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AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.

A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist.

The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

The AI-4510 System (AUTION EYE AI-4510) is a fully automated urine particle analyzer for in vitro diagnostic use that uses flow cell digital imaging technology in a clinical laboratory setting. Based on images captured in the flow method, the instrument automatically classifies the images of various formed elements. The AI-4510 System can quantitatively measure RBC, WBC, and SQEC; semi-quantitatively measure BACT, and CRYS; and qualitatively measure WBCC, NSE, HYAL, NHC, YST, MUCS and SPRM in urine samples. In addition, the AI-4510 System allows trained operators to manually review and reclassify all the element images collected by the system.

This document describes the validation of the AUTION EYE AI-4510 Urine Particle Analysis System. The device is intended for the quantitative, semi-quantitative, and qualitative measurement of various elements in urine samples. The validation primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (iQ200 Urine Analyzer).

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a single table for all performance measures. Instead, it states that "all results meeting the predefined acceptance criteria" for precision studies, and that "Quantitative, Semiquantitative and Qualitative parameters met the acceptance criteria" for the method comparison study. The reported performance is presented in various tables throughout the "Summary of Performance Data" section (5.6).

Here's an aggregated table derived from the provided performance data:

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

• Precision Studies:
  • Repeatability Study: Clinical urine samples were used.
    • Quantitative elements: Not explicitly stated, but "clinical urine samples in the evaluation of repeatability for all twelve (12) elements from low to high concentrations."
    • Semi-quantitative and Qualitative elements: n=10 replicates per test level (e.g., Level 1, 2, 3 etc.).
  • Within-Laboratory Precision Study: ARKRAY control materials prepared using clinical samples.
  • Reproducibility Study: Commercially available control materials and ARKRAY control materials prepared using clinical samples were used.
• Linearity Testing: Not specified for sample size beyond "one instrument."
• Limit of Detection: Not specified for sample size.
• Carryover Testing: High-level and low-level samples, aliquoted into 5 tubes each, measured in sequences (e.g., H1 L1 H2 L2 H3 L3 H4 L4 H5 L5, repeated 5 times).
• Interference Testing: Not specified for sample size beyond the substances tested.
• Sample Stability: Positive and negative samples for all 12 elements.
• Method Comparison:
  • Population for Reference Range results: n=247
  • Quantitative Elements (RBC, WBC, SQEC): n=377 (RBC), n=845 (WBC), n=382 (SQEC) for comparison between AI-4510 (M) and iQ200 (M).
  • Semi-quantitative & Qualitative Elements: n=1474 (CRYS, BACT, WBCC, MUCS, SPRM), n=765 (NSE, NHC, HYAL, YST).
  • Data Provenance: Clinical samples. The method comparison study was conducted at "three (3) CLIA-Moderate complexity laboratories." The document states samples were "collected fresh within two (2) hours or refrigerated up to six (6) hours post collection," implying a prospective collection directly for these studies. The country of origin is not explicitly stated, but the submission is for FDA clearance in the US, and the company and testing sites (CLIA labs) suggest operations relevant to the US market.

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

The ground truth for the method comparison study (especially for semi-quantitative and qualitative elements) appears to be established by comparison to the predicate device iQ200 (Manual) and Manual Microscopy.

• For the method comparison, it refers to "CLIA-trained operators" performing testing and "A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist." This indicates that trained technologists or CLIA-trained operators (which implies suitable qualifications for laboratory testing) established the "ground truth" or reference values, either by manual microscopy or using the predicate device's manual review function.
• The document does not specify the exact number of individual experts or their specific qualifications (e.g., specific years of experience, board certification as pathologists or medical technologists). It only refers to "CLIA-trained operators" and "trained technologists."

4. Adjudication method for the test set

• The document states: "All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist." This implies a form of human override or adjudication post-AI classification.
• For the "Method Comparison" tables (14, 15, 16), most comparisons are listed as "AI-4510 (Manual) vs. iQ200 (Manual)" or "AI-4510 (Manual) vs. Manual Microscopy." The "(M)" denotes "manually reviewed and reclassified results." This indicates that the results from both the investigational device and the predicate device/manual microscopy were subjected to manual review/adjudication by trained human operators to establish the final classification used for comparison.
• The specific method of adjudication (e.g., 2+1, 3+1 consensus) among multiple readers for establishing the ground truth is not specified. The comparison is against already "manual" classifications from the predicate or direct manual microscopy, suggesting that the human reading itself serves as the reference, likely by one or more trained technologists.

