(252 days)
The Integrated Laboratory Automation Solution (ILAS) is designed to transport clinical patient samples to clinical laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and test orders to be performed by the laboratory analyzer. The patient specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each analyzer station to determine if tests are to be run and if so the specimen is switched to a side track supplying the analyzer with the specimen.
The ILAS is an accessory to the Vitros 250 automated chemistry analyzer and other similar chemistry automated clinical analyzers. Automated clinical analyzers utilize various methods and technologies for the determination of numerous analytes, such as Glucose and other measurands that may be adaptable to each integrated analyzer.
Glucose on the ILAS system is for the quantitative in vitro diagnostic measurement of Glucose in plasma. 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 automation system (ILAS) is designed to transport clinical patient specimens (blood and urine) to the laboratory analyzers that perform the actual clinical tests.
The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and menu of tests to be performed by the laboratory analyzers. The patients specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each laboratory analyzer station to determine whether the specimen should be directed to that specific analyzer. If a test is to be run on the analyzer, the specimen is switched to a side track supplying the testing analyzer with clinical specimens. All reporting of clinical specimen test results are transmitted from the analyzer to the LIS and the ILAS software is not involved in test results reporting.
Here's a breakdown of the acceptance criteria and study information for the Integrated Laboratory Automation Solution (ILAS) based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation (r) between results obtained with the analyzer alone and with the ILIAS interface | r > 0.999 |
| Percent difference between results obtained with the analyzer alone and with the ILIAS interface | Within the range of analyte interassay variability |
Study Information
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Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "multiple individual analytes tested independently" but does not give a specific number of samples or cases. Data provenance (country of origin, retrospective/prospective) is also not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The device is an automation solution for transporting samples and does not involve expert interpretation for establishing ground truth. The "ground truth" here is the result from the analyzer operating alone.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The comparison is between the analyzer with and without the automation system, not between human interpretations.
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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 not an AI-assisted diagnostic device that involves human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, in essence. The "standalone" performance here refers to the analyzer's performance without the ILAS interface, which then serves as the baseline for comparison with the analyzer with the ILAS interface. The ILAS itself is an automation system, not a diagnostic algorithm.
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The type of ground truth used:
The "ground truth" for this study is effectively the results produced by the third-party analyzers operating independently, without the ILAS system. The study aims to demonstrate that the ILAS does not alter these established results. -
The sample size for the training set: Not applicable. The ILAS is an automation and transport system, not a device that uses machine learning classifiers requiring a training set in the conventional sense.
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How the ground truth for the training set was established: Not applicable, as there is no training set for a machine learning model.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.