The IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (C1-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selectrode (ISE) petentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu).

The IL Synthesis (hardware, software, and reagents) also permits the quantitative in vitro diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O2Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O ct) oxygen binding capacity (O2 cap) and oxygen saturation (sO2m).

The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeters on blood and gas samples.

Device Description

The IL Synthesis is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers. Its technology combines that of the IL BGElectrolytes Analyzer (IL 1400/1430) and the IL BGGE Blood Gas with Glucose Analyzer (IL 1660) with an integrated co-oximeter module - The IL Synthesis will be available in several different configurations of blood gas, electrolytes. co-oximeter, and glucose.

AI/ML Overview

Here's an analysis of the provided text regarding the IL Synthesis device, categorized by your requests.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance thresholds that the device must meet (e.g., pH %CV must be < 0.1%). Instead, it presents performance data (imprecision) from an internal study conducted on the IL Synthesis™. The reported device performance is shown in the tables below, representing the "Between Day Imprecision" for various parameters.

Blood Gas and Electrolyte Imprecision (pH, pCO2, pO2, Na, K, Ca, Cl, Glu, Hct)

Parameter	Level	n	Reported Max %CV (across instruments)
pH	1	60	0.19
	2	60	0.09
	3	60	0.08
pCO2 (mmHg)	1	60	1.81
	2	60	1.23
	3	60	1.29
pO2 (mmHg)	1	60	0.61
	2	60	1.84
	3	60	3.79
Na (mmol/L)	1	60	0.77
	2	60	0.65
	3	60	1.42
K (mmol/L)	1	60	2.05
	2	60	1.37
	3	60	2.27
Ca (mmol/L)	1	60	1.82
	2	60	2.84
	3	60	1.14
Cl (mmol/L)	1	60	4.01
	2	60	1.13
	3	60	0.58
Gluc (mg/dL)	1	60	2.88
	2	60	3.83
	3	60	3.72
Hct (%)	Low	12	1.31
	High	12	1.39

CO-Oximeter Imprecision (tHb, %O2Hb, %COHb, %MetHb)

Parameter	Level	n	Reported Max %CV (across instruments)
tHb (mg/dL)	1	15	5.42
	2	15	4.68
	3	15	5.12
O₂Hb (%)	1	15	0.34
	2	15	0.08
	3	15	0.35
COHb (%)	1	15	0.28
	2	15	1.04
	3	15	0.94
MetHb (%)	1	15	8.83
	2	15	4.79
	3	15	9.72

2. Sample Size Used for the Test Set and Data Provenance

Blood Gas, Electrolytes, Glucose:
- Sample Size: For pH, pCO2, pO2, Na, and K, 60 replicates (5 replicates/day for 12 days) were run on each of three IL Synthesis instruments. For Ca, Cl, and Glu, 60 replicates were run on each of two IL Synthesis instruments.
- Data Provenance: "The data were collected during in-house studies." This indicates the data is retrospective from internal company testing, likely conducted in the US (given the Lexington, MA address).
Hematocrit:
- Sample Size: 12 replicates (2 levels of Hct CHECK, run for 12 days) on each of three instruments.
- Data Provenance: "The data were collected during in-house studies." (Retrospective, likely US).
CO-Oximeter:
- Sample Size: 15 replicates (5 replicates/day for 3 days) for each parameter at each of three levels, on each of three IL Synthesis instruments.
- Data Provenance: "The data were collected during in-house studies." (Retrospective, likely US).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes performance testing of a diagnostic laboratory instrument rather than an AI/ML device relying on human expert labels for ground truth. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

For this type of device, the "ground truth" is typically established by:

The known, certified values of the quality control materials used (Contrill Plus, Hct CHECK, dye-based controls).
The inherent accuracy and precision of the analytical methods themselves, which are validated against reference methods or certified standards during the development process.

The document does not specify the qualifications of individuals performing these imprecision tests, but they would be laboratory technicians or scientists familiar with operating and calibrating the instruments and handling QC materials.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML device whose output requires clinical interpretation or consensus among experts, there is no adjudication method described or needed. The performance is based on direct measurement outputs compared against the known values of control materials.

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 a laboratory diagnostic instrument, not an AI/ML device intended to assist human readers or clinicians in interpreting complex data like images. Therefore, an MRMC study is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance data presented IS standalone performance of the device (i.e., the instrument's intrinsic ability to measure parameters on control materials) without human intervention in the interpretive process. The "algorithm" here refers to the instrument's internal measurement and calculation processes. There is no explicit "human-in-the-loop" component for performance evaluation beyond operating the device and analyzing the raw numerical results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance study (imprecision) was established using certified quality control materials (Contrill Plus, Hct CHECK, dye-based controls) with known target values for the measured parameters. This is a common and accepted method for assessing the analytical performance of in vitro diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. The IL Synthesis™ is a traditional in vitro diagnostic instrument, not an AI/ML device that requires a training set. Its internal logic and calibration are based on established physicochemical principles and engineering, not machine learning from a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device. The ground truth for the development and calibration of such instruments is typically based on:

Reference materials with known, traceable values.
Physical principles of measurement (e.g., ion-selective electrode chemistry, spectrophotometry).
Rigorous analytical validation against other established methods.

