VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application for non-invasive fat and muscle evaluation that enables the generation, display and review of magnetic resonance medical image data.

VitruvianScan produces quantified metrics and composite images from magnetic resonance medical image data which when interpreted by a trained healthcare professional, yield information that may assist in clinical decisions.

Device Description

VitruvianScan is a standalone, post processing software medical device. VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit).

When a referring healthcare professional requests quantitative analysis using VitruvianScan, relevant images are acquired from patients at MRI scanning clinics and are transferred to the Perspectum portal through established secure gateways. Perspectum trained analysts use the VitruvianScan software medical device to process the MRI images and produce the quantitative metrics and composite images. The device output information is then sent to the healthcare professionals for their clinical use.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study provided in the document for the VitruvianScan (v1.0) device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document unfortunately does not explicitly state the specific quantitative acceptance criteria for each performance aspect (e.g., a specific percentage for repeatability, a particular correlation coefficient). Instead, it states that "All aspects of the performance tests met the defined acceptance criteria." and that the device "successfully passed the acceptance criteria with no residual anomalies."

However, based on the described performance tests, we can infer the types of acceptance criteria that would have been defined. The document also lacks specific numerical results for the device performance that directly map to these criteria.

Performance Aspect	Inferred Acceptance Criteria (Example)	Reported Device Performance
Repeatability of metrics	Coefficient of Variation (CV) or Intraclass Correlation Coefficient (ICC) for various metrics (Visceral Fat, Subcutaneous Fat, Muscle Area) to be within a pre-defined threshold for the same subject, scanner, field strength, and day.	"met the defined acceptance criteria"
Reproducibility of metrics	Coefficient of Variation (CV) or Intraclass Correlation Coefficient (ICC) for various metrics (Visceral Fat, Subcutaneous Fat, Muscle Area) to be within a pre-defined threshold for the same subject, scanner (different field strength), and day.	"met the defined acceptance criteria"
Inter-operator variability	Low variability (e.g., high ICC or low CV) in metric measurements between different trained operators using VitruvianScan.	"Characterization of inter-operator variability" met acceptance criteria
Intra-operator variability	Low variability (e.g., high ICC or low CV) in metric measurements by the same trained operator over repeated measurements.	"Characterization of intra-operator variability" met acceptance criteria
Benchmarking against reference device	Established equivalence or non-inferiority in metric measurements when compared to a validated reference regulated device (OSIRIX MD).	"Results...compared with the results from testing using reference regulated device 'OSIRIX MD' for benchmarking performance" met acceptance criteria
Comparison to gold standard (human experts)	High agreement (e.g., high ICC, low mean absolute error) between device output and the gold standard (mean of 3 radiologists' results).	"Comparative testing between the operators' results and the gold standard (mean of 3 radiologists results)" met acceptance criteria

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

The document does not specify the sample size used for the test set.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated. However, the context of an FDA submission for a device used in clinical settings suggests the data would likely be from a clinical or research environment, potentially multi-center, but this is an inference.

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

Number of Experts: 3 radiologists
Qualifications of Experts: The document states "3 radiologists results" but does not provide specific qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The adjudication method used for the test set is implicitly a "mean (average) of 3 radiologists results" for establishing the gold standard. This suggests a form of consensus, where the average of their interpretations serves as the reference. It's not a typical "X+1" method (like 2 out of 3, or 3 out of 1 for disagreement), but rather a central tendency measure of their assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was NOT explicitly done in the sense of comparing human readers with AI assistance versus without AI assistance.

The study did involve "Comparative testing between the operators' results and the gold standard (mean of 3 radiologists results)," which evaluates the device's output and how operators use it against a human expert consensus. However, it doesn't describe a scenario where human readers improve with AI assistance in their own diagnostic performance compared to their performance without the AI. The stated use case is that "Perspectum trained analysts use the VitruvianScan software medical device to process the MRI images and produce the quantitative metrics and composite images," and then these are sent to "trained Healthcare Professionals who then utilize these to make clinical decisions." This suggests the device provides quantitative data to healthcare professionals, rather than directly assisting their image interpretation to improve their diagnostic accuracy from images alone.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance assessment was conducted. The "Comparative testing between the operators' results and the gold standard (mean of 3 radiologists results)" and the "benchmarking performance" against OSIRIX MD inherently assess the algorithm's output (via the trained analysts) against a reference, which signifies a standalone evaluation of the device's quantitative capabilities.

