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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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The ClipLoc™ Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure.

It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

The ClipLoc Soft Tissue Marker is a sterile, single patient use device comprised of a small nickeltitanium marker (clip), a well as a disposable introducer and applier. The introducer is a coaxial cannula with a beveled tip and a molded hub. The ClipLoc is preloaded near the distal end of the cannula. The applier is a stylette with a cap. A plastic safety connector holds the applier and introducer needle in the appropriate position ("Ready") and helps prevent premature deployment of the marker. After removal of the safety connector, the ClipLoc is deployed by manually advancing the needle.

The ClipLoc may be used with either visual or imaging guidance (such as ultrasound, X-Ray, stereotaxy, or Magnetic Resonance). It may be used directly, or applied through another coaxial needle or guide associated with percutaneous biopsy. The entire system including ClipLoc, introducer, and applier is Magnetic Resonance (MR) safe and compatible up to and including 1.5 Tesla magnetic field strength. The marker, when present in a patient undergoing an MR exam at 3.0 Tesla or less, will not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating.

Here's a summary of the acceptance criteria and the study details for the ClipLoc Soft Tissue Marker, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a premarket notification (510(k)) for the ClipLoc Soft Tissue Marker. The "study" referenced in the document is a preclinical testing phase to confirm the device performs as intended.

1. Sample size used for the test set and the data provenance:
   The document does not specify a "test set" in the context of human subjects or a dataset. The performance data presented refers to preclinical testing. Therefore, information on sample size and data provenance in this context (e.g., country of origin, retrospective/prospective) is not applicable or provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided as the performance data is from preclinical testing, not a study involving human interpretation or ground truth establishment by experts in the typical clinical study sense.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as the performance data is from preclinical testing and does not involve a "test set" requiring adjudication.

4. 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:
   No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (tissue marker), not an AI-powered diagnostic or assistive tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the "satisfactory radiographic visualization," the "ground truth" would be the direct observation and assessment of the marker's visibility by the engineers/technicians performing the preclinical tests using the specified imaging modalities (X-Ray, Ultrasound, MR). For MR safety and compatibility, the "ground truth" would be the physical measurements and observations of the device's behavior in MR environments according to established standards.

7. The sample size for the training set:
   Not applicable. This is a physical medical device, and the "performance data" refers to preclinical testing and material characteristics, not machine learning model training.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for a machine learning model.

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

Not Found

This is a 510(k) premarket notification letter from the FDA regarding MRI coils, not a study report or clinical trial. Therefore, the provided text does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is an FDA clearance letter, indicating that the device (HRK-63-8 PMS and HRK-127-8 Knee Array Coils) has been deemed substantially equivalent to a legally marketed predicate device. This process does not typically involve the detailed performance studies with acceptance criteria, ground truth, and expert adjudication that would be present in a clinical trial report.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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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-guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification clearance letter from the FDA for a device called "Biopsy Breast Coil BBC," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document includes:

• Device Name: Biopsy Breast Coil BBC
• Regulation Number: 21 CFR 892.1000 (Magnetic resonance diagnostic device)
• Regulatory Class: II
• Product Code: 90 MOS
• Indications for Use:
  1. To produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
  2. To permit MR-guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

However, there is no information regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. This letter is a regulatory approval, not a scientific study report.

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

Model KFA-12 Knee, Foot, and Ankle Array Coil

The provided text is a 510(k) premarket notification letter from the FDA regarding an MRI coil (Model KFA-12 Knee, Foot, and Ankle Array Coil). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as it would for an AI/CADe device.

Instead, this letter confirms the device's substantial equivalence to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. The core of a 510(k) for this type of device (an MRI coil) typically focuses on demonstrating that the new device has the same intended use and performance characteristics as a legally marketed predicate device, without raising new questions of safety and effectiveness.

Therefore, I cannot extract the information required in your request about acceptance criteria and study details from the provided text because it primarily concerns regulatory approval for a medical device (an MRI coil), not an AI/CADe software that would have performance metrics like sensitivity, specificity, or reader study results.

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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 HAC-12 and HAC-30 Head Array Coil

I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a clearance letter from the FDA for a device called "HAC-12 and HAC-30 Head Array Coil", indicating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but does not include details about specific performance metrics, studies, or acceptance criteria.

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