(150 days)
The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.
The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that performs a variety of instrument specific assays such as Sodium, Potassium and Chloride.
Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.
The system consolidates multiple Analytical instruments into a unified workstation.
The Automation software provides for workload management, sample routing to relevant Analytical instrument based on sample orders coming from LIS (Laboratory Information System) and instrument operational status monitoring. This is accomplished through communication connections between the Automation, Analytical instruments and LIS (Laboratory Information System) or middleware.
Pre-Analytical and Post-Analytical processing in details are as follows: sample loading and unloading and sample identification, sample transport along the system and routing to relevant modules, loading and unloading in centrifuge, decapping, sealing, storing in a temperature controlled environment, aliquot samples capping, sample presentation to connected Analytical instruments.
The FlexLab 3.6 Automation Systems perform the following pre and post analytical functions:
Sample bar code identification (previously performed by the analyzer) Sample transport and tracking Sample centrifugation (Optional functionality) Sample de-capping (Optional functionality) Sample re-capping (Optional functionality) Sample sealing (Optional functionality) Sample de-sealing (Optional functionality) Sample aliquoting (Optional functionality) Sample Storage and Retrieval (Optional functionality)
The provided document describes a 510(k) submission for the FlexLab 3.6 / ACCELERATOR a3600 system, a laboratory automation system designed to automate pre-analytical and post-analytical processing and sample handling.
The study presented focuses on demonstrating substantial equivalence to an existing predicate device (APS Accelerator, K093318) rather than meeting specific performance acceptance criteria for a new clinical device. The primary aim is to show that the new system, when integrated with an ARCHITECT c8000 analyzer, produces comparable results for Sodium, Potassium, and Chloride assays as the predicate system.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence study for a laboratory automation system, the "acceptance criteria" are implied to be the demonstration of comparable performance to the predicate device. The performance is measured by method comparison statistics.
| Analyte | Statistical Method | Parameter | Predicate (ACCELERATOR APS) vs. Test (FlexLab 3.6) Performance (Mean vs. Mean) |
|---|---|---|---|
| Chloride | Least Squares | Slope (95% CI) | 1.00 (1.00, 1.01) |
| Intercept (95% CI) | -1.13 (-1.68, -0.58) | ||
| Deming | Slope (95% CI) | 1.00 (1.00, 1.01) | |
| Intercept (95% CI) | -1.17 (-1.74, -0.59) | ||
| Passing-Bablok | Slope (95% CI) | 1.00 (0.99, 1.01) | |
| Intercept (95% CI) | -0.91 (-1.40, 0.28) | ||
| Bias / Total Error | Mean Bias | -0.85 | |
| Mean % Bias | -0.9 | ||
| SD of Mean % Bias | 0.56 | ||
| Absolute Value of % Total Error | 2.0 | ||
| Potassium | Least Squares | Slope (95% CI) | 1.00 (1.00, 1.01) |
| Intercept (95% CI) | -0.06 (-0.08, -0.03) | ||
| Deming | Slope (95% CI) | 1.00 (1.00, 1.01) | |
| Intercept (95% CI) | -0.06 (-0.08, -0.03) | ||
| Passing-Bablok | Slope (95% CI) | 1.00 (1.00, 1.01) | |
| Intercept (95% CI) | -0.04 (-0.06, -0.02) | ||
| Bias / Total Error | Mean Bias | -0.04 | |
| Mean % Bias | -0.9 | ||
| SD of Mean % Bias | 0.97 | ||
| Absolute Value of % Total Error | 2.8 | ||
| Sodium | Least Squares | Slope (95% CI) | 1.01 (1.01, 1.02) |
| Intercept (95% CI) | -2.46 (-3.20, -1.72) | ||
| Deming | Slope (95% CI) | 1.01 (1.00, 1.02) | |
| Intercept (95% CI) | -2.51 (-3.42, -1.59) | ||
| Passing-Bablok | Slope (95% CI) | 1.01 (1.01, 1.02) | |
| Intercept (95% CI) | -2.61 (-3.82, -1.74) | ||
| Bias / Total Error | Mean Bias | -0.87 | |
| Mean % Bias | -0.7 | ||
| SD of Mean % Bias | 0.74 | ||
| Absolute Value of % Total Error | 2.2 |
Acceptance Criteria (Implied): For a substantial equivalence claim, the expectation is that the comparative statistics (slope, intercept, bias) demonstrate close agreement between the FlexLab 3.6 integrated system and the ACCELERATOR APS integrated system. Ideally, slopes should be close to 1, intercepts close to 0, and biases minimal, indicating no significant difference in analytical results due to the automation system change. The reported 95% Confidence Intervals for slopes generally include 1, and for intercepts, they often include 0 or are small, supporting the claim of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 100 samples (indicated by "N=100" in all method comparison tables for Chloride, Potassium, and Sodium).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes a "Method Comparison Study" which typically involves prospective collection of samples to run on both systems simultaneously or in close sequence. The use of "individual sample tube barcode labels (SID)" suggests careful sample tracking.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of study (method comparison for a laboratory automation system) does not rely on "experts" to establish a ground truth in the traditional sense of clinical diagnosis. Instead, the "ground truth" is the measurement obtained from the predicate device system (ARCHITECT c8000 integrated with ACCELERATOR APS). The comparison is between two automated systems, not against a human expert interpretation or a gold standard diagnostic.
4. Adjudication Method for the Test Set
No adjudication method is relevant for this type of test. The comparison is between two objective measurement systems.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is about the analytical performance of an automation system in a clinical laboratory setting, not diagnostic interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, this is a standalone performance comparison of the new automation system (FlexLab 3.6) against the predicate automation system (ACCELERATOR APS), both integrated with the same analytical instrument (ARCHITECT c8000). The focus is on the impact of the automation system on the analytical results.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence comparison is the results obtained from the predicate device system (ARCHITECT c8000 analyzer integrated with the ACCELERATOR APS). The study aims to show that the new device system yields clinical measurements that are equivalent to a legally marketed predicate device, thereby confirming its safety and effectiveness.
8. The Sample Size for the Training Set
This study describes a verification and validation study, not a machine learning model development. Therefore, there is no "training set" in the context of AI/ML. The 100 samples mentioned were for the performance comparison.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML model, this question is not applicable. The study is a direct comparison of analytical measurements between two laboratory automation systems.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.