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iQ200 System: The iQ200 automated urine microscopy 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 iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments 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.

iChemVELOCITY Automated Urine Chemistry System: 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 Chemietry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 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 nitrite, 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 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 use and in vitro diagnostics use only.

The iQ200 System auto-identifies and processes specimens in 10-position racks by mixing. sampling, and analyzing automatically. The iQ200 Series Automated Urine Microscopy system presents a specimen sandwiched between enveloping layers of lamina to a microscope coupled to a CCD (charge coupling device) video camera. This lamination positions the specimen exactly within the depth of focus and field of view of the objective lens of the microscope. The iQ200 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. Individual particle images are isolated within each frame. The Auto-Particle Recognition (APR) software, uses size, shape, contrast and texture features to classify each image into one of 12 categories: RBCs, WBCs, WBC Clumps, Hyaline Casts, Unclassified Casts, Squamous Epithelial Cells, Non-squamous Epithelial Cells, Bacteria, Yeast, Crystals, Mucus and Sperm. Additionally, 27 predefined sub-classifications are available for identifying specific types of casts, crystals, non-squamous epithelial, dysmorphic, and others. Particle concentration is calculated using the number of particles images and the volume analyzed. User-defined release criteria are checked and results are sent to an operator review screen or directly uploaded to the LIS based on these criteria. Specimen results can be edited, imported, and exported.

The iQ Body Fluids Module is a software program that runs on the iQ Series Systems and automates body fluid sample handling, capturing particle images in a manner similar to that of the urinalysis application. The iQ200 Series System uses a CCD camera to capture images from each sample.

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. The device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVELOCITY Urine 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. 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.

The primary function of the iQ200 and iChemVELOCITY analyzers is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing, data storage, and external communications. The analyzers run embedded code on micro controllers and the workstation software runs Microsoft Windows 7 or Windows XP Operating System (OS). The workstation can be connected to: A printer for creating reports; A Laboratory Information System (LIS) for receiving test orders and releasing results.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Beckman Coulter iQ200 System and iChemVELOCITY Automated Urine Chemistry System.

Important Note: The provided document is a 510(k) Summary for a "Special 510(k)" submission. This type of submission is used when there are design modifications to a legally marketed device, and the modifications do not significantly alter the device's intended use or fundamental scientific technology. Therefore, the document focuses on demonstrating that the changes do not negatively impact the substantial equivalence to the original predicate device, rather than providing a full de novo performance study.

The primary change described is a software update (APUI software version 7.2) to address a duplicate specimen flagging issue and cybersecurity vulnerabilities.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy for classification of urine sediment elements or chemistry analytes) for the iQ200 System or iChemVELOCITY Automated Urine Chemistry System, nor does it report new device performance metrics directly tied to the software update.

Instead, the submission states that: "These software design changes do not impact the intended use or performance claims of the iQ200 Automated Urine Microscopy and iChemVELOCITY Automated Urine Chemistry analyzers."

The "acceptance criteria" in this context are related to demonstrating that the software changes do not adversely affect the previously established performance of the predicate device.

The "reported device performance" from the original predicate device (K022774 for iQ200 and K101852 & K171083 for iChemVELOCITY) is implicitly upheld by the assertion that the new software does not change performance.

However, specific to the new software features (duplicate specimen flagging and cybersecurity), the following can be inferred as "acceptance criteria" and "reported performance":