Summary

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K963800

SECTION 3 IL Synthesis™ - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 phone (617) 861-4182 fax (617) 861-4464

Contact Person:

Betty Lane phone (617) 861-4182

Summary Prepared:

September 20, 1996

Name of the device:

IL Synthesis™

Classification name(s):

75CHL	Electrode measurement, blood-gases (PCO2, PO2) and blood pH862.1120 Blood-Gases (PCO2, PO2) and blood pH test system	Class II
75JF98	Electrode, ion specific, calcium862.1145 Calcium test system	Class II
75CGZ	Electrode, ion specific, chloride862.1170 Chloride test system	Class II
75LFR	Glucose dehydrogenase, glucose862.1345 Glucose test system	Class II
75CEM	Electrode, ion specific, potassium862.1600 Potassium test system	Class II
	862.1665 Sodium test system	Class II

Section 3	IL Synthesis 510(k)	Page 1 of
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Classification name(s) (Cont.):

75JJE	Analyzer, chemistry (photometric. discrete), for clinical use862.2160 Discrete photometric chemistry analyzer for clinical use	Class I
75JJQ	Colorimeter, photometer, spectrophotometer for clinical use862.2300 Colorimeter, photometer or spectrophotometer for clinical use	Class I
91JKS	Spectral absorb, curve, oxyhemoglobin, carboxyhemoglobin,carbon-monoxide862.3220 Carbon monoxide test system	Class I
81GKF	Instrument, hematocrit, automated864.5600 Automated hematocrit instrument	Class II
81GKR	System, hemoglobin, automated864.5620 Automated hemoglobin system	Class II
81GHS	Assay, carboxyhemoglobin864.7425 Carboxyhemoglobin assay	Class II
81GLY	Oximeter to measure hemoglobin864.7500 Whole blood hemoglobin assays	Class II
	862.1150 Calibrator	Class II
	862.1660 Quality control material (assayed and unassayed)	Class I
	864.8625 Hematology quality control mixture	Class II

Identification of predicate device(s):

IL 1400 BGElectrolyte Analyzer	K890827/A
IL 1430 BGElectrolyte Analyzer	K935069/S2
IL BGGE Blood Gas with Glucose Analyzer	K955793
IL 682 CO-Oximeter	K945677/S2
Radiometer ICA2 Ionized Calcium Analyzer	K801848

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Description of the device/intended use(s):

The intended use, methodology, concentration levels, working range and analytical results of the IL Synthesis are substantially equivalent to the predicate devices: IL BGElectrolytes Analyzer (IL 1400/1430), IL BGGE Blood Gas with Glucose Analyzer (L 1660) and the ICA2 Ionized Calcium Analyzer.

The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeters on blood and gas samples.

Statement of how the Technological Characteristics of the Device compare to the Predicate device:

The IL Synthesis uses the same technological characteristics as the predicate devices. L BGElectrolytes Analyzer (IL 1400/1430), the BGGE Blood gas with Glucose Analyzer, and uses newer co-oximetry technology than the IL 682 CO-Oximeter. The IL Synthesis is substantially equivalent in performance, intended use, safety and effectiveness to the predicate devices: IL BGElectrolytes Analyzer (Cl), the IL BGGE Blood Gas with Glucose Analyzer (pH, pO2, pCO2, Na, K, Glu, Hct), Radiometer ICA2 Ionized Calcium Analyzer (Ca), and the IL 682 CO-Oximeter (co-ox).

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Summary of performance data:

BLOOD GAS BETWEEN DAY IMPRECISION USING contrIL PLUS and HCT CHECK QC MATERIAL

			INSTRUMENT 1			INSTRUMENT 2			INSTRUMENT 3
Parameter	Level	n	mean	SD	% CV	mean	SD	%CV	mean	SD	%CV
pH	1	60	7.597	0.141	0.19	7.596	0.015	0.02	7.596	0.0146	0.19
	2	60	7.418	0.006	0.08	7.418	0.007	0.09	7.418	0.0056	0.08
	3	60	7.138	0.006	0.08	7.137	0.006	0.09	7.138	0.0053	0.07
pCO2(mmHg)	1	60	20.63	0.32	1.57	20.54	0.37	1.81	19.75	0.30	1.53
	2	60	37.51	0.30	0.81	37.52	0.46	1.23	37.18	0.14	0.37
	3	60	64.21	0.83	1.29	65.30	0.58	0.89	66.25	0.37	0.56
pO2(mmHg)	1	60	146.6	0.83	0.57	145.6	0.81	0.56	145.9	0.89	0.61
	2	60	88.4	1.51	1.84	87.0	1.37	1.58	87.2	1.21	1.39
	3	60	51.3	1.65	2.02	50.3	1.90	3.79	51.27	1.75	3.41
Na(mmol/L)	1	60	114.8	0.70	0.61	118.6	0.58	0.49	116.9	0.65	0.77
	2	60	137.0	0.85	0.62	140.8	0.92	0.65	138.5	0.67	0.48
	3	60	159.1	2.26	1.42	162.4	2.07	1.28	159.5	1.89	1.18
K(mmol/L)	1	60	2.58	0.027	1.05	2.55	0.052	2.05	2.59	0.0242	0.93
	2	60	4.38	0.060	1.37	4.35	0.052	1.20	4.40	0.0495	1.13
	3	60	6.09	0.099	1.62	6.13	0.139	2.27	6.11	0.0722	1.18
Ca(mmol/L)	1	60	0.625	0.011	1.82	0.628	0.0095	1.51	N/A	N/A	N/A
	2	60	1.03	0.029	2.84	1.025	0.0257	2.51	N/A	N/A	N/A
	3	60	1.57	0.018	1.14	1.555	0.0146	0.94	N/A	N/A	N/A
Cl(mmol/L)	1	60	85.8	3.44	4.01	N/A	N/A	N/A	86.9	3.48	3.50
	2	60	108.9	1.23	1.13	N/A	N/A	N/A	109.6	1.13	1.03
	3	60	137.1	0.73	0.53	N/A	N/A	N/A	137.0	0.79	0.58
Gluc(mg/dL)	1	60	N/A	N/A	N/A	59.67	1.72	2.88	62.08	1.10	1.31
	2	60	N/A	N/A	N/A	84.75	3.24	3.83	86.56	1.09	1.26
	3	60	N/A	N/A	N/A	237.2	8.62	3.63	216.2	8.03	3.72
Hct(%)	Low	12	36.1	0.29	0.80	37.7	0.49	1.31	36.8	0.39	1.06
	High	12	63.7	0.89	1.39	65.0	0.49	1.31	64.9	0.51	0.79

Between day imprecision results were generated by using three levels of Contrill Plus. For pH, pCO2, pO2, Na and K, samples were run in replicates of 5 once a day for 12 days for a total of 60 replicates on each of three IL Synthesis instruments For calcium, chloride and glucose, samples were run in replicates of 5 once a day for 12 days for a total of 60 replicates on each of two IL Synthesis instruments. For hematocrit, two levels of Hct CHECK were run for 12 days for a total of 12 replicates on each of 3 instruments. The data were collected during in-house studies.

N/A = Not available. The IL Synthesis can be configured with any two of Ca++, Cl-, and Glu.

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Summary of performance data (continued):

CO-OX

BETWEEN DAY IMPRECISION USING DYE-BASED CONTROLS

			INSTRUMENT 1			INSTRUMENT 2			INSTRUMENT 3
Parameter	Level	n	mean	SD	%CV	mean	SD	%CV	mean	SD	%CV
tHb(mg/dL)	1	15	7.04	0.38	5.42	7.05	0.14	1.92	6.98	0.13	1.85
tHb(mg/dL)	2	15	13.78	0.65	4.68	13.82	0.35	2.55	13.52	0.18	1.33
tHb(mg/dL)	3	15	17.69	0.91	5.12	17.86	0.55	3.10	17.15	0.12	0.70
O₂Hb(%)	1	15	45.26	0.16	0.34	44.86	0.10	0.22	44.90	0.09	0.20
O₂Hb(%)	2	15	93.56	0.08	0.08	93.54	0.08	0.08	93.66	0.08	0.08
O₂Hb(%)	3	15	64.75	0.22	0.35	64.78	0.12	0.18	64.85	0.20	0.31
COHb(%)	1	15	53.73	0.15	0.28	54.15	0.08	0.14	54.13	0.09	0.18
COHb(%)	2	15	3.94	0.04	1.04	3.99	0.04	0.92	3.99	0.04	0.94
COHb(%)	3	15	34.71	0.22	0.63	34.72	0.09	0.27	34.70	0.20	0.57
MetHb(%)	1	15	0.50	0.00	0.00	0.473	0.04	8.62	0.413	0.04	8.83
MetHb(%)	2	15	1.99	0.04	1.84	1.88	0.06	3.07	1.78	0.09	4.79
MetHb(%)	3	15	0.50	0.00	0.00	0.50	0.00	0.00	0.46	0.04	9.72

Within run imprecision results were generated by using three levels of dye-based controls. For each parameter, samples were run in replicates of 5 once a day for 3 days for a total of 15 replicates on each of three IL Synthesis instruments. The data were collected during in-house studies.

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.