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510(k) Data Aggregation
(249 days)
The Mitaya aluminum interspaced x_ray grid is a standard style of ... x-ray grid, used in conventional radiography techniques.
X-Ray Grid
The provided text is a 510(k) premarket notification letter from the FDA to William Hague X-Ray Accessory Corporation regarding their "Mitaya Aluminum Interspaced X-Ray Grid" (K964025). This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.
The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, and therefore, it can be marketed.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving the device meets those criteria based on the provided text. The device described (an X-Ray Grid) is a physical accessory for conventional X-ray machinery, not an AI-powered device, and the document is a regulatory clearance letter, not a study report.
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(41 days)
Not Found
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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(16 days)
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(141 days)
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