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This device is intended to be used in the examination of the whole body.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TS W/FLUORO OPTION is the same as that of predicate device SCT-7000TS (K980837).
Consequently, the indications for use of the SCT-7000TS W/FLUORO OPTION are also the same as that of the SCT-7000TS(K980837) and there are no additional indications.

SCT-7000TS x-ray CT Scanner w/Fluoro Option

This is a 510(k) premarket notification for a CT scanner, not an AI/ML powered device. Hence, the traditional acceptance criteria, study design, and performance metrics for AI/ML devices, such as sensitivity, specificity, AUC, human-in-the-loop performance, etc., are not applicable in this context.

The provided document {0} is a letter from the FDA determining substantial equivalence for the Shimadzu Medical Systems SCT-7000TS x-ray CT Scanner w/Fluoro Option (K991553) to a legally marketed predicate device. The document {1} confirms the indications for use are the same as the predicate device (SCT-7000TS - K980837).

Therefore, I cannot extract the information required for the requested table of acceptance criteria and study details as this information is not present in the provided context for a CT scanner.

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This device is intended to be used in X-ray CT scanning on whole body.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient population.

SCT-7000TS

This is a 510(k) clearance letter for the Shimadzu Whole Body x-ray Computed Tomography Scanner SCT-7000TS, dated May 2, 1998. The letter states that the device is substantially equivalent to a predicate device marketed prior to May 28, 1976. This document does not provide details of acceptance criteria or a study proving the device meets acceptance criteria as would be found in a modern AI/ML device submission.

Here's why the requested information cannot be extracted from this document:

• Date: This document is from 1998. The FDA's regulatory framework and submission requirements for medical devices, particularly concerning performance studies and validation for software-driven or AI/ML components, were significantly different and less detailed than they are today.
• Device Type: The device is a "Whole Body x-ray Computed Tomography Scanner." While it is an imaging device, the focus of 510(k) submissions for such devices in 1998 was on demonstrating substantial equivalence to a predicate device, primarily in terms of safety and effectiveness related to its physical parameters, image quality, and intended use, rather than complex algorithm performance.
• Content of 510(k) Letter: This is the clearance letter from the FDA, not the original 510(k) submission itself. It primarily states the FDA's decision and the regulatory class. The actual submission, if available, might contain some performance data, but it is highly unlikely to include the specific types of studies (MRMC, standalone AI performance data) and detailed ground truth methodologies that are common in modern AI/ML device submissions.

Therefore, I cannot provide the requested information. The document pertains to a traditional CT scanner from 1998 and does not describe acceptance criteria or a study in the context of AI/ML performance.

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