measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
monitor liver iron burden in transfusion dependents and patients with sickle cell disease receiving blood transfusions:
aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox.

For Liver Fat Assessment

assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease.

When interpreted by a trained physician, the results can be used to:

monitor liver fat content in patients undergoing weight loss management;
aid in the assessment and screening of living donors for liver transplant.

Device Description

LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI (K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multiparametric 'LiverSmart' report.

LiverSmart automatically sorts and sends magnetic resonance imaging (MRI) datasets to each of the existing HepaFat-AI and FerriSmart devices and then receives results from those devices to generate a summary report which combines the HepaFat-AI results (an estimate of the patient's volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), steatosis grade), and the FerriSmat result (an estimate of the patient's liver iron concentration (LIC)).

To conduct analysis, the user simply uploads a single zipped folder containing HepaFat-AI and FerriSmart DICOM images, acquired in accordance with their respective acquisition protocols, to the LiverSmart software. No user input is required for the analysis thereby minimising the impact of human error. The LiverSmart software requires image input data that has been acquired in accordance with the existing and now well established HepaFat-AI (K201039) and FerriSmart (K182218) imaging protocols.

LiverSmart has two new components that are in addition to the existing components of HepaFat-AI and FerriSmart, namely a:

(i) Data Preparation Module; and
(ii) Report Generation Module

The rest of the components for LiverSmart are the existing components of the FDA cleared HepaFat-AI and FerriSmart devices, as follows:

For HepaFat-AI:

(i) Magnetic Resonance Imaging Protocol
(ii) HepaFat-AI Analysis Software
(iii) Volumetric Liver Fat Fraction Measurement
(iv) Proton Density Fat Fraction Measurement
(v) Steatosis Grade Measurement

For FerriSmart:

(i) Magnetic Resonance Imaging Protocol
(ii) FerriSmart Analysis Software
(iii) Liver Iron Concentration Measurement

The above HepaFat-AI and FerriSmart components are the same as previously provided to the FDA as the time HepaFat-AI and FerriSmart regulatory clearances were sought (and subsequently obtained).

AI/ML Overview

The provided document, K213776, describes the LiverSmart device, which combines the functionalities of two previously cleared devices, FerriSmart (K182218) and HepaFat-AI (K201039). The core claim is that LiverSmart is substantially equivalent to these predicates, not that it offers improved performance beyond what they individually provide. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating that LiverSmart accurately integrates the functions of its predicates and produces identical results from the same input data, as opposed to proving novel clinical performance.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for LiverSmart are implicitly derived from the established performance of its predicate devices, FerriSmart and HepaFat-AI, and the requirement for LiverSmart to accurately integrate and reproduce their results.

Acceptance Criteria Category	Specific Criteria (Implicitly from document)	Reported Device Performance and Evidence (from document)
Functional Equivalence	Detect anomalies in sequence acquisition and report accurate error messages.	"Verification testing confirms that the data preparation module of LiverSmart detects anomalies in the sequence acquisition and reports the accurate error message. If an error is detected LiverSmart prevents further analysis."
Result Concordance	Yield identical results for VLFF, PDFF, steatosis grade, and LIC when compared to independent analysis by HepaFat-AI and FerriSmart.	"Additionally, LiverSmart yields identical results for VLFF, PDFF, steatosis grade, and LIC, when the same image datasets are analysed by HepaFat-AI and FerriSmart devices independently."
Safety and Effectiveness	Maintain the safety and effectiveness profile established by the predicate devices.	"LiverSmart is based upon the same technologies, operating principle, and software technology as the two predicate devices. Risk activities were conducted in concurrence with established medical device development standards and guidance." and "Resonance Health believes that enough evidence has been presented in this dossier to conclude that LiverSmart is safe, effective and performs as well as two the predicates."
Quality Systems	Designed and manufactured under Quality System Regulations (21 CFR § 820 and ISO 13485 Standards).	"LiverSmart is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards."
Harmonization	Conformity with design controls; test methods are the same as those documented in previously cleared submissions of predicates.	"A statement of conformity with design controls is included in this submission." and "The test methods used are the same as those documented in the previously cleared submissions of the predicate devices, FerriSmart (K182218) and HepaFat-AI (201039)."

Study Proving Acceptance Criteria (Verification Testing)

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

The document states "Verification testing confirms that the data preparation module of LiverSmart detects anomalies..." and "Additionally, LiverSmart yields identical results...when the same image datasets are analysed by HepaFat-AI and FerriSmart devices independently."
Sample Size: The exact sample size used for this verification testing (test set) is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions using "the same image datasets" as analyzed by the predicate devices.

