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The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.

iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.

The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).

The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: iChem®VELOCITY™ Automated Urine Chemistry System with redesigned Color/Clarity Module (CCM)

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" with numerical targets for the redesigned CCM. Instead, it aims to demonstrate substantial equivalence to the predicate device (iChemVELOCITY with the original CCM). Therefore, the reported performance is compared to the predicate's expected performance, with the implicit criterion being that the redesigned CCM performs at least as well as, or is in agreement with, the predicate.

Here's an interpretation of the performance data in the context of implied acceptance:

Detailed Performance Tables from the Document:

Method Comparison Results Summary (Page 8):

Precision Results Summary (Page 9):

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

• Sample Size: The "Precision Results Summary" table on page 9 indicates that for each color and clarity level category, 240 samples were tested.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "Performance testing of the iChemVELOCITY with the redesigned CCM was conducted."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The "Method Comparison" results compare the "Redesigned CCM" to a "Comparator." Given the context of a design change to an existing device, the "Comparator" likely refers to the predicate iChemVELOCITY device with the original CCM. The ground truth, in this case, would be the results generated by the predicate device, not necessarily external human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method, as the comparison is primarily machine-to-machine (redesigned CCM vs. predicate CCM).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated urine chemistry system, and the study focuses on the performance of the redesigned CCM against its predicate, not on human reader performance or AI assistance.

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

Yes, a standalone performance study was done. The entire study focuses on the performance of the automated iChemVELOCITY system with the redesigned CCM. There is no mention of human-in-the-loop performance evaluation for the color and clarity measurements. The device is intended "for clinical laboratory and in vitro diagnostic use only" and "is not intended for visual reading."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth for the performance study is the predicate device's performance. The study aims to show that the redesigned CCM produces results equivalent to the iChemVELOCITY with the original CCM, which was previously cleared.

8. The sample size for the training set

The document does not specify a separate training set size. The study describes a design change to existing hardware/software components, including an updated algorithm. It's possible that the "new firmware has been written and installed on the CCM's microprocessor... to update the CCM algorithm" implies some form of development/training, but the specifics and size are not provided in this regulatory summary.

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

Since no specific training set and its size are explicitly mentioned, the method for establishing its ground truth is also not described. If algorithm development involved training, the ground truth would likely have been established using reference methods during the design phase of the original or updated algorithm, but this is not detailed in the provided text. The document focuses on the verification that the redesigned component performs equivalently to the existing, cleared device.

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The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.

The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer.

The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements.

These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

The proposed device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVelocity Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively.

Here's an analysis of the provided text to extract the acceptance criteria and study data for the iChem VELOCITY Automated Urine Chemistry System:

The provided 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (iChem 100 Urine Chemistry Analyzer and iChem 10SG strips) for regulatory clearance. It describes the device, its intended use, and compares its design, materials, safety, and electromagnetic compatibility with the predicate.

Crucially, the 510(k) summary does not include detailed acceptance criteria or a dedicated study section proving the device meets specific performance criteria beyond asserting "substantial equivalence." This is a common practice in 510(k) applications, where extensive performance data (like clinical trial results with predefined acceptance criteria) might not be explicitly summarized in the public document if the device is deemed substantially equivalent based on similarity to an already cleared device and analytical performance tests.

However, we can infer some "acceptance criteria" from the comparison section and general principles of diagnostic device performance. The study described is an analytical performance comparison to the predicate device, not a human reader study or a standalone clinical effectiveness study in the typical sense.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)

Since explicit acceptance criteria for performance are not listed, we can infer that the device's performance was deemed acceptable if it was substantially equivalent to the predicate device, the iChem 100 Analyzer and 10SG strips, for all analytes and measurements. The "Reported Device Performance" below refers to the general claim of equivalence, as specific numerical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are not provided in this summary.

Study Information (Based on 510(k) Summary)

Given the nature of a 510(k) for substantial equivalence, the "study" described is primarily an analytical performance comparison against a predicate device, rather than a full clinical trial.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated within this 510(k) summary. For a device like this, the "test set" would typically refer to a range of urine samples (both normal and abnormal, prepared or clinical) used for analytical validation across the measurement range of each analyte.
   • Data Provenance: Not explicitly stated. For a device manufactured by an US-based company (Iris Diagnostics, Chatsworth, CA), it is highly likely that the testing and data generation occurred in the United States, usually at the manufacturer's facility or an associated clinical/analytical laboratory. The summary does not specify if the data was retrospective or prospective, but analytical performance studies often involve prospective collection or preparation of samples.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. For this type of analytical device (measuring chemical properties of urine), the "ground truth" for the test set would typically be established by established reference methods or highly accurate laboratory analyzers, not necessarily by "experts" in the human interpretation sense (like radiologists). If visual assessments were part of a comparison (e.g., for color/clarity in early development stages), then trained laboratory personnel would likely be involved.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Adjudication method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where there's subjectivity and potential for disagreement among readers. For an automated chemistry analyzer, the comparison would be against a quantitative or semi-quantitative reference method, or the predicate device's output.

4. 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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated urine chemistry system, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data. Its function is to perform the measurements directly.

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

   • Standalone Performance: Yes, the fundamental "performance" of this device is inherently standalone. It is an automated system ("algorithm only" in a broader sense of automation) that performs measurements without direct human real-time intervention for each test. The summary explicitly states: "iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading." This clearly indicates it functions as a standalone system without human-in-the-loop for reading the strips themselves.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Ground Truth Type: While not explicitly detailed, for an analytical chemistry system, the ground truth would typically be established by reference laboratory methods (e.g., established gold standard chemical assays, refractometry for specific gravity) or by agreement with the predicate device's measurements on a diverse set of samples. The objective is to demonstrate that the new device measures the analytes accurately and consistently.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable/not specified in this summary. This document describes a medical device seeking 510(k) clearance, which would typically rely on pre-defined chemical reactions and optical detection methods, rather than machine learning algorithms requiring explicit "training sets" in the modern AI sense. While some internal calibration or parameter optimization (which could be loosely termed "training") would have occurred during development, it's not a "training set" in the context of deep learning or statistical model training that would be detailed in this type of regulatory submission in 2011.

8. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable, as no explicit training set in the AI sense is described. For calibration or development, ground truth would have been established through controlled experiments using known concentrations of analytes and reference methods.

In summary, the provided document is a 510(k) summary demonstrating "substantial equivalence," not a detailed clinical study report. It highlights the device's technical comparability and regulatory compliance (safety, EMC) with a previously cleared device. Detailed performance metrics with specific acceptance criteria and the methodologies for establishing ground truth for test and training sets (especially in the context of AI/ML) are typically more extensively covered in PMA submissions or in supporting documentation that is not part of this public summary.

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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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