(61 days)
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.
| Feature/Metric | Acceptance Criteria (Inferred) | Reported Device Performance (iQ™ 200 System) |
|---|---|---|
| Clinical Sensitivity (Abnormal specimens) | Exceed clinical sensitivity of predicate devices (939UDx Urine Pathology System and Sysmex UF-100). | Exceeded that of the 939UDx Urine Pathology System and Sysmex UF-100. Generally had greater sensitivity for detection of individual microscopic formed elements than either predicate device. |
| Clinical Specificity (Normal specimens) | Comparable to predicate devices (939UDx Urine Pathology System and Sysmex UF-100). | Comparable. When sensitivity for each microscopic formed element was fixed at 90%, iQ™ 200 System specificity was greater than that of either predicate device for most formed elements. |
| Automated Reported Concentrations (RBC, WBC, Squamous Epithelial Cells, Casts) | Match those determined from expert human identification, or match those of predicate device (939UDx) when measured by the square of the regression correlation coefficient (R Square). | Matched those determined from expert human identification as well as the 939UDx Urine Pathology System predicate automatically reported concentrations matched those of the human expert when measured by the square of the regression correlation coefficient, R Square. |
| Suitability for Intended Use | The device should be shown to be suitable for its intended use, which is automating the complete urinalysis profile including urine test strip chemistry panel and microscopic sediment analysis, producing quantitative or qualitative counts of formed elements, and allowing for operator review and override. | The iQ™ 200 System has been shown to be suitable for its intended use. |
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.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).