Search Results

NEONA 1.5T MRI system is indicated for use as a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.

The NEONA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.

The sponsor, Time Medical Limited, has demonstrated the substantial equivalence of their NEONA 1.5T MRI System to a legally marketed predicate device (EMMA 1.5T MRI System, K183621) through non-clinical performance data and clinical images.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a quantified manner for comparison. Instead, it focuses on demonstrating that the NEONA 1.5T MRI System performs as well as the predicate device and complies with recognized standards, indicating that meeting these standards and achieving comparable image quality to the predicate serves as the de facto acceptance.

The "Performance Data" section in the comparative table (page 9) implicitly suggests the acceptance criteria are compliance with:

• NEMA MS standards
• IEC standards: IEC 60601-1, IEC60601-1-2, IEC60601-2-33

The reported device performance is demonstrated by the non-clinical testing results and the sample clinical images.

2. Sample size used for the test set and the data provenance

The document states: "Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes." and "Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence of filing device to legally marketed predicate device."

• Sample Size: The exact number of clinical images or cases used in the test set is not specified in the provided document. It refers to "sample clinical images" and "sample clinical image sets."
• Data Provenance: The document does not specify the country of origin of the data nor whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that images are "interpreted by trained physician" to "assist medical diagnosis." However, it does not specify how many experts were involved in evaluating the sample clinical images for the substantial equivalence demonstration, nor does it detail their qualifications (e.g., years of experience, specific certifications).

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

The document does not specify any adjudication method used for establishing ground truth or evaluating the clinical image sets. The phrasing "interpreted by trained physician" suggests individual interpretation but doesn't detail a consensus process.

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

• No, an MRMC comparative effectiveness study was not done.
• The device in question, NEONA 1.5T MRI System, is a Magnetic Resonance Diagnostic Device (MRDD), which is the hardware system that produces images. It is not an AI-powered diagnostic software designed to assist human readers. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable to this submission. The comparison is between the performance of the new MRI system and a predicate MRI system.

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

• Not applicable. The NEONA 1.5T MRI System is an imaging device, not an algorithm, and its output (images) is explicitly intended to be "interpreted by trained physician." Therefore, a standalone algorithm-only performance assessment is not relevant in this context.

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

For the evaluation of the clinical images, the implicit ground truth appears to be the diagnostic information derived from the images when interpreted by trained physicians. The comparison of images from the filing device and the predicate device on the same pulse sequences suggests a direct visual and interpretive comparison, implying that the diagnostic conclusions reached from both sets of images should be comparable. However, no specific method like "pathology" or "outcomes data" is mentioned to serve as an independent, definitive ground truth reference beyond physician interpretation of the images themselves.

8. The sample size for the training set

This information is not applicable to the submission for the NEONA 1.5T MRI System. This device is a hardware MRI system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would relate to its manufacturing, calibration, and quality control processes to ensure image quality, not to a dataset for an AI model.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.

The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.

The provided text is a 510(k) summary for the EMMA 1.5T MRI System. It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical performance data and a comparison of clinical images.

Here's an analysis based on your request, highlighting the information available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EMMA 1.5T MRI System are largely based on compliance with various NEMA MS and IEC standards, demonstrating that its performance is equivalent to the predicate device. The text does not provide specific numerical acceptance criteria alongside numerical reported performance for each metric; instead, it states compliance with the standards.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes." and "Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence."

• Sample size used for the test set: Not explicitly stated. The term "sample clinical images" suggests a limited set, but no number is given.
• Data provenance: Not explicitly stated. It is implied these are clinical images, but information on country of origin or whether they are retrospective or prospective is not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The text states that the resulting images, "when interpreted by trained physician yield information that may assist medical diagnosis," but it does not detail an expert review process for a specific test set or the qualifications of any such experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. There is no mention of an adjudication method like 2+1 or 3+1 for establishing ground truth on a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in the document. The study performed focuses on demonstrating substantial equivalence through non-clinical performance and a visual comparison of sample clinical images, not on quantifying human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This is an MRI system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study in the context of AI is not applicable/not performed as described for diagnostic algorithms. The performance studies are for the imaging system itself. The document mentions "Software Verification and Validation Testing," which is focused on the software's functionality and safety within the device, not its standalone diagnostic performance.

