The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Device Description

The MIMOSA Imager is a non-contacting, cordless, battery powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device captures spatially-resolved images that is triggered by the end user via a smartphone-app interface. By tracking the spectral signatures of dominant chromophores in the patient's superficial tissue, the device calculates and displays the StO2 estimate on the connected android device screen.

The MIMOSA Imager is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that maps the tissue oxygen saturation (StO2) values to a spatially registered heatmap. The MIMOSA Imager shares fundamental principles with other oximeters and tissue oxygenation measurement systems. Tissue oximetry exposes tissue to optical radiation of known wavelengths and captures the remitted or reflected light. The remitted back scattered light is then used to calculate StO2 based on principles of multispectral imaging. Spectral analysis is used to measure StO2 using specific both visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths. Other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the MIMOSA Imager, which is a medical device intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in tissue. The document details the device's description, indications for use, comparison to a predicate device, and performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a table format with specific numerical targets. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ViOptix ODISsey Tissue Oximeter) through a comparative clinical study. The primary metric for this equivalence appears to be the statistical agreement of StO2 measurements between the two devices.

Acceptance Criteria (Inferred from Study Goal)	Reported Device Performance (MIMOSA Imager vs. ViOptix ODISsey)
Statistical Agreement of StO2 Measurements	95% Confidence Interval of the line of best fit: Narrowly constrains the slope of the line between 0.998 and 1.02.
	Conclusion: MIMOSA Imager measures were in statistical agreement with Vioptix for thenar eminence and forearm for age between 21-70 and range of Fitzpatrick skin types.
Safety	Conclusion: No adverse events or complications were encountered during or after clinical testing.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 39 individuals.
- Data Provenance: The document does not explicitly state the country of origin. It describes the study as "clinical testing," which implies it was a prospective study where data was collected specifically for this comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The concept of "ground truth" in this context is established by the measurements of the predicate device (ViOptix ODISsey Tissue Oximeter), which is legally marketed and considered a benchmark for StO2 estimation.
- No independent experts were used to establish a separate "ground truth" for the StO2 values themselves, as the study was comparative against an established device. The clinical study seems to have involved medical professionals ("healthcare professionals" as stated for device usage) who conducted the vascular occlusion test and measurements, but their number and specific qualifications for establishing ground truth are not detailed.
Adjudication method for the test set:
- No adjudication method (like 2+1 or 3+1) is mentioned, as the study's goal was to compare the MIMOSA Imager's measurements directly against those of the predicate device, not to adjudicate discrepancies between human readers or between a human and an AI.
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:
- No MRMC study was done. This device is a measurement tool (oximeter), not an AI-assisted diagnostic imaging device for human interpretation. The study focused on the device's direct measurement performance compared to a predicate device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The clinical study was a standalone device performance study in the sense that the MIMOSA Imager's measurements were directly compared against the predicate device's measurements. The device generates the StO2 map, and its performance (accuracy/agreement) is assessed as an output of the device itself. Human interaction is for operating the device and interpreting the display, but the core measurement is automated by the device's algorithms.
The type of ground truth used:
- The "ground truth" for the comparison was the measurements provided by the legally marketed predicate device (ViOptix ODISsey Tissue Oximeter) under controlled conditions (vascular occlusion test). This serves as a "clinical reference standard" rather than an independent expert consensus, pathology, or outcomes data.
The sample size for the training set:
- The document does not provide details on a separate "training set" or its size. As this is an oximeter, its underlying principles are based on spectrophotometry and known biological chromophores, rather than a machine learning model that requires a dedicated training set in the typical AI/ML sense. The device calculates StO2 based on spectral analysis. Any internal calibration or algorithm development (if using something akin to statistical models) would presumably rely on fundamental physics and potentially pre-clinical or simulated data, not explicitly described as a "training set" in the document.
How the ground truth for the training set was established:
- Given that no specific "training set" in the context of machine learning is identified, the method for establishing its ground truth is not applicable from the provided text. The device's StO2 estimation relies on principles of multispectral imaging and spectral analysis, with "bench data" demonstrating acceptable accuracy against "clinical/industrial gold standard" which likely refers to established physical or chemical standards for light absorption/reflection by oxygenated/deoxygenated blood.

