Search Results

The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Embrace Neonatal MRI System is a 1Tesla Permanent MRI system producing MR images of Neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.

The provided document is a 510(k) Premarket Notification for the Embrace Neonatal MRI System. It details the device's indications for use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical studies were conducted to establish substantial equivalence for this device. Therefore, it does not contain the acceptance criteria or study details regarding device performance from a clinical perspective.

Here's the information that can be extracted or inferred:

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

Based on the document, direct clinical acceptance criteria and reported device performance from a clinical study are not available. The document focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.

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

• Test set for clinical performance: Not applicable, as no clinical studies were performed.
• Test set for non-clinical performance (phantom images, V&V): Not specified in the document. The provenance of this data is from Aspect Imaging Ltd., likely internally generated during device development.

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 studies with expert-established ground truth were performed. The document mentions "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis," but this refers to the intended use of the device, not a performance study.

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

Not applicable, as no clinical studies with adjudication were performed.

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. The device is an MRI system, not an AI diagnostic tool designed to assist human readers. Moreover, no clinical studies were performed.

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

Not applicable. This is an MRI system, not a standalone algorithm. Its performance is evaluated on its ability to produce diagnostic quality images, which are then interpreted by a human physician.

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

Not applicable for a clinical study. For the non-clinical phantom images, the "ground truth" would be the known properties and geometry of the phantoms themselves, used to assess image quality, resolution, and artifact levels.

8. The sample size for the training set:

Not applicable. This is an MRI system, not an AI model that requires a specific training set in the conventional sense. The "training" of the system would involve engineering and calibration using test data and phantoms.

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

Not applicable. As described in point 8, this is an MRI system, not an AI model with a training set. If considering the calibration and engineering process, the "ground truth" would be established through physical measurements, known phantom compositions, and established MRI physics principles.

In summary, the provided FDA 510(k) letter and summary explicitly state that no clinical studies were conducted to support substantial equivalence for the Embrace Neonatal MRI System. The device was cleared based on non-clinical testing, including phantom images, to demonstrate its ability to provide diagnostic quality images, and comparison to a legally marketed predicate device (Wrist 3 MRI System). The rationale given for not performing clinical studies was the "vulnerable patient population" (neonates) and that the "benefits of sample clinical images did not outweigh the risks associated with acquisition of those images."

Ask a specific question about this device

The Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Wrist 3 MRI System is a 1Tesla Permanent MRI system producing MR images of the wrists and hands. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.

The provided document is a 510(k) premarket notification for the Aspect Imaging Wrist 3 MRI System. It primarily focuses on demonstrating substantial equivalence to a predicate device (M2 Wrist 2 MRI System K130692) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel diagnostic algorithm.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the Wrist 3 MRI System in terms of diagnostic accuracy, sensitivity, specificity, or other outcome-based measures. The evaluation is based on demonstrating compliance with voluntary consensus standards and comparing technical specifications to the predicate device.

• Magnet Physical Dimensions: 138x87x82 cm (vs. 125x87x82 cm)
• Bore opening: 85x220 mm (vs. 76x200 mm)
• Weight: 1300 Kg (1700 with Trolley) (vs. 1050 Kg)
• Field Strength: 1 Tesla Permanent Magnet (same).
• Gradient Strength: 215 mT/m (vs. 190 mT/m)
• Gradient Rise Time: 0.200mSec (vs. 0.475mSec)
• Gradient Slew Rate: 1074 T/m/Sec (vs. 400 T/m/Sec)
• Computer Display: 15" Touch Display (vs. 24" LCD Desktop Display)
• RF Coils: 2 Coils: Small/Large (vs. 1 Coil)
• Coil Type: TX/RX (same)
• Coil Geometry: Oval (same)
• Inner Dimensions (mm): 60X100X169 / 75X135X192 (vs. 50X108X86)
• Coil Design: Linear Volume (same). |

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 states, "The subject of this premarket submission, Wrist 3 MRI System, did not require clinical studies to support substantial equivalence." It mentions "Sample clinical images" were part of the design controls activity, but does not provide details on their sample size, provenance, or whether they constituted a formal "test set" for performance evaluation against ground truth.

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 applicable, as no formal clinical study with a detailed test set and ground truth establishment is described. The "sample clinical images" used were likely for qualitative assessment as part of design validation, but the ground truth establishment method and expert details are not provided.

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

Not applicable, as no formal clinical test set or adjudication process is described.

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. This device is an MRI system, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This is a medical imaging device, not an image analysis algorithm designed for standalone performance.

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

Not applicable, as no formal clinical study with ground truth establishment is described.

8. The sample size for the training set:

Not applicable, as this is an MRI system, not an AI model that requires a training set in the conventional sense.

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

Not applicable, as this is an MRI system, not an AI model that requires a training set.

Ask a specific question about this device

The M2 Wrist 2 MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.

