The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.

As part of this program, GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

Device Description

The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2 pO2, Na . K , CI , Ca * , glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iOM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.

As part of this program, GEM CVP 1 and 2 (Calibration Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartidge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

AI/ML Overview

The provided text focuses on the 510(k) summary for the GEM Premier 4000 with iQM and GEM CVP. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the way you've requested (e.g., specific sensitivity/specificity values, error rates, or statistical comparisons of performance benchmarks).

The document primarily states:

"In-house and field site testing supports that the GEM Premier 4000 with iOM in conjunction with GEM CVP 1 and 2 with CO-Ox and GEM CVP 3 and 4 Hematocrit is not materially different from the above listed predicate devices in performance, safety and effectiveness or intended use."

This indicates that studies were performed to demonstrate substantial equivalence, but the details of those studies, including acceptance criteria and results, are not provided in this 510(k) summary. These details would typically be found in the full 510(k) submission, which is not publicly accessible in its entirety.

Therefore, I cannot populate the table or answer most of your specific questions based on the information provided. I can only report what is explicitly stated in the document.

Here's what can be extracted based on the provided text, and where information is missing:

Acceptance Criteria and Device Performance

The document does not provide a table of explicit acceptance criteria or reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) for each analyte. It broadly states that the device is "not materially different" in performance from predicate devices, which is the basis for 510(k) clearance.

Analyte/Parameter	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
pH	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
pCO2	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
pO2	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
Na+	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
K+	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
Cl-	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
Ca++	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
Glucose	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
Lactate	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
Hematocrit	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
tHb (CO-Oximetry)	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
O2Hb (CO-Oximetry)	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
MetHb (CO-Oximetry)	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)
HHb (CO-Oximetry)	N/A (implied comparable to predicate)	N/A (implied comparable to predicate)

Study Information (Based on available text):

Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "In-house and field site testing" but does not give sample sizes, country of origin, or whether data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
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 in vitro diagnostic analyzer, not an AI-assisted imaging or diagnostic tool for human readers. It measures biochemical parameters directly.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device (GEM Premier 4000) itself performs the analysis automatically. The iQM system is described as "an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls." This implies standalone operation in terms of analytical performance. The external CVP solutions are for calibration verification.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for in vitro diagnostic devices measuring analytes, ground truth is typically established by reference methods or validated laboratory methods.
The sample size for the training set: Not applicable/specified. This is an analytical device, not a machine learning model that typically has a distinct "training set" in the sense of AI/ML. The internal iQM system learns/monitors from its ongoing operations and calibrations rather than a separate training set.
How the ground truth for the training set was established: Not applicable/specified (see point 7).

Summary

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K061974

510(k) Summary GEM Premier 4000 with iQM and GEM CVP

Submitted by:

Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

Contact Person:

Carol Marble, Regulatory Affairs Director 781-861-4467 Phone: 781-861-4207 Fax: cmarble@qa.ilww.com E-mail:

Summary Prepared:

July 11, 2006

Device Trade Names:

GEM® Premier 4000 with iQM® (Intelligent Quality Management) .
GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox .
GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit .

Regulatory Information:

GEM Premier 4000 with iQM (Intelligent Quality Management) .

Description	CFR Section	Device Class	Product Code
Blood gases and blood pH	862.1120	Class II	CHL
Sodium test system	862.1665	Class II	JGS
Potassium test system	862.1600	Class II	CEM
Calcium test system	862.1145	Class II	JFP
Chloride test system	862.1170	Class II	CGZ
Glucose test system	862.1345	Class II	CGA
Lactic acid test system	862.1450	Class I	KHP
Automated hematocrit instrument	864.5600	Class II	GKF
Carboxyhemoglobin assay	864.7425	Class II	GHS
Automated hemoglobin system	864.5620	Class II	GKR

GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox .

Description	CFR Section	Device Class	Product Code
Quality Control Material	862.1660	Class I	JJY

GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit .

Description	CFR Section	Device Class	Product Code
Hematocrit Control	864.8625	Class II	GLK

Section 5

SEP 15 2006

Page 1 of 2

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510(k) Summary GEM Premier 4000 with iQM and GEM CVP

Predicate Devices:

Description	510(k)	Analytes
GEM 3000 with iQM and GEM CVP	K052121	pH, blood gases, electrolytes (except chloride), glucose, lactate, hematocrit
IL Synthesis with traditional QC	K963800	Chloride
IL 682 CO-Oximeter with traditional QC	K945677	CO-Oximeter parameters

Device Description and Indications for Use:

The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2 pO2, Na . K , CI , Ca * , glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

In-house and field site testing supports that the GEM Premier 4000 with iOM in conjunction with GEM CVP 1 and 2 with CO-Ox and GEM CVP 3 and 4 Hematocrit is not materially different from the above listed predicate devices in performance, safety and effectiveness or intended use. The operating principles for the different analytes are the same between the GEM Premier 4000 and the predicates:

Operating Principle	Analyte(s)
Potentiometric	pH, pCO2, Na+, K+, Cl-, Ca++
Amperometric	pO2, Glucose, Lactate
Conductivity	Hematocrit
Spectrophotometry	CO-Oximeter parameters

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, rendered in a thick, black line. The eagle is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

SEP 1 5 2006

K061974 Re:

Trade/Device Name: GEM® Premier 4000 with iQM® (Intelligent Quality Management) GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood Ph test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKF, GHS, GKR, JJY, GLK, GLY Dated: July 11, 2006 Received: July 12, 2006

Dear Ms. Marble:

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 Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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Page 2 -

CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Carol C. Benson for

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K061974

GEM® Premier 4000 with iQM® (Intelligent Quality Management) Device Name: GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit

Indications for Use:

The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, Nat, K+, Cl , Ca+, glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

で Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Amy Daugherty for Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061974

Section 4

GEM Premier 4000 with iQM and GEM CVP 510(k)

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.