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The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, and sagittal cross-sectional images that display the internal structure of breast tissue, axilla, and chest wall local to the breast. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended for breast imaging.

• . Anatomical region: Breast tissue, axilla, and chest wall local to the breast
• . Nucleus excited: Proton
• . Diagnostic uses: 2D, 3D T1-/T2-weighted imaging T1. T2, proton density measurements Image processing
• Imaging Capabilities: 2D Spin Echo (SE) . 2D/3D Gradient Echo (GRE) Fat Suppression
• . Imaging Processing: Image Subtraction Image Filtering

The Aurora MR Spectroscopy Package is intended for use as a noninvasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.

The modified AURORA is identical to the AURORA breast imaging system cleared by the FDA through K032082 except for the addition of the Spectroscopy pulse sequence protocol and its corresponding user interface software.

The provided text describes an FDA 510(k) submission for the "Spectroscopy Package for AURORA MRI System" (K073425). However, it does not contain explicit acceptance criteria and corresponding performance metrics for the device, nor does it detail a comprehensive study proving the device meets specific acceptance criteria in the manner requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (Aurora MRI System K032082) for an added Spectroscopy Package. It states: "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." but does not elaborate on the nature of this testing, the acceptance criteria, or the results.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's what can be gathered and what remains unknown based on the input:

Description of Acceptance Criteria and Study (Derived Information and Gaps)

1. A 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 (Test Set): Not specified.
• Data Provenance: Not specified.

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 specified.
• Qualifications of Experts: Not specified. The document only states that the spectral data provide information "When interpreted by a trained medical practitioner."

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

• Adjudication Method: 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

• MRMC Study: Not mentioned or implied. This device is an MRI system with an added spectroscopy package, not explicitly described as an AI-assisted diagnostic tool in the document.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study or AI assistance is detailed.

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

• Standalone Performance: Not mentioned. The spectroscopy package provides "information based on relative concentration of the Choline metabolite" which is explicitly stated to be useful "When interpreted by a trained medical practitioner," indicating a human-in-the-loop scenario. No autonomous diagnostic capability is described.

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

• Type of Ground Truth: Not specified. Given the nature of spectroscopy for metabolite concentration, ground truth for performance validation could involve phantom studies, ex vivo tissue analysis, or comparison with established in vivo methods (e.g., biopsy for pathology confirmation, though this is not directly related to spectroscopy performance metrics, but rather its clinical utility). However, the document does not elaborate.

8. The sample size for the training set

• Sample Size (Training Set): Not specified. The document does not describe a machine learning algorithm that would require a distinct "training set" in the modern sense. The "testing" mentioned is likely validation of the pulse sequence and software, rather than training of a classification algorithm.

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

• Ground Truth Establishment (Training Set): Not applicable, as no training set for a machine learning model is described.

Summary of what is known:

• The device is an MRI system with an added Spectroscopy Package.
• The Spectroscopy Package is intended to provide information based on the relative concentration of the Choline metabolite in breast tissues.
• The output (spectral data) is meant to be interpreted by a trained medical practitioner.
• "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence."
• The submission claims substantial equivalence to a predicate MRI system (K032082) for its core function, acknowledging the new spectroscopy package as the modification.

Key Gaps in Information:

The document lacks critical details regarding the specific performance testing, acceptance criteria, study design (sample size, data provenance, expert involvement, ground truth methods), and results related to the spectroscopy package's diagnostic capabilities. The primary focus of this 510(k) summary is establishing substantial equivalence for the overall device due to the mere addition of a pulse sequence, rather than detailing a
comprehensive clinical performance study typical for novel diagnostic claims. For an addition to an already cleared system, often the focus for the 510(k) is demonstrating that the addition does not introduce new safety concerns and performs as expected technically, rather than a full clinical efficacy trial against specific diagnostic criteria.

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The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained noninvasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician. these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods.

• . Anatomical region: Breast tissue, axilla, and chest wall local to the breast
• . Nucleus excited: Proton
• Diagnostic uses: 2D, 3D T1-/T2-weighted imaging .

T1, T2, proton density measurements Image processing

• . Imaging Capabilities: 2D Spin Echo (SE) 2D/3D Gradient Echo (GRE) Fat Suppression
• . Imaging Processing: Image Subtraction Image Filtering

The modified AURORA is identical to the AURORA breast imaging system cleared by the FDA through K032082 except for the addition of the RODEO Spiral 3D pulse sequence.

The provided 510(k) summary for the AURORA Magnetic Resonance Diagnostic Device (K052698) describes modifications to an existing MRI system. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a study proving performance against those criteria, or the use of AI.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K032082) after adding a new pulse sequence (RODEO Spiral 3D). It states that "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence," but it does not elaborate on the nature of this testing, the acceptance criteria, or the results.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria or a direct comparison of device performance against such criteria. The testing was focused on validating the safety and performance of the new pulse sequence.

