(462 days)
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.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).