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The BS-400/CLC 720 Chemistry Analyzers are designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Glucose in serum samples plasma and urine samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

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

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

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.

Device Description

The BS-400/CLC 720 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K970664 and is the chosen assay to demonstrate performance for the photometric unit. The BS-400 Chemistry Analyzer has an optional lon-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, extracting the requested information about the device's acceptance criteria and the supporting study:

The document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD BS-400 Chemistry Analyzer (and CLC 720 Chemistry Analyzer, which is stated to be the same model). The device is an automated clinical chemistry analyzer for in vitro diagnostic use, performing photometric assays and having an optional Ion-Selective Electrode (ISE) module.

Summary of Acceptance Criteria and Device Performance:

The primary method for demonstrating performance is through correlation analysis with predicate devices and internal precision, linearity, and limit determination tests. The acceptance criteria are implicitly defined by the reported performance metrics falling within acceptable ranges for clinical diagnostic devices.

Performance Characteristic	Analyte	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation Coefficient (R²)	GLU (mg/dL)	Close to 1.0	0.999
	Serum K+ (mmol/L) (ISE)	Close to 1.0	0.9973
	Serum Na+ (mmol/L) (ISE)	Close to 1.0	0.9975
	Serum Cl- (mmol/L) (ISE)	Close to 1.0	0.9957
	Urine K+ (mmol/L) (ISE)	Close to 1.0	0.9996
	Urine Na+ (mmol/L) (ISE)	Close to 1.0	0.9994
	Urine Cl- (mmol/L) (ISE)	Close to 1.0	0.9996
Within Run Precision (%CV)	Glucose (ranges by concentration)	Low %CV	0.6% - 1.7%
	ISE analytes (ranges by level)	Low %CV	0.33% - 2.48%
Total Precision (%CV)	Glucose (ranges by concentration)	Low %CV	0.9% - 2.1%
Between-Run Imprecision (%CV)	ISE analytes (ranges by level)	Low %CV	0.56% - 4.75%
Linearity Range (Lower/Upper Limits)	GLU (mg/dL) Serum/Plasma	Defined clinical range	5 - 700
	GLU (mg/dL) Urine	Defined clinical range	2 - 700
	K (mmol/L) serum(ISE)	Defined clinical range	0.94 - 8.18
	Na (mmol/L) serum(ISE)	Defined clinical range	71.00 - 232.28
	CL (mmol/L) serum(ISE)	Defined clinical range	49.60 - 198.18
	K (mmol/L) Urine(ISE)	Defined clinical range	3.50 - 209.25
	Na (mmol/L) Urine(ISE)	Defined clinical range	9.25 - 725.50
	CL (mmol/L) Urine(ISE)	Defined clinical range	7.25 - 693.25
Limit of Detection (LoD)	GLU (mg/dL) Serum/Urine	Low LoD	2.6 / 0.9
	ISE analytes	Low LoD	0.10 - 8.98
Interference (Implicit Criterion)	Shift in results	< 3 mg/dL and < 3%	Generally "none" or qualified minimal shift

Study Details:

Sample sizes used for the test set and data provenance:
- Correlation Analysis (Method Comparison):
  - GLU: 218 samples
  - Serum K+, Na+, Cl- (ISE): 40 samples each
  - Urine K+, Na+, Cl- (ISE): 40 samples each
- Precision (Glucose):
  - Control 1, Pool 1, Control 2 (Serum): 120 replicates each
  - Pool 1, Pool 2 (Urine): 117 replicates each
  - Pool 3 (Urine): 120 replicates
- Within-Run Imprecision (ISE): Replicates for Level I and Level II controls/pools for each ISE analyte (number of replicates not explicitly stated, but common practice for this type of test involves significant replication, e.g., 20 or more per run).
- Between-Run Imprecision (ISE): Replicates for Level I and Level II controls/pools for each ISE analyte across multiple runs (number of replicates and runs not explicitly stated).
- Linearity, Limit of Detection, Interference: Sample sizes are not explicitly stated for individual tests but would involve multiple measurements across a range of concentrations or with interfering substances.
Data Provenance: Not explicitly stated. However, this type of performance testing is typically conducted in a laboratory setting, often in the manufacturer's R&D facilities or a collaborating clinical lab. The document does not specify country of origin for the data (e.g., China, US) nor whether it was retrospective or prospective, though performance evaluation studies are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of device (clinical chemistry analyzer), "ground truth" is established by comparative measurements against a legally marketed predicate device (SYNCHRON CX7 for photometric assays like Glucose, and BS-200 Chemistry Analyzer for ISE module) or using reference methods.
- Expert review for result interpretation (e.g., radiologist for imaging) is not applicable here. The "ground truth" is quantitative measurements from established, validated laboratory methods.
Adjudication method for the test set:
- Not applicable as this is a quantitative analytical device comparison and performance characterization, not subjective interpretation requiring adjudication.
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/imaging device that involves human reader interpretation. It's an automated clinical chemistry analyzer.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics (precision, linearity, limits of detection, interference) are all measures of the analyzer's standalone performance, i.e., the algorithm/instrument only, without human intervention in the assay execution or result calculation once initialized. The correlation analysis also assesses the device's standalone performance against a predicate device.
The type of ground truth used:
- Comparative Reference: For the correlation analysis, the results from the SYNCHRON CX7 analyzer (for photometric assays like Glucose) and the BS-200 Chemistry Analyzer (for the ISE module) served as the comparative "reference" or "ground truth" for demonstrating substantial equivalence. These are legally marketed predicate devices.
- Internal Validation Metrics: For precision, linearity, and limits of detection, the "ground truth" is derived from statistical models and expected performance ranges based on established analytical chemistry principles and industry standards for in vitro diagnostic devices. These are not external "ground truths" in the sense of a gold-standard clinical outcome or pathology.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a distinct "training set" in the conventional sense. The device's operational parameters and calibration curves are established through a different process than machine learning model training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The calibration and operational parameters are set using known standards and calibrators according to established analytical chemistry protocols.

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