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The Disposable High-pressure Extension Lines is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Disposable High-pressure Extension Lines," which is a medical device. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the text does not include:

• Details about acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Information on sample sizes for test sets (or training sets, for that matter).
• Any mention of data provenance (country of origin, retrospective/prospective).
• Details about experts used for ground truth establishment or their qualifications.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used (expert consensus, pathology, etc.).
• How ground truth for a training set was established.

This document specifically concerns a physical medical device (extension lines for angiographic injectors), not an AI/Software as a Medical Device (SaMD) that would typically involve the types of studies and criteria you've asked about (e.g., performance metrics, ground truth, expert readers, training sets).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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