(21 days)
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System. It has dimensions of 65" (165.1cm) x 35" (88.9cm) x 35" (88.9cm) and a maximum weight of 650 lbs (295.46 kg). It uses a grounded anode x-ray tube with a 0.005" (0.127 mm) Beryllium window and Stainless Steel with Al equivalence > 2.5mm beam filtration. The focal spot is 0.0018" (0.045mm) @ 7.5 watts. The field of view is operator selectable, 4" or 6" collimation (10.16 cm or 15.24 cm) at the plane of the Image Intensifier. The rated peak tube potential is 75kVp with a tube kVp range of 40 to 75kVp. The system includes a digital video camera, a 2.4 GHz processor with 512 MB RAM, Serial 80 GB HDD, DVD RAM drive, and a 3.5" Floppy drive. It runs on Windows XP and has a medical grade 2 Mega Pixel 19.8" Monochrome Flat LCD display. Input devices include a Keyboard, Footswitch, and Touch Screen.
The provided text is a 510(k) summary for the "Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System." This document aims to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/CAD system would.
Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable or cannot be directly extracted from this type of regulatory submission.
The 510(k) summary focuses on comparing the new device's technical specifications and intended use against a legally marketed predicate device (Fluoroscan Premier - FS-IV) to assert that it is substantially equivalent and thus safe and effective. It does not contain a study explicitly designed to prove performance against pre-defined acceptance criteria in terms of accuracy, sensitivity, specificity, or reader performance improvement.
Here's a breakdown of why some questions are not directly answerable by the provided text, along with what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document as performance metrics (e.g., specific accuracy thresholds, sensitivity, or specificity). The "acceptance criteria" in this context would implicitly be that the new device's technical specifications and intended use are substantially equivalent to the predicate device, and that it meets relevant regulatory standards for fluoroscopic imaging systems (e.g., radiation safety, image quality for diagnostic purposes).
- Reported Device Performance: The document provides a comparison of technical specifications between the new device (Fluoroscan InSight) and its predicate (Fluoroscan Premier FS-IV) in the "Substantial Equivalence" table. This comparison is the "performance" data relevant to this submission, demonstrating that the new device performs similarly or better in key technical aspects.
| Feature / Criterion (Implicit) | Predicate Device (Fluoroscan Premier - FS-IV) | Fluoroscan InSight (New Device) |
|---|---|---|
| Intended Use | Mini C-Arm Fluoroscopic Imaging System for general visualization in orthopedic, podiatry, critical, emergency, and light anatomy situations | Same (Substantially Equivalent) |
| Device Type | Mini C-Arm Fluoroscopic Imaging System | Same |
| 510(k) Number | K974058 | Same (implies substantial equivalence due to prior clearance) |
| Dimensions (HxWxD) | 60" x 36" x 32" (152cm x 91cm x 81cm) | 65" x 35" x 35" (165.1cm x 88.9cm x 88.9cm) (Slightly larger) |
| Weight (maximum) | 500 lbs (227 kg) | 650 lbs (295.46 kg) (Heavier) |
| Voltage (nominal) | 100/120/220/240 Single Phase | Same |
| Frequency | 50/60 Hz | Same |
| Source-Image receptor distance | 17.5" (44cm) | Same |
| X-Ray Source | Grounded anode x-ray tube 0.005" (0.127mm) Beryllium | Same |
| Beam Filtration | Stainless Steel with Al equivalence > 2.5mm | Same |
| Focal Spot | 0.0018" (0.045mm) @ 7.5 watts | Same |
| Field of View | Operator selectable, 4" or 6" collimation | Same |
| Rated peak tube potential | 75kVp | Same |
| Tube kVp range | 40 to 75kVp | Same |
| Tolerances (kVp, mA) | kVp ± 5%; mA ± 8% ≤ 0.035mA; mA ± 5% ≥ 0.035mA | Same |
| Maximum duty cycle at 75 kVp/0.100mA | 50% | Same |
| Video Camera | Analog | Digital (Improved) |
| System computer processor | 850 MHz | 2.4 GHz (Improved) |
| System computer RAM (minimum) | 128 MB | 512 MB (Improved) |
| System computer storage | CD-ROM, 20 GB HDD, 3.5" Floppy | Serial 80 GB HDD, DVD RAM drive, 3.5" Floppy drive (Improved) |
| Operating System | Windows NT Embedded | Windows XP (Improved/Updated) |
| Display | Dual 15" Hi-Res CRT | Medical grade 2 Mega Pixel 19.8" Monochrome Flat LCD (Improved) |
| Input Devices | Keyboard, Footswitch, Touch Screen | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) submission for a fluoroscopic imaging system, not an AI/CAD device. There is no "test set" in the sense of a dataset of patient images used to evaluate algorithmic performance. The evaluation is based on technical specifications and engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point 2. There's no test set requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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
- Not Applicable. This is not an AI/CAD device. It's a fluoroscopic imaging system. No MRMC studies are described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a fluoroscopic imaging system, "ground truth" relates to physical measurements and engineering standards (e.g., kVp accuracy, dose measurements, image resolution tests) rather than diagnostic patient outcomes. The document doesn't detail these underlying engineering tests.
8. The sample size for the training set
- Not Applicable. This is not an AI/CAD device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.