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

This question is not applicable in the traditional sense for this specific 510(k) submission. The LiverSmart device is an integration of two already cleared devices. The "ground truth" for the individual measurements (LIC, VLFF, PDFF, steatosis grade) would have been established during the original clearance processes for FerriSmart and HepaFat-AI, likely through comparison with biopsy or other approved methods.
For LiverSmart, the verification testing focuses on the concordance of results between LiverSmart and its predicates, not on establishing new clinical ground truth for the measurements themselves. Therefore, no new "experts" are noted as establishing ground truth for the LiverSmart test set in this document. The "trained physician" mentioned in the Indications for Use is for interpretation, not for establishing algorithmic ground truth.

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

The document does not specify any adjudication method for the verification testing. The primary "adjudication" is the direct comparison of LiverSmart's output to the output of FerriSmart and HepaFat-AI on the same datasets, aiming for "identical results."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

An MRMC comparative effectiveness study was not conducted for LiverSmart as described in this document. LiverSmart is presented as an integration of existing cleared devices, not an improvement or replacement necessitating a comparative effectiveness study involving human readers' diagnostic performance. The document focuses on the algorithmic output matching previously cleared algorithms.

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

Yes, the verification testing described for LiverSmart is a standalone (algorithm only) performance assessment. The text states LiverSmart "automatically sorts and sends...receives results...to generate a summary report" and "No user input is required for the analysis thereby minimising the impact of human error." The verification confirms that LiverSmart's algorithmic output is identical to that of its predicate algorithms on the same input.

7. The type of ground truth used:

For the verification of LiverSmart, the "ground truth" is effectively the results produced by the FDA-cleared predicate devices (FerriSmart and HepaFat-AI) when processing the same image datasets. The goal was to demonstrate "identical results."
The original ground truth methodologies (e.g., expert consensus, pathology, outcomes data) for the measurements themselves (LIC, VLFF, PDFF, steatosis grade) would have been established and reviewed during the original 510(k) clearances for FerriSmart and HepaFat-AI, but are not detailed here for LiverSmart.

8. The sample size for the training set:

The document states that LiverSmart utilizes the "existing components of the FDA cleared HepaFat-AI and FerriSmart devices." It further notes that "The above HepaFat-AI and FerriSmart components are the same as previously provided to the FDA at the time HepaFat-AI and FerriSmart regulatory clearances were sought (and subsequently obtained)."
Therefore, the training sets (and their sizes) for the underlying convolutional neural networks (CNNs) would pertain to the development of FerriSmart and HepaFat-AI. The sample size for these training sets is not provided in this document (K213776).

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

Similar to point 8, the ground truth for the training sets would have been established during the development and clearance of FerriSmart and HepaFat-AI.
The document mentions "Convolutional neural networks for the image analysis" for both LiverSmart and its predicates, implying that these models were trained. However, this document (K213776) does not detail how the ground truth for the training sets of the predicate devices was established. This information would be found in the original 510(k) submissions for FerriSmart (K182218) and HepaFat-AI (K201039).

Summary

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December 29, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text.

Resonance Health Analysis Services Pty Ltd Mitchell Wells Official Correspondent 141 Burswood Road Perth, Western Australia 6100 Australia

Re: K213776

Trade/Device Name: LiverSmart Regulation Number: 21 CFR 892.1001 Regulation Name: Liver Iron Concentrattion Imaging Companion Diagnostic For Deferasirox Regulatory Class: Class II Product Code: PCS, LNH Dated: November 24, 2021 Received: December 2, 2021

Dear Mitchell Wells:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213776

Device Name LiverSmart

Indications for Use (Describe) LiverSmart is indicated to:

For Liver Iron Concentration

measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
monitor liver iron burden in transfusion dependents and patients with sickle cell disease receiving blood transfusions:
aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox.

For Liver Fat Assessment

assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease.

When interpreted by a trained physician, the results can be used to:

monitor liver fat content in patients undergoing weight loss management;
aid in the assessment and screening of living donors for liver transplant.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K213776

510(k)SUMMARY

This Summary has been prepared in accordance with 21 CFR 807.92.

