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The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, mucus and sperm in urine.

This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.

The cobas u 701 microscopy analyzer is a fully automated urine analysis system. It is optimized for the high-volume professional laboratory market. The cobas u 701 microscopy analyzer performs a maximum theoretical throughput of up to 116 samples per hour.

The cobas u 701 microscopy analyzer consists of several major components:

• Rack transport system
• Liquid handling system
• Cuvette cassette compartment
• Centrifuge
• Built-in reverse microscope with movable objective lens for focusing procedure
• High resolution camera system
• Touch Screen
• Inbuilt Computer with the imaging and evaluation software for analyzing the sediment pictures

Key functions include sample loading and transport, sample identification, sample homogenization, sample pipetting into cuvettes, centrifugation of cuvettes, image acquisition with a camera, image assessment, automatic disposal of used cuvettes, result readout, result and image memory, optional manual classification and / or re-classification of particles, manual or Automatic validation of the result, optional formats for data output including electronic result communication, data export, remote service, quality control, processing of diluted samples, washing, filling water tank, emptying liquid and solid waste.

The cobas u cuvette is used by the cobas u 701 microscopy analyzer to transport, centrifuge and analyze patient and control samples.

No calibration of the device is necessary for its intended use. However, there is a microscope check utilizing a reference cuvette.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for cobas u 701 microscopy analyzer

The cobas u 701 microscopy analyzer is a fully automated urine microscopy system for a range of urine particle determinations.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state a single table of "acceptance criteria" against "reported device performance." Instead, it presents various performance studies (Precision, Analytical Sensitivity, Linearity, Dilution, Interferences, Assay Cut-Off, and Method Comparison) and states that "All predefined acceptance criteria were met" for each, or provides detailed results that demonstrate meeting criteria. The closest to reported performance criteria vs. actual results are in the Method Comparison section.

Here's an aggregated table focusing on the method comparison to the reference method, as this directly compares the device's output to a recognized standard or clinical assessment.

Note: The document generally states "All predefined acceptance criteria were met" for various studies. For quantitative parameters (RBC, WBC), the acceptance criteria are implied by the excellent regression and correlation results. For semi-quantitative and qualitative parameters, the acceptance criteria are implied by the high Cohen's Kappa, PPA, and NPA values, indicating very good agreement with the reference method.

2. Sample Size Used for the Test Set and Data Provenance

• Method Comparison Study: 689 samples
• Reference Range Study: 621 "urine healthy" residual samples.
• Total Clinical Evaluation Samples: 1310 samples (689 for method comparison + 621 for reference range, with interferences evaluated using these same samples).
• Data Provenance: Clinical samples (residual amounts from routine) were used. The studies were conducted at three sites: two European sites (Site 1, Site 2) and one site located in the US (Site 3). The samples were from patients with an age range of 1 month to 98 years. This indicates mixed geographic origin (local to the three sites) and a retrospective component (residual amounts from routine).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The ground truth for the method comparison study was established using manual microscopy with KOVA slides as the comparator method. The document does not specify the number of experts, or their specific qualifications (e.g., number of years of experience, certification). It only refers to "visual counting." For the qualitative and semi-quantitative parameters, the "agreement rates" (PPA, NPA, Cohen's Kappa) are reported relative to this manual KOVA method, performed by human operators.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1). It refers to the manual KOVA counting method as the "reference method." This implies that the KOVA results were considered the ground truth without further multi-reader adjudication for the ground truth itself. However, the "Method Comparison" section does state that "All instrument analyte image decisions may be reviewed and reclassified by a trained operator" as part of the device's intended use, which is a form of human-in-the-loop review, but not necessarily a part of establishing the initial ground truth for the study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with AI assistance versus without AI assistance. The study compares the device's performance (algorithm only) to a manual reference method. The device's indications for use mention that "All instrument analyte image decisions may be reviewed and reclassified by a trained operator," implying human-in-the-loop use, but the presented studies are for standalone device performance against a manual method.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The precision, analytical sensitivity, linearity, dilution, and interference studies directly evaluate the performance of the "cobas u 701 microscopy analyzer." The method comparison study also assesses the "cobas u 701 microscopy analyzer" against manual microscopy, effectively evaluating the standalone performance of the automated system. The results presented (Passing Bablok regression, agreement rates) are for the device's output.

7. Type of Ground Truth Used

The ground truth used for the method comparison study was manual microscopy using KOVA slides. This is a well-established laboratory method for urine sediment analysis and can be considered a form of expert consensus or reference method consensus if performed by trained laboratory professionals.

8. Sample Size for the Training Set

The document does not explicitly mention the sample size used for the training set for the device's image processing and evaluation software. The reported sample sizes (1310 total clinical samples) are for the non-clinical performance evaluation and external (clinical) testing (test set).

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established. It describes the "cobas u 701 microscopy analyzer" as evaluating images with "an image processing software which is able to detect and further classify the following urine particles," suggesting a machine learning or rule-based system. However, the methodology for creating the labeled data (ground truth) used to develop or train this software is not described in the provided text.

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