7. Type of Ground Truth Used

The primary type of ground truth used for the comparative testing was expert consensus (mean of 3 radiologists results).

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for the VitruvianScan algorithm. This information is typically crucial for understanding the generalizability and robustness of an AI/ML device.

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

The document does not provide any information on how the ground truth for the training set was established.

Summary

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October 2, 2024

Perspectum Ltd Bhaskar Chikkanna Director of Regulatory Affairs Gemini One. 5520 John Smith Drive Oxford, OX4 2LL United Kingdom

Re: K241925

Trade/Device Name: VitruvianScan (v1.0) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: September 11, 2024 Received: September 11, 2024

Dear Bhaskar Chikkanna:

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 (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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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

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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,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241925

Device Name

VitruvianScan (v1.0)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date Prepared:

25th June 2024

10056574

1 Applicant Details

Applicant Name and Address:

25th June 2024

Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL

Owner/Operator Number: Establishment Registration Number: Applicant Contact Name: Applicant Contact Email: Applicant Contact Phone:

3014232555 Bhaskar Chikkanna bhaskar.chikkanna@perspectum.com +44 (0) 1865 655329

2 Subject and Predicate Device

	Subject Device	Predicate Device	Reference Device
510(k) number	K241925	K211983	K101342
Legal Manufacturer	Perspectum Ltd.	AMRA Medical AB	PIXMEO SARL
Device Trade Name	VitruvianScan (v1.0)	AMRA Profiler	OSIRIX MD
Common Name	Software as a MedicalDevice	Software as a MedicalDevice	Picture ArchivingCommunications System
Panel	Radiology	Radiology	Radiology
Regulation	892.1000	892.1000	892.2050
Risk Class	Class II	Class II	Class II
Product Class code	LNH	LNH	LLZ
Regulation Name	Magnetic ResonanceDiagnostic Device	Magnetic ResonanceDiagnostic Device	Picture archiving andcommunications system

Subject Device Description ന

3.1 General Description

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The metrics produced by VitruvianScan are intended to provide insight into the composition of muscle and fat of a patient. The device is intended to be used as part of an overall assessment of a patient's health and wellness and should be interpreted whilst considering the device's limitations when reviewing or interpreting images. Therefore, VitruvianScan presents a low level of concern with respect to patient safety since its metrics only augment the clinical information utilized by trained Healthcare Professionals for the management of patients.

VitruvianScan is only used within Perspectum's secure infrastructure by trained analysts to process clinical images and generate metrics. The metrics and composite images output by VitruvianScan are then sent to trained Healthcare Professionals who then utilize these to make clinical decisions in combination with other relevant information obtained from other clinical sources.

3.2 Intended Use

VitruvianScan is a software medical device intended to assist trained healthcare professionals in the noninvasive evaluation of body fat and muscle composition in the general population.

3.3 Indications for Use

VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application for noninvasive fat and muscle evaluation that enables the generation, display and review of magnetic resonance medical image data.

3.4 Intended Patient Population

General population - VitruvianScan has no demographic or population restrictions.

3.5 Contraindications

None Software only device .

3.6 Warnings/Precautions

VitruvianScan must not be used for direct diagnosis of patients. o
o VitruvianScan generated metrics must only be interpreted by trained healthcare professionals.
VitruvianScan output must not be used on its own to make any treatment decisions relating o to any specific diseases or health conditions.

Substantial Equivalence ব

Table below provides a comparison of attributes between the subject device and the predicate device to demonstrate substantial equivalence. Differences between the devices are commented.

