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The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.

The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device 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.

The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.

The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.

The Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.

The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).

Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.

A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.

Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.

The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.

The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.

The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.

Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.

Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.

The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.

The target concentration of the albumin is 4.3 g/dL.

The provided document describes the Siemens Healthcare Diagnostics Trinidad CH System and its associated assays for Sodium (Na), Potassium (K), Chloride (Cl), and Albumin (Alb_P). The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices. It presents various performance characteristics of the device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail results. Instead, it presents performance data for various characteristics, and the underlying implication is that these results are acceptable for demonstrating substantial equivalence. The following table summarizes the reported performance characteristics:

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

Detection Limit (LoB, LoD):

• Na, K, Cl (Serum): 4 blank samples, 4 low/diluted patient serum samples. Each tested N=5, for 3 days, one run per day, 2 reagent lots (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte for LoB, similar for LoD).
• Na, K, Cl (Urine): 4 blank samples, 4 low/diluted patient urine samples. Each tested N=5, for 3 days, one run per day, 2 reagent lots (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte for LoB, similar for LoD).
• Albumin (Alb_P): 6 blank samples, 5 low/diluted serum samples. Blank samples: N=5 for 3 days, one run per day, 3 reagent lots (90 measurements per reagent lot). Low samples: N=5 for 3 days, one run per day, 3 reagent lots (75 measurements per reagent lot).

Limit of Quantitation (LoQ):

• Na, K, Cl (Serum/Urine): 4 low samples of diluted serum/urine. Processed on 2 IMT sensor lots for 3 days, on one instrument (Total determinations: 4 x 5 x 3 x 2 = 120 per analyte per matrix).
• Albumin (Alb_P): 5 low samples of diluted serum pools. Processed on 3 reagent lots for 3 days, on one instrument (Total determinations: 5 x 5 x 3 x 3 = 225).

Linearity Study:

• Na, K, Cl, Albumin: 9 equally spaced samples (prepared by mixing high and low concentration samples). Three replicates were measured for each sample. (Total determinations: 9 x 3 = 27 per analyte).

Precision Studies:

• Na, K, Cl (Serum & Urine Pools/QCs), Albumin (Serum Pools/QCs): Tested n = 2 replicates, two times a day for at least 20 days. (Total replicates: 2 x 2 x 20 = 80 replicates for each sample type/level, and in some cases 84).

Interferences:

• Na, K, Cl, Albumin: Samples spiked with interfering substances at varying concentrations (specific numbers of samples not explicitly stated, but it was a "worst case scenario" approach using low and high levels of measurand in serum pools).

Method Comparison (vs. Predicate Device):

• Na: 106 serum samples, 101 urine samples.
• K: 103 serum samples, 105 urine samples.
• Cl: 108 serum samples, 102 urine samples.
• Albumin: 130 serum samples.
• Data Provenance: Remnant de-identified samples. Country of origin not specified, but the study was "conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel." This typically implies a US-based or corporate lab setting. The data is retrospective as it used "remnant de-identified samples" and "no patient history information was obtained."

Method Comparison (vs. Reference Method):

• Na, K, Cl: 25 serum and plasma samples.
• Data Provenance: The reference measurements were made at INSTAND e.V, Ubierstrasse 20, 40223 Düsseldorf, GERMANY. This implies European provenance for the reference method data, likely used against test samples generated by Siemens.

Matrix Equivalency:

• Na, K, Cl: 50 matched serum and lithium heparin plasma samples.
• Albumin: 59 matched sample sets (Serum vs. Lithium Heparin, Serum vs. EDTA plasma).

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

The document describes performance studies for an in-vitro diagnostic device measuring analytes (Na, K, Cl, Albumin) directly. For such devices, "ground truth" is typically established by reference methods or predicate devices, rather than expert human interpretation of images or clinical findings.

• For Method Comparison against a Predicate Device: The predicate device is the ADVIA 1800 Chemistry System (cleared under K990346), which itself is a legally marketed device and provides the comparative "truth." The document states that "laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting" conducted the tests.
• For Method Comparison against Reference Methods: The reference methods used were flame emission spectrophotometry for Na and K, and coulometry for Cl. These are established analytical techniques. The measurements were made at INSTAND e.V, an organization involved in external quality assessment and reference materials, implying high-level analytical expertise. No "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for chemical measurements in this context.

4. Adjudication method for the test set

Not applicable. This is an in-vitro diagnostic device for quantitative chemical measurements. The "test set" refers to patient samples measured by the device itself or compared against a predicate/reference device, not assessments requiring clinical adjudication or consensus among experts.

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 in-vitro diagnostic device for automated chemical analysis, not an AI-assisted diagnostic imaging or clinical decision support tool for human readers. Therefore, an MRMC study and evaluation of human reader improvement with/without AI assistance are not relevant to this device.

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

Yes, the studies described are standalone performance studies of the device (Trinidad CH System and its assays). The device performs automated, quantitative chemical analysis without continuous human intervention in the result generation. The results are compared against predicate devices or reference methods, which is a standalone comparison. Human involvement is limited to sample preparation, loading, and result review, which are standard for laboratory instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies was established through:

• Comparison to a Legally Marketed Predicate Device: The ADVIA 1800 Chemistry System. This represents a "standard of care" or "established method" ground truth.
• Comparison to Reference Methods: Flame emission spectrophotometry (for Na and K) and coulometry (for Cl). These are highly accurate and precise analytical techniques considered definitive for these analytes.
• Spiked and Diluted Samples: For linearity, LoQ, and matrix equivalency studies, samples were artificially manipulated (spiked with analytes or diluted) to create samples with known or controlled concentrations.

8. The sample size for the training set

The document does not explicitly delineate a "training set" in the context of machine learning or AI. This is an automated clinical chemistry analyzer. The "training" of such a system typically refers to factory calibration and internal algorithm development based on extensive R&D data. The performance characteristics described are "test set" evaluations demonstrating the device's accuracy and precision in a real-world (or simulated real-world) setting after development. Therefore, a specific sample size for a machine learning training set is not provided or applicable in the way it would be for an AI/ML medical device.

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

Not applicable as there is no explicitly defined "training set" in the machine learning sense. The device's underlying principles (photometric and ion selective electrode technology) are based on established chemical and physical laws. The process of making the instrument accurate and precise involves internal calibration and characterization using various standards and control materials with known values, rather than a "training set" with ground truth assigned by human experts for interpretive tasks.

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