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The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to classify and enumerate WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymph#, Lymph%, Neut#, Neut%, Other WBC#, and Other WBC% in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.

The Tru Hematology Test (part of the TruWellness Panel™) is intended for use in adults 18 years of age or older. It is not intended for use in diagnosing or monitoring critical disease states such as oncology.

The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the Tru Analyzer and the TruWellness Panel™, a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.

The Tru Analyzer is a benchtop instrument that fully automates sample processing, assay execution, and result reporting. Its touchscreen interface allows operators to control workflows, initiate tests, and review results with minimal training. The Single-Use Consumable Kit and blood sample are loaded into the analyzer drawer, where all necessary processing takes place. Internally, the Tru Analyzer integrates:

• A high-precision pipettor for automated sample and reagent handling.
• An onboard centrifuge to separate whole blood into plasma.
• A closed-loop thermal control system to maintain precise assay temperatures.
• A motion control system to fully automate sample processing.
• Dedicated detection modules for clinical chemistry, immunoassay, and hematology testing.
• A high-definition camera used to collect assay readings, image capture, and instrument quality control checks.
• An electronics board to manage individual module boards and associated firmware.
• An integrated computer running the instrument software, accessible via the touchscreen user interface.

The Tru Analyzer is factory-calibrated and continuously monitors its performance using optical sensing and electronic feedback mechanisms. Every time the analyzer is powered on or a Single-Use Consumable Kit (TruWellness Panel™) is loaded, the system runs an automated self-test to verify that it remains within calibration and is functioning properly. Internal quality control (QC) checks occur throughout the testing process to ensure the integrity of the analyzer, Disc, and Support Pack. If any self-test or QC check fails to meet system specifications, the Tru Analyzer will display an error code and next steps on the touchscreen interface.

The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the Tru Analyzer, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards of at the end of the run.

The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test is an in-vitro diagnostic device intended to classify and enumerate WBC, Lymph # and %, Neut # and %, Other WBC # and %, RBC, HGB, HCT, MCH, MCHC, MCV, and PLT in lithium-heparinized venous whole blood samples.

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HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

SCT Screen and SCT Confirm are reagents intended to simplify and standardize the detection of LA in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times.

Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors. Using a ratio of screen and confirm allows the SCT to be insensitive to warfarin treated samples. As a result, SCT Screen and SCT Confirm are more specific tests for the evaluation of LA than APTT or dilute PT. Per CLSI Guideline H-60, patient samples containing heparin may exhibit falsely prolonged clotting times which could lead to incorrect results.

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The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

The CoaguChek XS Plus system is a portable coagulation monitoring system to monitor prothrombin time (PT) in patients receiving oral anticoagulant therapy. The system uses the amperometric detection of thrombin in the blood sample. A test strip is used to determine a PT value from 8 µL of whole blood. Onboard quality control is available on every test strip and the system also features an optional external quality control material (CoaguChek XS PT Control).

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The iQ200 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 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 iQ200 Series Automated Urine Microscopy system utilizes a specimen sandwiched between lamina layers presented to a microscope with a CCD video camera. This ensures the specimen is precisely within the microscope's focus and field of view. The system automates sample handling and analyte classification for improved data reporting and management. Specimens are aspirated by an autosampler, and individual particle images are isolated in each frame. The Auto-Particle Recognition (APR) software classifies images into 12 categories, and more, with 27 additional sub-classifications available. Particle concentration is determined by the number of images and the analyzed volume. Results are checked against user-defined criteria and sent for operator review or directly uploaded to the LIS. Specimen results can be edited, imported, and exported.

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The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics.

The QStat Cartridge is intended for in vitro diagnostic use by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL).

The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma, liver transplantation, and peripartum obstetric procedures.

Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.

For prescription use only.

The QStat Cartridge is a single-use, multi-channel disposable plastic cartridge used with the Quantra Hemostasis Analyzer for the evaluation of blood coagulation and clot lysis. The measurements are performed in four test channels of the disposable cartridge which enable differential testing with different sets of reagents without the need for any reagent preparation or controlled pipetting. The cartridge utilizes a citrated evacuated blood collection tube filled with a patient whole blood sample The proprietary technology SEER Sonorheometry measures the evolution of shear modulus (i.e., clot stiffness) in all four channels as a function of time. The QStat Cartridge is intended for use in patients 18 years or older by professionals in a hospital setting (point of care or laboratory) to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.

