ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.

AI/ML Overview

The provided text describes the Radiometer America Inc. ABL555, an automated blood gas, electrolyte, and metabolite analyzer. However, it does not contain specific acceptance criteria, study data, or details about the methodology used to prove the device meets any such criteria. The document is a 510(k) summary for premarket notification, primarily focused on establishing substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's what can be inferred or stated based on the provided text:

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

Cannot be provided. The document does not specify any acceptance criteria (e.g., accuracy, precision targets) nor does it report specific device performance metrics against such criteria. It states that the ABL555 is "substantially equivalent in features and characteristics to the current ABL505."

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 provided. The document does not mention any specific test set, its sample size, or the provenance of any data used for testing.

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)

Cannot be provided. There is no mention of a test set, ground truth establishment, or experts involved in this document.

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

Cannot be provided. No information on a test set or adjudication methods is present.

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 an automated analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

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

Implied, but details are absent. The ABL555 is described as an "automated blood gas, electrolyte and metabolite analyzer" and a "stand-alone" device. This implies its performance is assessed independently, without human-in-the-loop performance as a primary measure. However, no specific "standalone" study details, methodology, or results are provided in this document.

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

Cannot be provided. The document does not describe how any ground truth was established for performance evaluation. For a blood gas analyzer, ground truth would typically come from reference methods or established calibration standards, but this is not detailed here.

8. The sample size for the training set

Not applicable / Cannot be provided. This device, as described, is a physical instrument for measuring analytes, not a machine learning algorithm that requires a "training set" in the conventional AI sense. If it contains internal algorithms for calibration or data processing, the details of those are not provided, nor is the concept of a "training set" used.

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

Not applicable / Cannot be provided. As above, the concept of a "training set" for an AI model is not mentioned or relevant to the description of this device in the document.

Summary

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NHI 55001

RADIOMETER AMERICA INC.

MEDICAL DIVISION

EXHIBIT VI

811 SHARON DRIVE, WESTLAKE, OHIO 44146-1508 800-736-0600, 216-871-8900 FAX 216-892-8117

OCT - 6 1997

SUBJECT: 510(k) SUMMARY

FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145 (440)871-8900, Ext. 287 or 1-800-736-0600 Fax (440)871-8117
DATE: September 5, 1997
PRODUCT: Trade Name - ABL555 Common Name -Blood Gas, Electrolyte and Metabolite Measuring System Classification Name - Blood Gas

PREDICATE

DEVICE: ABL505 and EML105

PRODUCT

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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

DESCRIPTION: ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.

INTENDED

USE: ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, and glucose on whole blood.

TECHNOLOGICAL CHARACTERISTICS

VERSUS PREDICATE

DEVICE: ABL555 (with glucose) is technologically similar to the current version ABL505.

SUBSTANTIAL EQUIVALENCE:

ABL555 is substantially equivalent in features and characteristics to the current ABL505 marketed by Radiometer America Inc. (K914166). The major difference is the addition of the glucose analyte and the elimination of the Ca and CI electrodes.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three heads, depicted in a stylized, flowing manner.

0CT - 6 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America, Inc. 811 Sharon Drive Westlake, Ohio 44145-1598

Re : K973367 ABL555 Analyzer Requlatory Class: II Product Code: CHL, JGS, CEM, CGA September 5, 1997 Dated: Received: September 8, 1997

Dear Mr. Baker:

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 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 The general controls provisions of the Act 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 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entification" (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/dsmamain.html".

Sincerely yours,
Steven Pitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ of

10(k) Number (if known):

ABL5555 Device Name:_

ndications For Use:

ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, a
nd alone, the contract and the blood ABL555 is a stand alone, blood glucose on whole blood.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 2923367

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.