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/ This device is intended to be used in the diagnosis of circulatory vascular system.

/ This device is operated and used by the physicians and X-ray technologist.

As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-9400f is the same as that of predicate device of BRANSIST safire (K062360) and DAR-8000f (K052500).

Consequently, the indications for use of DAR-9400f are also the same as that of BRANSIST safire (K062360) and DAR-8000f (K052500) and there are no additional indications.

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The provided document is a 510(k) clearance letter from the FDA for a device named DAR-9400f, an angiographic x-ray system. The letter states that the device is "substantially equivalent" to legally marketed predicate devices.

However, this letter does not contain any information about the acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications that would allow me to answer your specific questions. The letter is an administrative document confirming regulatory clearance based on substantial equivalence, rather than a summary of performance studies.

Therefore, I cannot provide the requested table or answer most of the questions based on the information given. The document does not describe a study that "proves the device meets the acceptance criteria" in the way you're asking, as 510(k) clearance for this type of device often relies on demonstrating equivalence to a predicate device rather than extensive new clinical trials with specific performance metrics and acceptance criteria.

To elaborate on why most of your questions cannot be answered from this document:

1. Acceptance criteria and reported device performance: Not present. The letter only states the device is substantially equivalent to predicates.
2. Sample size and data provenance: No study details are provided.
3. Number of experts and qualifications: No study details are provided.
4. Adjudication method: No study details are provided.
5. MRMC comparative effectiveness study: No information about such a study is present. This is an X-ray system, not typically an AI-driven interpretive device, so "human readers improve with AI vs without AI assistance" is likely not applicable in the context of this device's 2007 clearance.
6. Standalone performance study (algorithm only): Not applicable for an angiographic x-ray system in this context.
7. Type of ground truth used: Not applicable, as no performance study details are given.
8. Sample size for training set: Not applicable, as this is a hardware system, not an algorithm being trained.
9. How ground truth for training set was established: Not applicable.

The "Indications for Use" section (page 21 of the original submission, page 2 of the provided text snippet) briefly mentions:

• "This device is intended to be used in the diagnosis of circulatory vascular system."
• "This device is operated and used by the physicians and X-ray technologist."

It then states that the intended use and indications for use are the same as two predicate devices (BRANSIST safire K062360 and DAR-8000f K052500). This reinforces that the clearance is based on equivalence, not new performance data against specific acceptance criteria.

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