7. Type of Ground Truth Used

For the clinical image comparison, the ground truth is implicitly based on the visual interpretability of the images by a "trained physician" for diagnostic assistance. However, a formal "ground truth" (e.g., pathology, clinical follow-up) for a specific diagnostic outcome for these sample images is not explicitly stated or detailed. The comparison is about the quality and diagnostic utility of the images produced by the new device versus the predicate device.

8. Sample Size for the Training Set

This information is not applicable as the document describes an MRI system, not an AI algorithm that requires a training set in that conventional sense. The "software" in this context refers to the operating and image reconstruction software, which is traditionally developed and validated through engineering processes, not trained on radiological data like an AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

Pica Whole-Body MRI System is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Hybrid Pica may also be used for imaging during interventional procedures when performed with NMR compatible devices such as, in room display and MR safe biopsy needles.

Pica Whole-Body MRI System is a 0.35T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RE Transmission Coil, RE Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body NMR System (K093984), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.

The provided text describes a medical device, the Pica Whole-Body MRI System, and its 510(k) submission for substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested information regarding study methodology, sample sizes, ground truth establishment, or expert involvement.

The document states: "Safety and performance testing were conducted to validate and verify that the filing device, Hybrid Pica Whole-Body MRI. System met all design specifications and was substantially equivalent to the predicate device." This is a high-level statement and does not provide the specifics requested in your prompt.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

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

• Sample size for the test set: Not stated.
• Data provenance: Not stated.

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):

• Number of experts: Not stated.
• Qualifications of experts: Not stated.

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

• Adjudication method: Not stated.

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:

• MRMC comparative effectiveness study: Not mentioned. The device is an MRI system, not an AI-assisted diagnostic tool in the context described.
• Effect size of human reader improvement with AI: Not applicable, as no AI assistance is described.

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

• Standalone algorithm performance: Not applicable. The device is a diagnostic imaging system.

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

• Type of ground truth: Not stated. The assessment focused on "design specifications" and "substantial equivalence to the predicate device" (K093984), implying technical and performance comparison rather than clinical outcomes against a pathology or expert consensus ground truth.

8. The sample size for the training set:

• Sample size for the training set: Not applicable to an MRI system described as a hardware and software upgrade to a predicate device, rather than an AI/ML algorithm requiring a training set in the conventional sense.

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

• How ground truth for the training set was established: Not applicable.

Summary of what is available:

• Device Name: Pica Whole-Body MRI System TMS-MRI-3500WB-02
• Predicate Device: Pica Whole Body MRI System TMS-MRI-3500WB-01 (K093984)
• Conclusion of Testing: "Safety and performance testing were conducted to validate and verify that the filing device, Hybrid Pica Whole-Body MRI. System met all design specifications and was substantially equivalent to the predicate device."

Missing Information:
The document lacks the detailed performance study information, including specific acceptance criteria, quantitative results, sample sizes, ground truth methodology, and expert involvement, that would be required to fully answer your prompt. This type of detail is often found in the actual testing reports or clinical study summaries, which are not part of this 510(k) summary letter.

Ask a specific question about this device

Pica Whole Body MRI System, TMS-MRI-3500WB-01, is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

It may be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Pica Whole Body MRI System is a 0.35T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP Professional is an interactive program with user friendly interface. It is a modified system to the existed and cleared Pica Whole Body MRI System (K091580), in Magnet (Static Field Strength), Appearance, Receive Coil and some specifications.

The provided text is a 510(k) Summary for a Pica Whole Body MRI System. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain any information about acceptance criteria, device performance, sample sizes used for testing, ground truth establishment, or clinical study results in the manner requested.

Specifically, the document states: "Performance testing was conducted to validate and verify that the proposed device, Pica Whole Body MRI System met all design specifications and was substantially equivalent to the predicate device." It also mentions "modifications" to the existing and cleared Pica Whole Body MRI System (K091580) in Magnet (Static Field Strength), Appearance, Receive Coil, and some specifications.

Without further documentation, it's impossible to answer the specific questions about acceptance criteria and study details. This 510(k) summary is a high-level overview and does not delve into the detailed performance data or study methodology.

Therefore, for each point requested:

1. A table of acceptance criteria and the reported device performance

• Not available in the provided text. The text only states that performance testing was conducted to meet "all design specifications" and demonstrate "substantial equivalence," but no specific criteria or performance metrics are listed.

