FIBRE INTERSPACED X-RAY GRID

• K Number: K963893
• Device Name: FIBRE INTERSPACED X-RAY GRID
• Manufacturer: SMIT RONTGEN
• Date Cleared: 1996-11-07 ( 41 days)
• Product Code: IXJ
• Regulation Number: 892.1910
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Fibre Interspaced X-ray grids

AI/ML Overview

The provided document is a 510(k) summary for Smit Roentgen Fibre Interspaced X-Ray Grids, dated November 7, 1996. This document is a regulatory submission for premarket notification to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, it focuses on demonstrating substantial equivalence to predicate devices under regulatory guidelines. The "summary of safety and effectiveness information" in this context refers to regulatory compliance, not clinical performance metrics based on patient data.

Therefore, I cannot provide the requested information related to acceptance criteria, device performance, sample sizes, ground truth, or study types (MRMC, standalone) because this information is not present in the provided text.

The document states:

• "The Fibre Interspaced X-ray grids are subject to Federal Performance Standards, defined in 21CFR- 982.1910"
• "The Fibre Interspaced X-ray grids will be manufactured in accordance with voluntary safety standards, such as IEC publication 627"
• "Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when properly used."

These statements indicate compliance with manufacturing and general safety standards for X-ray grids, but they do not describe an evaluation of diagnostic accuracy or clinical utility data that would have specific acceptance criteria like sensitivity or specificity.

Regulation Number and Section

§ 892.1910 Radiographic grid.

(a)
Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.