MINOLTA PULSOX-2 by KONICA MINOLTA SENSING, INC.

The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.

Device Description

The Minolta PULSOX-2, is the device for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease or pulmonary dysfunction. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.

AI/ML Overview

The provided document is a 510(k) summary for the Minolta PULSOX-2, a pulse oximeter. It states that the device is substantially equivalent to a predicate device (Minolta PULSOX-3) and highlights its function and intended use. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study details, and ground truth establishment.

A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed report of a new clinical study with specific acceptance criteria and performance metrics in the way you've outlined for AI/ML device validation.

Therefore, I cannot populate the table or answer most of your detailed questions from the provided text. The document states "Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-2 is safe and effective." but does not provide the specifics of that testing.

Here's what can be inferred or explicitly stated from the document, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Missing: Specific numerical performance metrics (e.g., accuracy, precision, bias) for SpO2 measurement, often expressed against a reference method (e.g., co-oximetry).	General Statement: "Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3." Also, "Testing results are also in compliance with those in published literature for pulse oximeters."
Missing: Defined thresholds for equivalence or non-inferiority to the predicate device or a recognized standard (e.g., ISO 80601-2-61).	Missing: Specific numerical results to demonstrate this compliance/equivalence.

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

Missing from document.

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

Not applicable / Missing from document. For pulse oximeters, the "ground truth" for SpO2 accuracy is typically established by arterial blood gas analysis using a co-oximeter, not by expert review of images or interpretations. The document does not describe such a study.

4. Adjudication method for the test set:

Not applicable / Missing from document. As the ground truth isn't established by expert review, an adjudication method isn't relevant in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No indication of an MRMC study. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret data, rather than a standalone physiological monitor like a pulse oximeter.

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

Yes, implicitly. A pulse oximeter is a standalone device that provides a measurement (SpO2 and pulse rate) without human interpretation affecting the output. The performance assessment would be of the device's accuracy against a reference standard. However, the details of this assessment are missing from the provided text.

7. The type of ground truth used:

Not explicitly stated, but typically for pulse oximeters, the ground truth is established using arterial blood gas analysis with a co-oximeter. The document states: "The Minolta PULSOX-2 is the device for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease or pulmonary dysfunction." This implies direct measurement validation, but the details are not provided.

8. The sample size for the training set:

Not applicable / Missing from document. Pulse oximeters are typically based on optical principles and calibration rather than being "trained" in the machine learning sense. Any calibration data or parameter optimization would not be typically referred to as a "training set" in this context.

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

Not applicable / Missing from document. (See above point for rationale).

In summary, the provided 510(k) document is a regulatory submission for a basic medical device (a pulse oximeter) that relies on demonstrating substantial equivalence to an existing device and compliance with general performance expectations for its category. It does not contain the detailed study design, acceptance criteria, or performance data that would be expected for a complex AI/ML device requiring rigorous clinical validation with specific metrics and ground truth establishment by experts.

Summary

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K021469

Image /page/0/Picture/1 description: The image shows a logo for Compliance Systems +, LLC. The logo features a square with a target symbol inside it. The logo also has a dotted line above the company name.

2703 Josephine Street Denver, CO 80205 Phone: (303) 359-9791

FEB 1 2 2003

SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS Minolta PULSOX-2TM

May 01, 2002

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Minolta PULSOX-2 is similar in function, design and construction to other products which were in the market place prior to May 28, 1976. The Minolta PULSOX-2 is also similar to several other products currently being marketed in the United States including the legally marketed predicate device and a substantial equivalence claim is made. The predicate device is the Minolta PULSOX-3. The predicate device is a legally marketed Class II post-amendment device, K-984570 currently manufactured by Minolta Co., Ltd., Osaka, Japan.

Performance indicates that the Minolta PULSOX-2, is equivalent to the Minolta PULSOX-3. The testing results are also in compliance with those in published literature for pulse oximeters. The testing conducted demonstrates that the Minolta PULSOX-2 is safe and effective.

Nanci Dingle

Nanci Dexter Owner, Compliance Systems +, LLC

05/01/02

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2003

Minolta Company Limited C/O Ms. Nanci Dexter Compliance Systems, LLC 2703 Josephine Street Denver, Colorado 80205

Re: K021469

Trade/Device Name: PULSOX-2 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: December 20, 2002 Received: January 2, 2003

Dear Ms. Dexter:

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 - Ms. Dexter

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 (OS) 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 Ruane

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

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Indications for Use Statement

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: PULSOX-2

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Lisa Ettensohn

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________ K021469

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).