Search Results

The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of the scan.

The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

The modification performed on the uMR 780 (K191157) in this submission is due to the following changes that include:

• 1. Addition and modification of pulse sequences
  • New pulse sequences: gre_quick_wfi, hise, gre_quick_4dcemra, gre_ute, a) gre_maps.
  • Broadened application scope of contrast characteristic for certain sequences: b) T1, T2, Pd.
  • Added associated options for certain sequences: dark blood, navigator, multic) echo, reduced-FOV, computed DWI.
  • d) Added reconstruction methods for certain sequences: compressed sensing, AI-assisted compressed sensing.
• 2. Addition of imaging processing methods: FACT (Fat Analysis and Calculation Technique), PSIR (Phase Sensitive Inversion Recovery), cDWI (Computed DWI), Inline T1/T2* Map, SWI+ (Susceptibility Weighted Imaging Plus).

The provided text is a 510(k) summary for the uMR 780 device, a magnetic resonance diagnostic device. Based on the content, this document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device due to software modifications (new pulse sequences and imaging processing methods).

Crucially, the document explicitly states: "No clinical testing was conducted on the proposed devices." This means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be provided from this document.

The 510(k) summary asserts that the modifications "don't affect the intended use or alter the fundamental scientific technology of the device" and that "the test results demonstrated that the device performs as expected." However, it does not elaborate on the specific acceptance criteria or the study design/results for these non-clinical tests.

Therefore, for the information requested in your prompt, the answer is:

Based on the provided 510(k) summary, clinical testing was explicitly stated as "No clinical testing was conducted on the proposed devices." Therefore, the document does not contain the information required to answer the following questions regarding acceptance criteria and performance studies for the device:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sizes used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth established.
4. Adjudication method for the test set: Not applicable.
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 as no clinical study or AI assistance comparison was detailed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as "AI-assisted compressed sensing" is mentioned but no performance data for it is provided, and no standalone algorithm was described as being evaluated clinically.
7. The type of ground truth used: Not applicable as no clinical ground truth established.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document discusses "Performance evaluation report for Spectroscopy, Computed DWI, AI-assisted compressed sensing" under "Non-Clinical Tests," but it only states that "The test results demonstrated that the device performs as expected" without detailing the specific criteria, methods, or results of these non-clinical performance evaluations.

Ask a specific question about this device

The uMR 780/uMR790 system is indicated for use as a magnetic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of the scan.

The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

The uMR 790 is a 3.0T superconducting magnetic resonance diagnostic device with a 60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 790 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

The modification performed on the previously cleared devices (K181370 for uMR 780 and K181371 for uMR 790) is due to the modification of magnet. The modification, which do not affect the intended use or alter the fundamental scientific technology of the device, is following:

A modify magnet with a new model number;

In addition, seven coils which have been previously cleared by FDA via K183186 (Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24) are added in this submission.

This document is a 510(k) Summary for medical device clearance, specifically for the uMR 780 and uMR 790 Magnetic Resonance Diagnostic Devices. It describes modifications to previously cleared devices (K181370 for uMR 780 and K181371 for uMR 790) and the addition of previously cleared coils.

It explicitly states that no clinical testing was conducted on the proposed devices. Therefore, the information requested regarding acceptance criteria based on clinical performance, sample sizes for test sets, expert-established ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set sample sizes, and ground truth establishment for training sets is not available within this document. The provided text indicates a reliance on non-clinical testing and substantial equivalence to predicate devices rather than new clinical effectiveness studies.

The acceptance criteria described in the document relate to engineering and safety standards, not clinical performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The document states, "No clinical testing was conducted on the proposed devices." The non-clinical tests would have involved physical measurements of the devices themselves, not patient data sets.

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

• Not Applicable. No clinical test set or ground truth established by experts is mentioned in this document.

4. Adjudication method for the test set:

• Not Applicable. No clinical test set or adjudication process is mentioned.

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. The document explicitly states "No clinical testing was conducted on the proposed devices." This type of study would fall under clinical effectiveness.

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

• No. As a Magnetic Resonance Diagnostic Device (MRDD), it is a hardware system that produces images for interpretation by a physician. There is no mention of an "algorithm only" component with standalone performance in this document. The device is not an AI-driven image analysis tool, but an imaging system.

7. The type of ground truth used:

• Not Applicable. For the non-clinical tests described, the "ground truth" would be established engineering specifications and measurement standards, not medical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• Not Applicable. No training set is mentioned as no machine learning or AI algorithm development is described in this document.

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

• Not Applicable. No training set is mentioned.

Ask a specific question about this device

The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

The provided text does not contain detailed acceptance criteria for a medical device's performance, nor does it describe a study specifically designed to "prove the device meets the acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis of the provided information based on your requested points:

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

The document lists several NEMA MS standards that the uMR 780 conforms to, which implicitly define performance criteria. However, it does not explicitly state acceptance criteria in a quantitative form (e.g., "SNR must be > X dB") nor does it present the specific numerical results obtained for each of these performance metrics. It only states: "The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared."

Therefore, a table cannot be constructed with the provided information.

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

The document mentions:

• "A volunteer study was used to determine the safety limits associated with gradient-induced nerve stimulation."

• "Sample clinical images were provided to support the ability of uMR 780 to A generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions."

• Sample size for gradient-induced nerve stimulation study: Not specified.

• Sample size for diagnostic image quality study: Not specified (referred to as "Sample clinical images").

• Data provenance: Not specified (e.g., country of origin, retrospective or prospective nature).

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)

This information is not provided. The diagnostic images were "interpreted by a trained physician," but the number of physicians, their qualifications, or the process for establishing ground truth from these images is not detailed.

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

This information is not 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

• No MRMC comparative effectiveness study is mentioned.
• The device is a Magnetic Resonance Diagnostic Device (uMR 780), which is an imaging scanner, not an AI-assisted diagnostic tool for interpretation. Therefore, the question about human reader improvement with AI assistance is not applicable in this context.

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

• A "standalone" study in the context of an algorithm's performance is not applicable to a physical imaging device like the uMR 780.
• The document implies that the device itself (uMR 780) was tested for its performance metrics (NEMA standards, SNR, uniformity, geometric distortion, etc.) and for its ability to produce diagnostic quality images, which can be seen as standalone performance for the device's image acquisition capabilities.

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

• For the "sample clinical images" used to support diagnostic quality, the ground truth is implicitly understood to be the interpretation by "a trained physician." However, the method for establishing a definitive "ground truth" (e.g., expert consensus, comparison to another gold standard like pathology, or follow-up outcomes) is not explicitly described.
• For the NEMA standards testing, the "ground truth" is the established reference values or methods defined by those standards.

8. The sample size for the training set

The document does not describe any "training set" as it pertains to AI/machine learning algorithms. The uMR 780 is a hardware device for acquiring images.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

In summary:

This document is a 510(k) summary focused on demonstrating substantial equivalence for a new MRI scanner (uMR 780) to a predicate device (SIEMENS MAGNETOM SKYRA). It primarily relies on engineering and performance testing against industry standards (NEMA, IEC, ISO) and a volunteer safety study, along with providing "sample clinical images" to show diagnostic quality. It does not provide the detailed diagnostic performance studies (like sensitivity, specificity, accuracy against a clinical ground truth, or reader studies) that would typically be described for a diagnostic AI algorithm.

Ask a specific question about this device