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The ePlex Instrument is an automated in vitro diagnostic (IVD) device designed to perform multiplexed nucleic acid tests for the simultaneous detection and identification of nucleic acid targets by processing single-use cartridges developed and manufactured by GenMark Diagnostics, Inc.

The ePlex® Instrument is used to run single-use assay cartridges that incorporate digital microfluidics and GenMark's eSensor® detection technology (used by products that are currently FDA-cleared: K073720 and K090901) to automate all aspects of nucleic acid testing. The ePlex Instrument is designed to: provide a nucleic acid amplification testing solution directly from various sample types, provide random access testing capability, and require minimal operator interaction.

The ePlex Instrument includes the following components:

• . Base: A touchscreen graphical user interface (GUI) powered by a PC with a Windows Operating System 7. The base communicates with the bays to transfer data. The instrument software installed on the ePlex base processes the raw data generated by the individual bays and determines the test result.
• Tower: A chassis housing six bays. ePlex is scalable from one to four towers . connected to either side of the base.
• . Bay: 6 bays are housed in each tower. Each bay will accept cartridges independent of the testing status of the other bays allowing for random access testing. Each bay has an Ethernet port for communication with the base unit to receive user inputs and deliver test data to the ePlex Instrument software.

The touchscreen graphical user interface (GUI) is flanked on either side by a tower with six bays containing a slot for the cartridge and an LED to indicate bay status (in-use or available for use). The instrument is designed to be scalable with configurations to accommodate a single tower with 6 bays or up to four towers with 24 bays.

The ePlex system is used to run multiplex microarray-based assays developed by GenMark. This type of assay is based on the principles of competitive nucleic acid hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to a sequencespecific solution-phase signal probe and a solid-phase electrode-bound capture probe. The test employs nucleic acid extraction, target amplification via polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR) and hybridization of target DNA. In the process, the double-stranded PCR amplicons are digested with exonuclease to generate single-stranded DNA suitable for hybridization.

Nucleic acid extraction from biological samples occurs within the cartridge via cell lysis, nucleic acid capture onto magnetic beads, and release for amplification. The nucleic acid extraction is processed through microfluidic liquid handling. Once the nucleic acid targets are captured and inhibitors are washed away, the magnetic particles are delivered to the electrowetting environment on the printed circuit board (PCB) and the targets are eluted from the particles and amplified.

During hybridization, the single-stranded target DNA binds to a complementary, singlestranded capture probe immobilized on the working gold electrode surface. Single-stranded signal probes (labeled with electrochemically active ferrocenes) bind to specific target sequence / region adjacent to the capture probe. Simultaneous hybridization of target to signal probes and capture probe is detected by alternating current voltammetry (ACV). Each working electrode on the array contains specific capture probes, and sequential analysis of each electrode allows detection of multiple analyte targets.

Here's an analysis of the acceptance criteria and study information provided for the GenMark Diagnostics, Inc. ePlex Instrument, based on the provided text:

Important Note: The provided document is a 510(k) summary for the ePlex Instrument itself, not a specific assay. It states that detailed clinical performance data will be included in the traditional 510(k) for the ePlex RP Panel. Therefore, the information below primarily relates to the instrument's performance as demonstrated through a reproducibility study, rather than the diagnostic accuracy of a specific assay.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that acceptance criteria were established in advance for the reproducibility study and all were met. However, it does not explicitly list the quantitative acceptance criteria or the specific reported device performance metrics (e.g., specific percentages for run validity, agreement, or variability) for the ePlex Instrument in the provided text.

In the context of the ePlex Instrument, the reported performance is qualitative:

2. Sample Size and Data Provenance for the Test Set

• Test Set Description: The test set for the reproducibility study consisted of samples prepared at three concentration levels: moderate (3x LoD), low (1x LoD), and negative. These samples were run as a panel.
• Sample Size: The exact number of individual samples or runs used in the reproducibility study is not specified in the provided document. It states "samples prepared as a panel at moderate (3x LoD), low (1x LoD) and negative."
• Data Provenance: The study was conducted at three separate testing sites, implying multi-site data collection. The country of origin is not explicitly stated, but given the FDA submission, it is likely the United States. It was a prospective study as it was specifically conducted to evaluate the instrument's reproducibility.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment: For the reproducibility study of the instrument, the ground truth would likely be based on the known state of the prepared samples (i.e., 'positive' at specific concentrations or 'negative'). Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists reviewing images) is not directly applicable here. The ground truth is intrinsic to the sample preparation.
• Number of Experts: Not applicable in this context.
• Qualifications of Experts: Not applicable in this context.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The nature of a reproducibility study with pre-defined positive/negative samples at specific concentrations doesn't typically involve expert adjudication of results. The "truth" is determined by the sample preparation.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned as part of the ePlex Instrument's submission. This type of study would be more relevant for evaluating the impact of an AI-powered diagnostic algorithm on human performance, which is not the primary focus of this instrument submission.
• Effect Size: Not applicable.

