The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor).

Device Description

The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients.

AI/ML Overview

The document provided is a 510(k) summary for the Dolphin Medical 2100 Pulse Oximeter, which is a medical device regulation submission to the FDA. It outlines the product's intended use, predicate devices, and compliance with various standards. However, it does not contain the detailed study information required to answer many of your specific questions regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment.

A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with specific performance metrics and study design details as might be found in a clinical trial publication.

Based on the provided text, here’s what can be extracted and what cannot:

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

Cannot be created. The document mentions compliance with standards like ISO 9919:1992 and EN 865:1997, and the FDA Guidance Document for Pulse Oximeters: 9/7/1992. These standards and guidance documents define the acceptance criteria for pulse oximeters (e.g., accuracy against a co-oximeter in induced hypoxia studies). However, the actual acceptance criteria values (e.g., A_rms value) and the reported device performance values against these criteria are not present in this 510(k) summary. The summary only states that the device has been "designed to comply" and implies that "additional performance validation testing has been performed," but it does not present the results of that testing or the specific acceptance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be determined. The document mentions "additional performance validation testing" for certain sensor models but provides no details about the sample size, the nature of the test set (e.g., number of subjects, type of patients), or data provenance (e.g., country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Cannot be determined. For pulse oximeters, the "ground truth" for SpO2 accuracy is typically established by arterial blood gas analysis using a co-oximeter during controlled desaturation studies, not by human experts interpreting data. The document does not mention any role for human experts in establishing ground truth for performance testing.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret medical images or data and their interpretations need to be reconciled to establish a consensus ground truth. This is not how pulse oximeter performance accuracy is determined.

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. This device is a standalone pulse oximeter, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

Yes, implicitly. A pulse oximeter by nature is a standalone device that provides a measurement (SpO2 and pulse rate) without human interpretation in the loop to determine the primary output. The document states its intended use is for "continuous noninvasive monitoring." The performance validation mentioned would evaluate the accuracy of this standalone measurement against a reference standard.

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

Implicitly, a reference standard for physiological measurement. For pulse oximeters, the ground truth for SpO2 accuracy is established by a reference method, typically an invasive co-oximetry measurement of arterial blood samples, often performed during controlled desaturation studies in human volunteers. The document does not explicitly state this, but it is the standard method for SpO2 accuracy testing as per relevant standards (e.g., ISO 9919, EN 865, FDA Guidance 1992 mentioned).

8. The sample size for the training set

Not applicable/Cannot be determined. Traditional pulse oximeters use established optical principles and signal processing algorithms, not machine learning or AI that requires a "training set" in the common sense of the term. While algorithms are part of the device, they are typically developed using engineering principles and validated, not "trained" on a dataset in the way a neural network would be. The document does not mention any training set.

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

Not applicable. As above, the concept of a "training set" and its associated ground truth establishment is not relevant to this type of traditional medical device, particularly as described in this 510(k) summary.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Dolphin Medical 2100 Pulse Oximeter and Accessories 12/10/02

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Submitter Company

Dolphin Medical - FL 13801 McCormick Dr Tampa, FL 33626

Contact: Jon Werner Phone: 813-818-7488 x216 Fax: 813-818-7488

Sponsor Company

Dolphin Medical, Inc. 12525 Chadron Avenue Hawthorne, CA 90250

Contact: Tammy Conway Phone: 310-349-2308 Fax: 310-978-1816

Manufacturing Facility

Opto Sensors (M) Sdn. Bhd. No. 6 Jalan Angkasa Mas 1 Tebrau Industrial Estate II 81100 Johor Bahru. Malaysia

Common, Classification & Proprietary Names

Common Name: Oximeter Oximeter Class II - 21 CFR 870.2700 - 74 DQA Classification Name: Proprietary Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories.

Intended Use

The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor).

Predicate Device

The Dolphin Medical Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):

. Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #K012533, #K012626, #K020075 and #K021959.

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The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpQs) and pulse rate, and provide for the connection to the connecting cable.

The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module) and a charge time of about 4.5 hours to 80% capacity.

The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.

The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.

The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.

The oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories have been designed to comply with the following standards:

1. CSA C22.2 No. 601.1
1. IEC 601-1, Part 1 and Amendments 1 and 2
1. IEC 601-1-1, Part 1
IEC 601-1-2, Part 1 4.
ISO 9919: 1992 5.
EN 865: 1997 6.
1. FDA Guidance Document for Pulse Oximeters: 9/7/1992
1. ASTM 1415:1992, and Draft 10.1
1. UL2601-1: Second Edition. 1997
1. IEC 60068-2-6
1. IEC 60068-2-27
1. IEC 60068-2-64
1. ISTA Procedure 2A

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories is substantially equivalent in design concepts, technologies and materials to the Dolphin Medical Stand-Alone Pulse Oximeter Model No. 2100 and Accessories previously reviewed. Additional performance validation testing has been performed for the Y sensor models (320, 360) and has been included in this submission.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the department's name around the perimeter. Inside the circle is a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Public Health Service

MAR 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jon Werner Quality Assurance Manager Dolphin Medical, Incorporated 13801 McCormick Drive Tampa, Florida 33626

Re: K024235

Trade/Device Name: Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 7, 2003 Received: March 10, 2003

Dear Mr. Werner:

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.

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Page 2 - Mr. Werner

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 yours.

Susan Runner, DDS, MA

Interim Director V 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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510(k) Number (if known):

Device Name: Dolphin Medical Stand-Alone Pulse Oximeter, Model No., 2100

December 10, 2002

Indications for Use:

The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO2 sensor).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesia, General Hospital, Infection Control, and Dental Devices (DAGID)

KO24235 510(k) Number:

Prescription Use (Per 21 CFR 801.109)

over-the-counter Use

v. General Hospital.

510(k) Number .

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).