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

• This document describes performance characteristics of the device itself, often compared to a predicate device or manual microscopy.
• It does not describe an MRMC comparative effectiveness study where the performance of human readers with AI assistance is directly compared to human readers without AI assistance to quantify improvement or effect size. The AI-4510 System is an automated analyzer with a manual review component, not an AI assistance tool for human interpretation of images outside of the system.

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

• The document mentions "The software processes the recorded images, automatically identifying and classifying the formed elements based on the sorting algorithm." (Section 5.5)
• However, the indications for use explicitly state: "A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist."
• Furthermore, the "Method Comparison" tables are predominantly listed as "AI-4510 (Manual) vs. iQ200 (Manual)" or "AI-4510 (Manual) vs. Manual Microscopy," where "(M)" denotes "manually reviewed and reclassified results."
• This strongly suggests that the reported performance data for clinical claims (method comparison) represents the combined human-in-the-loop performance after technologist review and reclassification, particularly for the semi-quantitative and qualitative elements.
• While the device has an "automatic classification" function (also mentioned in section 5.4 under "Automatic Classification"), the reported clinical performance data does not appear to be purely standalone (algorithm-only) without human intervention.
• Table 11 (Interference Effect on Auto-classified Results) hints at some testing of the auto-classified performance in specific scenarios (interference), but the bulk of the clinical validation on the main intended use appears to involve human review.

7. The type of ground truth used

The ground truth used for the method comparison study was established through:

• Comparison to the iQ200 System (Manual): This means the results obtained from the predicate device after its own manual review and reclassification process.
• Manual Microscopy: This is considered the traditional gold standard for urine particle analysis, established by trained technologists.

Therefore, the ground truth is a combination of expert consensus (implied via "trained technologist" review) and comparison to a legally marketed predicate device (also with human review), with manual microscopy serving as a reference.

8. The sample size for the training set

The document provided does not contain any information about the training set for the AI-4510 System's algorithm. This K submission focuses on device performance studies for validation and comparison to a predicate, not on the developmental aspects of the AI model.

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

As no information about the training set is provided, how its ground truth was established is also not available in this document.

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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 cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, mucus and sperm in urine.

This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.

The cobas u 701 microscopy analyzer is a fully automated urine analysis system. It is optimized for the high-volume professional laboratory market. The cobas u 701 microscopy analyzer performs a maximum theoretical throughput of up to 116 samples per hour.

The cobas u 701 microscopy analyzer consists of several major components:

• Rack transport system
• Liquid handling system
• Cuvette cassette compartment
• Centrifuge
• Built-in reverse microscope with movable objective lens for focusing procedure
• High resolution camera system
• Touch Screen
• Inbuilt Computer with the imaging and evaluation software for analyzing the sediment pictures

Key functions include sample loading and transport, sample identification, sample homogenization, sample pipetting into cuvettes, centrifugation of cuvettes, image acquisition with a camera, image assessment, automatic disposal of used cuvettes, result readout, result and image memory, optional manual classification and / or re-classification of particles, manual or Automatic validation of the result, optional formats for data output including electronic result communication, data export, remote service, quality control, processing of diluted samples, washing, filling water tank, emptying liquid and solid waste.

The cobas u cuvette is used by the cobas u 701 microscopy analyzer to transport, centrifuge and analyze patient and control samples.

No calibration of the device is necessary for its intended use. However, there is a microscope check utilizing a reference cuvette.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for cobas u 701 microscopy analyzer

The cobas u 701 microscopy analyzer is a fully automated urine microscopy system for a range of urine particle determinations.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state a single table of "acceptance criteria" against "reported device performance." Instead, it presents various performance studies (Precision, Analytical Sensitivity, Linearity, Dilution, Interferences, Assay Cut-Off, and Method Comparison) and states that "All predefined acceptance criteria were met" for each, or provides detailed results that demonstrate meeting criteria. The closest to reported performance criteria vs. actual results are in the Method Comparison section.

Here's an aggregated table focusing on the method comparison to the reference method, as this directly compares the device's output to a recognized standard or clinical assessment.

Note: The document generally states "All predefined acceptance criteria were met" for various studies. For quantitative parameters (RBC, WBC), the acceptance criteria are implied by the excellent regression and correlation results. For semi-quantitative and qualitative parameters, the acceptance criteria are implied by the high Cohen's Kappa, PPA, and NPA values, indicating very good agreement with the reference method.

