The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual. The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

Device Description

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. This method of “spatial resolution” also allows estimation of scattering to improve measurement accuracy.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the SOMANETICS INVOS 5100C Cerebral/Somatic Oximeter System. The document focuses on establishing substantial equivalence to a predicate device (Somanetics INVOS 5100C Cerebral/Somatic Oximeter System, K080769) for revised indications for use and labeling.

Based on the provided text, the specific details regarding acceptance criteria and a study proving those criteria are not explicitly present. The document states: "Extensive literature references and clinical studies are submitted demonstrating the substantial equivalence of the device for its stated indication." However, it does not provide the details of these studies, including acceptance criteria, sample sizes, ground truth establishment, or performance metrics.

Therefore, I cannot fully answer all the requested questions with the provided input. Below is an outline of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the provided text.
Reported Device Performance: Not explicitly stated in terms of specific metrics against acceptance criteria. The document only mentions "extensive literature references and clinical studies... demonstrating the substantial equivalence."

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

Sample Size for Test Set: Not explicitly stated.
Data Provenance (country of origin, retrospective/prospective): Not explicitly stated.

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

Not explicitly stated.

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

Not explicitly stated.

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:

Not applicable/Not stated. The device is an oximeter, not an AI-powered diagnostic imaging tool that would typically involve human reader studies in this context. The document refers to "regional hemoglobin oxygen saturation of blood," which is a physiological measurement.

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

The INVOS 5100C is an oximeter system, which inherently functions as a standalone measurement device. Its performance relates to its accuracy in measuring regional hemoglobin oxygen saturation. No "algorithm only" performance separate from the device itself is detailed in terms of a study.

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

Not explicitly stated. For an oximeter, the "ground truth" would typically involve a reference standard for blood oxygen saturation measurements (e.g., co-oximetry of arterial or venous blood samples) for accuracy studies.

8. The sample size for the training set:

Not explicitly stated. The document refers to "extensive literature references and clinical studies" but does not detail their methodology or if a "training set" in the machine learning sense was involved.

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

Not explicitly stated.

Conclusion Drawn from the Testing (as stated in the document):

"The conclusion drawn is that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness."

In summary, the provided text does not contain the detailed information necessary to answer most of your questions about specific acceptance criteria and study methodologies, as it is a 510(k) summary focused on substantial equivalence rather than a detailed clinical study report.

Summary

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APR - 3 2009

K082327

SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION

-SOMANETICS® Section 5 ____________________________________________________________________________________________________________________________________________________________________

510(k) Summary

Date of Submission:	August 12, 2008
Device Trade Name:	INVOS 5100C Cerebral/Somatic Oximeter System
Device Common Name:	Oximeter, Cerebral/Somatic
Device Classification Name:	Oximeter, Tissue Saturation (21 CFR 870.2700,Product Code MUD)
Submitted by:	Somanetics Corporation1653 East Maple RoadTroy, MI 48083Phone: 248-689-3050Fax: 248-689-4272
Contact Person:	Ronald A. WidmanVice President, Medical Affairs248-526-5865rwidman@somanetics.com
Predicate Device:	Somanetics INVOS 5100C Cerebral/SomaticOximeter System, K080769
Device Description:	The INVOS 5100C is a 2 wavelength, diffusereflectance spectroscopy system employing nearinfrared light to estimate the percentage ofhemoglobin saturated with oxygen in tissueunderneath the sensor. An adhesive sensorcontaining a light source and 2 photodiodes isapplied to the skin over the tissue of interest and thereturning light is analyzed for oxyhemoglobin anddeoxyhemoglobin light absorption. Absorptionsignals from the photodiode closer to the lightsource are subtracted from those from the fartherphotodiode where the returning photons penetratemore deeply in the tissue. This suppressesabsorption events originating in the outer layers oftissue that are common to both photodiodes,including the effects of skin pigmentation andsubcutaneous tissues. This method of “spatialresolution” also allows estimation of scattering toimprove measurement accuracy.
Accessories	SAFB-SM	Small Adult SomaSensor (>40 kg)
	SPFB	Pediatric SomaSensor (<40 kg)
	IS-C	Infant/Neonatal Cerebral OxyAlertNIRSensor (<40 kg)
	IS-S	Infant/Neonatal Somatic OxyAlertNIRSensor (<40 kg)
	RSC-1	Reusable Sensor Cable Channel 1
	RSC-2	Reusable Sensor Cable Channel 2
	RSC-3	Reusable Sensor Cable Channel 3
	RSC-4	Reusable Sensor Cable Channel 4
	5100C-W	One-year Extension of Warranty
	5100C-M	5100C System Operations Manual
	5100-FTD	Field Test Device
	5100C-RS	Portable Mobile Stand
	5100C-SA	Swivel Arm
	5100C-GCX	Mounting Plate
	5100C-TC	Travel Case
	5100C-USB	USB Flash Drive
	312170	Computer Connection Serial Cable
	VL1	Philips VueLink Adaptor Cable
Indications for Use:	.The noninvasive INVOS 5100C is intended for useas an adjunct monitor of regional hemoglobinoxygen saturation of blood in the brain or in othertissue beneath the sensor. It is intended for use inindividuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intendedfor use as an adjunct trend monitor of regionalhemoglobin oxygen saturation of blood in the brainor in other tissue beneath the sensor in anyindividual. The clinical value of trend data has notbeen demonstrated in disease states. The INVOSSystem should not be used as the sole basis fordiagnosis or therapy.
Technological Characteristics:	.Technological characteristics of the device,including design, material, chemical compositionand energy source are identical to the INVOS5100C predicate device.
Performance Data:	.Extensive literature references and clinical studiesare submitted demonstrating the substantialequivalence of the device for its stated indication.

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SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION

5-2

and the state of the states of the states of the states

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SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION

Conclusion Drawn from the Testing:............The conclusion drawn is that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2009

Somanetics Corporation % Mr. Ronald A. Widman VP of Medical Affairs 1653 East Maple Road Troy, Michigan 48083-4208

Re: K082327

Trade/Device Name: Somanetics INVOS® 5100C System and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: February 16, 2009 Received: February 17, 2009

Dear Mr. Widman:

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.

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

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Page 2 - Mr. Ronald A. Widman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 Biometric's (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 yours,

David Krone

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4

510(k) Number (if known) K 082327

Device Name: Somanetics INVOS® 5100C System and Accessories

Indications For Use:

It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual. The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

Prescription Use X (Part 21 CFR 801 subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Sign-Division of General, Restorative, and Neurological Devices

510(k) Number L082327

Page 1 of 1

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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).