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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Inferred/Assumed for MRI Spect.)	Reported Device Performance (Not explicitly stated in document)
Preamble: The document states the 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 NMR properties. When interpreted by a trained medical practitioner, these spectral data provide information useful in diagnosis.	Preamble: The document states "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." However, no specific performance metrics like sensitivity, specificity, accuracy, or quantitative measures of choline concentration accuracy are provided in relation to any acceptance criteria.
Specific Performance Criteria: Not specified within the document. For the addition of a Spectroscopy Package, typical performance criteria might include:	No specific performance data is provided to correlate with these inferred criteria.
- Spectral quality/resolution: Ability to clearly identify and separate choline peaks.
- Accuracy of metabolite quantification (e.g., choline concentration): How close measured values are to true values.
- Reproducibility/Repeatability: Consistency of spectral data and quantification over multiple scans.
- Consistency with established spectroscopy methods: Comparison to other validated spectroscopy devices or techniques.
- Safety: Ensuring the new pulse sequence does not introduce new risks to the patient or operator.	(General safety validation is mentioned for the system as a whole.)
- Performance equivalent to predicate device for imaging: The core MRI system remains substantially equivalent to K032082.	(Implied through substantial equivalence claim for the core system.)

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.

Summary

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Spectroscopy Package for AURORA MRI System

SEP 1 6 2008

510 (k) Number: K073425

510(k) Summary for the

AURORA Magnetic Resonance Diagnostic Device

(Revised Version of "510(k) Summary" of the Original Submission)

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510(k) Summary for the

AURORA Magnetic Resonance Diagnostic Device

(per 21 CFR 807.92)

1. Sponsor

Aurora Imaging Technology Inc. 39 High Street North Andover, MA 01845

Contact Person:	J. P. Ouellette
Telephone:	978.975.7530 x4345

Date Prepared: September 12, 2008

2. Device Name

Proprietary Name: Aurora Common/Usual Name: Magnetic Resonance Imaging Device Classification Name: Magnetic Resonance Diagnostic Device

3. Predicate Device(s)

Aurora MRI System (K032082) GE Probe (K930265) Siemens (K951650)

4. Device Description

5. Intended Use

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

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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

Technological Characteristics and Substantial Equivalence 6.

Aurora Imaging Technology, Inc., makes a claim of substantial equivalence of the modified AURORA to the predicate AURORA (K032082) based on similarities in intended use, design, and technological and operational characteristics. Both are indicated for magnetic resonance imaging of the breast. Both systems use the same hardware and software except that the modified device includes a new Spectroscopy Package.

7. Testing

Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence.

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Spectroscopy Package for AURORA MRI System

510 (k) Number: K073425

Indications for Use Statement

(Revised Version of Section "Indications for Use Statement" of the Original Submission)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

SEP 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J.P. Ouellette, M.S. Director of Quality Assurance & Regulatory Affairs Aurora Imaging Technology, Inc. 39 High Street NORTH ANDOVER MA 01845

Re: K073425

Trade/Device Name: AURORA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 25, 2008 Received: August 27, 2008

Dear Mr. Ouellette:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

hope Mr. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K073425

Device Name: Spectroscopy Package for AURORA MRI System

Indications for Use: AURORA

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 physician without the use of ionizing radiation. The MR system produces transverse, coronal, and sagittle cross-sectional images that display the internal structure of breast tissue, axilla, and sagillal cross-sectional images production in agest. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine (hydrogen nuclei)
profon density spin Jotties relovetion (in extroperties that determine the image appearanc proton density spin-latice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained of blackers the (11), Spir-Spill relaxation 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 .

Imaging Capabilities:	T1, T2, proton density measurementsImage processing2D Spin Echo (SE)2D/3D Gradient Echo (GRE)Fat Suppression
Imaging Processing:	Image SubtractionImage Filtering

The Aurora MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra a 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 proctitioner, these since (12), and onemical shift. When interpreted by a trained
dotermination determination

PRESCRIPTION USE
(21 CFR 801 SUBPART D)

Over-the-counter use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.