6. Standalone Performance Study

• Standalone Performance: Yes, the reproducibility study evaluated the standalone performance of the ePlex Instrument. It assessed the instrument's ability to consistently generate results based on its internal processes (cell disruption, nucleic acid extraction, RT-PCR, single-stranding, signal detection) when processing known samples. The study evaluated "run validity, agreement, and variability."

7. Type of Ground Truth Used

• Ground Truth Type: The ground truth used was based on known sample preparation. Samples were intentionally prepared at specific concentrations (3x Limit of Detection, 1x Limit of Detection) or as negative controls. This is a form of analytical gold standard derived from controlled experimental design.

8. Sample Size for the Training Set

• Training Set Size: The document does not specify a separate training set size for the ePlex Instrument itself. This is expected because the ePlex Instrument is hardware, and while it contains software, the "training" in the AI/machine learning sense isn't explicitly discussed here for the instrument's core functions. Any algorithm "training" would likely be specific to individual assays run on the instrument (e.g., for interpreting an RP panel), and that information is deferred to the specific assay 510(k) submission.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Since a separate training set for the instrument's core functionality is not described, the method of establishing ground truth for such a set is not provided in this document. If the instrument's software incorporates machine learning for result interpretation (beyond simple thresholding), that information would typically be detailed in the specific assay submission for which the training was performed.

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The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels. The FilmArray 2.0 is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens.

The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed to work with specific FilmArray reagent panels to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with a reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray 2.0 software automatically determines the results and provides a test report.

The FilmArray 2.0 permits up to eight instruments to connect to one computer. This configuration reduces the space requirements for the system and offers centralized data management. Accessories for the FilmArray 2.0 include a computer stand and printer, a barcode scanner, an external Ethernet switch that allows several instruments to connect to a single computer, and an optional modular rack system to stack two instruments.

The main functions of the FilmArray 2.0 are as follows:

• Moving liquids within the pouch and delivering rehydrated reagents in a specified . sequence to drive the nucleic acid purification and PCR amplification reactions.
• . Heating and cooling to drive the PCR reactions and DNA melting.
• . Capturing and processing of fluorescence images for analysis by the software.
• . Automated data interpretation and test report generation.

The FilmArray 2.0 device is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels to detect multiple nucleic acid targets in clinical specimens. The device's performance was evaluated through a series of studies comparing it to the previously cleared FilmArray device (K103175).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list "acceptance criteria" in a numerical format that can be directly compared to reported device performance. However, the summary of performance data indicates that the device was deemed substantially equivalent to its predicate. The functional equivalence implies that the performance of the FilmArray 2.0 met the expected performance standards demonstrated by the predicate device for various parameters.

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

The document mentions that each panel (Respiratory Panel (RP), Blood Culture Identification (BCID) Panel, and Gastrointestinal (GI) Panel) was evaluated in three types of studies:

• Clinical specimen comparison study: Involved testing a set of clinical samples. The exact number of samples is not specified for this summary document, but it compares FilmArray 2.0 to the current FilmArray. The provenance (e.g., country of origin) is not specified, and the study type appears to be retrospective (using existing clinical samples).
• Low analyte study: Compared the performance of the two devices by testing contrived samples spiked around the previously-determined limit of detection (LoD) for each assay on the panel. The number of contrived samples is not specified.
• Reproducibility study: Involved testing a set of well-characterized contrived samples. The number of contrived samples is not specified. This study was conducted at three different testing sites over several days.

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 specified in the provided document. The device automatically interprets results, and the ground truth would likely be established through standard microbiology/molecular diagnostic methods against which the device's results are compared, rather than expert human interpretation of the device's raw output.

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

This information is not specified in the provided document. Given the nature of an automated IVD device, the primary ground truth is usually established by a reference method, not by human adjudication of device outputs.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The FilmArray 2.0 is an automated instrument that provides a direct result without human interpretation of complex images or data that would necessitate a MRMC study. Its output is a test report.