Missing Information: A table of acceptance criteria and reported device performance is not provided in the summary. The summary is primarily a regulatory filing for substantial equivalence based on a new pulse sequence, not a detailed clinical or performance study report.

Sample Size and Data Provenance:

The document states "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence."
Missing Information: The summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

Number and Qualifications of Experts for Ground Truth:

Missing Information: There is no mention of experts used to establish ground truth for a test set, as this level of detail is not typically included in a 510(k) summary that focuses on validating a pulse sequence addition.

Adjudication Method:

Missing Information: No adjudication method is mentioned, as the summary does not detail any studies involving multiple readers or the establishment of ground truth in that way.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Missing Information: A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document does not describe any human reader studies, either with or without AI assistance. The device is an MRI system, not an AI-powered diagnostic tool.

Standalone (Algorithm Only) Performance Study:

Missing Information: A standalone performance study for an algorithm is not described. This device is a magnetic resonance imaging device, and the submission is about a new pulse sequence for image acquisition, not an AI algorithm for image interpretation.

Type of Ground Truth Used:

Missing Information: The summary does not describe the type of ground truth used, as it doesn't detail any studies requiring such a ground truth for diagnostic accuracy. The testing mentioned is for the "safety and performance" of a new MRI pulse sequence, which would typically involve image quality assessments or phantom studies, rather than clinical ground truth like pathology or outcomes data.

Sample Size for Training Set:

Missing Information: There is no mention of a training set sample size. This is consistent with the nature of the device being an MRI system with a new pulse sequence, rather than an AI or machine learning algorithm that requires a training set.

How Ground Truth for Training Set was Established:

Missing Information: As no training set is mentioned, there is no information on how its ground truth might have been established.

In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence for a hardware/software modification (addition of a pulse sequence) to an existing MRI device. It does not contain the detailed performance study information, including acceptance criteria, sample sizes, expert involvement, or AI-specific data, that your request outlines.

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The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods.

The modified AURORA is identical to the AURORA breast imaging system cleared by FDA through K032082 except for the addition of the RODEO fat-suppression pulse sequence.

The provided text describes a 510(k) summary for the AURORA Magnetic Resonance Diagnostic Device. It states that "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." However, no specific acceptance criteria or detailed study results demonstrating how the device meets those criteria are included in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on similarities in intended use, design, and technological characteristics, particularly the addition of a new fat-suppression pulse sequence.

Therefore, the following information cannot be extracted from the given text:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 mentioned.
• If a standalone performance study was done: The document mentions "Testing was performed to validate the safety and performance," but doesn't detail the type of study or its results, making it impossible to confirm if standalone performance was specifically assessed and reported.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

The document primarily serves as a regulatory submission (510(k)) to demonstrate substantial equivalence for a modification to an existing MRI system, focusing on the addition of a new fat-suppression pulse sequence, rather than a detailed report of clinical validation studies with specific performance metrics and acceptance criteria.

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The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods.

The modified AURORA is identical to the AURORA breast imaging system cleared by FDA through K012154 except that the magnet is ramped to 1.5 T and the RF system and spectrometer have been changed to operate at the higher frequencies required for 1.5 T operation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AURORA Magnetic Resonance Diagnostic Device:

Critical Observation: The provided document is a 510(k) summary for a modification to an existing medical device (AURORA MRI system, K012154). The modification is specifically an upgrade from a 0.5 T magnet to a 1.5 T magnet and associated RF system and spectrometer changes. This significantly impacts the type of "study" described, as it's not a full de novo clearance for a new device, but rather a demonstration of substantial equivalence.

Based on the provided text, the "study" conducted for this 510(k) clearance is primarily focused on technical performance validation rather than clinical efficacy or diagnostic accuracy with human interpretation.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this specific 510(k) are implicitly tied to demonstrating that the 1.5 T AURORA system performs as expected for an MRI device and is substantially equivalent to the predicate device, despite the magnet strength increase. The testing focused on technical specifications rather than diagnostic performance.

The document explicitly states:

• Acoustic Noise Measurement: Measured to ensure it meets safety and performance standards.
• Specific Absorption Rate (SAR) Measurement: Measured to ensure patient safety regarding RF energy absorption.
• Slice Thickness Measurement: Measured to confirm imaging precision.
• Signal-to-Noise Ratio (SNR) Measurement: Measured to assess image quality and clarity.
• Image Uniformity Measurement: Measured to ensure consistent image quality across the scanned area.