The M2 Wrist 2 MRI System is a 1 Tesla, compact, high-performance solution, based on a permanent magnet. Due to its remarkable structure, the external magnetic field is very low, thus offering unique safety advantage. The system has very low Eddy currents and exhibits very low gradient-related acoustic noise. The magnet is self-shielded and thus no RF shielded room is required. The type of installation is fixed. The M2 Wrist 2 MRI System's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the M2 Wrist 2 MRI System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not list specific numerical acceptance criteria with corresponding device performance metrics for diagnostic accuracy. Instead, it focuses on demonstrating that the revised device (M2 Wrist 2 MRI System) is substantially equivalent to its predicate device (M2 Wrist MRI System) and meets various safety and performance standards relevant to MRI systems.

The acceptance criteria are implicitly derived from the performance standards met, which ensure the device functions as intended and produces images of sufficient quality for diagnostic use by a trained physician. The "reported device performance" is a statement of compliance with these standards.

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

The document does not explicitly mention a "test set" in the context of clinical images or diagnostic performance. The performance data presented are "Non-Clinical" and consist of engineering tests and evaluations against industry standards. Therefore:

• Sample Size for Test Set: Not applicable/not explicitly stated in the context an imaging-based performance test with patient data. The tests performed are on the device itself (e.g., phantom images, electrical measurements) rather than on a dataset of patient images with ground truth.
• Data Provenance: Not applicable, as the tests are non-clinical engineering and performance evaluations.

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

This information is not applicable to the non-clinical performance data presented. No "experts" were used to establish ground truth for a test set of images; rather, the device's technical specifications and image quality were assessed against predefined objective standards using test equipment.

4. Adjudication Method for the Test Set

Not applicable, as no human-read test set requiring adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The summary explicitly states: "7. Clinical Performance Data: Not applicable". The submission focuses on non-clinical performance and substantial equivalence to a predicate device based on technical characteristics.

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

Not applicable. This device is an MRI system, not an AI algorithm. Its performance is inherent in its ability to produce diagnostic images for interpretation by a human physician, not to provide an automated diagnosis.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests consisted of the technical specifications and requirements defined by the various IEC and NEMA standards (e.g., specific SNR values, geometric distortion limits, acoustic noise levels). The device's performance was compared against these objective, established standards using measurement tools and phantoms.

8. The Sample Size for the Training Set

Not applicable. The M2 Wrist 2 MRI System is a medical imaging device, not an AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The M2 Wrist MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.

The Wrist MRI is a 1 Tesla high-performance solution, using NdFeB magnetic material, providing routinely 250 micron or better resolution. The system is Eddy - currents free with gradients which have high strength and a fast slew rate. The Wrist MRI is designed to ensure maximum safety of operation. Its negligible external magnetic-field eliminates the need for a specially shielded room and other limiting operational procedures. The Wrist MRI system's main components are: Magnet Sub-system, Wrist Coil, Electronics Cabinet, Aspect Imaging Proprietary Software, Computer, Isolation Transformer.

Here's a breakdown of the acceptance criteria and study information for the ASPECT IMAGING's WRIST MRI SYSTEM (K120701), based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Performance)

The document does not explicitly state quantitative "acceptance criteria" against which the device performance was measured in a table format. However, it lists several performance standards and states that the device "functioned as intended and/or met the requirements of the standard." These standards effectively serve as the acceptance criteria for the non-clinical performance.

Study Details:

Based on the provided document, the submission focuses entirely on non-clinical performance data and software validation to demonstrate substantial equivalence. No clinical study was conducted or reported.

Here's the information extracted given the lack of a clinical study:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable, as no clinical test set was used. Performance was assessed on the device itself against established standards.
   • Data Provenance: Not applicable for clinical data. The non-clinical tests were conducted on the device components and the integrated system. The applicant is from Israel.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable, as no clinical test set requiring expert ground truth establishment was used.

3. Adjudication Method for the Test Set:

   • Not applicable, as no clinical test set requiring adjudication was used.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

   • No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: Not Applicable."

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

   • The "device" in this case is the MRI system itself, not an AI algorithm. The performance evaluation focused on the physical and software components of the MRI system as a standalone imaging device, without human interpretation for the purpose of this submission (as it was non-clinical). So, in a sense, the non-clinical tests assess the "standalone" performance of the imaging system. However, this is not an AI algorithm evaluation.

6. The Type of Ground Truth Used:

   • For the non-clinical performance, the "ground truth" was defined by industry performance standards (IEC, NEMA) and the device's own design specifications. The device's performance was compared against these established standards and specifications.

7. Sample Size for the Training Set:

   • Not applicable. This is a medical imaging device (MRI system), not an AI algorithm that requires a training set in the typical sense.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there was no training set in the context of an AI algorithm.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on the technological characteristics and comprehensive non-clinical performance testing against recognized industry standards, and not through clinical trials or AI algorithm performance evaluation.

Ask a specific question about this device