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 sense that they evaluate the device's ability to autonomously detect nucleic acid targets and provide a test report. The device’s software automatically determines the results and provides a test report, indicating that a human is not in the loop for the primary result interpretation.

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

The ground truth for the test set would have been established using reference laboratory methods for detecting nucleic acid targets in clinical specimens, and potentially the established Limit of Detection (LoD) for contrived samples. For clinical studies, this would likely involve results from other FDA-cleared diagnostic tests or gold-standard laboratory techniques. The document mentions "well-characterized contrived samples", implying a known composition/presence of analytes.

8. The sample size for the training set:

The document describes performance studies for a medical device that has been developed. It does not provide information on a "training set" in the context of machine learning. The term "training set" is usually associated with the development of AI/ML algorithms. This device relies on established PCR and DNA melting analysis principles, with software interpreting these biophysical reactions. Therefore, there isn't a "training set" in the typical AI sense mentioned here.

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

As noted above, there is no mention of a "training set" in the context of AI/ML, as this device uses established molecular diagnostic techniques and software for interpretation. The software's "knowledge" is based on the expected melting curves and PCR amplification patterns of known targets, not on being trained on a dataset with ground truth labels in the same way a deep learning model would be.

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The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples.

The NMR LipoProfile® test, when used with the Vantera® Clinical Analyzer, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.

The Vantera Clinical Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically blood plasma and serum.

The Vantera Clinical Analyzer system design is divided into 3 major subassemblies: a sample handling assembly, an NMR subassembly, and an enclosure. The Vantera Clinical Analyzer control system is distributed across three separate computers:

• The Host (1 U) controls user interface, data handling, results calculation, system startup and shutdown.
• The Process Control (4U) schedules and manages all activities required to process a sample, controls all hardware in the sample handling subsystem.
• The NMR Control Computer controls all magnet operations. Two of these computers are contained within the Sample Handling Subassembly (1 U and 4U) and one in the NMR Subassembly (NMR Console).

The NMR LipoProfile test involves measurement of the 400 MHz proton NMR spectrum of a plasma/serum sample, deconvolution of the composite signal at approximately 0.8 ppm to produce signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma/serum signal, and conversion of these subclass signal amplitudes to Lipoprotein subclass concentrations. The -0.8 ppm plasma NMR signal arises from the methyl group protons of the lipids carried in the LDL, HDL and VLDL subclasses of varying diameters. The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which is accounted for in the deconvolution analysis model. Each subclass signal amplitude is proportional to the number of subclass particles emitting the signal, which enables subclass particle concentrations to be calculated from the subclass signal amplitudes derived from the spectral deconvolution analysis. LDL subclass particle concentrations, in units of nanomoles of particles per liter (nmol/L), are summed to give the reported total LDL particle concentration (LDL-P). By employing conversion factors assuming that the various lipoprotein subclass particles have cholesterol and triglyceride contents characteristic of normolipidemic individuals, HDL cholesterol and triglyceride concentrations are also derived.

Here's a breakdown of the acceptance criteria and study information for the Vantera Clinical Analyzer and NMR LipoProfile® test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K113830) rather than explicitly stating pre-defined "acceptance criteria" for novel performance features. However, the comparisons in the tables serve as the de-facto acceptance criteria: the candidate device's performance must be comparable to or better than the predicate device across various analytical metrics.

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the specific sample sizes for each analytical validation study for the "test set" in terms of number of patient samples. It mentions "Level 1, Level 2, Level 3" for precision studies, implying control samples at different concentrations. For linearity, there are ranges of values. For the method comparison, it gives regression parameters, which typically require a reasonable number of samples, but the exact count isn't specified.

The data provenance (country of origin, retrospective/prospective) is not provided in the document.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not applicable and not provided. The device (Vantera Clinical Analyzer with NMR LipoProfile® test) is an IVD for quantitative measurement of lipoprotein particles, HDL cholesterol, and triglycerides. The ground truth for these measurements in analytical validation studies would typically be established by:

• Reference methods (e.g., ultracentrifugation for lipoproteins, enzymatic assays for cholesterol/triglycerides).
• Certified reference materials.
• Highly qualified laboratory personnel following established protocols for the reference methods.

Experts in the sense of clinical reviewers (e.g., radiologists for imaging devices) are not typically involved in establishing ground truth for this type of analytical device.

