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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

Models HRW-63-8 and HRW-127-8 Wrist Array Coils

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for MRI Devices Corporation's Models HRW-63-8 and HRW-127-8 Wrist Array Coils, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document mentions:

• Trade/Device Name: Models HRW-63-8 and HRW-127-8 Wrist Array Coils
• Regulation Number: 21 CFR 892.1000
• Regulation Name: Magnetic resonance diagnostic device
• Regulatory Class: II
• Product Code: MOS

It also includes the Indications for use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician."

However, there is no discussion of any performance acceptance criteria, test methodology, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of detailed study information is typically found in the supporting documentation submitted for 510(k) clearance, not in the clearance letter itself.

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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck when interpreted by a trained physician.

Model NVA-127-8-A Neurovascular Array Coil

This document is a 510(k) premarket notification approval letter for a Magnetic Resonance (MR) diagnostic device. It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. The letter confirms substantial equivalence to a predicate device but does not detail performance data, sample sizes, expert qualifications, or ground truth methodologies.

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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

Not Found

This is a 510(k) premarket notification for a medical device (MRI coils for foot and ankle imaging), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training data for AI/ML performance is not applicable to this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market, but it doesn't involve the types of performance and validation studies typically associated with AI/ML systems.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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To be used in conjunction with a Magnetic Resonance Scanner to produce images that can be interpreted by a trained physician.

HRK-123 Knee Array Coil

I am sorry, but the provided text from the FDA Pre-Market Notification (510(k)) K050299 for the HRK-123 Knee Array Coil does not contain information about acceptance criteria or a study that proves the device meets those criteria.

This document is a letter from the FDA granting substantial equivalence to the device, allowing it to be marketed. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include details of the performance testing, clinical studies, or specific acceptance criteria that would be relevant to the questions asked.

Therefore, I cannot provide the requested information based on the input text.

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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Magnetic Resonance Diagnostic Device (NVA-63-8-A and NVA-63-16-A Neurovascular Array Coil). This document does not contain information about acceptance criteria, device performance results, specific study details, or comparative effectiveness studies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing, approved devices that it doesn't require a new, full pre-market approval application (PMA). Substantial equivalence is often established by comparing the new device's technological characteristics and performance to a predicate device, but the details of those specific tests and their acceptance criteria are not included in this letter.

Therefore, I cannot fulfill your request for the tables and study details based solely on the provided text. The document is an FDA clearance letter, not a detailed technical report or clinical study summary.

To answer your questions, I would need a different type of document, such as:

• A clinical study report
• A section of the 510(k) submission that details the performance data and testing methods
• A summary of regulatory compliance testing

Without such information, any attempt to provide the requested details would be speculative and inaccurate.

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