(80 days)
This device is intended to be used in the fluoroscopy and fluorography.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this notification, the intended use of the IA-16LM is the same as that of predicate device IA-16VMA12 in KV-RF (K984111).
The purposes of the IA-16LM are also the same as that of the IA-16VMA12 in KV-RF (K984111) and there are no additional indications.
Shimadzu Image Amplifiers: IA-16LM IA-16LT, IA-16LD, IA-12LD/HG, IA-12LT/F
I am sorry, but the provided text from the FDA 510(k) summary for the Shimadzu Image Amplifiers does not contain sufficient information to answer your request regarding acceptance criteria and study details.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample size for test sets or data provenance.
- Information on the number or qualifications of experts for ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document mainly focuses on the regulatory clearance based on substantial equivalence and refers to the "Indications For Use" statement. To find the information you're looking for, you would typically need to review the full 510(k) submission, specifically the sections related to performance data and clinical studies, which are not included in these provided pages.
§ 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.