The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. The index finger is the recommended site.

Device Description

The Onyx® II Model 9550 is a small, lightweight, portable, finger pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light omitting diodes (LEDs) are contained within the sensor along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and heart rate are displayed on the LED digital displays contained within the finger clip sensor. A tricolor LED display provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates as inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by inserting a patient's finger. This allows the power to be applied to all the internal circuitry upon activation. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

AI/ML Overview

The provided text is a 510(k) summary for the Onyx® II Model 9550 Finger Pulse Oximeter. It unfortunately lacks detailed information regarding specific acceptance criteria for performance metrics and the associated study data that would directly "prove" the device meets them in the way requested. This document primarily focuses on establishing substantial equivalence to a predicate device.

However, based on what is available, I can extract and infer some information, particularly around the "Functional and Safety Testing" section:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Nonin's Model 9550 Finger Pulse Oximeter has successfully undergone bench testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device." While specific numerical acceptance criteria are not provided, the implied acceptance criterion is "has appropriate functional features and is substantially equivalent to the predicate device." The reported performance is that the device "successfully undergone bench testing" and meets this criterion.

Acceptance Criterion (Implied)	Reported Device Performance
Device has appropriate functional features and is substantially equivalent to the predicate device.	Successful completion of bench testing, demonstrating appropriate functional features and substantial equivalence to the predicate device.

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

Sample Size for Test Set: Not explicitly stated. The summary refers to "bench testing" but does not give numerical sample sizes for any performance testing.
Data Provenance: Not explicitly stated. However, "bench testing" typically implies laboratory or controlled environment testing, not necessarily clinical data with geographic provenance. It's likely prospective for the specific tests conducted for this submission.

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

This information is not provided in the document. Oximeters typically rely on direct comparison to arterial blood gas analysis (co-oximetry) for accuracy, which wouldn't involve "experts" establishing ground truth in the same way an imaging study would.

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

This information is not provided. Given the nature of oximetry testing, an adjudication method for ground truth establishment as typically seen in image interpretation studies is not usually applicable.

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:

No, an MRMC study was NOT done. This device is a pulse oximeter, not an AI-assisted diagnostic imaging tool. Therefore, the concept of "human readers improve with AI" is not applicable.

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

Yes, in essence. A pulse oximeter operates as a standalone device, providing SpO2 and pulse rate readings directly. The "bench testing" mentioned would assess the algorithm's accuracy in calculating these values against a reference standard. There is no explicit "human-in-the-loop" component for interpretation of the raw data by the end-user.

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

While not explicitly stated for this specific submission, the industry standard for establishing ground truth for pulse oximeters is typically co-oximetry (arterial blood gas analysis). This involves simultaneous measurement of SpO2 by the device and a laboratory co-oximeter from an arterial blood sample.

8. The sample size for the training set:

Not applicable. This device is not described as involving machine learning or AI models that require a "training set."

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

Not applicable. (See point 8.)

Summary

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JAN 1 1 2006

SECTION 2. SUMMARY AND CERTIFICATION

510(k) Summary A.

Submitter:	Nonin Medical, Inc.
Contact Person:	Lori M. RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Avenue NorthPlymouth, MN 55441-5443
Date Prepared:	November 4, 2005
Trade Name:	Onyx® II Model 9550 Finger Pulse Oximeter
Classification Name:and Number:	Class II, 21 CFR 870.2700
Product Code:	74 DQA
Predicate Device(s):	Nonin's Onyx® II Model 9550 is substantially equivalentto the Onyx® II Model 9550 Finger Pulse Oximetermanufactured by Nonin Medical, Inc. that was cleared bythe FDA under K051107 on 06/01/05.
Device Description:	The Onyx® II Model 9550 is a small, lightweight, portable,finger pulse oximeter that displays numerical values forfunctional oxygen saturation of arterial hemoglobin (SpO2)and pulse rate by measuring the absorption of red andinfrared (IR) light passing through perfused tissue.Changes in the absorption caused by the pulsation of bloodin the vascular bed are used to determine oxygen saturationand pulse rate.
	Light omitting diodes (LEDs) are contained within thesensor along with the photo detector, which is on theopposite side of the probe from the LEDs. The SpO2 andheart rate are displayed on the LED digital displayscontained within the finger clip sensor. A tricolor LEDdisplay provides a visual indication of the pulse qualitysignal, while blinking at the corresponding pulse rate. Thisdisplay changes colors to alert you to changes in pulsequality that may affect the readings: green indicates a goodpulse quality signal, yellow indicates a marginal pulsequality, and red indicates as inadequate pulse signal. All
	associated electronics and the microprocessor are withinthe sensor, which is activated by inserting a patient'sfinger. This allows the power to be applied to all theinternal circuitry upon activation. The device is intendedfor spot-checking adult and pediatric patients who are wellor poorly perfused.
Intended Use:	The Nonin® Onyx® II Model 9550 Finger Pulse Oximeteris a small, lightweight, portable device indicated for use inmeasuring and displaying functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate of patients whoare well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (otherthan the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm)thick. The index finger is the recommended site.
Functional andSafety Testing:	Nonin's Model 9550 Finger Pulse Oximeter hassuccessfully undergone bench testing in order todemonstrate that it has appropriate functional features andis substantially equivalent to the predicate device.
Conclusion:	Nonin's Model 9550 is substantially equivalent to theModel 9550 Finger Pulse Oximeter manufactured by NoninMedical, Inc. and cleared by the FDA under K051107 on06/01/05.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its head and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2006

Ms. Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443

Re: K053130

Trade/Device Name: Onyx® II Model 9550 Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 4, 2005 Received: November 8, 2005

Dear Ms. Roth:

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

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

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Page 2 - Ms. Roth

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 mean that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Fet of mrly 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 and noting (2) est forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) I mis feter wifi ation. The FDA finding of substantial equivalence of your device to a premainter lettreations on 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), n 93st contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You onnived, "This was al 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ches

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(K) Number: (If known)

Device Name:

Onyx® II Model 9550 Finger Pulse Oximeter

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division S	General Hospital,
Division of	services
Infection Co.	K053130
510(k) Numbe

. . .

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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).