(57 days)
The Elecsys 2010 analyzer is intended to be used for the in vitro quantitative and qualitative analysis of analytes in body fluids.
The Elecsys 2010 analyzer is an immunoassay analyzer intended for the in vitro. The formation of qualitative determination of analytes in human serum and plasm
The Elecsys 2010 analyzer is a fully automated, random access, computer controlled analytical system for quantitative and qualitative determinations of analytes in body fluids
The Elecsys 2010 Analyzer is intended for in vitro quantitative and qualitative analysis of analytes in body fluids. The study compared the Elecsys 2010 Analyzer to the predicate device, the ES300 Immunoassay system, to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria (Implied by equivalence to predicate) and Reported Device Performance:
The acceptance criteria for the Elecsys 2010 Analyzer are implicitly defined by its equivalence to the predicate ES300 Analyzer's performance. The study demonstrates this equivalence through method comparison data using least squares regression. The reported device performance is presented as the regression equations, the standard error of the estimate (SEE), and the correlation coefficient (r) for various analytes.
| Feature | Acceptance Criteria (Implied by equivalence to ES300) | Reported Device Performance (Elecsys 2010 vs. ES300) |
|---|---|---|
| Method Comparison | ||
| T4 | Substantial equivalence to ES300 | Y = 1.02x + 0.85 |
| SEE = 5.39 | ||
| r = 0.947 | ||
| Method Comparison | ||
| FT4 | Substantial equivalence to ES300 | Y = 0.954X + 0.18 |
| SEE = 1.11 | ||
| r = 0.981 | ||
| Method Comparison | ||
| TSH | Substantial equivalence to ES300 | Y = 1.09X + 0.14 |
| SEE = 0.798 | ||
| r = 0.991; n = 132 | ||
| Method Comparison | ||
| T-Uptake | Substantial equivalence to ES300 | Y = 0.99X - 0.03 |
| SEE = 0.04 | ||
| r = 0.908; n = 319 | ||
| Method Comparison | ||
| hCG | Substantial equivalence to ES300 | Y = 1.35X - 9.21 |
| SEE = 17.50 | ||
| r = 0.989; n = 64 | ||
| Method Comparison | ||
| Troponin-T | Substantial equivalence to ES300 | Y = -0.033 + 0.996 |
| SEE = 0.547 | ||
| r = 0.969; n = 54 |
2. Sample Size Used for the Test Set and the Data Provenance:
The sample sizes for the method comparison test sets are as follows:
- TSH: n = 132
- T-Uptake: n = 319
- hCG: n = 64
- Troponin-T: n = 54
- T4 and FT4: Sample sizes are not explicitly stated within the provided text.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is generally not applicable to immunoassay analyzer performance studies. The "ground truth" for method comparison studies like this is typically the measurements obtained from the predicate device (ES300 Analyzer), which is itself a legally marketed and presumably validated device. There are no "experts" establishing a subjective ground truth in this context.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this study evaluates the equivalence of quantitative measurements between two instruments. There is no subjective assessment requiring adjudication.
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:
This information is not applicable. The Elecsys 2010 Analyzer is an automated immunoassay analyzer, not an AI-assisted diagnostic imaging or analysis tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance study conducted for the Elecsys 2010 Analyzer is inherently a standalone performance evaluation. It assesses the analytical capability of the instrument itself in comparison to another automated instrument (the predicate ES300 analyzer). There is no "human-in-the-loop" component in the performance data presented.
7. The Type of Ground Truth Used:
The "ground truth" used in this study is the analytical results obtained from the predicate device, the Boehringer Mannheim ES300 Immunoassay system. This is a form of comparative measurement; the performance of the new device is benchmarked against an established and legally marketed device.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. Immunoassay analyzers are typically developed and validated through analytical studies, not through AI/machine learning training sets in the traditional sense. The phrase "training set" is usually associated with machine learning model development, which is not the primary methodology for validating a device like the Elecsys 2010 Analyzer.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no mention of a "training set" in the context of machine learning for this device. The development and validation of the Elecsys 2010 Analyzer would have involved rigorous analytical studies to establish its precision, accuracy, linearity, and other performance characteristics, often against reference methods or established standards, rather than a labeled training dataset for an AI model.
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.