Summary

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MIMOSA Diagnostics Inc Yuan Fang Chief Regulatory Officer 1 Yonge St., Suite 201 Toronto, CA M5E1E5 Ontario

November 1, 2019

Re: K190334

Trade/Device Name: MIMOSA Imager Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: October 1, 2019 Received: October 4, 2019

Dear Yuan Fang:

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

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

Neil R.P. Ogden, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices 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)

K190334

Device Name MIMOSA Imager

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

[As required by 21 CFR 807.92]

Submitter's Name:	MIMOSA Diagnostics, Inc.
Address:	1 Yonge Street, Suite 201, Toronto, ON M5E 1E5
Contact:	General Leung, PhD CTO
Telephone:	(844) 646-6721
Primary Email:	general@mimosadiagnostics.com
Secondary Email:	yuan@mimosadiagnostics.com
Date Summary was prepared:	October 29, 2019
Information Regarding the device classification:
Trade Name:	MIMOSA Imager
Common Name:	Tissue Oximeter
Classification Regulation:	21 CFR 870.2700
Classification Regulation Name:	Oximeter
Product Code:	MUD
Device Class:	II
	Information regarding the legally marketed device to which we are claiming equivalence [807.92(a)(3)]
510(k) Reference #:	K042657
Device Name:	ODISsey Tissue Oximeter
510(k) Holder:	ViOptix, Inc.
Information regarding Reference Devices with the MUD product code:
Reference Device:
510(k) Reference #:	K113507
Device Name:	Kent Camera
510(k) Holder:	Kent Imaging, Inc.

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Image /page/4/Picture/3 description: The image shows the word "MIMOSA" in a sans-serif font, with each letter in a dark blue color. To the left of the word is a stylized flower-like graphic. The graphic is composed of several teardrop-shaped petals arranged around a central point. The petals are colored in a gradient of yellow and orange, giving them a three-dimensional appearance. The overall design is clean and modern, suggesting a brand or logo.

Description of the Device:

Indications for Use:

The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Parameter	Subject Device: MIMOSAIMAGER	Predicate Device(ODISsey)	Comparison
510k #	This Submission	K042657
Indicationsfor Use	The MIMOSA Imager isintended to non-invasivelyestimate the spatialdistribution of percentoxygen saturation in avolume of tissue (StO2).This is performed inmedical environmentsincluding physician offices,hospitals, ambulatory careand Emergency MedicalServices.	The ViOptix ODISseyTissue Oximeter isintended to non-invasivelyestimate the percentoxygen saturation in avolume of tissue (StO2).This is performed inmedical environmentsincluding physician offices,hospitals, ambulatory careand Emergency MedicalServices.	Similar: only difference is"spatial distribution of."
	The MIMOSA Imager isindicated for use inmonitoring patients duringcirculatory or perfusionexaminations of skeletalmuscle or when there is asuspicion of compromisedcirculation.	The ODISsey TissueOximeter is indicated foruse in monitoring patientsduring circulatory orperfusion examinations ofskeletal muscle or whenthere is a suspicion ofcompromised circulation.
MeasuredParameters	Tissue oxygen saturation(StO2) information	Tissue oxygen saturation(StO2) information	Same
OperatingPrinciple	Spectrophotometricoximetry	Spectrophotometricoximetry	Same
Light Source	Near-infrared light Source:LED chips Wavelengths:620, 630, 700, 810, 880,980 nm	Near-infrared light Source:laser diodes Wavelengths:690, 830 nm	Similar: the MIMOSAImager deliversadditional wavelengths oflight to the tissue in orderto improve measurementreliability and providing amore robust dataset. Theadditional wavelengthshave been assessedbased on IEC 62471 andwere found to not poseany safety concerns andeffectivenessdemonstrated throughperformance (bench andclinical) testing . Thisdoes not raise any newquestions in safety orefficacy.
Reusable	Yes	Yes	Same
Contact	Non-Contact	Direct Contact	Different: The MIMOSAImager is a non-contactdevice while thepredicate is not. Otherdevices within the MUDclass, includingreference device (KentCamera, K113507) isnon-contacting. In ourperformance testing, thisdifference raises no newquestions regardingeither safety or efficacy.
Power Source	Powered with arechargeable Li-polymerbattery.	AC power-operated with30-minute lithium-ionbattery backup.	Different: The MIMOSAlmager is powered by alithium-polymer batterycertified to IEC 62133and UN 38.3. This raisesno new questions insafety or efficacy.
MeasurementRange	1-99% StO2	1-99% StO2	Same
Display	Attached Android DeviceDisplay	Computer console displaymodule	Similar
Materials	Plastic (Nylon 12 / PETG)Enclosure connected to afront-glass, aluminum bodysmartphone with a PVCcover sheath USBconnector cable.	Plastic Enclosure, Metaland Epoxy probe head.PVC cable cover sheath.	Similar
InternalStorage	32000 MB	2000 MB	Similar
Ambient Light	Insignificant contribution toimage (relative to NIRLEDs) due to shortexposure time	Probe must physicallyblock out all ambient light.	Different: Both devicescompensate for ambientlight. The MIMOSAlmager uses a shortexposure time and abackground lightcompensation algorithm.The predicate devicephysically attempts toblock out light by puttingthe probe in contact withthe imaged tissue. Thischange in filtering of lighthad no effect onperformance and doesnot present anyadditional safety oreffectiveness concerns.
PatientPopulationandEnvironment	Healthcare environment forpatient population withpotential circulatorycompromise	Healthcare environment forpatient population withpotential circulatorycompromise	Same
ControlMethod	Android Device controlled	PC controlled	Similar
Sterility	non-sterile	non-sterile	Same