• Flag specimens with duplicate IDs and same Medical Record Number.
• Flag specimens with duplicate IDs and different Medical Record Number.
• Allow user-configurable time window (12-72 hours) for duplicate detection.
• Hold results for operator review if a duplicate is flagged. | Duplicate Specimen Detection:
• Software generates "DUPLICATE SPECIMEN ID (SAME MEDICAL RECORD NUMBER)" flag if condition met.
• Software generates "DUPLICATE SPECIMEN ID (DIFFERENT MEDICAL RECORD NUMBER)" flag if condition met.
• APUI software uses a user-configurable time window from 12 to 72 hours (default 12 hours).
• Specimen result is held until operator review. |
  | Cybersecurity Vulnerability Mitigation (Windows XP):
• Address Bluekeep vulnerability.
• Address WannaCry vulnerability. | Cybersecurity Update (Windows XP):
• Vulnerability Assessment scan successfully performed.
• Penetration test successfully done; XP OS patched for most common Bluekeep and WannaCry viruses.
• Source code review successfully done, vulnerabilities triaged. |
  | Cybersecurity Vulnerability Mitigation (Windows 7):
• Not susceptible to Bluekeep.
• Not susceptible to WannaCry. | Cybersecurity Update (Windows 7):
• Does not have Bluekeep vulnerability (Remote Desktop Protocol ports closed).
• Not susceptible to WannaCry (firewall enabled, communication ports closed to external connections). |
  | Maintenance of Intended Use and Performance Claims:
• Software changes do not alter intended use.
• Software changes do not impact existing performance claims. | Maintenance of Intended Use and Performance Claims:
• "No change" to intended use for all listed predicate devices.
• "These software design changes do not impact the intended use or performance claims..." |

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

The document does not specify a "test set" in the traditional sense for evaluating the primary diagnostic performance of the device, as this is a software update to an already cleared device.

For the duplicate specimen detection feature, the document describes the functionality of the software (how it flags duplicates) but does not provide details of a specific test set (number of samples, etc.) used to validate this functionality. The validation would likely involve software testing to confirm correct flagging under various conditions (same ID/same MRN, same ID/different MRN, within/outside time window). Data provenance for such internal software testing is not provided.

For the cybersecurity updates, "Vulnerability Assessment scan" and "penetration test" were mentioned, but no sample size (e.g., number of systems tested) or data provenance (country of origin, retrospective/prospective) is specified. These are typically internal verification activities rather than clinical studies.

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

Not applicable in this context. This submission focuses on a software update to an already cleared device, and the changes are not related to the classification or diagnosis of specific analytes that would require expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission does not detail a clinical test set that required expert adjudication for ground truth.

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 MRMC comparative effectiveness study was done. The device (iQ200 System) is an automated cell counter and the iChemVELOCITY is an automated urine chemistry system. The software update is on the Analytical Processing User Interface (APUI) and cybersecurity, not on a feature that directly assists human readers in interpretation where an "AI vs. human" comparison would be relevant. The iQ200 does produce particle images and allows human review and override, but the modifications described here do not pertain to that specific human-in-the-loop performance measurement.

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

While the iQ200 System has "Auto-Particle Recognition (APR) software" that classifies images into categories, the document for this specific 510(k) does not detail standalone performance testing for the current software version's classification algorithm. The original clearance for the predicate device would have established this. This submission mainly addresses the APUI (user interface) functionality and cybersecurity.

7. The Type of Ground Truth Used

For the software functionalities specifically mentioned (duplicate specimen flagging, cybersecurity), the ground truth would be based on:

• For Duplicate Specimen Flagging: The actual specimen IDs, Medical Record Numbers, and timestamps in a simulated or real system environment, and whether the software correctly identifies and flags duplicates based on its configured rules.
• For Cybersecurity: Known vulnerabilities (e.g., Bluekeep, WannaCry technical specifications) and standard cybersecurity testing methodologies to verify patch effectiveness.

For the underlying diagnostic performance of the iQ200 (urine sediment analysis) and iChemVELOCITY (urine chemistry), the ground truth for their original clearances would have been clinical reference methods, expert microscopy, and laboratory-confirmed results (pathology, etc.), but this is not detailed in this particular submission for the software update.

8. The Sample Size for the Training Set

Not applicable. This document describes a software update to an existing device, not the development of a new AI algorithm that would require a training set in the machine learning sense. The "Auto-Particle Recognition (APR) software" in the iQ200 system would have had a training set for its initial development and clearance, but details of that are not provided here, as this submission is for a modification.

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

Not applicable, as no new training set is described for this software update. For the original APR software (if it involves machine learning), ground truth would typically have been established by expert consensus or reference laboratory methods for classifying urine sediment particles.

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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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