4. Adjudication Method for the Test Set

Not applicable. This is not a human interpretation-based diagnostic device requiring adjudication of expert opinions.

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

Not applicable. This is an automated analytical laboratory device, not an imaging or interpretation aid for human readers. Therefore, an MRMC study and effects of AI assistance on human readers are not relevant.

6. Standalone Performance Study

Yes, the studies presented are standalone (algorithm only) performance studies. The results in the tables (Measuring Range, LoB, LoD, LoQ, Linearity, Precision, Method Comparison, Carryover, Interference) directly reflect the performance of the Vantera Clinical Analyzer and NMR LipoProfile® test itself, without any human-in-the-loop interaction for interpretation, beyond the standard operation of an automated laboratory instrument.

7. Type of Ground Truth Used

The ground truth for the analytical validation studies would be established using reference methods or reference materials. For example:

• Method Comparison: Comparison against a recognized reference method for lipoprotein quantification, HDL-C, and triglycerides. While not explicitly stated, standard practice would involve a comparison to a well-characterized, clinically accepted method. The "Deming fit" and "Linear regression" indicate comparison to another quantitative measurement.
• Linearity, LoB, LoD, LoQ: These are typically established using characterized control materials (known concentrations) or serial dilutions of patient samples.
• Precision: Established using control materials at different concentrations.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its size. This device is an analytical instrument based on Nuclear Magnetic Resonance (NMR) spectroscopy and a deconvolution analysis model. While the deconvolution model itself would have been developed and "trained" or optimized using a dataset of known NMR spectra and corresponding reference measurements, the document focuses on the validation of the integrated device. The details of the dataset used for the initial development/training of the deconvolution algorithm are not provided here.

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

As above, the document does not provide details on the training set for the deconvolution model. However, for a device based on a physical principle like NMR spectroscopy, the ground truth for establishing the deconvolution model and conversion factors would likely involve:

• Carefully characterized samples with known concentrations of lipoproteins, HDL-C, and triglycerides, determined by highly accurate reference methods (e.g., ultracentrifugation for lipoprotein subfractions, established enzymatic methods for cholesterol and triglycerides).
• Spectral data from these characterized samples would be used to build and optimize the deconvolution algorithm (i.e., establish unique frequencies and lineshapes) and the conversion factors from signal amplitudes to concentrations.

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The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument with the SDS Software is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.

The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument integrates a thermal cycler, a fluorimeter and application specific software. The instrument houses the thermal cycler and the fluorimeter, while the application software is run on a PC that is attached to the instrument. Samples are placed in a tube strip or 96-well low-head space plate that is moved to a Peltier-based thermal block and positioned relative to the optics using a tray loading mechanism. Excitation for all samples is provided by a halogen tungsten white source that passes through 5 switchable excitation filters prior to reaching the sample. Fluorescence emission is then detected through 5 color emissions filter wheel to a charge coupled device (CCD) camera. The instrument is designed to complete quantitative RT-PCR runs in about 40 minutes. The Sequence Detection Software (SDS) is used for instrument control, data collection and data analysis. The software provides a wizard for user-friendly set-up. The software measures cycleby-cycle real-time signals from the sample and provides a variety of tools to help the user analyze the data extracted from the samples. In addition, the software provides lamp-life monitoring and other instrument maintenance information. The software runs as an application on the Windows 7 platform.

This document is a 510(k) summary for the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software. It describes a Class II medical device used for real-time nucleic acid amplification and fluorescence detection.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy) in a quantitative manner. Instead, the focus of this 510(k) is on demonstrating substantial equivalence to a predicate device due to minor modifications.

The summary states: "Based on the risk analysis evaluation results, verification testing was conducted to support the modifications in the instrument computer operating system. The verification testing report included in the submission supports substantial equivalence to the predicate device."

This implies that the "acceptance criteria" are implicitly met by demonstrating that the updated device performs equivalently to the predicate, particularly in light of the operating system change. The performance of the predicate device (K082562) would have been established previously.

A conceptual table based on the document's content would look something like this:

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

The document mentions "verification testing was conducted to support the modifications in the instrument computer operating system." However, it does not provide any specific sample sizes for this testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not describe the use of experts to establish ground truth for this specific verification testing. Given that the changes were primarily to the operating system and the focus is on substantial equivalence in functionality, this type of expert review is unlikely to have been a primary component of this particular submission.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method. This is not typically relevant for a submission focused on demonstrating functional equivalence of an instrument's operating system update.

