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Fibre Interspaced X-ray grids
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.
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smit röntgen
Postbox 218 5600 MD Eindhoven, The Netherlands Tel. 31.40.2762707 Fax. 31.40.2762478
Image /page/0/Picture/2 description: The image shows a logo with the word "Smit" in large, bold letters on the top line. Below "Smit" is the word "röntgen" in a smaller font size. The word "röntgen" is set against a horizontally striped background, which provides contrast and makes the text stand out. The overall design is simple and clean, with a focus on readability.
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Premarket Notification section
NOV - 7 1996
Smit Roentgen Approbation XB36150/96-09-26/RR/LS
XB 36150/RR/LS. 1996.09.26
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
SMIT ROENTGEN FIBRE INTERSPACED X-RAY GRIDS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990
The undersigned certifies that the 510(k) Premarket Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence
The information is summarized as follows:
- 】. 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 2. safety standards, such as IEC publication 627
- Past experience with substantially equivalent predicate devices has shown our device to 3. be safe and effective when properly used.
Ing. R.W. Rijntjes
Approbation Manager Smit Roentgen Eindhoven , The Netherlands
§ 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.