GENERAL INFORMATION

Date Prepared	23 December 2021
Submitted by	Resonance Health Analysis Service Pty Ltd141 Burswood RdBurswood 6100AUSTRALIA
Main Contact	Mr Mitchell WellsManaging Directormitchellw@resonancehealth.comTel: +61 8 9286 5300Fax: +61 8 9286 5399
US Contact (US Agent)	Michael van der WoudeDirector & GMEmergo Global Representation LLC2500 Bee Cave Road, Building 1, Suite 300Austin, TX 78746Phone: 512 3279997Fax: 512 3279998Email: USAgent@ul.com

DEVICE INFORMATION

Name of Device	LiverSmart
Trade/proprietary Name	LiverSmart™
Classification	Class II
Product Code	90-PCS and LNH
CFR Section	892.1001 and 892.1000
Panel	Radiology

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Description of the Device

LiverSmart has two new components that are in addition to the existing components of HepaFat-AI and FerriSmart, namely a:

(i) Data Preparation Module; and
(ii) Report Generation Module

The rest of the components for LiverSmart are the existing components of the FDA cleared HepaFat-AI and FerriSmart devices, as follows:

For HepaFat-AI:

(i) Magnetic Resonance Imaging Protocol
(ii) HepaFat-AI Analysis Software
(iii) Volumetric Liver Fat Fraction Measurement
(iv) Proton Density Fat Fraction Measurement
(v) Steatosis Grade Measurement

For FerriSmart:

(i) Magnetic Resonance Imaging Protocol
(ii) FerriSmart Analysis Software
(iii) Liver Iron Concentration Measurement

The above HepaFat-AI and FerriSmart components are the same as previously provided to the FDA as the time HepaFat-AI and FerriSmart regulatory clearances were sought (and subsequently obtained).

Intended Use

For Liver:

(i) For the measurement of R2 and iron concentration in the liver from MRI scans.
(ii) For quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF).

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Indications for Use

LiverSmart is indicated to -

For Liver Iron Concentration:

(i) measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
(ii) monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; and
(iii) aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox.

For Liver Fat Assessment:

(i) Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease.
when interpreted by a trained physician the results can be used to:
(ii) Monitor liver fat content in patients undergoing weight loss management; and
(iii) Aid in the assessment and screening of living donors for liver transplant

PREDICATE INFORMATION

LiverSmart is substantially equivalent to (and is a combination of) the following Resonance Health existing 510(k) cleared devices:

FerriSmart - K182218
HepaFat-AI - K201039

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SUBSTANTIAL EQUIVALENCE INFORMATION

The table below summarizes the main similarities and differences between LiverSmart and the predicates.

