The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.

Device Description

The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoqlobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 520A monitor. The Model 2001 displays digital values of SpO2 and pulse rate as well as a graphic display of the plethysmogram. The Model 2001 monitor consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor performs the functions of the existing Model 520A including data acquisition, display, trending and communications with external devices. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Novametrix Medical Systems, Inc. Model 2001 Pulse Oximeter. It describes the device, its intended use, and its technological characteristics, and asserts substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or a detailed study report proving the device meets specific performance criteria beyond general assertions of accuracy and compliance with industry standards.

The document states: "In addition, inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This is the only mention of studies conducted to evaluate the device's accuracy.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from this document.

Here's an attempt to answer the questions based on the limited information available:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, specific numerical acceptance criteria and a detailed report of the device's performance against these criteria are not available. The document only generally states that "inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This implies the acceptance criteria were related to achieving accuracy comparable to previous models and meeting sensor specifications, but the specific metrics are not quantified.

A hypothetical table structure would look like this if the information were present:

Performance Metric (Acceptance Criteria)	Reported Device Performance
Accuracy (SpO2)	(e.g., ±X% compared to reference)
Accuracy (Pulse Rate)	(e.g., ±Y bpm compared to reference)
Performance in motion artifact	(e.g., maintains accuracy under defined motion conditions)
...	...

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

The document only mentions "inter-device comparison studies and non-invasive controlled hypoxia studies." It does not specify the sample size (number of subjects or cases) used in these studies, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide details on how ground truth was established for the "inter-device comparison studies" or "non-invasive controlled hypoxia studies." It does not mention the use of experts, their number, or their qualifications for establishing ground truth.

4. Adjudication method for the test set

The document does not describe any adjudication method for establishing ground truth in the studies mentioned.

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 MRMC comparative effectiveness study is mentioned. This device is a pulse oximeter, which provides a direct measurement (SpO2 and pulse rate) rather than diagnostic images requiring human interpretation, so an MRMC study would not be applicable in this context. The document focuses on the device's accuracy in measuring physiological parameters.

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

The device itself is a standalone algorithm (Model 2001 Pulse Oximeter) that "measures functional oxygen saturation data" and performs "filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction." The mentioned "inter-device comparison studies and non-invasive controlled hypoxia studies" would inherently evaluate this standalone performance.

7. The type of ground truth used

While not explicitly stated with detail, "non-invasive controlled hypoxia studies" typically involve inducing controlled levels of hypoxia in subjects and comparing the device's SpO2 readings against a gold standard method, such as arterial blood gas analysis (co-oximetry) or another highly accurate reference oximeter. Therefore, the ground truth would likely be a reference measurement from an established medical device or direct physiological measurement. The "inter-device comparison studies" would likely use readings from the predicate devices as a comparative "ground truth" or reference.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning, as this device was developed in 1999 and pre-dates widespread use of complex AI algorithms requiring large training datasets as we understand them today. The device uses "proprietary algorithms" and "artifact filtering software" developed based on "existing algorithms." Therefore, there's no explicitly defined "training set" in the modern sense.

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

As there is no mention of a "training set" for AI/machine learning algorithms, the method for establishing its ground truth is not applicable or described in the document. The algorithms were likely developed and refined based on engineering principles, signal processing, and performance against known physiological responses and noise conditions rather than a labeled training dataset.

Summary

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K993979

510(K) Summary

November 17, 1999

Applicant's Name and Address a.
Novametrix Medical Systems, Inc. 5 Technology Drive Wallingford, CT 06492
b. Contact Person
Robert H. Schiffman, R.A.C. Q.A. and Regulatory Manager (203) 284-2542 (203) 284-0753 (facsimile)
Name of Device ﻥ ﻧ
Device Names (Proprietary/Trade Names):

Device Name (Common Name):

Classification:

Pulse Oximeter Class II, 21 C.F.R. 870.2700 /74DQA

Model 2001 MARSpO2 Pulse Oximeter

d. Equivalent Devices

Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and for the Model 2001, as well as testing to accepted industry standards. In addition, inter-device comparison studies and non-invasive controlled hypoxia studies were conducted to establish the Model 2001 accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 2001. The predicate devices are as follows:

Model 520A Pulse Oximeter, Novametrix Medical Systems, Inc., K913516 1.
1. Model 2000 Pulse Oximeter, Ivy Biomedical Systems, Inc., K982255
N-395 Pulse Oximeter, Nellcor Puritan Bennett Inc., K991823 3.

Device Description e.

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The Model 2001 can be powered by either an internal power supply operating on AC or by a sealed rechargeable lead-acid gel battery. Audible and visual alarms for high/low saturation and pulse rate are available. The Model 2001 also includes a temporary (2 minute) and permanent alarm silence and other configurable settings. The Model 2001 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The Model 2001 Pulse Oximeter has visual indicators for pulse error conditions, power mode (i.e. AC vs. battery) and alarm silence. There is also a serial port that provides user configurable data output capable of communicating with printers and other devices.

Intended Use f.

The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care The Model 2001 Pulse Oximeter and its sensors are intended to be used by units. trained operators when pulse oximetry monitoring is required in the judgement of a physician. The intended use, patient population and environments of use are the same or similar to the predicate devices, the Novametrix Model 520A Pulse Oximeter, Ivy Biomedical Model 2000 Oximeter, and the Nellcor Puritan Bennett N-395 Pulse Oximeter.

Technological Characteristics q.

The Model 2001 Pulse Oximeter measures functional oxygen saturation and pulse rate with sensors that contain red and infrared light sources. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation. The light energy from red and infrared LEDs is beamed through a sample cell- a pulsating vascular bed, the patient's finger or toe for example. The remaining light energy not absorbed by the sample cell reaches a photodiode, on the opposing side of the sensor. The signal received by the photodiode is split into its red and infrared components, sampled, software filtered, processed using proprietary algorithms and displayed as a numerical value for functional oxygen saturation and as a waveform, the plethysogram.

The Model 2001 uses a similar SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 520A Pulse Oximeter, cleared under K913516. In addition, the Model 2001 possesses artifact filtering software that reduces the effects of artifact such as patient/sensor motion. This allows the Model 2001 to provide valid SpO2 and pulse rate readings for increased levels of artifact as compared to previous generations. With this capability the Model 2001 provides a decrease in false/nuisance alarms due to the effect of motion artifact.

h. Certification Statement

In accordance with the requirements of 21 CFR 807.87(i), the following certification is provided:

Novametrix Medical Systems, Inc. believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.

Robert H. Schiffman

Robert H. Schiffman, R.A.C. Q.A. and Regulatory Manager

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2000

Mr. Robert H. Schiffman Novametrix Medical Systems, Inc. 5 Technology Drive P.O. Box 690 Wallingford, CT 06492-1926

K993979 Re: Model 2001 MARSpO2 Requlatory Class: II (two) Product Code: 74 DQA Dated: November 17, 1999 Received: November 24, 1999

Dear Mr. Schiffman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert H. Schiffman

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,

for

Witten, Ph.D., M.D. SECTION N Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K993979
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Model 2001 Pulse Oximeter_ Device Name: __

Indications For Use:

(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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Prescription Use_ (Per 21 CFR 801.109)

(Division Sign-Off) (Striaton Sign-OII)
Division of Cardiovascular, Respiratory Over-The-Counter Use_ 510(k) Number_

(Optional Format 1-2-96)

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).