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The iQ 200 System is intended for analysis of urine chemistry, color, clarity, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

The iQ 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations.

Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of postsurqical or post-therapeutic recovery.

The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

The iQ 200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Each image is analyzed and assigned a classification by an auto analyte recognition algorithm. Using these classifications and the known observation volume, microscopic analyte concentrations may be automatically reported. If results from a specimen are not autoreported, microscopic examination results are displayed on an independent Computer WorkStation. Operators can then confirm or modify analyte classifications and release reports off-line for enhanced convenience, obviating the need to process a second aliquot for review. Chemistry results from the companion ARKRAY AUTION MAX AX-4280 are automatically consolidated by the Computer WorkStation for display and reporting.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the iQ™ 200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria. Instead, it describes the performance relative to predicate devices and relative to expert human identification. The acceptance criteria can be inferred from the "Conclusions Drawn From Clinical Tests" section.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "specimens" and "individual microscopic formed elements" but doesn't provide a numerical count for the test set used in the comparative studies.
• Data Provenance: Not explicitly stated. The document refers to "clinical sensitivity" and "clinical specificity," suggesting the data was collected in a clinical setting, but it does not specify the country of origin or whether it was retrospective or prospective.

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

• Number of Experts: Not explicitly stated. The document refers to "expert human identification" in the context of establishing ground truth for automated reported concentrations but does not specify the number of experts involved.
• Qualifications of Experts: The experts are referred to generally as "expert human identification" or "human expert." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided within this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "a competent human operator can set criteria for auto-reporting and flagging specimens for review" and "All instrument analyte image decisions may be reviewed and overridden by a trained technologist." This indicates a human-in-the-loop process where human review and override are possible, but it does not detail a specific adjudication method for establishing the initial ground truth for comparative studies (e.g., 2+1, 3+1 consensus).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• The document describes comparative performance studies of the iQ™ 200 System against predicate devices (939UDx Urine Pathology System and Sysmex UF-100) and against "expert human identification."
• However, it does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with AI assistance is compared to their performance without AI assistance. The study focuses on the standalone performance of the iQ™ 200 system (which includes an auto analyte recognition algorithm) against existing automated systems and human expert classification.
• Therefore, no effect size for human reader improvement with AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance assessment was done. The "Summary of Technological Characteristics" states, "Each image is analyzed and assigned a classification by an auto analyte recognition algorithm." The "Conclusions Drawn From Clinical Tests" section directly compares the "iQ™ 200 System automatically reported concentrations" to "expert human identification" and predicate device results, indicating that the automatic classification (algorithm only) performance was evaluated. The device is designed for auto-reporting, though human review is an option.

7. The Type of Ground Truth Used

• The primary type of ground truth used was expert human identification/consensus. This is explicitly stated: "iQ™ 200 System automatically reported concentrations of RBC, WBC, squamous epithelial cells and casts matched those determined from expert human identification..."

8. The Sample Size for the Training Set

• Not specified. The document does not provide any information regarding the sample size used for training the "auto analyte recognition algorithm."

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

• Not specified. The document does not describe how the ground truth was established for any training data used to develop the auto analyte recognition algorithm.

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The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations.

It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count.

The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.

The Yellow IRIS urinalysis workstation, an already existing commercial in-vitro diagnostic device

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria: The document implies that the acceptance criterion for the Yellow IRIS urinalysis workstation was to demonstrate increased sensitivity in the detection of abnormal microscopic content compared to traditional urine test strips and popular screening algorithms. While specific numerical targets are not explicitly stated as "acceptance criteria," the reported performance metrics clearly aimed to prove superiority in sensitivity.

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

• Sample Size for Test Set: More than 18,000 abnormal urine specimens.
• Data Provenance: The study was carried out among more than 100 clinical laboratories. This suggests a multi-site, potentially nationwide or regional, collection effort. The data appears to be retrospective, as it describes "comparisons of detection...by dipstick screening and by visual observation of flow microscopy using The Yellow IRIS" in a population of specimens where both methods were already in use for "complete routine urinalysis."

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. However, it mentions "visual observation of flow microscopy using The Yellow IRIS" which implies that trained laboratory personnel or medical professionals were performing the visual assessments. Given it's a urinalysis workstation, these would typically be clinical laboratory scientists, medical technologists, or pathologists. Specific experience (e.g., "radiologist with 10 years of experience") is not provided.

4. Adjudication Method for the Test Set

The document does not provide details on any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set. The comparison is described as "comparative measures...carried out among more than 100 clinical laboratories," suggesting that the performance of each method (dipstick vs. Yellow IRIS) was assessed against each other, rather than against a single, independently adjudicated "gold standard" truth for each specimen.

