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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 post-surgical or posttherapeutic 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 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 Lamina Cradle is a new accessory to be used with the iQ Series of Urine Microscopy Analyzers (K022774). The iQ Lamina Cradle is connected to the iQ Series via a 5V DC USB bus, and is under software control of the desktop computer that is part of the iQ Series. The cradle contains a RFID transceiver and antenna. In simple terms, it recognizes a legitimate IRIS RFID tag embedded in the container label of each 7 liter iQ Lamina Bottle. The software tracks the consumption of iQ Lamina. Visual warning and error messages are displayed as flags in the system software. Audio alerts are communicated through the cradle's speaker. The tracking will alert the operator when a bottle is empty or when a bottle not containing an Iris RFID chip is being used.

The provided document pertains to the 510(k) submission for the "iQ®200 System with Lamina Cradle" by International Remote Imaging Systems, Inc. However, it explicitly states that performance studies are "Not applicable to the addition of Lamina Cradle" and "No clinical tests were performed with the addition of the Lamina Cradle."

Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. The submission focuses on the Lamina Cradle as an accessory to an already cleared device (the iQ®200 System) and asserts substantial equivalence without new performance data for the accessory itself.

The document describes the Lamina Cradle as a new accessory to be used with the iQ Series of Urine Microscopy Analyzers. Its function is primarily to track the consumption of "iQ Lamina" (which appears to be a reagent or consumable used with the system) using an RFID transceiver. It provides visual and audio alerts for bottle status. Since this accessory’s function is tracking and alerting for consumables, and not directly involved in the analytical performance of the urinalysis system, no new performance studies or clinical tests were deemed necessary for its 510(k) clearance.

In summary, the provided text does not contain the requested information about acceptance criteria or a study demonstrating the device's performance against such criteria because, for this specific submission, those studies were considered "not applicable."

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The iChem100 Urine Chemistry Analyzer (iChem100) is a semiautomated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.

The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem10 SG Urine Chemistry Strips.

The provided text is a 510(k) summary for the Iris Diagnostics iChem 100 Urine Chemistry Analyzer. It details the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical performance studies. However, it does not provide detailed acceptance criteria or the specific results of a study designed to prove the device meets these criteria in the format requested.

Here's an analysis based on the information provided, highlighting what is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the provided text. The document states:

• "A correlation study demonstrated substantial equivalence when results from the iChem 100 were compared to the predicate device."
• "Additional studies for precision and linearity demonstrated acceptable performance of the iChem 100 System for its intended use."

However, no specific performance metrics (e.g., sensitivity, specificity, accuracy, concordance rates, or quantitative limits for precision and linearity) or their corresponding acceptance criteria are presented in a table format or even as narrative descriptions.

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

This information is not provided in the text. There is no mention of the number of samples used in the "correlation study" or "additional studies for precision and linearity," nor the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the text. The document refers to "non-clinical studies" and comparisons to a "predicate device." It does not mention the involvement of human experts for establishing ground truth, as would be typical for evaluating diagnostic device performance against a gold standard.

4. Adjudication Method for the Test Set

This information is not provided in the text. Since no experts are mentioned for establishing ground truth, no adjudication method would be detailed.

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

This is not applicable and not provided. The iChem 100 is described as a "semi-automated benchtop instrument" and an "algorithm only" device for analyzing urine test strips (reflectance spectroscopy). It does not appear to involve human interpretation of images or data that would be augmented by AI, hence an MRMC study with human readers assisting AI is not relevant to this device's evaluation as described.

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

Yes, implicitly. The description of the iChem 100 as a "semi-automated benchtop instrument" that "automatically move the test strip to the Optical Block for analysis" and "designed to analyze and generate results" strongly suggests a standalone, algorithm-only performance evaluation. The "correlation study" and "precision and linearity" studies would have evaluated the performance of the instrument itself.

7. The Type of Ground Truth Used

The text indicates that the performance was evaluated by comparing it to a "predicate device" and through "precision and linearity" studies. Therefore, the "ground truth" implicitly relies on:

• Predicate Device Performance: For the correlation study, the results from the ARKRAY AUTION JET "AJ-4270 Urine Analyzer (K030600)" served as the comparator or "ground truth" for establishing substantial equivalence.
• Established Analytical Methods: For precision and linearity, the ground truth would typically be established through controlled samples with known target values, using established analytical methods to determine accuracy and reproducibility.

8. The Sample Size for the Training Set

This information is not provided in the text. The iChem 100 is presented as a medical device for chemical analysis (reflectance spectroscopy), not explicitly as an AI/ML device that requires a distinct "training set" in the common AI sense. While such devices are calibrated and developed using data, the document does not use the terminology of "training set" or specify its size.

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

This information is not provided in the text. As mentioned above, the concept of a "training set" with established ground truth as understood in AI/ML is not explicitly discussed for this device. The development and calibration processes for chemical analyzers typically involve reference materials and established analytical methods.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and general acceptable performance through non-clinical studies (correlation, precision, linearity). However, it lacks the detailed quantitative performance metrics, specific acceptance criteria, sample sizes, and expert ground truth establishment information typically required to fully answer the detailed questions posed about acceptance criteria and study proving its fulfillment.

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The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids.

Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses.

The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids 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. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Two aliquots from each body fluid specimen sample are prepared. One aliquot is diluted in normal saline to provide a concentration in the linear range of the instrument. The second aliquot is treated with a lysing reagent to allow unambiguous identification of nucleated cells by eliminating RBC confusion. Particle images are captured and saved electronically as the sample flows past a microscope objective at a high speed, electronically concentrating particles. Particle images are then ordered by size into assigned categories on a video display. A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported.

Here's a summary of the acceptance criteria and study details for the iQ® 200 Urine Analyzer Body Fluids Module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was compared to manual chamber counting. The acceptance criteria were not explicitly stated as distinct numerical thresholds, but rather implied by the statistical results (R2 values, slope within a CI, and non-significant intercepts) demonstrating substantial equivalence.

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

• RBC Test Set Sample Size: 304 samples
• Nucleated Cells Test Set Sample Size: 299 samples
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is presented as a "Clinical Trial," implying prospective data collection, but it's not explicitly labeled as such or as retrospective.

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

The ground truth was established by "manual chamber counting" performed by a "competent human observer." The number of observers is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison is between the device's performance and manual chamber counting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's performance to "manual chamber counting," not to human readers' performance with and without AI assistance. The device itself still involves a "competent human observer" to potentially change machine assignments, but the primary performance study focuses on the instrument's accuracy compared to a manual method.

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

The device is explicitly described as being "used by a competent human observer to examine and count red blood cells and nucleated cells" and that "A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported." Therefore, the reported performance is not a standalone (algorithm only) performance, but rather a system performance including the human-in-the-loop for review and potential correction.

7. The Type of Ground Truth Used

The ground truth used was expert manual chamber counting.

8. The Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The focus is on the performance comparison of the device against the manual method.

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

Since no training set information is provided, there is no information on how its ground truth was established.

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