Substantial Equivalence Comparison

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Image /page/5/Picture/3 description: The image shows the word "MIMOSA" in blue font, with a stylized yellow flower to the left of the word. The flower has a central circle with six petals radiating outwards. The font is a simple sans-serif typeface. The overall design is clean and modern.

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Image /page/6/Picture/3 description: The image shows the word "MIMOSA" in a sans-serif font, with each letter in a dark blue color. To the left of the word is a stylized flower with multiple petals in shades of yellow and orange. The flower is positioned so that it appears to be blooming or radiating outward.

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Image /page/7/Picture/3 description: The image shows the logo for Mimosa. The logo consists of a stylized flower on the left and the word "MIMOSA" in blue on the right. The flower has multiple petals and a gradient from yellow to orange. The text is in a sans-serif font.

Performance Testing - Non-Clinical & Clinical

Using NIST-calibrated spectrometer instruments, the device's LED-system is systematically tested to ensure that it meets tolerances set for illumination wavelength ranges, relative intensity differences between LEDs, as well as overall system endurance. The following core tests are administered on a random sample of our manufactured devices:

-Spectral response to varying amperage
-Transmittance profile, as a function of wavelength
-Stress testing device for endurance, consistency and maximum output

Software documentation and testing have been provided per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Clinical: A comparative study was performed for the MIMOSA Imager and predicate device with side-byside comparison of clinical performance in order to demonstrate substantial equivalence. The objective of the study was to compare StO2 measurements for MIMOSA Imager and the Vioptix ODISsey in order to demonstrate substantial equivalence between the two devices. In terms of methodology, the study monitor tissue oxygen saturation in the thenar eminence and forearm during a vascular occlusion test (VOT) using both devices. The study population included a total of 39 individuals ranging from 21 to 70 years of age and (1-5) Fitzpatrick skin types. The study results in terms of the 95% confidence interval of the line of best fit narrowly constrains the slope of the line between 0.998 and 1.02. MIMOSA Imager measures were in statistical agreement with Vioptix for thenar eminence and forearm for age between 21-70 and range of Fitzpatrick skin types. The statistical agreement between the two devices support substantial equivalence of MIMOSA Imager and Vioptix, and no adverse events or complications were encountered during or after clinical testing.

Conclusion

The MIMOSA Imager has the same intended use as the predicate, has similar technology that does not raise new types of questions of safety or effectiveness. Bench data demonstrates acceptable accuracy of the MIMOSA Imager with respect to the clinical/industrial gold standard in estimating StO2%. Furthermore, precision data demonstrates substantial equivalence between MIMOSA Imager and the predicate device. Overall, the performance data shows that this device provides reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.

REFERENCES:

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[1] Section VI. Specifications: Ranges and Precision (Table). T.Ox™ Operator's Manual, ViOptix Inc. http://www.vioptix.com/wp-content/uploads/2015/10/OXY-2-USM-1-Rev-I-ViOptix-Tissue-(2016). Oximeter-Manual1.pdf

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).