.
The C-arm supports the X-ray tube and image detector assembly and patient coverage is achieved through a combination of C-arm movements and table top movements. The C-arm has angulation and rotational movements, and the source to detector distance is variable. The image detector can be positioned above or below the tabletop depending on the specific examination requirement.
The control room control panel for gantry movements, imaging system, generator and collimator are located in the control room. To facilitate interventional studies to be performed on this type of system, most controls are duplicated on a mobile tableside control panel. The imaging system is normally connected to PACS and Hospital Information System, e.g. patient lists, through the hospital network.
The Intelli-C device will be offered in two main variants:
NRT REF No.: 03400000 Device name: Intelli-C, Right side suspended table
NRT REF No.: 03400010 Device name: Intelli-C, Left side suspended table
The main systems will be offered with a range of options and accessories as listed in section 11 of this application.
The provided text describes the NRT Intelli-C, an all-digital multipurpose tilt-C X-ray system. The submission is a 510(k) premarket notification, indicating the intent to market the device based on substantial equivalence to a legally marketed predicate device.
The document does not contain explicit "acceptance criteria" and "reported device performance" in the format of a table as requested. Instead, it argues for substantial equivalence by comparing the Intelli-C with its predicate device, the GE Precision MPi, and by citing scientific literature supporting the technological advancements.
Therefore, the following information is extracted and presented based on the available content:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria or device performance metrics against those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adopting established technology. The "performance" is implicitly deemed acceptable due to the use of a previously cleared digital X-ray receptor and "adequate verification and validation testing results document[ing] adequate image quality and integration."
| Acceptance Criteria (Implied) | Reported Device Performance/Argumentation |
|---|---|
| Safety and Effectiveness | The Intelli-C is believed to perform "as safe and as effective or better than the predicate device." This conclusion is based on a substantial equivalence discussion and literature summary, documenting technological differences including a digital X-ray receptor, user interfaces, X-ray generation component upgrades, and other minor modifications. No new issues of safety or effectiveness are perceived with the introduction of the Intelli-C. |
| Image Quality and Integration | "adequate verification and validation testing results document adequate image quality and integration." The use of a previously cleared digital X-ray receptor is cited. |
| Regulatory Compliance | The device is tested to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54) and FDA performance standards 21 CFR 1020.30, 31, and 32. Design and production controls are under a Quality Management System compliant with 21 CFR 820 and ISO 13485 requirements. |
| Technological Equivalence | The Intelli-C incorporates a digital flat panel detector (FPD) as an upgrade from the Image Intensifier (II) of the predicate device. Scientific literature is provided to support the benefits of FPD technology (improved patient access, lower patient radiation doses, wider dynamic ranges, better stability, lower radiation dose rates, improved dynamic range, elimination of glare and geometric distortions, more flexible positioning, more stable performance, zero geometrical distortion and vignetting, less physical dimensions with great versatility). |
2. Sample size used for the test set and the data provenance:
The document does not provide information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to a predicate device and citing peer-reviewed literature regarding the FPD technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document as there is no mention of a specific test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document as there is no mention of a specific test set or an adjudication process.
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:
This is not applicable to the provided document. The Intelli-C is an X-ray system, not an AI-powered diagnostic tool, and therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to the provided document. The Intelli-C is an X-ray system and not an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document as there is no mention of a specific ground truth establishment for a diagnostic test. The device itself is a diagnostic imaging system.
8. The sample size for the training set:
This information is not provided in the document. The Intelli-C is an X-ray imaging system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
This information is not provided in the document, as it is not relevant for the type of device described.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.