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

No, an MRMC comparative effectiveness study was not conducted or described in this document. This type of study is more common for diagnostic algorithms or imaging devices where human interpretation is a key component and the AI aims to assist or replace it. This document concerns a PCR instrument and its software, not an AI-assisted diagnostic interpretation tool.

6. If a Standalone Performance Study was done:

The document refers to "verification testing." While this testing would have evaluated the device's standalone performance after the operating system upgrade, it is presented in the context of demonstrating substantial equivalence to the predicate, rather than a de novo standalone performance study providing new, extensive performance metrics like sensitivity and specificity. The document states: "The verification testing report included in the submission supports substantial equivalence to the predicate device."

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the verification testing. Given that it's a real-time PCR instrument, the ground truth for any performance validation would typically involve:

• Reference standards/materials: Well-characterized samples with known concentrations of nucleic acid targets.
• Comparison to a reference method: Performance compared against a gold standard or extensively validated method.
• Known positive/negative controls: Established biological or synthetic samples with known outcomes.

The testing would primarily confirm that the upgraded system continues to accurately detect and quantify nucleic acids as expected, without being negatively affected by the new operating system.

8. The Sample Size for the Training Set:

This device is an instrument and its software, not a machine learning model that requires a "training set" in the typical sense of AI development. Therefore, there is no concept of a "training set" as described for AI studies. The software handles instrument control, data collection, and data analysis using established algorithms, not by learning from a large dataset.

9. How the Ground Truth for the Training Set was Established:

As there is no "training set" in the context of AI for this device, this question is not applicable. The software's functionality is based on pre-programmed algorithms for signal processing and quantification inherent to real-time PCR, not on learning from labelled data.

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The Luminex® FLEXMAP 3D® system with xPONENT® software is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.

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I am sorry, but the provided text is a formal letter from the FDA regarding a 510(k) premarket notification for the Luminex FLEXMAP 3D device. It confirms the substantial equivalence of the device and outlines general regulatory obligations.

The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.

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The provided text is a 510(k) summary for the Luminex FLEXMAP 3D® Instrument System, not a study report or clinical trial. Therefore, it does not contain the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document is a letter from the FDA granting substantial equivalence to the device based on its intended use as a clinical multiplex test system for in vitro diagnostic assays. It discusses regulatory compliance and general controls, but not the specific technical performance or validation studies of the device itself.

Therefore, I cannot fulfill your request for the tables and information as it is not present in the provided document.

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The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic test for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA of human saliva samples collected using the Oragene® Dx Device, as an aid in the identification of patients at risk for increased warfarin sensitivity.

The eSensor® Warfarin Sensitivity Saliva Test is a multiplex microarray-based genotyping test system. It is based on the principles of competitive DNA hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to sequence-specific solution-phase signal probe and solid-phase electrode-bound capture probe. The test employs polymerase chain reaction amplification, exonuclease digestion and hybridization of target DNA. In the process, the double stranded PCR amplicons are digested with exonuclease to generate single stranded DNA suitable for hybridization. Hybridization occurs in the eSensor XT-8 Cartridge (described below) where the singlestranded target DNA is mixed with a hybridization solution containing labeled signal probes.

During hybridization, the target DNA binds to a complementary, single-stranded capture probe immobilized on the working electrode surface. Single-stranded signal probes (labeled with electrochemically active ferrocenes) bind to the target adjacent to the capture probe. When inserted into the eSensor XT-8 instrument (described below), simultaneous hybridization of target to signal probes and capture probe is detected by alternating current voltammetry (ACV). Each pair of working electrodes on the array contains a different capture probe, and sequential analysis of each electrode allows genotyping of multiple mutations or polymorphisms.

The Assay Cartridge (eSensor XT-8 Cartridge): The eSensor XT-8 cartridge device consists of a printed circuit board (PCB) with a multi-layer laminate and a plastic cover that forms a hybridization chamber has a volume of approximately 140 µl. The cartridge consists of a diaphragm pump and check valves (microfluidic components) that circulate the hybridization solution in the hybridization chamber when inserted into the eSensor XT-8 instrument. The PCB chip consists of an array of 72 gold-plated working electrodes, a silver/silver chloride reference electrode, and two gold-plated auxiliary electrodes. Each working electrode has a connector contact pad on the opposite side of the chip for electrical connection to the eSensor XT-8 instrument. Each electrode is modified with a multicomponent, self-assembled monolayer that includes presvnthesized oligonucleotide capture probes specific for each polymorphic site on the test panel and insulator molecules. The cartridge also contains an electrically erasable programmable read-only memory component (EEPROM) that stores information related to the cartridge (e.g., assay identifier, cartridge lot number, and expiration date).

