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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 iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations.

Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of post-surgical or posttherapeutic recovery.

The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

The iQ 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

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

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

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

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

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

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The Sysmex® UF-500i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-500i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

The Sysmex® UF-500i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists of three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-500i is equipped with a Sampler that provides continuous automated sampling for up to 60 tubes. The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-500i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results. Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

The provided document primarily consists of a 510(k) summary for the Sysmex® UF-500i, an automated urine particle analyzer. It focuses on demonstrating substantial equivalence to a predicate device (Sysmex® UF-1000i) rather than presenting a standalone study with detailed acceptance criteria and performance against those criteria in a typical clinical study format.

Therefore, many of the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated within this 510(k) summary. These types of detailed studies are generally performed during the development and validation phases and are summarized or referenced in the 510(k) where substantial equivalence to a known predicate is the primary claim.

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study with specific thresholds for sensitivity, specificity, accuracy, etc. Instead, it refers to "method and flagging comparison studies along with reference interval comparison to the UF-1000i," concluding that "there is no difference between the UF-1000i and the UF-500i."

This implies that the acceptance criterion was demonstrating "no difference" or substantial equivalence to the predicate device (Sysmex® UF-1000i) in terms of its ability to analyze and flag specific parameters.

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

The document does not specify the exact sample size used for the comparison studies. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

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

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

An MRMC study is not applicable here because the device is an automated urine particle analyzer. It processes urine samples directly and classifies elements, not assisting human readers with interpretation of images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

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

Yes, the device (Sysmex® UF-500i) is an automated urine particle analyzer. It operates as a standalone algorithm (flow cytometry and adaptive cluster analysis) without human-in-the-loop for its primary analysis and classification of particles. The comparison studies described in the 510(k) summary would have evaluated this standalone performance against the predicate device.

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

The document implies that the ground truth for comparison was the performance of the predicate device, the Sysmex® UF-1000i. The studies focused on demonstrating that "there is no difference" between the UF-500i and the UF-1000i, meaning the UF-1000i's established performance served as the reference or "ground truth" for the comparison. It indicates "method and flagging comparison studies" which would typically involve comparing the results of both instruments on the same samples.

8. The sample size for the training set

The document does not provide information about a "training set" as this device is a substantial equivalence claim to an existing technology (flow cytometry with adaptive cluster analysis) rather than a novel AI/ML algorithm that would typically undergo explicit training on a large dataset. The underlying analysis principles are established.

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

As there's no explicit mention of a "training set" for a novel AI/ML algorithm in this 510(k) summary, this question is not directly applicable. The device relies on established flow cytometry principles and classification algorithms.

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Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes.

The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results.

Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

The provided text is a 510(k) summary for the Sysmex® UF-1000i with Urinalysis WAM. It details the device, its intended use, and substantial equivalence to a predicate device, but it does not contain detailed information about acceptance criteria or specific studies proving device performance against such criteria for the Urinalysis WAM software.

The key assertion made in the document is about the substantial equivalence of the modified device (UF-1000i with Urinalysis WAM) to the predicate device (UF-1000i without Urinalysis WAM). The document states: "Design validation studies were completed and sample integrity study was performed. and there is no difference between the UF-1000i and the UF-1000i with Urinalysis WAM software." and "The UF-1000i with Urinalysis WAM software demonstrates substantial equivalence to the UF-1000i without the Urinalysis WAM software."

Therefore, the provided text does not offer the specific granular details (acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) that would typically be found in a detailed study report demonstrating performance against acceptance criteria for a new device or a significant modification.

Based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and a study proving the device meets them because this specific detail is not present. The document focuses solely on asserting substantial equivalence through a modification that is stated to have "no difference" in how the core analytical function performs.

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The Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.

The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes.

The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results.

Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.

The provided text does not contain detailed acceptance criteria or a study design to prove the device meets specific criteria for the Sysmex UF-1000i beyond general statements of equivalence to a predicate device. It primarily focuses on 510(k) submission information, device description, intended use, and a comparison table to its predicate.

Here's an analysis of the available information in relation to your request:

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

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (Sysmex UF-100) through performance comparisons.

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

The document states: "Data consisting of carryover, linearity, accuracy and reproducibility show performance to the manufacturer's specifications." However, it does not provide:

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

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 document. The document refers to "manufacturer's specifications" but does not detail how ground truth was established for the comparison studies.

