ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.

Device Description

ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.

AI/ML Overview

This is an in vitro diagnostic device, not one for which the requested information (like expert readers, adjudication methods, multi-reader multi-case studies, or ground truth types like pathology/outcomes data) is typically relevant or provided in a 510(k) summary. The document describes a blood gas analyzer, and its performance is typically evaluated against reference methods or established predicate devices, not through human interpretation of images or signals.

Therefore, much of the requested information cannot be extracted from the provided text because it doesn't pertain to this type of medical device submission.

However, I can provide what is relevant and available:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (HSC130) is a 510(k) summary for the Radiometer America Inc. ABL700 Series. It states that the device is "substantially equivalent" to predicate devices, namely the ABL625 (K962334) and ABL555 (K973367). In 510(k) submissions for in vitro diagnostic (IVD) devices like blood gas analyzers, "acceptance criteria" and "reported device performance" are typically demonstrated through comparisons to these predicate devices or established reference methods. However, the specific numerical performance data or acceptance criteria are not detailed in this summary. The summary focuses on technological characteristics and intended use.

Therefore, an explicit table of acceptance criteria and reported device performance from the provided document cannot be constructed. The statement of substantial equivalence implies that the device performs comparably to the predicate devices and meets a level of performance acceptable for its intended use, but the detailed metrics are not included in this summary.

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

Sample Size: Not specified in the provided summary.
Data Provenance: Not specified in the provided summary. Performance studies for IVD devices typically involve testing patient samples, but details on the source (e.g., country of origin) or whether it was retrospective/prospective are not present.

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

This information is not relevant for this type of in vitro diagnostic device. The "ground truth" for a blood gas analyzer's measurements would typically be established by comparing its results to a well-calibrated reference method or accepted laboratory standard, not through expert consensus on images or interpretations.

4. Adjudication method for the test set:

Not relevant for this type of in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not applicable here.

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 is an automated blood gas analyzer, not an AI-assisted diagnostic tool that aids human readers in interpreting images or data.

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

Yes, the ABL700 Series is described as a "stand-alone blood gas analyzer." Its performance evaluation would inherently be "standalone" in this context, meaning the device itself produces the measurement results without human interpretation being part of the primary diagnostic output being evaluated.

7. The type of ground truth used:

The type of "ground truth" for a blood gas analyzer would be established by:

Reference methods: Comparison of the ABL700's measurements (pH, pCO2, pO2, etc.) against established, highly accurate reference laboratory methods.
Predicate device comparison: Performance comparison against the ABL625 and ABL555 predicate devices, implying that the predicate devices' established performance serves as a benchmark for "truth."

This exact detail is not explicitly stated as "ground truth" in the summary but is implied by the nature of device testing.

8. The sample size for the training set:

Not applicable or specified. Blood gas analyzers are typically calibrated using known standards and reagents, not "trained" on a data set in the same way machine learning algorithms are.

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

Not applicable for this type of device. Calibration of the device is typically done using standardized calibrants with known values, not through establishing "ground truth" for a training set in the context of machine learning.

Summary

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HSC130

RADIOMETER AMERICA INC.

MEDICAL DIVISION

1998

EXHIBIT VI

811 SHARON DRIVE, WESTLAKE, OHIO 44145-1688 800-736-0600, 218-871-8

510(k) SUMMARY SUBJECT:

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)871-2633
January 5, 1998 DATE:
Trade Name: ABL700 Series PRODUCT: Common Name: Blood Gas, Co-oximetry, Electrolyte and Metabolite Measuring System Classification Name: Blood Gas

PREDICATE

ABL625 and ABL555 DEVICE:

PRODUCT

DESCRIPTION: ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.

INTENDED

ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, USE: pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.

TECHNOLOGICAL CHARACTERISTICS

VERSUS PREDICATE

ABL700 Series is technologically similar to the ABL625 and ABL555. DEVICE:

SUBSTANTIAL EQUIVALENCE:

ABL700 Series is substantially equivalent in features and characteristics to the current ABL625 (K962334) and ABL555 (K973367) marketed by Radiometer America Inc.

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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 stylized eagle with three tail feathers, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 9 1008

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

Re : K980130 ABL700 Series Analyzer Regulatory Class: I & II Product Code: CHL, JFP, CGZ, CGA, KHP, CEM, JGS January 5, 1997 Dated: January 14, 1997 Received:

Dear Mr. Baker:

regulations.

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 Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (Size Co), Child Concernine 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 acious in your may 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 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 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/dsmamain.html".

Sincerely yours,
Steven Butman

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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EXHIBIT V

510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, p02 , cNat, cK+, cCa+, cCL, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.

P. Bierhaus (Lois A. Montgomery)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980130

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801-109)

Over-The-Counter-Use (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.