The eSensor XT-8 Instrument (Same as cleared under K073720): The eSensor XT-8 is a clinical multiplex instrument that has a modular design consisting of a base module and one, two, or three cartridge-processing towers containing 8, 16, or 24 cartridge slots, respectively. The cartridge slots operate independently of each other. Any number of cartridges can be loaded at one time, and the remaining slots are available for use while the instrument is running. The base module controls each processing tower, provides power, and stores and analyzes data. The base module includes the user interface, and a 15-in. portrait-orientation display and touch panel. The instrument is designed to be operated solely with the touch screen interface. Entering patient accession numbers and reagent lot codes can be performed by the bar code scanner, the touch screen, or uploading a text file from a USB memory stick. Each processing tower consists of eight cartridge modules, each containing a cartridge connector, a precision-controlled heater, an air pump, and electronics. The air pumps drive the diaphragm pump and valve system in the cartridge, eliminating fluid contact between the instrument and the cartridge. The pneumatic pumping enables recirculation of the hybridization solution allowing the target DNA and the signal probes to hybridize with the complementary capture probes on the electrodes. The diaphragm pump in the cartridge is connected to a pneumatic source from the eSensor XT-8 instrument and provides unidirectional pumping of the hybridization mixture through the microfluidic channel during hybridization. Using microfluidic technology to circulate the hybridization solution minimizes the unstirred boundary layer at the electrode surface and continuously replenishes the volume above the electrode that has been depleted of complementary targets and signal probes. The XT-8 instrument provides electrochemical detection of bound signal probes by ACV and subsequent data analysis and test report generating functions. All hybridization, ACV scanning and analysis parameters are defined by a scanning protocol loaded into the XT-8 Software, and then specified for use by the EEPROM on each cartridge.

The Assay Kit: The Warfarin Sensitivity Saliva Test consists of the test cartridge and the following components: 1) PCR REAGENTS consisting of: PCR Mix [PCR buffer containing primers and dNTP mixture (dCTP, dGTP, dATP, and dUTP)], MgCl2 thermostable DNA polymerase (Taq Polymerase ); and 2 GENOTYPING REAGENTS consisting of: lambda exonuclease, signal probes and hybridization buffer ingredients (Buffer-1 and Buffer-2).

Here's a breakdown of the acceptance criteria and the study details for the eSensor® Warfarin Sensitivity Saliva Test, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the comparison to DNA sequencing, which is considered the gold standard for genotyping. The device performance is reported as agreement percentages with DNA sequencing.

Note: The document implies acceptance criteria by comparing the device's performance to DNA sequencing, which is implicitly considered the standard for accuracy. Specific numeric thresholds for "acceptance" are not explicitly stated, but the high agreement percentages (mostly 100%) and the lower bounds of the 95% confidence intervals (LCB) suggest a requirement for high concordance.

Study Information

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

• Sample Size: A total of 316 gDNA samples were extracted from saliva specimens for the method comparison study.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It uses "saliva specimen" without further context on donor recruitment or source.

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

• Experts: Not applicable. The "ground truth" for the genotyping results was established by DNA sequencing, not by human experts.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the traditional sense of human consensus. The reference method (ground truth) was DNA sequencing. The study reports "No-Calls" and "Miscalls" by the eSensor® device when compared to DNA sequencing. The "After Retest" results suggest that initial "No-Calls" were re-evaluated and resolved, leading to higher agreement.

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:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) for genotyping, which is an automated process, not an imaging device requiring human interpretation alongside AI.

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

• Standalone Performance: Yes, the performance reported is essentially a standalone (algorithm only) performance. The eSensor® Warfarin Sensitivity Saliva Test is an automated system that generates results which are then compared to DNA sequencing, without human-in-the-loop interpretation being part of the primary performance evaluation.

7. The Type of Ground Truth Used:

• Ground Truth Type: DNA sequencing (referred to as "bidirectional DNA sequencing" or "DNA Sequencing Result"). This is considered a gold standard for genetic polymorphism detection.

