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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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DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD V1.0 supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MRI data sets. DynaCAD also provides an intervention planning tool (DynaLOC) which assists with MRI guidance of percutaneous interventional procedures.

When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues. Patient management decisions should not be made based solely on the results of DynaCAD analysis.

DynaCAD image analysis relies on the assumption that pixels having similar MRI signal intensities represent similar tissues. The DynaCAD software simultaneously analyzes the pixel signal intensities from multiple MRI sequences and applies parametric fitting methods to perform tissue segmentation and classification.

The DynaCAD system consists of proprietary software developed by MRI Devices Corporation which is installed on an off-the-shelf personal computer and a monitor configured as a DynaCAD display station.

The provided text describes the DynaCAD V1.0, a post-processing software package for viewing and analyzing MRI studies. However, it does not contain acceptance criteria for device performance or any specific study details (like sample sizes, ground truth establishment, or expert qualifications) that would allow for a comprehensive table of acceptance criteria and reported device performance to be constructed.

The document mostly focuses on the device's intended use, general description, software development processes, and its substantial equivalence to predicate devices for regulatory approval. It mentions "Performance testing" and "Clinical Evaluation" but provides no quantitative results, acceptance thresholds, or specifics of these evaluations.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified. The document mentions "clinical datasets" but does not quantify them.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document indicates that a "skilled physician" interprets the device information, but it does not describe how ground truth was established for testing purposes or the specific qualifications of experts involved in such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not specified. The document refers to DynaCAD as a "Computer Aided Detection (CAD) system" but does not describe any MRMC studies or comparative effectiveness with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• This is implied to some extent for the "Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom." This sounds like an evaluation of the system's ability to assist in needle placement, which would involve the algorithm's direct output. However, a formal "standalone" performance study with metrics separate from human interaction is not explicitly described or quantified. The device is generally described as a post-processing tool to be interpreted by a skilled physician, suggesting it's always human-in-the-loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For DynaLOC (intervention planning): The "target accuracy was verified... using a realistic patient care procedure and placing needles in a phantom." This implies the "ground truth" for DynaLOC's accuracy was the known target within the phantom.
• For other features (segmentation, enhancement characteristics): Not specified.

8. The sample size for the training set

• Not specified.

9. How the ground truth for the training set was established

• Not specified. The document mentions "parametric fitting methods" for tissue segmentation and classification, but not how these models were trained or how ground truth was established for any training data.

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To be used in conjunction with a Magnetic Resonance Scanner to:

• 1. Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
• 2. Permit MR-quided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Model BBC-127 Biopsy Breast Coil

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Model BBC-127 Biopsy Breast Coil" and primarily addresses the regulatory approval process and indications for use.

Therefore, I cannot provide the requested information about acceptance criteria or a study from this document.

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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.

Model HRW-127 Wrist Array Coil

The provided text is a 510(k) clearance letter from the FDA for a device called "Model HRW-127 Wrist Array Coil." This letter confirms that the device is "substantially equivalent" to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter and does not contain the detailed study information, acceptance criteria, or performance data that would be found in a submission dossier or a scientific publication. The FDA letter is the result of the review process, not the detailed content of the review itself.

Therefore, based solely on the provided text, I cannot answer most of your questions as the information is not present.

Here's what I can and cannot infer from the given text:

What can be inferred from the text:

• Device Name: Model HRW-127 Wrist Array Coil
• Regulation Number: 21 CFR 892.1000 (Magnetic resonance diagnostic device)
• Regulatory Class: II
• Product Code: 90 MOS
• 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."
• Type of Use: Prescription Use
• 510(k) Number: K040349
• Clearance Date: March 9, 2004

What cannot be inferred from the text (and why):

1. A table of acceptance criteria and the reported device performance: This information would be in the device manufacturer's 510(k) submission, not the FDA clearance letter. The letter simply states that the FDA found the device "substantially equivalent."
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: This device is a "Wrist Array Coil," which is hardware for an MRI scanner. It's not an AI algorithm. Therefore, an MRMC study comparing human readers with/without AI assistance is not applicable to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned (and likely not applicable in the same way an AI model has a "training set," as this is a hardware device).
9. How the ground truth for the training set was established: Not mentioned.

To get the answers to these questions, you would need to access the original 510(k) submission documentation for K040349, which often contains performance data, bench testing results, and potentially clinical data depending on the device and predicate. This information is typically proprietary or only available in heavily redacted forms through FOIA requests.

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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.

Model HNC-127-INT Neurovascular Array Coil

This document is a 510(k) clearance letter from the FDA for a medical device, specifically an MRI coil. It does not contain the requested information regarding acceptance criteria, study data, or ground truth establishment for an AI/ML powered device.

The letter confirms that the Model HNC-127-INT Neurovascular Array Coil is substantially equivalent to legally marketed predicate devices and can be used to produce diagnostic images of the head and neck. It outlines regulatory requirements for the device but does not describe any performance studies or acceptance criteria that would be relevant to an AI/ML powered device.

Therefore, I cannot provide the requested information from the provided text.

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

Model QSC-127-INT Shoulder Array Coil Set

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Model QSC-127-INT Shoulder Array Coil Set). It confirms the device's substantial equivalence to predicate devices and outlines regulatory compliance.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval letter, not a technical report or study summary.

Therefore, I cannot extract the requested information from this text.

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