(46 days)
The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used for diagnosis in diseases with high and low Potassium levels.
Chloride measurements are primarily use to detect and treatment of metabolic disorders.
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.
Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders.
Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The Siemens Healthcare Diagnostics Dimension® clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The systems can process samples in random access, batch and stat modes. The systems are multi-functional analytical tools that process chemical and immunochenical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension systems include the ability to communicate and connect with laboratory information system (LIS) networks.
With revision 10.0 software, the Operating System of the Dimension clinical chemistry analyzers, RxL/ RxLMax (K963498), Xpand Plus (K010061), will change from QNX to Linux.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Dimension® RxL/RxL Max clinical chemistry analyzer (with Linux Operating System)
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner. Instead, the acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device. The key performance metrics evaluated were Method Comparison and Precision (within run, within lab) for specific representative assays. The performance is reported as meeting this equivalency.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence in Principle | Determined based on similarity of system design (floor model, microprocessor-controlled, integrated instrument systems using prepackaged Siemens Flex® reagent cartridges and integrated ion selective multisensor technology). The primary change is the OS from QNX to Linux. |
| Substantial Equivalence in Performance for Representative Methods (Method Comparison) | "Comparative data for Method Comparison...demonstrate equivalent performance in evaluations of the representative methods." |
| Substantial Equivalence in Performance for Representative Methods (Precision - within run, within lab) | "...and Precision (with in run, within lab) demonstrate equivalent performance in evaluations of the representative methods." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "representative methods were tested" and compares "the same samples and methods" on predicate and test instruments. However, the specific number of samples (sample size) used for the test set for Method Comparison and Precision studies is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective in the sense that samples were deliberately run on both the predicate and test devices for comparison purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an in vitro diagnostic chemistry analyzer, and its performance is evaluated against itself (predicate device performance) using quantitative measurements, not against expert human interpretations or diagnoses. The ground truth would be the actual concentration of analytes in the samples.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is a quantitative analytical device comparison, not a diagnostic interpretation where adjudication of expert opinions would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study (MRMC) is typically performed for diagnostic imaging or similar devices where multiple human readers interpret cases. This submission is for a clinical chemistry analyzer, which does not involve human interpretation of outputs in the same way. The evaluation is purely based on instrument performance.
6. Standalone (Algorithm Only) Performance:
Yes, an equivalent of a "standalone" performance was done. The study directly compared the analytical results obtained from the Dimension® clinical chemistry system with the Linux operating system (test device) against the analytical results obtained from the Dimension® clinical chemistry system with the QNX operating system (predicate device). The evaluation focuses solely on the output of the instrument itself, without human intervention in the result generation.
7. Type of Ground Truth Used:
The ground truth implicitly used for the performance comparison is the analytical result produced by the predicate device. The goal was to show that the new device (with Linux OS) produces equivalent results to the established predicate device (with QNX OS) when processing the same samples. The underlying ground truth for the analytes themselves would be the true concentration in the human body fluids, likely measured by a highly accurate validated method, but the comparison here is between two versions of the same product.
8. Sample Size for the Training Set:
Not applicable. This device is a measurement instrument, not an AI or machine learning model that requires a training set in the conventional sense. The "training" of such a system would involve instrument calibration and quality control procedures, but not a data-driven training set like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reasons as point 8.
§ 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.