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

This information is not provided in the document.

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 Sysmex UF-1000i is an automated urine particle analyzer, not an AI-assisted diagnostic tool that relies on human readers interpreting its output in a "multi-reader multi-case" study context. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device. It's a standalone automated analyzer.

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

Yes, the device is an "automated urine particle analyzer" and operates as an "algorithm only" system. The entire submission details its standalone performance in comparison to a predicate device.

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

The document does not explicitly state the type of ground truth used for performance evaluation (e.g., manual microscopy by experts, culture results for bacteria). It relies on "comparison to the UF-100" and "manufacturer's specifications" for performance parameters like accuracy and reproducibility.

8. The sample size for the training set

The device described is a flow cytometry instrument that classifies particles based on physical properties (forward scatter, fluorescence, adaptive cluster analysis). While it utilizes "adaptive cluster analysis," which implies some form of algorithmic learning or classification, the document does not specify a "training set" sample size in the context of machine learning. The classification algorithms are likely pre-defined or trained during the instrument's development, but the specifics are not disclosed here.

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

As with the test set, the document does not specify how ground truth for any potential training data or for the development of its classification algorithms was established.

Summary of missing information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, quantitative acceptance criteria and a comprehensive study report for standalone performance. Many specific details regarding sample sizes, ground truth establishment, expert involvement, and study design are absent. This is common for 510(k) summaries which aim to provide a high-level overview required for regulatory submission. More detailed information would typically be found in the full 510(k) submission document, which is not provided here.

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The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.

The Sysmex® UF-100i, automated urine cell analyzer is a dedicated system for the analysis of microscopic formed elements in urine specimens. It accomplishes this by the principles of Laser Flow Cytometry and Impedance. The UF-100i attached to a commercially available reagent strip reader provides all that is required to perform an automated urinalysis profile consisting of chemistries and microscopic results.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Sysmex® UF-100i Automated Urine Cell Analyzer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with independent acceptance criteria and data for the new device's performance.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report for a new medical device.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit): The implicit acceptance criterion is "substantial equivalence" to the predicate device (Sysmex UF-100). The document states:

  "Comparison to the UF-100 demonstrated excellent correlation."

• Reported Device Performance: The specific numerical performance (e.g., sensitivity, specificity, accuracy, precision) for each parameter (RBC, WBC, Epithelial Cells, Cast, Bacteria, Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell) is not provided in this summary. The summary only makes a general statement about "excellent correlation" to the predicate for "Accuracy."

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

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)

• Not applicable / Not specified. The study described is a comparison to a predicate device, not an independent assessment against a "ground truth" established by experts in the context of a new clinical claim. The predicate device's performance was "established in the previous 510(k) submission."

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

• Not applicable / Not specified. No expert adjudication process is described.

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, an MRMC study was not done. This device is an automated 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

• Yes, a standalone performance assessment (relative to the predicate) was implied. The device is an automated analyzer, so its performance is inherently standalone. The study was a "Comparison to the UF-100" to "demonstrated excellent correlation." However, the specific metrics of this standalone performance are not detailed in this summary beyond "excellent correlation."

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

• The "ground truth" for the comparison study was the performance of the predicate device (Sysmex UF-100). The summary states, "Comparison to the UF-100 demonstrated excellent correlation," implying the UF-100's results served as the reference.
• For the predicate device itself, its performance was "established in the previous 510(k) submission," but the type of ground truth used for the predicate is not detailed here.

8. The sample size for the training set

• Not applicable / Not specified. This document does not describe the development of a machine learning model requiring a training set. The device uses "Laser Flow Cytometry and Impedance," which are well-established measurement principles, not typically requiring a distinct "training set" in the context of 510(k) submissions focusing on substantial equivalence to an existing device using the same methodology.

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

• Not applicable / Not specified. See point 8.

In summary: This 510(k) summary serves to demonstrate that the Sysmex® UF-100i is substantially equivalent to its predicate (Sysmex® UF-100) based on shared intended use, methodology, reagents, and "excellent correlation" in performance. It does not provide the detailed performance metrics or study design typically associated with a de novo submission or a clinical trial for a novel device, as the primary goal here is to show it's "just as good as" an already approved device.

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