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

• Not available in the provided text. The document does not mention any sample sizes, data provenance, or study design (retrospective/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 available in the provided text. The document does not describe the establishment of ground truth or the involvement of experts for any test sets.

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

• Not available in the provided text. No information about adjudication methods is provided.

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 applicable / Not available in the provided text. This device is an MRI system, not an AI-powered diagnostic tool for image interpretation. Therefore, a MRMC comparative effectiveness study comparing human readers with AI assistance would not be relevant for this type of submission. The document focuses on the hardware and basic functionality of the MRI system.

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

• Not applicable / Not available in the provided text. As this is an MRI system, standalone algorithm performance in the context of AI is not relevant. The device's performance relates to image acquisition quality, field strength, and other physical/technical specifications.

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

• Not available in the provided text. Ground truth information is not provided. For an MRI system, ground truth might relate to image quality metrics, object visibility, or signal-to-noise ratios, often established through phantom studies or comparison with accepted reference standards, but these details are not in the document.

8. The sample size for the training set

• Not applicable / Not available in the provided text. This is an MRI hardware system, not a machine learning algorithm that requires a training set in the typical sense.

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

• Not applicable / Not available in the provided text. See point 8.

Ask a specific question about this device

Mona - Orthopedic MRI System is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Mona - Orthopedic MRI System is a 0.2T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is aninteractive program with user friendly interface.

The provided text describes an Abbreviated 510(k) Report for the MONA MRI system.

Here's an analysis of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets (e.g., specific signal-to-noise ratios, image resolution metrics, or diagnostic accuracy thresholds). Instead, it states a general performance goal for the device:

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing including clinical and laboratory testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the clinical data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for any clinical test set. The intended use states "These images when interpreted by a trained physician yield information that may assist in diagnosis," implying interpretation by medical professionals, but specifics are missing.

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

The document does not specify any adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study nor any effect size of human readers with vs. without AI assistance. The device in question is an MRI system, not an AI-powered diagnostic tool, so such a study would not typically be part of its clearance process in 2009.

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

The device is an MRI system, which is a diagnostic imaging device. Its function is to produce images for human interpretation. Therefore, a "standalone algorithm only" performance study in the context of AI would not be relevant or performed for this type of medical device in 2009. The document only refers to the system meeting design specifications and being substantially equivalent to a predicate.

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

The document does not specify the type of ground truth used for any clinical testing. It only generally states that testing was done to ensure the device met specifications and was substantially equivalent. For an MRI system, general ground truth would relate to image quality (e.g., resolution, contrast, artifact levels) and the ability to visualize anatomical structures, typically established by physicists, engineers, and clinical radiologists.

8. The sample size for the training set:

The document does not provide any information about a training set size. This is consistent with the device being an MRI system rather than an AI/ML algorithm that requires a training set.

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

Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable and not provided.

Summary of available information:

The provided 510(k) summary focuses on demonstrating that the Mona - Orthopedic MRI System is "substantially equivalent" to a predicate device (mStar MPF4500) and complies with relevant international and national standards. It broadly states that "performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device... met all design specifications." However, it lacks specific details regarding the methodology, sample sizes, ground truth establishment, or expert involvement for any clinical or performance studies. This level of detail is typical for 510(k) summaries for devices cleared prior to the more recent emphasis on detailed AI/ML performance evaluations and statistical rigor in some device categories.

Ask a specific question about this device

PICA is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Pica may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Pica Whole Body MRI System is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is an interactive program with user friendly interface.

The provided text is a 510(k) Summary for the Pica Whole Body MRI System. It details the device's technical specifications and claims of substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria for device performance, nor does it describe a study proving the device meets particular performance metrics with reported results like sensitivity, specificity, or accuracy.

The document focuses on the regulatory submission process, device description, intended use, and a statement of substantial equivalence. It mentions "Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device... met all design specifications," but it does not provide the acceptance criteria or the study results in this summary.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text.

The text does state:

• Test Conclusion: "Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, Pica Whole Body MRI System met all design specifications and was substantially equivalent to the predicate device."
• SE Conclusion: "Pica Whole Body MRI System, is claimed to be Substantially Equivalent (SE) to the predicate device, mStar MPF4500 (K073457)."

This indicates that some performance testing was done, but the specifics are not detailed in this summary. The summary is primarily a regulatory document asserting substantial equivalence.

Ask a specific question about this device