Methodology: According to NEMA (National Electrical Manufacturers Association) standards, indicating recognized industry testing protocols for MR systems. |
| Substantial Equivalence to Predicate Device (K012154) | The entire submission is based on the claim of substantial equivalence. The argument is that the intended use, design, and technological/operational characteristics are similar, with the key difference being the magnet strength and corresponding RF/spectrometer changes. |

Study Details

Given the nature of the 510(k) (upgrade to an existing system, not a new clinical diagnostic device), many of the requested details about clinical studies, expert-read data, and ground truth are not present or applicable in this specific document. The "study" described is a technical validation of system performance.

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

   • Test Set Sample Size: Not applicable. The testing described focuses on device parameters (acoustic noise, SAR, etc.) using standards and phantoms, not a sample of patient data for diagnostic evaluation.
   • Data Provenance: Not applicable in the context of clinical data. The testing was conducted according to NEMA standards, which implies controlled laboratory or testing environments using phantoms or specialized measurement equipment. No country of origin for clinical data is mentioned as no clinical data study of diagnostic accuracy is discussed. The testing is likely internal engineering validation.
   • Retrospective/Prospective: Not applicable to the described technical testing.

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

   • Not applicable. Ground truth for diagnostic performance is not established because the "test set" is not a set of clinical cases requiring diagnosis. The "ground truth" for the technical measurements would be the NEMA standard specifications themselves.

3. Adjudication Method for the Test Set:

   • Not applicable. No expert adjudication of diagnostic findings is mentioned.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. No MRMC study is mentioned. The focus is on the technical performance of the MRI hardware, not on reader performance or diagnostic accuracy.
   • Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no AI component or clinical reader study is discussed.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, in spirit, but not as an "algorithm." The "standalone" performance here refers to the device's technical specifications (SNR, uniformity, etc.) measured independently, without human diagnostic interpretation as part of the evaluation for this 510(k). There is no "algorithm" in the sense of AI being evaluated.

6. The Type of Ground Truth Used:

   • For the technical performance evaluations (acoustic noise, SAR, slice thickness, SNR, image uniformity), the ground truth is against pre-defined technical specifications and NEMA standards. There is no clinical "ground truth" (e.g., pathology, outcomes data) mentioned in this submission as it's not a clinical performance study.

7. Sample Size for the Training Set:

   • Not applicable. This device is an MRI scanner, not an AI-powered diagnostic tool. There is no "training set" in the context of machine learning or algorithms. The "training" for the device would involve calibration and quality control procedures, not data for an algorithm.

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

   • Not applicable, as there is no "training set" for an algorithm.

In summary, this 510(k) is for a technical upgrade of an existing MRI device. The "study" described is a technical validation of the physical and imaging performance characteristics of the 1.5 T system against established engineering and NEMA standards, not a clinical study to assess diagnostic accuracy or the performance of an AI algorithm.

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The Aurora® MR-Guided Interventional System (the System) is an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device. The System is intended to aid in the performance of minimally invasive diagnostic procedures of the lateral or medial side of either breast and adjacent anatomies, which may be facilitated by MR guidance. Such procedures must be performed with MR-compatible devices as selected and evaluated by the clinical user.

The use and operation of the Aurora® MR-Guided Interventional System and other MR-guided biopsy systems is based on the well-known method of target planning to determine the desired placement of an interventional device in three dimensions from an MR image. The basic targeting technique uses a three-dimensional MR-visible crosshair mounted near the needle guide in a fixed and known location. The stage is moved so that the needle guide and, consequently, the marker are moved to the general vicinity of the lesion to be targeted. The Aurora® MR-Guided Interventional System consists of four major subsystems: (1) Base plate system and components, (2) Needle guidance stage and components, (3) Position display unit (PDU), and (4) Target Planning Application (software).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aurora® MR-Guided Interventional System:

Based on the provided 510(k) summary, the information regarding robust clinical studies with specific acceptance criteria, sample sizes, and expert adjudication is not present. This document focuses primarily on establishing substantial equivalence to predicate devices through design and performance specifications, quality control, and general verification/validation.

Here's a breakdown of the requested information, noting what can (and cannot) be found in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly detailed in the provided summary. The document states: "The Aurora® MR-Guided Interventional System was tested to and demonstrated in compliance with design and performance specifications and included biocompatibility testing, reprocessing validation, and verification/validation testing." This implies that internal acceptance criteria were met for these tests, but the specific metrics are not publicly disclosed in this document.