8. The Sample Size for the Training Set:

• Training Set Sample Size: The document does not specify a separate training set. For IVD devices, especially those based on established molecular biology principles, the "training" (development) often involves optimizing reagents and protocols, rather than machine learning algorithm training with distinct datasets. The method comparison study appears to be the primary validation of the device's performance against a reference method.

9. How the Ground Truth for the Training Set was Established:

• Training Set Ground Truth: As no explicit training set is mentioned in the context of machine learning, this question is not directly applicable. For the performance validation, as stated above, DNA sequencing was used as the ground truth.

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The BeadXpress® System is an in vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology. The BeadXpress System consists of the BeadXpress Reader and VeraScan software.

The BeadXpress® System is an open platform fluidic microbead reader which includes a dual-color laser detection system that enables optical scanning of multiplexed assays developed using the VeraCode digital microbead technology and VeraScan 2.0 software. The instrument performs a routine set of operating steps: Reader Initialization, Fluidic Initialization, Scanning, Data Consolidation and Flushing. Hardware is contained within a single instrument housing. The system consists of four sub-systems (fluidics, opto-mechanical, motion and electrical) that interact with each other to provide the desired results. The fluidic system consists of the parts that move fluids and beads through the system as well as the key groove plate upon which the beads lay to be scanned. The optomechanical system contains the two lasers and all the optical components that are involved with the optical alignment and delivery of the beams to the beads and collection of the signals generated. This motion system contains all the hardware that is involved with the physical movement of the internal parts of the reader and utilizes four major axes to control the movement and spacial orientation of the specific sub-systems. The electrical system contains all the electronic components that are responsible for control of the individual components and system overall.

The VeraScan software is installed on a PC directly connected to the BeadXpress Reader. It is used for operating the BeadXpress Reader and through the use of software modules, analyzing the scan results and genotype calls.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

The provided document describes the Illumina, Inc. BeadXpress Reader System with VeraScan Software (v. 2.0.17.0). However, the document does not contain specific acceptance criteria or the study that directly proves the device meets those criteria for the BeadXpress Reader System itself.

Instead, the document consistently refers to the clearance of a separate assay (K093129), the "VeraCode® Genotyping Test for Factor V and Factor II," for which the BeadXpress System is intended to be used. The performance characteristics of the system (accuracy, precision, linearity, carryover, interfering substances) are stated to have been assessed during the clearance of that assay.

Therefore, I cannot provide the complete requested information for the BeadXpress Reader System itself based on this document alone, as the performance evaluation is explicitly tied to a different, separately cleared assay.

However, I can extract what is implied about the acceptance criteria and the study structure from the provided text, while making it clear that specific numbers are missing.

Implied Acceptance Criteria and Reported Device Performance (Table)

Since the document states that "Accuracy," "Precision/Reproducibility," "Linearity," and "Carryover" were "assessed during the clearance of the assay (K093129)," this implies general expectations for these performance metrics. The specific quantitative acceptance criteria or reported performance values for the BeadXpress system itself are not provided in this document.

Detailed Study Information (Based on implications and absence of data)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in this document for the BeadXpress Reader System itself. The performance assessment refers to "clearance of the assay (K093129)," which would have its own test set.
   • Data Provenance: Not specified in this document. Given it's an FDA 510(k) submission, it would likely involve controlled laboratory studies, but specific country of origin or whether it's retrospective/prospective is not mentioned for the system's performance.

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

   • Not applicable/not specified for the BeadXpress Reader System's performance validation in this document. The "ground truth" would be related to the genetic mutations detected by Assay K093129, and the establishment of that ground truth (e.g., through Sanger sequencing or other gold standard methods) is not detailed here.

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

   • Not applicable/not specified. Clinical adjudication methods are typically for subjective interpretations (e.g., imaging), which is not the primary function of this instrument. For a genotyping system, "ground truth" is typically established by definitive molecular methods, not expert human adjudication of the instrument's output in the same way.

4. 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. This is an instrument and software system for automated genotyping, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study related to human reading improvement with AI assistance is not relevant and was not performed.

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

   • Yes, implicitly. The "VeraScan software" with the "Genotyping (GT) Module" "analyzes scan data to call genotypes." This describes a standalone algorithmic performance. The document states: "Once analysis is completed, the software displays data results and graphical visualizations to help the user interpret run success." The system's primary function is automated detection and calling. The "performance characteristics" (accuracy, precision, etc.) of the system would be assessed in this standalone mode through the assay's validation (K093129).

