Search Results

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.

Ask a specific question about this device