Attributes	Subject Device	Predicate Device	Comments
Device trade name	VitruvianScan	AMRA Profiler	N/A
Manufacturer	Perspectum Ltd	AMRA Medical AB	N/A
510(k) number (ifassigned)	TBD	K211983	N/A
Regulation	892.1000	892.1000	No difference
Product Code	LNH	LNH	No difference
Intended use	VitruvianScan is asoftware medical device	Not defined	Subject device has a separateintended use statement.
	intended to assist trainedhealthcare professionalsin the non-invasiveevaluation of body fatand muscle compositionin the general population
Indications for use	VitruvianScan is indicatedfor use as a magneticresonance diagnosticdevice softwareapplication for non-invasive fat and muscleevaluation that enablesthe generation, displayand review of magneticresonance medical imagedata.VitruvianScan producesquantified metrics andcomposite images frommagnetic resonancemedical image data whichwhen interpreted by atrained healthcareprofessional, yieldinformation that mayassist in clinicaldecisions.	Indicated for use as amagnetic resonancediagnostic devicesoftware application fornon- invasive fat andmuscle evaluation thatenables the generation,display and review of 2Dmagnetic resonancemedical image data.Designed to utilizeDICOM 3.0 compliantmagnetic resonanceimage datasets, acquiredfrom compatible MRSystems, to display theinternal structure of thebody including the liver.Other physicalparameters derived fromthe images may also beproduced. Provides anumber of quantificationtools, such as Region ofInterest (ROI)placements, to be usedfor the assessment ofregions of an image toquantify liver tissuecharacteristics, includingthe determination of fatfraction in the liver, T2 *and muscle volume.These images and thephysical parametersderived from the images,when interpreted by atrained clinician, yieldinformation that mayassist in diagnosis.	Subject device does notquantify liver tissuecharacteristics, liver fatfraction, T2* and musclevolume. Other than thesedifferences, both the subjectdevice and the predicatedevice are indicated for non-invasive fat and muscleevaluation.

Intended users	Perspectum trainedanalysts use the device toanalyze MRI data andproduce output.	AMRA operators use thedevice to analyze MRIdata and produceresults.	Similar users
	Trained healthcareprofessionals interpretthe device output foradditional support in theirclinical decisionpathways.	Trained cliniciansinterpret the results.
Application	Health and wellness	Health and wellness	No difference
Anatomy andmeasurements	Abdomen.	Abdomen and Thighs.	Subject device anatomy andmeasurements are a subset ofthe predicate device anatomyand measurements
	Visceral Fat	Visceral Fat
	Subcutaneous Fat	Subcutaneous Fat
	Muscle Area	Muscle Fat
		Muscle Volume
		Liver Fat
Target population	General population	Adults	Subject device is intended forall ages who are suitable forMRI scans
Contraindications	None, Software only	None, Software only	No difference
Imaging modality	Magnetic resonanceimaging systems	Magnetic resonanceimaging systems	No difference
Data format	DICOM 3.0 compliant MRimage datasets fromcompatible MR scanners	DICOM 3.0 compliant MRimage datasets fromcompatible MR scanners	No difference
MRI Scanners	GE, Siemens and Philips	GE, Siemens and Philips	No difference
MR field strength	1.5T and 3T	1.5T and 3T	No difference

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Perspectu D

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5 Software Testing

VitruvianScan is a software medical device. The documentation document justifies only basic documentation is applicable to VitruvianScan as per FDA guidance, Content of Premarket Submissions for Device Software Functions for Industry and Food and Drug Administration Staff Document issued on June 14, 2023. The device has undergone the following tests and successfully passed the acceptance criteria with no residual anomalies.

a. Unit testing
b. Integration testing
c. Software system verification
d. Software system validation
e. User acceptance tests

6 Performance Testing

VitruvianScan underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that the subject device is at least as safe and effective as the predicate device.

Scanners Assessed
Siemens 1.5T
Siemens 3T
GE 1.5T
GE 3T
Philips 1.5T

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Philips 3T

The performance was tested for the following aspects:

Repeatability of metrics for the same subject, on the same manufacturer and field strength, a. acquired on the same day
b. Reproducibility of metrics for the same subject, on the same manufacturer but a different field strength, acquired on the same day
c. Characterization of inter-operator variability
d. Characterization of intra-operator variability
e. Results from testing using the subject device were compared with the results from testing using reference requlated device `OSIRIX MD' for benchmarking performance
f. Comparative testing between the operators' results and the gold standard (mean of 3 radiologists results)

All aspects of the performance tests met the defined acceptance criteria, thereby assuring robust clinical performance of the device across different scanners, field strengths and patient characteristics.

7 Conclusion

The subject device and the predicate device have similar indications for use and are meant for the same application in health and wellness. The differences highlighted do not constitute a new intended use, are accompanied by information that demonstrates that the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate.

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.