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 document describes a comparison between a device (Yellow IRIS) and traditional methods (urine test strips), not a study explicitly evaluating human reader improvement with AI assistance. The Yellow IRIS is described as an "urinalysis workstation" that utilizes "flow microscopy" for visual observation, which could involve an automated component for image capture and analysis, but it is still overseen by a "competent human operator."
• Therefore, an MRMC comparative effectiveness study as typically defined in the context of AI assistance to human readers was not explicitly conducted or reported here. The device itself (Yellow IRIS) is being compared to the existing standard of care, not human performance with and without the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document explicitly states that "The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations." This indicates that the device operates with a human-in-the-loop, and therefore, a standalone (algorithm only) performance study was not conducted or reported.

7. The Type of Ground Truth Used

The ground truth for the comparison was essentially the visual observation of flow microscopy using The Yellow IRIS itself, compared against the results from urine test strips. It's a comparison between two different diagnostic methods rather than against a completely independent "gold standard" such as pathology or outcomes data. The document states its goal is to show increased sensitivity of the Yellow IRIS compared to dipstick screening.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. The description focuses solely on the performance comparison study. This implies that if there was any machine learning or algorithm development, the details of its training and validation are not included in this summary.

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

Since no information is provided about a training set, there is no information on how its ground truth might have been established.

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The White IRIS is a leukocyte differential analyzer intended for in vitro diagnostic use in determining the proportional leukocyte count (WBC differential) on peripheral blood specimens that have been flagged by an automated hematology analyzer performing differential counts as well as for peripheral blood specimens for which no automated differential has been performed.

Combining unique cytoprobe, rapid hemacyte fractionation and novel color image analysis, The White IRIS extends automated intelligent microscopy to leukocyte differentiation. It provides flow cytometry precision and microscopical resolution to review specimens flagged by hematology analyzers with differential capabilities or to complement other analyzers without these capabilities. The system includes compartments for closed sampling, rapid leukocyte-rich plasma preparations, cytoprobeinduced metachromasia, and collection and color analysis of leukocyte images, and presents the results as a single-view 500-cell differential on a 20-in touchscreen monitor for examination by a skilled competent observer.

Acceptance Criteria and Device Performance Study for The White IRIS

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state formal acceptance criteria with numerical targets for each performance metric. However, the study aims to demonstrate substantial equivalence to the predicate method (Wright-stain/light microscope) in terms of accuracy, clinical sensitivity, and precision. The "acceptance criteria" are thus inferred from the comparisons made and the overall conclusion of "results equal to or better than the reference method."

• Agreement (Pre-removal of CI cases): 82.95% (Table 11)
• Cohen's Kappa (4x4 Classification): 0.49 (rejects random agreement). (Table 12) |
  | Precision | Standard deviations similar to or better than the reference method. | - SD compared to Wright-Stain (H20-A method): Generally lower or comparable SDs for most cell types (e.g., Neutrophils: 2.72 vs 3.55; Lymphocytes: 3.17 vs 3.68; Monocytes: 1.62 vs 2.29).
• Within-run Precision (22 replicates): Neutrophils (± 5.0%), Lymphocytes (± 5.0%), Monocytes (± 2.5%), Eosinophils (± 1.5%), Basophils (± 1.0%) at 95% CI. (Table 6) |
  | Clinical Sensitivity | Ability to correctly identify abnormal specimens (defined by H20-A criteria and reference ranges) with comparable or better performance than the reference method. | - The study evaluated 1202 specimens, including those required by H20-A for various abnormal conditions (e.g., Granulocytosis, Monocytosis, Eosinophilia, Lymphocytosis, Immature Cells).
• False Negative Rate: 4.79% (2.98% after specific removals). (Table 9)
• False Positive Rate: 15.36% (14.12% after specific removals). (Table 9) |

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

• Sample Size:
  • Accuracy: 1,202 normal and abnormal patient specimens (for correlation and overall agreement analysis).
  • Precision (H20-A calculation): 1,014 specimens for The White IRIS; 1,277 specimens for Wright-stain.
  • Precision (within-run): 22 replicates of the same sample.
  • Clinical Sensitivity: 1,202 Leukocyte Differential Summaries (the same set as for accuracy).
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as taking place in a clinical laboratory setting, comparing results to a standard reference method. It indicates a retrospective/cross-sectional design as it involves collecting specimens and analyzing them using both the new device and the predicate method for comparison.

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

• Number of Experts: Two skilled technologists.
• Qualifications: "Skilled technologists." The document also mentions "competent human observer... well skilled in both the use of the instrument and in the recognition of leukocyte classes." This implies trained medical laboratory professionals with expertise in manual leukocyte differential counting.