	LiverSmart (Subject Device)	FerriSmart (Predicate)	HepaFat-AI (Predicate)
Regulatory Class	II	II	II
510(k) number	K213776	K182218	K201039
ClassificationName	Liver Iron Concentration ImagingCompanion Diagnostic for DeferasiroxSystem, Nuclear Magnetic ResonanceImaging, System, Image ProcessingRadiological	Liver Iron Concentration ImagingCompanion Diagnostic for Deferasirox	System, Nuclear Magnetic ResonanceImaging, System, Image ProcessingRadiological
CFR Section	892.1001 and 892.1000	892.1001	892.1000
Product Code andClassificationPanel	90 PCS and 90 LNH	90 PCS	90 LNH
Description	Standalone software package thatautomatically analyses magnetic resonanceimaging (MRI) datasets to generate anestimate of the patient's volumetric liver fatfraction (VLFF), proton density fat fraction(PDFF), steatosis grade, and liver ironconcentration (LIC). LiverSmart evaluatesimages acquired using the FerriSmart andHepaFat-AI protocols and analyses theacquired data to produce a 'multi-parametric' reporting both fat metrics andLIC.	Standalone software package thatautomatically analyses multi-slice, spin-echo MRI data sets encompassing theabdomen to provide objective andreproducible determination of liverparameters to support clinicians in theassessment of liver iron status. Thesoftware tool determines the signal decayrate (R2) that is used to characterize ironloading in the liver, which is thentransformed by a defined calibration curveto provide a quantitative measure of liveriron concentrations in vivo.	Standalone software platform designed toautomatically analyse within secondsmagnetic resonance imaging (MRI) datasets togenerate an estimate of the patient'svolumetric liver fat fraction (VLFF),converted into proton density fat fraction(PDFF) and steatosis grade. No user input isrequired for the analysis thus minimising theimpact of human error on obtained results.
	LiverSmart (Subject Device)	FerriSmart (Predicate)	HepaFat-AI (Predicate)
Technology	Convolutional neural networks for theimage analysis.Algorithmic for the image's quality checks,R2 conversion into LIC, and Alphaconversion into VLFF.	Convolutional neural networks for theimage analysis.Algorithmic for the image's quality checksand R2 conversion into LIC.	Convolutional neural networks for the imageanalysis.Algorithmic for the image's quality checkingand Alpha conversion into VLFF.
Intendedpurpose(s)	1. Supporting clinical diagnoses about thestatus of LIC and the status of liver fatcontent.2. Supporting the subsequent clinicaldecision-making processes.3. Supporting the use in clinical researchtrials, directed at studying changes inLIC and liver fat as a result ofinterventions.	1. Supporting clinical diagnoses about thestatus of LIC.2. Supporting the subsequent clinicaldecision-making processes.3. Supporting the use in clinical researchtrials, directed at studying changes inLIC as a result of interventions.	1. Supporting clinical diagnoses about thestatus of liver fat content.2. Supporting the subsequent clinicaldecision-making processes.3. Supporting the use in clinical researchtrials, directed at studying changes in liverfat as a result of interventions.
Intended Use	1. For the measurement of R2 and ironconcentration in the liver from MRIscans.2. For quantitative measurement of thetriglyceride fat fraction in magneticresonance images of the liver, alsoknown as volumetric liver fat fraction(VLFF).	1. Measurement of R2 and ironconcentration in the liver from MRIscans	1. For quantitative measurement of thetriglyceride fat fraction in magneticresonance images of the liver, also knownas volumetric liver fat fraction (VLFF).*It utilises magnetic resonance images thatexploit the difference in resonance frequenciesbetween hydrogen nuclei in water andtriglyceride fat. The quantitative triglyceridefat fraction is based on the measurement of amagnetic resonance parameter that reflects theratio of the proton density signal oftriglyceride fat to the total proton densitysignal in the liver.When interpreted by a trained physician, theresults provide information that can aid indiagnosis.
	LiverSmart (Subject Device)	FerriSmart (Predicate)	HepaFat-AI (Predicate)
Indications	LiverSmart is indicated to:For Liver Iron Concentration1. measure liver iron concentration inindividuals with confirmed or suspectedsystemic iron overload;2. monitor liver iron burden in transfusiondependent thalassemia patients andpatients with sickle cell diseasereceiving blood transfusions;3. aid in the identification and monitoringof non-transfusion-dependentthalassemia patients receiving therapywith Deferasirox.For Liver Fat Assessment1. assess the volumetric liver fat fraction,proton density fat fraction and steatosisgrade in individuals with confirmed orsuspected fatty liver disease.When interpreted by a trained physician, theresults can be used to:2. monitor liver fat content in patientsundergoing weight loss management;3. aid in the assessment and screening ofliving donors for liver transplant.	FerriSmart is Indicated to:1. measure liver iron concentration inindividuals with confirmed orsuspected systemic iron overload;2. monitor liver iron burden intransfusion dependent thalassemiapatients and patients with sickle celldisease receiving blood transfusions;3. aid in the identification and monitoringof non-transfusion-dependentthalassemia patients receiving therapywith Deferasirox.	HepaFat-AI is indicated to:1. assess the volumetric liver fat fraction,proton density fat fraction and steatosisgrade in individuals with confirmed orsuspected fatty liver disease.When interpreted by a trained physician, theresults can be used to:2. monitor liver fat content in patientsundergoing weight loss management;3. aid in the assessment and screening ofliving donors for liver transplant.
User	Radiologist	Radiologist	Radiologist
Hosting platform	Cloud-based or on-site hosting	Cloud-based or on-site hosting	Cloud-based or onsite platform
	LiverSmart (Subject Device)	FerriSmart (Predicate)	HepaFat-AI (Predicate)
Image-typeutilized	Magnetic Resonance	Magnetic Resonance	Magnetic Resonance
Image format	DICOM	DICOM	DICOM
Data Acquisitionmethod	Single Spin Echo (SSE)Gradient Recalled Echo (GRE)	Single Spin Echo (SSE)	Gradient Recalled Echo (GRE)
Anatomical Sites	Liver	Liver	Liver
Analysis SystemComponents	LiverSmart:(i) Data Preparation Module; and(ii) Report Generation ModuleFerriSmart:(i) Magnetic Resonance ImagingProtocol;(ii) FerriSmart Analysis Software; and(iii) Liver Iron ConcentrationMeasurement.HepaFat-AI:(i) Magnetic Resonance ImagingProtocol;(ii) HepaFat-AI Analysis Software;(iii) Volumetric Liver Fat FractionMeasurement;(iv) Proton Density Fat FractionMeasurement	(i) Magnetic Resonance ImagingProtocol(ii) FerriSmart Analysis Software(iii) Liver Iron ConcentrationMeasurement	(i) Magnetic Resonance Imaging Protocol(ii) HepaFat-AI Analysis Software(iii) Volumetric Liver Fat FractionMeasurement(iv) Proton Density Fat FractionMeasurement(v) Steatosis Grade Measurement
	LiverSmart (Subject Device)	FerriSmart (Predicate)	HepaFat-AI (Predicate)
Result reportcontent	(v) Steatosis Grade MeasurementPage 1(i) Report No., patient ID, patient name anddate of birth for full identification of thepatient.(ii) Scan date, and analysis date.(iii) Referrer and MRI centre.(iv) Results displayed: LIC (mg/g drytissue), LIC (mmol/kg dry tissue),associated with confidence intervals andnormal range.(v) Results displayed: VLFF (%), PDFF (%)and Steatosis grade, associated withconfidence intervals and normal range.	(i) Patient ID, patient name and date ofbirth forfull identification of thepatient.(ii) Scan date, and analysis date.(iii) Referrer and MRI centre.(iv) Results displayed: LIC (mg/g drytissue), LIC (mmol/kg dry tissue),associated with confidence intervalsand normal range.(v) Pictures of the 5 TEs of the analysedslice.(vi) LIC thresholds table	(i) Patient ID, patient name and date ofbirth for full identification of the patient.(ii) Scan date, and analysis date.(iii) Referrer and MRI centre.(iv) Results displayed: VLFF (%), PDFF (%)and Steatosis grade, associated withconfidence intervals and normal range.(v) NASH-CRN Steatosis Grading Guide(vi) Pictures of the 3 TEs of the analysedslice.(vii) Liver colour map (for illustrationpurpose only, not for diagnostic)
	Page 2As per FerriSmart reportPage 3As per HepaFat-AI report
Result reportformat	HTML and PDF	HTML and PDF	HTML and PDF