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

• Method Comparison Study: 689 samples
• Reference Range Study: 621 "urine healthy" residual samples.
• Total Clinical Evaluation Samples: 1310 samples (689 for method comparison + 621 for reference range, with interferences evaluated using these same samples).
• Data Provenance: Clinical samples (residual amounts from routine) were used. The studies were conducted at three sites: two European sites (Site 1, Site 2) and one site located in the US (Site 3). The samples were from patients with an age range of 1 month to 98 years. This indicates mixed geographic origin (local to the three sites) and a retrospective component (residual amounts from routine).

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

The ground truth for the method comparison study was established using manual microscopy with KOVA slides as the comparator method. The document does not specify the number of experts, or their specific qualifications (e.g., number of years of experience, certification). It only refers to "visual counting." For the qualitative and semi-quantitative parameters, the "agreement rates" (PPA, NPA, Cohen's Kappa) are reported relative to this manual KOVA method, performed by human operators.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1). It refers to the manual KOVA counting method as the "reference method." This implies that the KOVA results were considered the ground truth without further multi-reader adjudication for the ground truth itself. However, the "Method Comparison" section does state that "All instrument analyte image decisions may be reviewed and reclassified by a trained operator" as part of the device's intended use, which is a form of human-in-the-loop review, but not necessarily a part of establishing the initial ground truth for the study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with AI assistance versus without AI assistance. The study compares the device's performance (algorithm only) to a manual reference method. The device's indications for use mention that "All instrument analyte image decisions may be reviewed and reclassified by a trained operator," implying human-in-the-loop use, but the presented studies are for standalone device performance against a manual method.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The precision, analytical sensitivity, linearity, dilution, and interference studies directly evaluate the performance of the "cobas u 701 microscopy analyzer." The method comparison study also assesses the "cobas u 701 microscopy analyzer" against manual microscopy, effectively evaluating the standalone performance of the automated system. The results presented (Passing Bablok regression, agreement rates) are for the device's output.

7. Type of Ground Truth Used

The ground truth used for the method comparison study was manual microscopy using KOVA slides. This is a well-established laboratory method for urine sediment analysis and can be considered a form of expert consensus or reference method consensus if performed by trained laboratory professionals.

8. Sample Size for the Training Set

The document does not explicitly mention the sample size used for the training set for the device's image processing and evaluation software. The reported sample sizes (1310 total clinical samples) are for the non-clinical performance evaluation and external (clinical) testing (test set).

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

The document does not provide details on how the ground truth for the training set was established. It describes the "cobas u 701 microscopy analyzer" as evaluating images with "an image processing software which is able to detect and further classify the following urine particles," suggesting a machine learning or rule-based system. However, the methodology for creating the labeled data (ground truth) used to develop or train this software is not described in the provided text.

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The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer that is used in the clinical laboratory to analyze formed elements in urine samples quantitatively and flag for the presence of particles/cells in the sample. It provides screening of abnormal samples, as well as automation and better efficiency in the laboratory. The analyzer reports analysis results on five enumerated parameters in urine: RBC (Red Blood Cells), WBC (White Blood Cells), EC (Epithelial Cells), CAST and BACT (Bacteria). It also reports flagging information on the following parameters in urine: Pathologic Cast; Crystal; Sperm; Yeast like cell; and Mucus. This flagging information alerts the operator for the need of further testing and/or review.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is a dedicated system for the analysis of microscopic formed elements in urine and uses a Microsoft® Windows Operating System. The analyzer consists of the following units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples and processes data from the main unit and provides the operator interface with the system; (2) Sampler Unit which supplies samples to the main unit automatically; and (3) Pneumatic Unit which supplies pressure and vacuum to the main unit.

The analyzer uses five reagents-UF-CELLSHEATH (sheath reagent), UF-CELLPACK CR and UF-CELLPACK SF (diluents) and UF-Fluorocell CR and UF-Fluorocell SF (both stains). The quality control material is UF-CONTROL.

The provided text describes the performance data and conclusions for the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer, seeking to prove its substantial equivalence to the predicate device, the Sysmex® UF-1000i. This is a submission for a 510(k) premarket notification, which focuses on demonstrating equivalence rather than establishing novel claims.

