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Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

Device Description

Teco Carbon Dioxide Reagent Set is a single reagent kit. Reagent contains Good's buffer, phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC), malate dehydrogenase (MDH), magnesium ions, NADH analog, nonreactive stabilizer, preservative, and Buffer. Approximately 90% of carbon dioxide present in serum is in the form of bicarbonate. The measurement of bicarbonate is useful in the assessment of disturbances of acid-base balance resulting from metabolic or respiratory causes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Teco Carbon Dioxide Reagent Set, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Teco Carbon Dioxide Reagent Set)
Linearity/Reportable Range	Range over which the assay demonstrates a linear relationship to the analyte concentration. (Predicate: 2.0 to 40.0 mmol/L)	8.7 to 40.0 mmol/L (linear up to 64 mmol/L)
Accuracy/Correlation	Comparison to a predicate device, typically measured by linear regression with a high R-squared value. (Predicate: $y = 0.965x + 1.200$)	$y = 0.9785x + 0.2636$, $R^2 = 0.9925$, and $R = 0.9962$
Detection Limit (LoQ)	The lowest concentration at which the analyte can be quantitatively determined with acceptable precision (<=10%CV). (Predicate: 2.0 mmol/L)	LoQ: 1.77 mmol/L
Analytical Specificity	No significant bias (defined as ±10% difference from control results) in the presence of specified interferents at certain concentrations.	Hemoglobin: 1,000 mg/dL (no interference) Total Bilirubin: 60 mg/dL (no interference) Conjugate Bilirubin: 30 mg/dL (no interference) Triglycerides: 2,000 mg/dL (no interference) Intralipid: 2,000 mg/dL (no interference) Ascorbic Acid: 6 mg/dL (no interference)
Precision/Reproducibility	Defined by within-laboratory precision (SD and %CV) and repeatability (SD and %CV) across different concentration levels.	QC Level 1 (30.6 mmol/L): Repeatability SD 0.1782, %CV 0.582; Within-Laboratory Precision SD 1.62, %CV 5.31 QC Level 2 (20.5 mmol/L): Repeatability SD 0.7065, %CV 3.426; Within-Laboratory Precision SD 1.87, %CV 9.07 Serum Level 1 (12.0 mmol/L): Repeatability SD 0.1275, %CV 1.065; Within-Laboratory Precision SD 0.69, %CV 5.75 Serum Level 2 (26.6 mmol/L): Repeatability SD 0.1521, %CV 0.571; Within-Laboratory Precision SD 0.85, %CV 3.21 Serum Level 3 (37.4 mmol/L): Repeatability SD 0.1949, %CV 0.521; Within-Laboratory Precision SD 0.59, %CV 1.58
Storage Temperature	2-8 °C	2-8 °C (Accelerated stability: at least 21 months; real-time stability verification ongoing)

Study Details

Sample sizes used for the test set and data provenance:
- Accuracy/Method Comparison: 176 patient serum samples.
- Linearity: Undisclosed number of unaltered human serum samples (prepared by mixing a diluted patient serum sample (2 mmol/L) and a spiked patient serum sample (64 mmol/L) to obtain 11 different concentrations).
- Precision/Reproducibility: Unaltered human serums spiked with carbon dioxide concentrations and commercial serum-based controls.
- Detection Limit (LoB, LoD, LoQ):
  - LoB: One artificial serum base matrix pool.
  - LoD: Four (4) separate pools.
  - LoQ: Five (5) separate pools.
- Analytical Specificity: Two (2) different concentrations of sodium bicarbonate (20 mmol/L and 35 mmol/L) human serum samples. Pooled human serum samples with added potential interferents.
- Data Provenance: The document does not explicitly state the country of origin for the patient samples. All studies appear to be prospective as they were conducted as part of the device's validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes an in vitro diagnostic (IVD) reagent set. For such devices, ground truth is typically established by reference methods or established analytical techniques, not by human expert interpretation in the way a diagnostic imaging AI might be evaluated. Therefore, no information is provided regarding human experts for establishing ground truth.
Adjudication method for the test set:
Not applicable to an IVD reagent set. Ground truth is determined analytically.
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 IVD reagent set, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, all performance studies described are for the standalone Teco Carbon Dioxide Reagent Set. There is no human-in-the-loop component mentioned. The device directly measures carbon dioxide levels.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this device's performance studies is established by:
- Reference methods and quantitative analysis: This is evident in the comparison to a predicate device (Pointe Scientific Inc., Carbon Dioxide Reagent) and the use of standards (NIST SRM 351 traceable CO2 standard).
- Known concentrations: For linearity, precision, and detection limit studies, samples were prepared with known or measured concentrations of carbon dioxide.
- Spiked samples: Used for linearity and precision to cover a range of concentrations.
The sample size for the training set:
Not applicable. This is an IVD reagent set, not a machine learning or AI algorithm that requires a "training set." Its function is based on established enzymatic reactions, not learned patterns from data.
How the ground truth for the training set was established:
Not applicable, as there is no "training set."

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