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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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The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids.

Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses.

The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Two aliquots from each body fluid specimen sample are prepared. One aliquot is diluted in normal saline to provide a concentration in the linear range of the instrument. The second aliquot is treated with a lysing reagent to allow unambiguous identification of nucleated cells by eliminating RBC confusion. Particle images are captured and saved electronically as the sample flows past a microscope objective at a high speed, electronically concentrating particles. Particle images are then ordered by size into assigned categories on a video display. A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported.

Here's a summary of the acceptance criteria and study details for the iQ® 200 Urine Analyzer Body Fluids Module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was compared to manual chamber counting. The acceptance criteria were not explicitly stated as distinct numerical thresholds, but rather implied by the statistical results (R2 values, slope within a CI, and non-significant intercepts) demonstrating substantial equivalence.

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

• RBC Test Set Sample Size: 304 samples
• Nucleated Cells Test Set Sample Size: 299 samples
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is presented as a "Clinical Trial," implying prospective data collection, but it's not explicitly labeled as such or as retrospective.

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

The ground truth was established by "manual chamber counting" performed by a "competent human observer." The number of observers is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison is between the device's performance and manual chamber counting.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's performance to "manual chamber counting," not to human readers' performance with and without AI assistance. The device itself still involves a "competent human observer" to potentially change machine assignments, but the primary performance study focuses on the instrument's accuracy compared to a manual method.

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

The device is explicitly described as being "used by a competent human observer to examine and count red blood cells and nucleated cells" and that "A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported." Therefore, the reported performance is not a standalone (algorithm only) performance, but rather a system performance including the human-in-the-loop for review and potential correction.

7. The Type of Ground Truth Used

The ground truth used was expert manual chamber counting.

8. The Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The focus is on the performance comparison of the device against the manual method.

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

Since no training set information is provided, there is no information on how its ground truth was established.

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