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

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

The document does not present a formal table of specific acceptance criteria (e.g., target accuracy percentages, precision ranges) that the Sysmex® UF-5000 had to meet. Instead, it describes general categories of performance testing conducted to demonstrate "equivalent performance" to the predicate device:

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

The document does not explicitly state the sample size used for the test set. It mentions "Clinical and analytical validation testing" and "Method Comparison" but provides no numbers of samples or patients.

Regarding data provenance: The document identifies Sysmex America Inc. (Illinois, USA) as the submitter. While it doesn't explicitly state the country of origin for the clinical samples, it's highly likely to be the USA, given the submitter's location and the FDA submission context. The study is implicitly prospective in nature, as it involves newly conducted validation testing for a new device to demonstrate its performance characteristics.

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For a device like an automated cell counter, the "ground truth" for method comparison studies is typically established by comparing its results against a "gold standard" or reference method, which might be manual microscopy performed by trained laboratory professionals (medical technologists, clinical pathologists), or by comparing against the predicate device itself. However, the text does not elaborate on this.

4. Adjudication method for the test set

The document does not describe any adjudication method. Given that the device is an automated cell counter, the "ground truth" would likely be established through a reference laboratory method rather than a panel of human adjudicators in the way an imaging AI might use.

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 performed. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component of the diagnostic pathway. For an automated laboratory analyzer, the performance is assessed against reference methods and statistical agreement with the predicate.

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

Yes, the studies described are inherently "standalone" in the context of the device's operation. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated device designed to analyze urine samples and report parameters directly. The performance evaluation (LoB/LoD/LoQ, linearity, precision, carryover, method comparison) assesses the device's analytical performance on its own, without direct real-time human intervention in the analysis process itself. Human interpretation of the results (e.g., flagging information leading to further testing) is part of its intended use, but the analytical performance is standalone.

7. The type of ground truth used

The document implies that the ground truth for the performance studies, particularly "Method Comparison," would be established by comparing the Sysmex® UF-5000's results against those of the predicate device (Sysmex® UF-1000i) and/or other established laboratory reference methods for urine particle analysis. It does not explicitly state which ultimate ground truth was used (e.g., pathology, manual microscopy, or clinical outcomes data). For quantitative parameters like RBC and WBC counts in urine, the "ground truth" often refers to the accepted values obtained from a reference measurement method.

8. The sample size for the training set

This document describes a 510(k) submission for an automated laboratory instrument, not a machine learning or AI model in the modern sense that typically involves "training sets." The "algorithm" or measurement principles (flow cytometry, laser detection, specific reagents) are embedded in the device's design. Therefore, the concept of a "training set" as it applies to AI models is not relevant here, and no information on a training set sample size is provided.

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

As explained above, the concept of a "training set" for the Sysmex® UF-5000 as an automated instrument is not applicable in the same way it would be for AI/ML algorithms. The device's operational parameters and internal algorithms are based on established scientific principles of flow cytometry and are likely refined during product development and engineering, rather than "trained" on a dataset in the AI sense.

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The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.

The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.

The GloCyte® Automated Cell Counter System is an automated cell counter that concentrates and enumerates total nucleated cells (TNCs) and red blood cells (RBCs) using fluorescent microscopy and digital image analysis principles. The test method uses one of two reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti- human RBC antibody in buffer with stabilizers), and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.

The GloCyte® Automated Cell Counter System includes the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes (10 and 30 µL), Test Cartridge, TNC and RBC Reagents, Low and High Level Controls.

Here's an analysis of the provided text regarding the GloCyte® Automated Cell Counter System, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a dedicated table. However, it implicitly defines successful performance by stating that "Results were shown to meet acceptance criteria" for accuracy and "The results of the repeatability study met acceptance criteria." The reproducibility study also "met acceptance criteria." Based on the reported data, the implicit acceptance criteria would relate to achieving results within the stated ranges, slopes, intercepts, and CVs.