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SUMMARY OF CHANGE(S)

LiverSmart consists of two additional modules, over and above the FerriSmart and HepaFat-AI modules;

(i) the Data Preparation Module, and
(ii) the Report Generation Module.

PERFORMANCE PARAMETERS

No change from the predicates, FerriSmart (K182218) and HepaFat-AI (K201039).

SUMMARY OF DESIGN CONTROL ACTIVITIES

Hazard analysis has been performed and documented. Hazard analysis is included in this submission. The test methods used are the same as those documented in the previously cleared submissions of the predicate devices, FerriSmart (K182218) and HepaFat-AI (201039). A statement of conformity with design controls is included in this submission.

SAFETY

LiverSmart is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. LiverSmart is based upon the same technologies, operating principle, and software technology as the two predicate devices. Risk activities were conducted in concurrence with established medical device development standards and guidance.

TESTING

Risk analy sis and verification testing conducted are documented and included in this submission, which demonstrate that the performance requirements have been met.

SUBSTANTIAL EQUIVALENCE

Verification testing confirms that the data preparation module of LiverSmart detects anomalies in the sequence acquisition and reports the accurate error message. If an error is detected LiverSmart prevents further analysis. Additionally, LiverSmart yields identical results for VLFF, PDFF, steatosis grade, and LIC, when the same image datasets are analysed by HepaFat-AI and FerriSmart devices independently.

CONCLUSION

The special 510(k) premarket notification for LiverSmart contains adequate information and data to enable the FDA-CDRH to determine substantial equivalence to the predicate devices. Resonance Health believes that enough evidence has been presented in this dossier to conclude that LiverSmart is safe, effective and performs as well as two the predicates.

Regulation Number and Section

§ 892.1001 Liver iron concentration imaging companion diagnostic for deferasirox.

(a)
Identification. The liver iron concentration imaging companion diagnostic for deferasirox is an image processing device intended to aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox. The device calculates a numeric value for liver iron concentration based on magnetic resonance images acquired under controlled conditions. The calculated numeric value is used to assess the need for deferasirox treatment and for monitoring treatment in patients with non-transfusion-dependent thalassemia. The liver iron concentration imaging companion diagnostic for deferasirox is essential to the safe and effective use of deferasirox in patients with non-transfusion-dependent thalassemia.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include nonclinical and clinical performance testing demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements.
(2) Labeling must include specifying:
(i) Instructions for acceptance testing of images prior to processing;
(ii) Data processing quality assurance protocols; and
(iii) The sensitivity and specificity of liver iron concentration measurements.