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The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.

The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell Carcinoma.

The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Description

The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.

The instrument includes of the following main parts;

. Sampling Arm (for sample addition to cuvettes)
Reagent Arm (for reagent addition to cuvettes) .
Reaction Station (cuvettes) .
Sample Plate Station (for loading samples) .
Reagent Plate Station (for on board reagents) .
. Photometer (for reaction analysis reading)
Wash Station (for cleaning of reaction cuvettes) .
Electronic Boards (for controlling the open functions) .

The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.

The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the JAS XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, and ISE Reagent Pack, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials. Therefore, information regarding human reader studies (MRMC), standalone AI performance, and expert qualifications for ground truth in the traditional sense of AI/ML studies are not typically found in these submissions as the device is not an AI/ML diagnostic tool. The "ground truth" here refers to established, validated reference methods or materials in clinical chemistry.

1. Table of Acceptance Criteria and Reported Device Performance

Device: XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Tests: Glucose, Sodium, Potassium, Chloride

Performance Characteristic	Acceptance Criteria (Implicit from Results)	Reported Device Performance (Glucose)	Reported Device Performance (Sodium)	Reported Device Performance (Potassium)	Reported Device Performance (Chloride)
Linearity	Data linear within allowable nonlinearity (e.g., 3mg/dL or 5%)	9 to 500 mg/dL	100 to 200 mEq/L	1.0 to 10.0 mEq/L	50 to 150 mEq/L
	Slope between 0.90 and 1.10	1.001 (Glucose linearity)	-	-	-
	Intercept close to 0 mg/dL	-0.1 mg/dL (Glucose linearity)	-	-	-
Calibrator Traceability Accuracy	"Accuracy test passed and results linear" with acceptable slope and intercept.	Slope: 0.972, Intercept: 2.1mg/dL, Error: 1.4%	Slope: 1.007, Intercept: 4.4mmol/L, Error: 0.1%	Slope: 0.902, Intercept: 0.1mmol/L, Error: 1.3%	Slope: 1.012, Intercept: 2.0mmol/L, Error: 1.3%
Interferences	Glucose values remain within 10% of unspiked sample value.	Hemoglobin: up to 400 mg/dLBilirubin: up to 21.4 mg/dLLipemia: up to 412 mg/dLAscorbic Acid: up to 10.0 mg/dL	Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL	Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL	Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL
Method Comparison (Correlation)	R > 0.95, Slope between 0.90 and 1.10, Intercept close to 0	R: 0.9970, Slope: 1.002, Intercept: 1.8 mg/dL (vs. Olympus 400 Glucose Reagent)	R: 0.9917, Slope: 0.984, Intercept: 2.256 mmol/L (vs. Olympus 400 ISE)	R: 0.9954, Slope: 0.999, Intercept: 0.05 mmol/L (vs. Olympus 400 ISE)	R: 0.9856, Slope: 1.070, Intercept: -4.3 mmol/L (vs. Olympus 400 ISE)
Precision/ Reproducibility (CV%)	CV (%) < 5% for both within run and total precision.	Within Run: Level 1: 1.7%, Level 2: 1.2%, Level 3: 1.2%Total: Level 1: 2.6%, Level 2: 1.8%, Level 3: 1.3%	Within Run: Level 1: 0.3%, Level 2: 0.3%, Level 3: 0.5%Total: Level 1: 0.7%, Level 2: 0.8%, Level 3: 0.8%	Within Run: Level 1: 1.9%, Level 2: 0.3%, Level 3: 0.6%Total: Level 1: 2.1%, Level 2: 0.8%, Level 3: 1.1%	Within Run: Level 1: 0.5%, Level 2: 0.6%, Level 3: 0.3%Total: Level 1: 0.8%, Level 2: 0.7%, Level 3: 0.5%

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

Glucose Correlation (Test Set): 103 sample pairs (serum), multiple days, various glucose levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Sodium Correlation (Test Set): 101 sample pairs (serum), multiple days, various analyte levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Potassium Correlation (Test Set): 90 sample pairs (serum), multiple days, various analyte levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Chloride Correlation (Test Set): 88 sample pairs (serum), multiple days, various analyte levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Precision (Test Set): Three glucose, sodium, potassium, and chloride sample levels, each run 20 times in duplicate over 20 days.
- Data Provenance: In-house laboratory testing.

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

Not applicable. This is a clinical chemistry analyzer, not an image-based diagnostic AI/ML device requiring expert interpretation for ground truth. The "ground truth" for the test set is established by the measurements from the predicate device (Olympus AU400 Clinical Chemistry Analyzer) or by reference materials/methods (e.g., Verichem Laboratories Matrix Plus Chemistry Reference Kit, NIST-traceable materials).

4. Adjudication method for the test set

Not applicable. As this is a clinical chemistry device, adjudication in the sense of reconciling human expert opinions is not relevant. The comparison is between the device's measurements and those of a predicate device/reference standard.

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 not an AI/ML diagnostic device involving human readers.

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

Yes, the studies presented are for the standalone performance of the device (XL-200 Analyzer with its reagents). The device itself performs the quantitative measurements without human-in-the-loop diagnostic interpretation of results in the context of an AI/ML algorithm. The results are reported as numerical values.

7. The type of ground truth used

The ground truth for the performance studies is primarily established by:

Predicate Device Measurements: For correlation studies, the measurements from the legally marketed Olympus AU400 Clinical Chemistry Analyzer (using Olympus reagents) served as the reference standard.
Reference Materials: For calibrator traceability studies, Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500), verified and lot certified using National Institute of Standards and Technology (NIST) traceable standard reference materials, was used.
Theoretically Prepared Standards: For linearity studies, serial dilutions of stock standards with known concentrations were used.
Established Analytical Methods: The hexokinase/G-6-P enzymatic method for glucose and ion-selective electrodes for electrolytes are well-established analytical principles in clinical chemistry.

8. The sample size for the training set

Not applicable. This device is a traditional clinical chemistry analyzer and reagent system, not an AI/ML device that requires a "training set" in the machine learning sense. The device's performance characteristics (e.g., linearity, precision, interference) are determined to define its operating range and robustness, not to train an algorithm.

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 validating the device's performance is established as described in point 7.

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