(158 days)
The LCV+ Version 2 is indicated for use in generating fluoroscopic images of human analomy for cardiology diagnostic interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.
The LCV+ Version 2 is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a fiber channel link to an acquisition equipment then to a network (using DICOM) for applications such as post-processing, printing, viewing and archiving. LCV+ Version 2 consists of a cardiac monoplane positioner, a vascular table, an X-RAY system and a digital detector.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Digital images have equivalent image capability to image-intensifier recorded images. | "Six (6) cardiologists from two (2) hospitals compared digital and Summary of Studies: image-intensifier recorded images from 31 pairs of patients, and found that the digital images had equivalent image capability." |
| Diagnostic capabilities of recorded fluoroscopic sequences resulting from LCV+ Version 2 are equivalent to Image Intensifier images. | "The LCV+ Version 2 provides recorded fluoroscopic sequences that result in diagnostic capabilities equivalent to Image Intensifier images." |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: 31 pairs of patients (implying 31 cases with both digital and image-intensifier recorded images).
- Data Provenance: Not explicitly stated, but the study involved "two (2) hospitals." The type of study (retrospective or prospective) is also not specified.
3. Number of Experts and Qualifications:
- Number of Experts: Six (6) cardiologists.
- Qualifications: "Cardiologists" from two hospitals. No further details on years of experience or specific sub-specialties are provided.
4. Adjudication Method:
- The text states that the cardiologists "compared" the images. It does not describe a formal adjudication method (like 2+1 or 3+1). It seems they individually evaluated the images, and the overall finding was a consensus of "equivalent image capability." There's no mention of a tie-breaking or reconciliation process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a formal MRMC comparative effectiveness study in the sense of measuring improvement in human readers with AI vs. without AI assistance was not done.
- The study described is a comparison of two imaging modalities (digital vs. image-intensifier) to establish equivalence in diagnostic capability, involving multiple readers (6 cardiologists) and multiple cases (31 pairs of patients). However, the device itself is an imaging system, not an AI assisting human readers, so this type of MRMC study would not be applicable here.
6. Standalone (Algorithm Only) Performance:
- Yes, a standalone evaluation was performed implicitly. The study assessed the diagnostic capability of the digital images produced by the LCV+ Version 2 system compared to traditional image-intensifier images. The "device" in question is the imaging system itself, and its performance (producing images with equivalent diagnostic capability) was evaluated directly.
7. Type of Ground Truth Used:
- Expert Consensus/Clinical Equivalence: The ground truth was established by the subjective evaluation and comparison of the diagnostic capabilities of images by six cardiologists. It's essentially a clinical equivalence assessment based on expert opinion. There's no mention of a gold standard like pathology or long-term outcomes data to definitively determine the "true" diagnosis for each case.
8. Sample Size for the Training Set:
- The document does not mention a training set. The LCV+ Version 2 is described as an X-ray imaging system with a digital detector, not a machine learning or AI-based diagnostic algorithm that would typically require a training set. The comparison study described is for validation, not training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set is mentioned for this device.
§ 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.