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

• Accuracy Study (Hemocytometer vs. GloCyte):
  • TNC Pediatric: 129 samples
  • TNC Adult: 223 samples
  • RBC Pediatric: 196 samples
  • RBC Adult: 267 samples
  • Data Provenance: "clinical sites and in-house using clinical and contrived CSF specimens." This indicates a mix of prospective (clinical) and possibly retrospective (clinical) or laboratory-prepared (contrived) data. The country of origin is not specified but implicitly US, given the FDA submission.
• Repeatability Study:
  • TNC: 26 samples
  • RBC: 29 samples
  • Data Provenance: "three clinical sites and in-house using clinical and manipulated CSF specimens as well as GloCyte® Low and High Level Controls." Similar to accuracy, a mix of data types and locations.
• Precision/Reproducibility Study:
  • Each TNC and RBC level (Low/High) had 480 measurements (likely 2 operators * 2 measurements/day * 20 days * 3 sites).
  • Data Provenance: "three clinical sites," using GloCyte® Low and High Level Controls.
• Linearity Study:
  • Used "Contrived RBC and TNC CSF samples, created by dilution of human blood cells into blank CSF." Tested on three GloCyte® Automated Cell Counter Systems.
• Determination of LoB, LoD, LoQ:
  • No specific sample size mentioned, but studies were conducted "according to CLSI EP17-A2."
• Interfering Substances:
  • No specific sample size mentioned for each interferent, but "Interference testing was conducted."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. For the accuracy study comparing GloCyte to Hemocytometer, the Hemocytometer results would serve as the comparative method. However, who performed the hemocytometer counts and their qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies in the test set.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is an automated cell counter, which aims to replace or assist manual counting, but the study described focuses on the device's analytical performance against established methods, not human reader performance.

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

Yes, the studies described are standalone performance evaluations of the GloCyte® Automated Cell Counter System. The device is designed to be an automated system, and the reported accuracy, repeatability, precision, linearity, and reportable range studies all reflect the algorithm and instrument's performance without direct human intervention in the cell counting process for the test results.

7. The Type of Ground Truth Used

• For the accuracy study, the ground truth for TNC and RBC counts was established by comparison against Hemocytometer counts ("Hemocytometer vs. GloCyte TNC and RBC counts").
• For repeatability, precision/reproducibility, linearity, LoB, LoD, LoQ, and interfering substances, the ground truth was implicitly the expected value or reference method result derived from standard laboratory practices and controlled preparations, rather than expert consensus on individual cases or pathology reports. For example, linearity uses "true concentrations of the analyte" and "expected values."

8. The Sample Size for the Training Set

The document does not mention the sample size for a "training set." The GloCyte® Automated Cell Counter System uses digital image analysis principles to count cells. While such systems are often developed using training data, this submission focuses on the validation or performance testing datasets. It does not provide details about model development or the data used to "train" its algorithms.

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

Since no training set is discussed or implied in the provided text, the method for establishing its ground truth is also not elaborated upon.

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BD FACSPresto System:
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
· For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
· For use in children, adolescents, and adults.
· For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
· Not for point-of-care use.
· For in vitro diagnostic use.

BD FACSPresto CD4/Hb Cartridge & BD FACSPresto CD4/Hb Cartridge Kit:
The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
· For use in children, adolescents, and adults
· For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
· Not for point-of-care use.
· For in vitro diagnostic use.

BD Multi-Check Control:
The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.

BD Multi-Check CD4 Low Control:
The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and data analysis.
The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.

Eurotrol FACSPresto Hb Control:
Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPrestoTM System.

The BD FACSPresto System is an accurate, robust, and portable CD4, %CD4, and hemoglobin (Hb) System. The BD FACSPresto System has fluorescence microscopy and light absorbance capabilities. In addition, the instrument has integrated BD FACSPresto Software and instrument quality controls.
The BD FACSPresto CD4/Hb Cartridge contains antibody-fluorophore conjugates dried on a reagent disc and is embedded with reagent quality controls. The cartridge is designed with onboard reagents that mix well into the blood sample, and enumerate cells populations using fluorescence only. The cartridge is designed with fluidic properties that distribute a sufficient volume and sample into the imaging field of view for precise cell counting.
The BD FACSPresto CD4 and %CD4 assays are designed to stain cells with antibody-fluorophore conjugates for three color fluorescence reading using the BD FACSPresto System. CD4 PE-Cy5 stains CD4-positive cells; while CD3-APC and CD45RA-APC stains total lymphocytes for use in the %CD4 calculation (CD3 stains T cells, while CD45RA stains B and NK cells in a patented formulation). CD14-PE is used for staining monocytes to exclude CD4 and/or CD45RA expressing monocytes from analysis.
BD Multi-Check Control and BD Multi-Check CD4 Low Control are process controls for the CD4 and %CD4 assay on the BD FACSPresto system. They are composed of human leukocytes and erythrocytes in a stabilizing medium and are intended to be used as a complete process control for antibody staining. instrument performance, and data analysis on the BD FACSPresto system.
The BD FACSPresto Hb assay is performed by a spectrophotometric method. using absorbance at an isobestic point for multiple forms of hemoglobin, with correction for scatter. The cartridge microfluidic channel permits absorbance reading of blood and of a reference area.
Eurotrol FACSPresto Hb Control is used as a process control for the Hb assay on the BD FACSPresto system. It is composed of purified bovine hemolysate and is intended to be used as an assayed hemoglobin process control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto System.

Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BD FACSPresto System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally described as meeting CLSI document standards and "study acceptance criteria" or "acceptable results." Specific quantitative targets are less frequently provided in this summary but are indicated as having been met.

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The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.

The provided document is a 510(k) summary for the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System, Uriflet™ S 9HA Urine Test Strips, and AUTION Control Solution. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in this 510(k) summary. The document emphasizes comparison to predicate devices and states that "Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices."

However, I can extract the available information and also highlight what is not present in the document.

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

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format for the new device against predefined thresholds. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (AUTION MAX AX-4030 Urinalysis System (K093098), SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887), and Sysmex UF-II Control (K070910)).

The "performance" demonstration is primarily through comparison of technological characteristics, intended use, operating principles, and design features to the predicate devices. The assumption is that since the predicate devices are already cleared, demonstrating equivalence implies acceptable performance.

Here's a summary of the comparisons provided, which implicitly serve as performance benchmarks by virtue of their equivalence:

Note: Changes in operational characteristics like "Processing Speed," "Sample Volume," "Display," "Built-in Printer," "Dimensions," and "Weight" are noted but are not considered performance criteria in the context of substantial equivalence for accuracy or clinical efficacy. The critical aspect for this type of submission is that these changes do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical and bench testing was used to verify the performance characteristics of this device." However, it does not provide details on:

• The specific sample sizes used for any test sets.
• The provenance of the data (e.g., country of origin, retrospective or prospective nature of the studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. For in-vitro diagnostic devices like this, expert review for ground truth might involve clinical pathologists or laboratory professionals, but the document does not elaborate.

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

This information is not provided in the 510(k) summary.

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

The device is an automated urine analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed or referenced. The device performs the analysis automatically.

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

Yes, the device is inherently a standalone (algorithm only) device as it is a fully automated integrated urine analyzer system performing in vitro measurements. Its performance would be evaluated based on the accuracy and precision of its automated measurements against a reference method or predicate device, independent of direct real-time human interpretation assistance during the analysis. The "comparison to predicate devices" and "clinical and bench testing" mentioned constitute this standalone performance evaluation relative to known performance.

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

The document does not explicitly state the specific type of ground truth used. For IVD devices, "clinical and bench testing" typically refers to studies where:

• Bench testing might involve spiked samples, controls, or samples with known concentrations/particle counts verified by confirmatory lab methods.
• Clinical testing would involve patient samples, likely compared against a reference method (e.g., manual microscopy for urine sediment, or established clinical chemistry methods for parameters like glucose, protein) which would effectively serve as the ground truth. Since the application is for "in vitro diagnostic use in screening patient populations," the ground truth would likely be established by clinical laboratory standards and reference methods.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The document describes a traditional automated analyzer, not a machine learning/AI device that typically employs distinct "training" datasets in the computational sense. Performance verification for this device involved "clinical and bench testing."

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

As the document does not describe a "training set" in the context of machine learning, this information is not applicable/provided. For traditional IVD analyzers, ground truth for sample data used in method comparison or verification studies (analogous to validation) would be established by reference laboratory methods, sometimes using spiked samples or certified reference materials for precision and accuracy assessments.

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The ADVIA 2120 and ADVIA 2120i with autoslide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories:

• A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Hct, MCH, MCHC, CHCM, RDW, HDW, CH, Plt, MPV.
• A leukocyte differential count consisting of Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
• A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
• A nucleated red blood cell count consisting of NRBC(%/#).
• Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
  Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens with K2 and/or K3 EDTA anti-coagulants).
• Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#),PMN (%/#).
  In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a microscope slide.