4. Adjudication Method for the Test Set

The primary reference method involves two skilled technologists reading manually prepared and observed Wright-stained smears. The analysis directly compares The White IRIS's results (reviewed by these same two technologists) against this "reference method."

While not explicitly stated as a formal "adjudication" in the sense of a third reader resolving discrepancies, the predicate method itself inherently relies on consensus or comparison between the two technologists' readings (implied when the "Wright-Stain Mean (%)" is presented). The study then compares the device's output, post human review, to this established reference.

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

• Was it done? Yes, in a limited sense. The study compares the performance of human readers (the two skilled technologists) when using The White IRIS (assisted interpretation) versus their performance using the traditional Wright-stain/light microscope method (unassisted interpretation).
• Effect Size (Improvement with AI vs. without AI assistance): The study reports on the "efficacy" of The White IRIS, highlighting that its use "provides results equal to or better than the reference method with less time expenditure and less biohazard exposure." However, it does not provide a quantifiable effect size specifically on how much human readers improve their accuracy or efficiency when using The White IRIS compared to their standalone performance. It mainly demonstrates equivalence or superiority of the combined system (IRIS + human review) to the manual method. For example, precision (SD) for most cell types is better with The White IRIS.

6. Standalone (Algorithm Only) Performance

• Was it done? No. The White IRIS explicitly requires a "skilled competent observer" to confirm or modify the classification of each cell. The device provides "presumptive" classifications, but human review is an integral part of its intended use. Therefore, a standalone algorithm-only performance assessment was not conducted, as it would not represent the intended clinical workflow.

7. Type of Ground Truth Used

• Expert Consensus / Reference Method: The ground truth for the test set was established by the Wright-stain/light microscope reference method, performed by two skilled technologists. This is a widely accepted, "Approved Standard" (NCCLS document H20-A) in hematology.

8. Sample Size for the Training Set

• The document does not specify a separate training set size. The reported studies (accuracy, precision, clinical sensitivity) are all described as evaluations of "The White IRIS" which implies the full, ready-for-use device. The technology involves "color image analysis" and classifies cells "presumptively," suggesting an underlying algorithm, but there's no mention of a distinct training phase or dataset with its own associated ground truth establishment.

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

• As no separate training set is explicitly mentioned or analyzed in the provided text, information on how its ground truth was established is not available. The document focuses on the validation of the final device-with-human-in-the-loop system against the established predicate method.

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The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

The 900UDx Urine Pathology System provides automatic sample handling for automated intelligent microscopy and improved data presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Microscopic examination results are displayed on an independent ViewStation computer with higher image resolution, and operators can confirm and release reports off-line for enhanced convenience. Chemistry results from the external Boehringer Mannheim Hitachi CHEMSTRIP® Super UA Urine AnalyzerTM are automatically consolidated by the ViewStation for display and reporting.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IRIS 900UDx Urine Pathology System:

Summary of Device Performance and Acceptance Criteria

The information provided describes the IRIS 900UDx Urine Pathology System as a device for automated urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination. The study's primary goal was to demonstrate substantial equivalence to a predicate device, The Yellow IRIS Urinalysis Workstation.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only states "Clinical Tests."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• Was one done? Not explicitly stated or detailed. The study compared the device's microscopic analysis performance to a predicate device. This implies a comparison of the device's output to the output of the predicate device, not necessarily a human reader study with and without AI assistance to measure reader improvement. The focus is on the device's performance attributes (detection, reproducibility, sensitivity).
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable or not reported based on the provided text, as this type of MRMC study isn't clearly described.

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

• Was one done? Yes, effectively. The study evaluated the "Microscopic analysis performance of the 900UDx Urine Pathology System" compared to a predicate device. This is a standalone performance evaluation of the device's analytical capabilities. The system itself performs "automated intelligent microscopy," implying an algorithm's role in differentiation and detection. The statement "operators can confirm and release reports off-line" suggests the device generates results independently before human review.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the comparison was the performance of the "Yellow IRIS Urinalysis Workstation." This means the predicate device's results served as the reference standard against which the 900UDx was evaluated for equivalence and improved sensitivity. Indirectly, the predicate device itself would have been validated against some form of established diagnostic criteria or expert interpretation in its own development.

8. Sample Size for the Training Set

• Sample Size: Not specified. (It's unclear if there was a separate "training set" for the system's algorithm as the primary focus is on comparison to a predicate device, rather than de novo algorithm development and validation specified here).

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

• How Established: Not specified. (As above, information on a specific training set and its ground truth establishment is not provided in the context of this 510(k) summary).

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