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MRI needles are intended for use with 1.5 Tesla (or lower field strength) magnetic resonance imaging procedures, including initial puncture, aspiration and injection, biopsies and diagnostic sampling.

The MRJ Needle is intended for use for the same indications as the predicate devices listed above. These indications include initial puncture, aspiration and injection, biopsies, diagnostic sampling and other interventional procedures. The materials used in this device are widely used in medical device manufacturing and their biocompatibility has been verified. In addition, design validation studies have been performed to assure the device can be expected to perform its intended function when used according to the recommendations in the product's labeling which will be provided with the device. The device will be made in 25 to 16 gage diameters, in lengths from 2.5 cm to 20 cm. It will be supplied sterile.

The provided 510(k) Premarket Notification for MRI Needles from COOK INCORPORATED primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study against specific acceptance criteria for a device or algorithm.

Therefore, the input document does not contain the requested information to describe acceptance criteria and a study proving a device meets them.

The document discusses:

• Intended Use: MRI needles for use with 1.5 Tesla (or lower) MRI procedures, including puncture, aspiration, injection, biopsies, and diagnostic sampling.
• Predicate Devices: Mentions existing COOK INCORPORATED needles and E-Z-EM®, INC. MRI needles (K#882601).
• Device Description: Materials, biocompatibility, design validation studies to assure intended function, and different sizes.
• Substantial Equivalence: Claims similarity in indications, materials, physical construction, manufacturing controls, packaging, and sterilization to predicate devices.

There is no mention of a formal study with defined acceptance criteria, a test set, ground truth, or statistical analysis of performance parameters like accuracy, sensitivity, or specificity for the MRI Needle. The "design validation studies" are mentioned but not detailed in terms of their methods, results, or acceptance criteria.

This type of 510(k) filing for a basic medical device like a needle often relies on demonstrating substantial equivalence to a legally marketed predicate device, especially for Class I exempt devices, without the need for extensive clinical performance studies that would typically involve acceptance criteria and detailed statistical analysis of performance metrics.

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