For a medical device of this nature, typical performance criteria would include:

• Targeting Accuracy: The precision with which the system guides an interventional device to a lesion.
• Reproducibility: Consistency of targeting accuracy across multiple uses.
• Ease of Use/Workflow: How efficiently and intuitively the system can be operated by a clinician.
• System Latency: The time delay between user input and system response.
• Biocompatibility: Assessment of materials in contact with the patient.
• Reprocessing Validation: Confirmation that the device can be effectively sterilized or disinfected.

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

Not specified. The document does not provide details on sample sizes for any specific performance tests. There is no mention of "test sets" in the context of clinical data for performance evaluation in patients. The focus is on technical "design and performance specifications."

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

Not Applicable/Not Specified. Since there are no explicit details about a test set with patient data requiring ground truth, there is no information about experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set

Not Applicable/Not Specified. As above, no explicit test set with patient data is described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention any MRMC study or any comparative effectiveness study with human readers, either with or without AI assistance. The device is purely an accessory for MR-guided intervention, not an AI software interpreting images.

6. If a Standalone Study Was Done

No relevant standalone study described in this context. The device itself is an accessory system for MR-guided procedures. Its "standalone" performance would likely refer to its mechanical and software accuracy in guiding a needle, which is covered under general "design and performance specifications" and "verification/validation testing" but not detailed as a distinct 'standalone study' with specific metrics.

7. The Type of Ground Truth Used

Not explicitly specified for performance evaluation. For biocompatibility and reprocessing validation, the ground truth would be established by validated laboratory standards and protocols. For the core functionality of the device (targeting), the ground truth for "design and performance specifications" would likely come from engineering measurements against a known target or phantom, rather than clinical pathology or outcomes data.

8. The Sample Size for the Training Set

Not Applicable/Not Specified. The document describes a mechanical/software system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.

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

Not Applicable/Not Specified. Since there's no mention of a training set, the method for establishing its ground truth is also not applicable.

Summary of Findings:

The provided 510(k) summary for the Aurora® MR-Guided Interventional System focuses on demonstrasting substantial equivalence to predicate devices and adherence to general design and performance specifications, biocompatibility, reprocessing, and verification/validation testing. It does not include detailed specific acceptance criteria, clinical study designs, sample sizes, expert involvement, or adjudication methods typically found in submissions for AI-powered diagnostic devices or those requiring extensive clinical outcome studies to demonstrate efficacy. This is common for accessory devices where performance is primarily assessed through engineering and bench testing rather than large-scale human clinical trials.

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The AURORA MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (12), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods.

The AURORA Magnetic Resonance Diagnostic Device is being enhanced by a "forklift upgrade" to increase the clinical utility of the AURORA in the stationary configuration. With the "forklift upgrade," the AURORA is available in a stand-alone configuration, and as an upgrade path to existing AURORA installations.

The "forklift upgrade" enhancement is an alternate main MRI magnet, operating at a nominal field strength of 0.5T, and improved RF-chain and gradient-chain subsystems. No changes in software or pulse sequences were necessary to support full functionality of these "forkliff upgrade" enhancements.

The provided document is a 510(k) premarket notification for the AURORA Magnetic Resonance Diagnostic Device. It largely focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance studies with quantitative results, or specific expert evaluations beyond general statements of intended use and safety.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria or quantitative reported device performance metrics in the way one would typically find for a new, substantially different device or software. The submission focuses on a "forklift upgrade" to an existing device (AURORA K003561) and claims substantial equivalence.

The "performance" described is in terms of its functional capabilities and imaging characteristics, which are implicitly considered 'acceptable' because they are identical to the predicate device.

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

The document does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states, "Laboratory and clinical testing to internationally-accepted standards were performed to support this claim of substantial equivalence," implying that such testing occurred, but no details are provided about the datasets used or their characteristics.

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. Given that the submission focuses on hardware upgrades and claims "identical" technological characteristics to a predicate device, it's possible that a formal ground truth establishment process with multiple experts for novel diagnostic performance was not deemed necessary for this specific 510(k) submission.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The AURORA device described here is an MRI system, not an AI-powered diagnostic algorithm designed to assist human readers. Thus, an MRMC study comparing human readers with and without AI assistance would not be relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The AURORA is a complete MRI system, not a standalone algorithm.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation. As noted, the submission emphasizes substantial equivalence based on the hardware upgrade and existing predicate device characteristics, rather than a novel diagnostic performance claim requiring extensive new clinical ground truth establishment.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this submission. The AURORA is an MRI system; it is not an AI/ML algorithm that is "trained" in the conventional sense with a distinct training set. The "software or pulse sequences" are mentioned as being unchanged, implying they were developed and validated prior to this upgrade, but no training set details are given.

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

This information is not provided and is not applicable. As explained above, this submission is for an MRI hardware upgrade and does not involve an AI/ML algorithm with a training set and corresponding ground truth.

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