The ADVIA 2120/210i Hematology systems with Auto slide are an integrated option of a Hematology analyzers with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability, nucleated red blood cell count, quantitative determination of blood cells in Cerebrospinal Fluid (CSF), enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.
The ADVIA 2120/210i Hematology systems with Auto slide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an auto sampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides primary user interface with the instrument and manages the data produced by the instrument; a printer that optionally generates reports based on the instrument results and an auto slide module that prepares a wedge smear from a drop of blood, places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grnwald Giemsa Staining techniques.

The provided text is a 510(k) Summary for the ADVIA® 2120/2120i Hematology auto-analyzers. This document focuses on demonstrating substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device. It does not describe a study that proves the device meets specific acceptance criteria in the way you might expect for a novel AI device with a defined set of performance metrics.

Instead, the submission shows the new device with an ARM9 CPU board performs similarly or identically to the predicate device (the ADVIA 2120/2120i with the current CPU board) across various specifications. The "acceptance criteria" here are essentially the established performance characteristics of the predicate device, and the "study" is the comparison data presented to support substantial equivalence.

Here's an attempt to answer your questions based on the provided text, acknowledging that some information you requested (like AI-specific details, ground truth establishment for a training set, and expert adjudication for a test set) are not relevant or present in this type of FDA submission for a hardware/firmware upgrade to an existing analyzer.

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

The acceptance criteria are implied to be the performance characteristics of the predicate device. The "reported device performance" is the expectation that the new device (AVIA 2120/2120i with ARM9 CPU) will exhibit identical performance.

• RBC (10⁶/μL): 0.0 to 7.0 (Max Deviation: 0.1)
• HGB (g/dL): 0 to 22.5 (Max Deviation: 0.2 or 2.0%)
• PLT (10³/μL): 5.0 to 3500 (Max Deviation: 5.0 or 5.0%)
• %RETIC: 0.2 to 24.5 (Max Deviation: 5.0%)
• CN-free HGB (g/dL): 1 to 22.5 (Max Deviation: 0.3 or 3.0%)
• CSF WBC (cells/µL): 0 to 50 (Max Deviation: 5)
• CSF RBC (cells/µL): 50 to 5000 (Max Deviation: 10%)
• BF TNC (10³/µL): 0 to 50 (Max Deviation: 5)
• BF RBC (10⁶/µL): 50 to 1500 (Max Deviation: 10%) | Same |
  | Within-Run Precision| (See detailed table in original text; e.g., WBC: Nominal 7.5, SD 0.2, CV 2.66%) | Same |
  | Carryover | Less than or equal to 1% | Same |
  | Physical/Electrical | (Various detailed specifications for Temperature, Humidity, Noise, Weight, Dimensions, Vacuum/Pressure, Reaction Chamber Temp, Power Pack Temp, Light Intensities, Power Supply Voltages, Sample Mode Volumes, Throughput, Sample Capacity, Tube Sizes/Types, Barcode Reader functionality) | Same |
  | Data Management | TDC version 9 or higher, Database storage, Review/edit, User-defined reports/ranges, Bi-directional communication, QC features, ILQC programs, User assistance | Same |
  | Consumables/Reagents| CBC TIMEPAC Baso HGB RBC/PLT Defoamer CN-Free CBC TIMEPAC; DIFF TIMEPAC, Perox 1, 2, 3, Perox Sheath, autoRetic, EZ KLEEN, Sheath/Rinse, CSF | Same |
  | Calibrators | ADVIA OPTIpoint, ADVIA SETpoint | Same |
  | Controls | ADVIA TESTpoint Low/Normal/High, Retic Low/High, 3-in-1 Abnormal1/Normal/Abnormal2 | Same |

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document lists performance specifications (linearity, precision) but does not specify the sample sizes or data provenance (country, retrospective/prospective) used to establish these predicate device performance characteristics. The context is that the new device's performance is expected to be identical to the established predicate performance, implying that these performance metrics have been previously validated and are being maintained.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to this submission. The "ground truth" for hematology analyzers is typically established through reference methods, calibrated controls, and comparison to established, validated manual methods, not through expert consensus in the way an imaging AI algorithm's ground truth might be. The document focuses on the technical specifications and equivalence of a hardware component change.

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

Not applicable. This type of submission does not involve adjudication of diagnostic decisions as would be relevant for an AI algorithm.

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

Not applicable. This is for a hematology auto-analyzer, not an AI-assisted diagnostic tool for human readers.

