(132 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document beyond general statements of meeting requirements. |
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.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements 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.(b)
Classification. Class II.