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The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

The Atellica™ A-L YTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion 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. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease 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 Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers. The submission also covers the Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, and Atellica™ CH Vancomycin (Vanc) assay, which are reagents/assays used with the Atellica Solution.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Siemens Atellica™ Solution. It details the device's indications for use, its substantial equivalence to predicate devices, and some performance characteristics.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "The device must achieve a precision CV of X% or less"). Instead, it demonstrates performance by comparing the new Atellica™ Solution (new device) to the predicate devices (Trinidad IM and CH modules) by showing precision and method comparison studies. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device, as confirmed by the statistical results (slope, intercept, correlation, and precision CVs falling within generally acceptable laboratory ranges).

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance demonstrated and compared to the established performance of the predicate devices. The clinical relevance of the reported performance is tied to the previously cleared predicate devices.

Implicit Acceptance Criteria (Performance should be comparable to predicate):

2. Sample size used for the test set and the data provenance

• Precision Studies:
  • Sample Size: N = 25 for each control/serum pool per assay. This means 5 replicates per day over 5 days (5 x 5 = 25).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, conducted by Siemens Healthcare Diagnostics. The samples are described as "controls and serum pools."
• Method Comparison Studies:
  • Sample Size:
    • Na: 121
    • K: 125
    • Cl: 122
    • Albumin (Alb_P): 105
    • Vancomycin (Vanc): 112
    • TSH: 116
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies used "patient samples" as per CLSI EP09-A3. This implies a prospective collection for the purpose of the study or retrospective collection of anonymized patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes the performance of in-vitro diagnostic (IVD) assays, not the diagnostic performance of an image analysis algorithm or a device requiring human interpretation for ground truth. The "ground truth" for the method comparison studies is the result obtained from the predicate device's analytical modules (Trinidad IM and CH), which are already cleared for clinical use.

4. Adjudication method for the test set

Not applicable. As noted above, this is an IVD assay performance study, not a study requiring adjudication of expert interpretations.

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 applicable. This is an IVD device, not an AI-assisted diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the performance studies described (Precision and Method Comparison) represent the standalone performance of the Atellica™ Solution analytical modules. There is no human-in-the-loop component mentioned for the analytical measurement process itself. The "device" in this context is the automated analyzer system.

7. The type of ground truth used

The "ground truth" for the method comparison studies is the measurement obtained from the predicate devices (Trinidad IM module and Trinidad CH module as cleared under K151792, K151767, and K160202). The new device's results are compared to these established methods. For precision studies, it's about the reproducibility of the device's own measurements against its internal calibration and controls.

8. The sample size for the training set

Not applicable. This is an IVD instrument and assay system, which does not involve a "training set" in the context of machine learning or AI models. The assays are based on established chemical and immunological principles, with parameters (e.g., calibration curves) set during manufacturing and validated through performance studies.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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