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K Number
K973073
Device Name
DRTS IMAGE INTENSIFIER DRAPE
Manufacturer
MINRAD, INC.
Date Cleared
1997-10-08

(51 days)

Product Code
JAA
Regulation Number
892.1650
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MINRAD™ DRTS™ Image Intensifier Drape is intended to provide a closed, sterile cover for the Image Intensifier end of all presently marketed, mobile C-Arm X-ray machines.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a medical device (MINRAD™ Inc.'s DRTS™ Image Intensifier Drape), and as such, it primarily focuses on regulatory approval rather than a detailed study report with performance metrics, acceptance criteria, or ground truth establishment.

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts used or their qualifications.
  4. Adjudication method.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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.