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GLP systems Track:

The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.

Alinity i Total β-hCG Reagent Kit:

The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (ß-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

Alinity i system:

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 antibodies, and analytes in samples.

Alinity ci-series:

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 Almity c processing modules, or a combination of up to four of 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, climical 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 antibodies, and analytes in samples.

The GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.

The provided text describes the 510(k) premarket notification for the GLP systems Track and the Alinity i Total β-hCG Reagent Kit. The focus of the acceptance criteria and study detailed in the document is on the GLP systems Track laboratory automation system, and its ability to maintain the performance of connected analyzers, specifically exemplified with the Alinity i Total β-hCG assay. The document does not provide specific acceptance criteria or performance data for the Alinity i Total β-hCG Reagent Kit as a standalone diagnostic assay; instead, it focuses on the GLP systems Track's compatibility and non-inferiority when integrated with such assays.

Here's a breakdown of the information based on your request:

Acceptance Criteria and Reported Device Performance

The document describes a method comparison study to demonstrate that the GLP systems Track does not negatively impact the performance of connected assays. The acceptance criteria are implicitly defined by the results of this method comparison.

Table of Acceptance Criteria and Reported Device Performance (Implicit for the GLP systems Track):

* **Slope:** 0.99
* **Correlation Coefficient:** 1.00                                                                                                                                                                       |

| Ensure acceptable performance for a representative immunoassay. | Demonstrated with the Alinity i Total β-hCG assay. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a number of samples. The range of mIU/mL for the tested samples is given as 4.78 to 14,965.80 mIU/mL, indicating a broad range of concentrations were tested.
   • Data Provenance: The study was described as "Nonclinical testing was performed on-site at Abbott." This indicates an internal, prospective study. Country of origin is implicitly the US, where Abbott Laboratories is located.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. This was a method comparison study for a laboratory automation system, not a diagnostic study requiring human expert interpretation of results to establish ground truth. The "ground truth" was established by comparing direct loading (comparator method) to processing via the GLP systems Track (investigational method) using established laboratory procedures.

3. Adjudication Method for the Test Set:

   • Not applicable. As this was a method comparison of automated systems, there was no human adjudication process involved. The comparison was based on quantitative measurements.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is typically for image-based diagnostic aids where human readers interpret cases. This study focused on the performance of a laboratory automation system.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The study assessed the performance of the GLP systems Track (an automated system) without human intervention in the analytical process, demonstrating its ability to deliver results comparable to direct sample loading. The Alinity i Total β-hCG assay itself is a standalone quantitative assay.

6. The Type of Ground Truth Used:

   • Reference Method Comparison/Comparator Method. The "ground truth" was established by testing specimens on the Alinity i Total β-hCG assay when front-loaded (the comparator method/reference) and comparing those results to specimens loaded using the GLP systems Track (investigational method). This essentially assumes that the front-loaded method provides the accurate measurement.

7. The Sample Size for the Training Set:

   • Not applicable. The GLP systems Track is a mechanical/software automation system designed for sample processing, not an algorithm that undergoes "training" with data in the typical machine learning sense to learn patterns or make predictions. Its "training" would be through engineering design, development, and testing processes. The document does not mention any machine learning or AI components that would require a training set.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. (See point 7).

In summary, the provided document focuses on demonstrating the substantial equivalence of the GLP systems Track to its predicate and its ability to integrate with and maintain the performance of an existing cleared assay (Alinity i Total β-hCG) through a nonclinical method comparison study.

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The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and postanalytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.

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 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 GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.

The provided text describes a 510(k) premarket notification for the "GLP systems Track" device. However, it does not contain the detailed acceptance criteria for performance, the study that proves the device meets those criteria, or information on sample sizes for test/training sets, expert qualifications, or adjudication methods.

The document states that "Nonclinical testing was performed on-site at Abbott to ensure the product met the requirements and aligned with the quality system. This testing included design verification, including both software and hardware verification, as well as design validation. Testing was performed for Chain of Custody of the sample ID, and a Method Comparison study comparing the use of the GLP systems Track to a manual method was also performed. Additionally, Electromagnetic Compatibility and Electrical Safety testing was completed."

This broadly indicates that testing was conducted, but the specific details requested in your prompt (Acceptance Criteria, reported performance, sample sizes, expert involvement, etc.) are absent from this regulatory summary.

Therefore, I cannot populate the table or answer most of your questions based on the information provided.

Here's what I can extract based on the limited information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified.
• Data provenance: "Nonclinical testing was performed on-site at Abbott." The country of origin and retrospective/prospective nature are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The testing mentions "Chain of Custody of the sample ID" and a "Method Comparison study comparing the use of the GLP systems Track to a manual method," but details on ground truth establishment and expert involvement are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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 specified. This device is a modular laboratory automation system, not typically a device that involves human readers interpreting results in the same way as, for example, a medical imaging AI. The "human-in-the-loop" aspect does not directly apply here in the context of interpretation improvement assisted by AI.

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

• The document presents the "GLP systems Track" as a modular laboratory automation system. Its performance evaluation would likely focus on its ability to automate pre-analytical and post-analytical processing steps accurately and efficiently, rather than "algorithm-only" performance in the sense of a diagnostic AI. A "Method Comparison study comparing the use of the GLP systems Track to a manual method" was performed, which implies a comparison of the automated system's output to a reference method, but details are not provided.

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

• For the "Method Comparison study comparing the use of the GLP systems Track to a manual method," the "manual method" likely serves as the reference or ground truth. No further details are provided on its establishment.

8. The sample size for the training set

• Not specified. (This device is a hardware/software system for lab automation, not an AI model in the common sense that requires a "training set" for machine learning, although its software components would certainly undergo extensive testing and validation.)

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

• Not applicable/Not specified, as there is no mention of a "training set" in the context of machine learning model development.

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