Search Results

The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements 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.

Potassium measurements are used to monitor electrolyte balance 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 such as cystic fibrosis and diabetic acidosis.

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. 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 Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

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

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

• Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
• Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

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

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

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 submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.

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

This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

Ask a specific question about this device

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements 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.

Potassium measurements are used to monitor electrolyte balance 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 such as cystic fibrosis and diabetic acidosis.

The Alinity c ICT Sample Diluent is a reagent kit containing Reagent 1 (Buffer). It is used with the Alinity c ICT Serum Calibrator and Alinity c ICT Urine Calibrator on the Alinity c analyzer. The system utilizes ion-selective electrodes (ISE) for sodium, potassium, and chloride, which develop an electrical potential across membranes selective to each ion. This voltage is compared to calibrator voltages and converted into ion concentration. The methodology is Ion-selective electrode diluted (Indirect) and the detection is Potentiometric.

The provided document describes the Alinity c ICT Sample Diluent, a device used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. The document mainly focuses on non-clinical performance studies to demonstrate substantial equivalence to a predicate device, rather than a clinical study with acceptance criteria in the traditional sense of diagnostic accuracy or reader performance.

Here's an analysis of the provided information based on your requested criteria:

The studies presented are primarily analytical performance studies (precision, linearity, interference, method comparison, and tube type equivalency) to demonstrate the device's accuracy and reliability compared to a predicate device. The acceptance criteria are internal, predefined thresholds for these analytical performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, for patient samples. The studies are described as "Within-Laboratory Precision" and "Method Comparison," implying they were conducted in a controlled laboratory setting.

• Precision Studies (Test Set):
  • Serum Samples: For Sodium, Potassium, and Chloride assays, each control level (3 levels) typically had n=243 to n=252 measurements per control lot. For patient panels, n=485 to n=498 measurements were performed.
  • Urine Samples: For Sodium, Potassium, and Chloride assays, each control level (2 levels) typically had n=240 measurements per control lot. For patient panels, n=479 to n=480 measurements were performed.
• Method Comparison (Test Set):
  • Sodium (Serum): n=141
  • Sodium (Urine): n=101
  • Potassium (Serum): n=122
  • Potassium (Urine): n=107
  • Chloride (Serum): n=120
  • Chloride (Urine): n=112
  • Data Provenance: "Human serum and urine specimens that spanned the measuring interval of the assay were evaluated." The specific origin (e.g., country) is not mentioned. These are likely prospective samples collected for testing.
• Interference Studies (Test Set): Not explicitly stated, but typically these studies use spiked samples or samples with naturally elevated interferents.
• Tube Type Equivalency (Test Set): Samples were collected from a minimum of 40 donors.

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

This type of device (in-vitro diagnostic for electrolyte measurement) does not typically involve human experts establishing ground truth in the way medical imaging or pathology devices do. The "ground truth" for these analytical studies is established by:

• Reference Methods: For calibrator concentrations, "flame photometry calibrated against NIST Standard Reference Material" and "titration with silver calibrated against NIST Standard Reference Material" were used.
• Predicate Device: For method comparison, the "ARCHITECT ICT Sample Diluent Sodium, Potassium, and Chloride" is used as the comparator method, implying its results are considered the established values for comparison.
• Known Concentrations: For precision, linearity, and interference studies, samples are often prepared with known concentrations or spiked with specific substances.

Therefore, the concept of "experts establishing ground truth" as in qualitative diagnostic interpretation is not applicable here.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical performance study. Adjudication methods like 2+1 or 3+1 are used for qualitative assessments, typically when human interpretations are being compared, or when there's disagreement among experts on a ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This is an analytical performance study for an in-vitro diagnostic instrument component, not a diagnostic imaging or AI-driven interpretive device. Therefore, a MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The entirety of the reported Nonclinical Performance (precision, linearity, interference, method comparison, and tube type equivalency) represents the standalone performance of the Alinity c ICT Sample Diluent device on the Alinity c analyzer. There is no "human-in-the-loop" aspect to the measurement of electrolyte concentrations by this automated system.

7. Type of Ground Truth Used

• Reference Methods: NIST Standard Reference Materials, flame photometry, and titration with silver were used to establish the ground truth for calibrator concentrations.
• Comparator (Predicate) Device: The ARCHITECT ICT Sample Diluent was used as the comparator for method comparison studies.
• Known Concentrations/Spiked Samples: For precision, linearity, and interference studies, samples with known or precisely prepared concentrations were used.

8. Sample Size for the Training Set

This document does not describe the development of an algorithm that would require a separate "training set" in the context of machine learning. The device is an in-vitro diagnostic reagent and system based on established ion-selective electrode technology. Its performance is evaluated through analytical studies, not by training a model on a dataset.

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

Not applicable. As explained in point 8, there is no "training set" in the machine learning sense for this device.

Ask a specific question about this device