The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals. medical facilities. home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients.

Device Description

The Model 9600 Pulse Oximeter determines arterial hemoglobin saturation (%SpO2) by measuring absorption of red and infrared (IR) light passed through the tissue. The Model 9600 also measures pulse rate and displays the rate in beats per minute.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Nonin Avant Model 9600 Pulse Oximeter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the same way a PMA (Premarket Approval) submission would.

Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth) is not explicitly available within this document. The document primarily describes the device, its intended use, and states that testing was performed to confirm performance and safety.

Here's an attempt to answer the questions based on the available information and highlighting what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner or provide a table of performance figures against such criteria. It generally states: "Bench and safety testing have been done to verify the performance of the device."

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

This information is not provided in the document.

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. For a pulse oximeter, "ground truth" for SpO2 is often established through in-vivo studies involving induced hypoxia, with comparison to arterial blood gas measurements, rather than expert consensus on images or data. However, the details of such studies are not present here.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. Pulse oximeters are standalone diagnostic devices that provide direct measurements (SpO2 and pulse rate), not an AI-assisted interpretation for human readers. Therefore, the concept of "human readers improve with AI" does not apply in this context.

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

Yes, a pulse oximeter is inherently a standalone device that performs its function (measuring SpO2 and pulse rate) without human interpretation as part of its core performance evaluation. Its accuracy is assessed as a standalone algorithm/device. The document states "Bench and safety testing have been done to verify the performance of the device." This implies standalone performance testing.

7. The type of ground truth used

While not explicitly stated, for pulse oximeters, the ground truth for arterial oxygen saturation (SpO2) is typically established through arterial blood gas analysis (SaO2), often verified in controlled clinical studies with induced hypoxemia. The document mentions following "Reviewer Guidance for Premarket Notification Submission of November of 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and Neurological Devices," which would include guidelines for oximeter testing, likely referring to such methods.

8. The sample size for the training set

This information is not provided in the document. Pulse oximeters generally rely on physiological models and signal processing rather than machine learning "training sets" in the contemporary sense. If any form of algorithm optimization or calibration occurred, the details of the data used for that are not included here.

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

As noted in point 8, the concept of a "training set" in the modern AI sense is likely not applicable to this device in the way it is asked. If any calibration data was used, the ground truth for that would similarly be established through comparison to a gold standard like arterial blood gas analysis. This information is not provided in the document.

Summary

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Ko23044

SUBMITTER:	Nonin Medical, Inc.
Address:	Nonin Medical, Inc.2605 Fernbrook Lane NorthPlymouth, MN 55447-4755
Telephone:	763-553-9968
CONTACT PERSON:	Richard P. Bennett, Director of Regulatory Affairs
DATE PREPARED:	August 26, 2002
TRADE NAME:	Nonin® Avant™, Model 9600, Pulse Oximeter
COMMON NAME:	Pulse Oximeter

SUBSTANTIALLY EQUIVALENT TO:

The Nonin, Model Avant 2120 Pulse Oximeter/Non Invasive Blood Pressure (NIBP) Monitor

DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

INTENDED USE:

The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients for Oxygen saturation SpO2 and pulse rate.

SUMMARY OF TESTING:

The Model Avant 9600 Digital Pulse Oximeter has followed (where applicable) the Reviewer Guidance for Premarket Notification Submission of November of 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and Neurological Devices. In addition, Nonin has conducted a Hazard Analysis and Risk Assessment, and developed extensive software/hardware procedures to confirm the performance of the design requirements. Bench and safety testing have been done to verify the performance of the device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or flowing lines.

Public Health Service

JUL 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard P. Bennett Director of Regulatory Affairs Nonin Medical, Inc. 2605 Fernbrook Lane North Plymouth, MN 55447

Re: K023044

Trade/Device Name: Model 9600 Avant Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 1, 2003 Received: May 2, 2003

Dear Mr. Bennett:

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 vour 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 - Mr. Richard P. Bennett

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 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Patricia Cucerite/for

Susan Runner, DDS, MA Interim 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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Attachment 2

Indications for Use Statement

510(k) Number:

KO236.44

Device Name:

Nonin Medical Inc AVANT™, Model 9600

Indications for Use:

The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording function of arterial hemoglobin (SpO-3) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 is intended for continuous monitoring and/or spot-checking of patients.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
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Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	R023044
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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).