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

The device itself is a standalone automated hematology analyzer. The submission is not for a new algorithm, but for a hardware (CPU board) and associated software upgrade to an existing analyzer. The performance characteristics presented are those of the entire automated system.

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

Not explicitly stated for the predicate device's original validation. However, for hematology analyzers, "ground truth" for parameters like cell counts, hemoglobin, etc., is typically established using:

• Reference methods: Highly accurate and precise laboratory methods.
• Calibrated materials: Use of control materials with known values traceable to international standards.
• Manual microscopy or other established techniques: For differential counts or specific cell morphology, comparison to manual review by highly trained laboratorians.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning. It's a change to a pre-programmed analytical instrument.

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

Not applicable, as there is no "training set" in the AI sense.

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The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.

The iQ®200 Urine Analyzer Body Fluids Module for use with synovial fluid is an additional use for the iQ®200 Urine Analyzer (K022774 – cleared October 21, 2002). It is used by a competent human observer to examine and count red blood cells and nucleated cells in synovial fluid and is an added body fluid to the previously cleared iQ®200 Urine Analyzer Body Fluids Module cerebrospinal and serous fluids (K050235 -Cleared March 23, 2005).

The provided text describes the 510(k) submission for the iQ® 200 Urine Analyzer Body Fluids Module with the addition of Synovial Fluid capability. It compares the device to a predicate device, the Sysmex® XT-4000i. However, the document does not provide a table of acceptance criteria or the specific performance data against those criteria. It states that "Clinical trial performance data demonstrated that the Synovial Fluid parameter on the iQ®200 Urine Analyzer Body Fluids Module is substantially equivalent to its predicates," and that "Data consisting of Accuracy, Precision, Linearity and Carryover was collected to show performance to the manufacturer's specification for the Body Fluid mode." However, these specific data points and the defined acceptance criteria are not included in the provided text.

Therefore, I can only address parts of your request based on the available information.

Summary of Available Information:

The iQ® 200 Urine Analyzer Body Fluids Module, with the new Synovial Fluid parameter, is an in-vitro diagnostic device used by trained laboratory users to examine and count red blood cells and nucleated cells in synovial fluid (along with cerebrospinal and serous fluids). It operates by adding hyaluronidase to the specimen, preparing two aliquots (one diluted, one lysed), capturing particle images as the sample flows past a microscope objective, ordering images by size into categories, and allowing a human observer to change machine assignments before re-computing and reporting concentrations.

The device's substantial equivalence to the Sysmex® XT-4000i (K091313) is claimed based on similarities in intended use, specimen collection (K2EDTA for synovial fluid), and the fact that both devices collect data on Accuracy, Precision, Linearity, and Carryover to demonstrate performance to manufacturer's specifications.

Information NOT available in the provided text:

• Specific Acceptance Criteria: The document mentions that performance data was collected "to show performance to the manufacturer's specification," but it does not specify what those specifications or acceptance criteria are (e.g., minimum accuracy percentages, precision ranges, linearity R-squared values, etc.).
• Reported Device Performance (against specific criteria): While the document states that clinical trial data "demonstrated substantial equivalence," the actual performance values for Accuracy, Precision, Linearity, and Carryover for the iQ® 200 Synovial Fluid module are not provided.
• Sample size used for the test set and data provenance: The document mentions "clinical trial performance data" and "Data consisting of Accuracy, Precision, Linearity and Carryover was collected," but it does not specify the sample size of the test set, the country of origin of the data, or whether it was retrospective or prospective.
• Number of experts and their qualifications for ground truth: This information is not provided.
• Adjudication method for the test set: This information is not provided.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: The document does not describe an MRMC study. The device is used by a "competent human observer" who "may change machine assignments," indicating a human-in-the-loop process, but no comparative effectiveness study with and without AI assistance is described.
• Standalone (algorithm-only) performance: The device description clearly states that a "competent human observer may change machine assignments, after which particle concentrations are recomputed and reported," indicating it's not a standalone device. Therefore, standalone performance data would not be applicable or provided.
• Type of ground truth used: Given the context of a cell counter, it's highly likely that ground truth for performance studies would be established by manual microscopy with expert review, but this is not explicitly stated in the document.
• Sample size for the training set: The document does not mention any training set for an algorithm, as it describes a device that captures images and categorizes them, with human oversight. This suggests a more rule-based or image processing approach rather than a machine learning model requiring a distinct training set.
• How the ground truth for the training set was established: As no training set is described, this information is not applicable.

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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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