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

   • For genotyping, the ground truth would typically be established by a gold-standard molecular method (e.g., Sanger sequencing, another validated genotyping method, or verified reference materials). This document does not explicitly state the ground truth method used for the assay (K093129) to which the system's performance is tied.

7. The sample size for the training set:

   • Not specified. The document does not describe a machine learning model developed with a training set for the BeadXpress Reader itself. The "Genotyping (GT) Module" configures run settings and calls genotypes "by using a process flow that associates fluorescence data in each color channel with calling thresholds supplied by the kit manifest." This implies a rule-based or threshold-based algorithm, rather than a machine learning model that undergoes a training phase with a specific dataset.

8. How the ground truth for the training set was established:

   • Not applicable, as no machine learning training set is described for the system. The "kit manifest" provides the "calling thresholds," which represent the established parameters for interpreting the fluorescence data for specific assays.

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The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with the SDS Software version 1.4 is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed RNA and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.

The AB 7500 Fast Dx RT-PCR instrument integrates a thermal cycler, a fluorimeter and application specific software. The instrument houses the thermal cycler and the fluorimeter, while the application software is run on a PC that is attached to the instrument. Samples are placed in a tube strip or 96-well low-head space plate that is moved to a Peltier-based thermal block and positioned relative to the optics using a tray loading mechanism. Excitation for all samples is provided by a halogen tungsten white source that passes through 5 switchable excitation filters prior to reaching the sample. Fluorescence emission is then detected through 5 color emissions filter wheel to a charge coupled device (CCD) camera. The instrument is designed to complete quantitative RT-PCR runs in about 40 minutes. The Sequence Detection Software (SDS) version 1.4 for the 7500 Fast Dx Instrument is used for instrument control, data collection and data analysis. The software can measure cycle-by-cycle real-time signals from the sample. The software provides a variety of tools to help the user analyze the data extracted from the samples. The software also provides lamp-life monitoring and other instrument maintenance information. The software runs as an application on Windows XP platform. Changes to the Dx software are subject to change control in accordance with 21 CFR Part 820.40.

This 510(k) summary (K082562) for the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria.

The document primarily focuses on:

• Device Identification: Name, classification, submitter information.
• Predicate Device: Identifies the Affymetrix GeneChip Microarray instrument System as the predicate.
• Device Description: Explains the physical components and basic functionality of the instrument and its software.
• Intended Use/Indications for Use: States what the device is designed to do.
• FDA Correspondence: The FDA letter confirming substantial equivalence.

Crucially, it lacks the following information that would be necessary to answer the prompt directly:

• Specific performance metrics: No mention of sensitivity, specificity, accuracy, precision, limit of detection, or any other quantitative measure.
• Defined acceptance criteria: There are no thresholds or targets stated for any performance metric.
• Study design details: No description of any clinical or analytical study, including sample sizes, data collection methods, ground truth establishment, or expert involvement.
• Results of a study: No reported device performance values are provided against any criteria.

Therefore, I cannot populate the requested table or answer most of the specific questions based on the provided text.

Here's a breakdown of what cannot be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document does not describe any test set or study.

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 specified. No information on ground truth establishment or expert involvement.

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

• Not specified. No test set 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:

• Not applicable. This device is an RT-PCR instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting images. The document does not mention any MRMC study.

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

• This device is an instrument with software for data analysis, not an "algorithm" in the sense of an AI model. The document does not provide details on standalone performance testing in this context.

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

• Not specified. No ground truth information provided.

8. The sample size for the training set:

• Not applicable/Not specified. This is an instrument and software, not a machine learning model that would have a separate "training set" in the common sense. If it refers to data used to develop the algorithms for the SDS software, that information is not provided.

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

• Not applicable/Not specified. See point 8.

Conclusion:

The provided 510(k) summary is a high-level document intended to demonstrate substantial equivalence, not a detailed technical report of performance studies. To obtain the requested information, one would typically need to consult a more detailed submissions, such as an FDA review memo, or the full 510(k) submission, which would include the performance data and methodology.

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The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.

Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device ("Affymetrix Genechip Microarray Instrumentation System"), indicating that the device has been deemed substantially equivalent to a predicate device.

While it mentions the device name, regulation number, and product code, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for an AI model.
• Information on expert reviews, adjudication methods, or MRMC studies.
• Any discussion of standalone algorithm performance.

The document is purely a regulatory clearance notice and does not contain the technical study data you are asking for.

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