Each QStat Cartridge is pre-filled with lyophilized reagent beads individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A whole blood sample, collected in a 3.2% sodium citrate anticoagulant blood collection tube (minimum volume 2.7 mL), is attached directly to the cartridge and the test is initiated using the touch screen interface on the Quantra Hemostasis Analyzer. The cartridge is the only component of the Quantra System that is in direct contact with blood. The fluidic system within the instrument draws the sample into the cartridge where it is warmed to 37°C, aliquoted, introduced and mixed with the lyophilized reagents, and analyzed. When the test is complete, the cartridge is released from the dock to be disposed of in an appropriate biosafety sharps container.

The analyzer displays the test results (n=5) in three different views: dial display screen, stiffness curves data, and trend screen. The dial display screen is the primary viewing screen and has a dial for each of the five output parameters. Each dial shows the reference range, assay measurement range, parameter abbreviation, and the numerical result for the corresponding parameter. The stiffness curves are a graphical display of shear modulus measurements over time that enable the user to view the development of clot stiffness over time. The trends screen displays results from a patient for up to six time points.

There are two levels of external QStat Controls (QSL1 and QSL2) that are supplied separately (required but not provided materials) for testing on the Quantra System when changing cartridge lots, changing control lots, or after significant changes are made to the Quantra instrument (e.g., software update).

The FDA 510(k) clearance letter for the Quantra QStat Cartridge describes its intended use for evaluating blood coagulation and clot lysis, specifically extending its indication to peripartum obstetric patients. The submission refers to non-clinical and clinical tests to demonstrate the device meets acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it describes acceptable performance in relation to interference and clinical agreement.

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

• Sample Size (Clinical Study): 322 subjects
• Data Provenance: Prospective observational study, conducted across seven clinical sites in the US. The study involved parturients (women in labor) aged 18 years or older with concerns for coagulopathy.
• Sample Size (Interference Study): Not explicitly stated with a specific number for the test set, but it mentioned "normal and hypercoagulable whole blood specimens" and that the "number of replicates at each level of a screening study was targeted to provide a 95% confidence interval (2-sided), per CLSI EP07-A2 Guideline."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. Instead, ground truth for some parameters appears to be established by comparison to other legally marketed and established devices (ROTEM delta, TEG 5000) and conventional coagulation testing (aPTT, PT/INR, fibrinogen level, platelet count).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for establishing ground truth. The comparison is made against existing, accepted methods and devices.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is an in vitro diagnostic (IVD) device that measures coagulation parameters, not an AI-assisted diagnostic imaging or interpretation tool.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are standalone performance studies. The clinical and analytical specificity studies evaluate the performance of the QStat Cartridge and Quantra Hemostasis Analyzer directly, not in conjunction with human interpretation for the primary measurement. The comparisons are to other standalone diagnostic methods (ROTEM delta, TEG 5000, conventional coagulation tests).

7. Type of Ground Truth Used

The ground truth used for the clinical performance evaluation was based on:

• Comparison to legally marketed viscoelastic testing devices: ROTEM delta or TEG 5000.
• Comparison to conventional coagulation testing: aPTT, PT/INR, fibrinogen level, platelet count.
• The "concern for coagulopathy" as a trigger for testing suggests clinical suspicion as an initial selection criterion, with the aforementioned tests serving as the gold/reference standard for comparison.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The studies described appear to be focused on performance validation.

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

As no training set is mentioned, there is no information on how its ground truth was established.

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CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2 % citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use.

CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components:

• Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizer.
• Reagent 2: Human FIIa, bovine FIXa, calcium chloride and phospholipids.
• Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor.
• Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.

In the first stage of the chromogenic assay, test plasma (containing an unknown amount of functional FVIII) is added to a reaction mixture comprised of calcium, phospholipids, human purified thrombin and FIXa, and bovine FX (Reagent 1 and Reagent 2). This mixture swiftly activates FVIII to FVIIIa, which works in concert with FIXa to activate FX. When the reaction is stopped, FXa production is assumed to be proportional to the amount of functional FVIII present in the sample. The second stage of the assay is to measure FXa through cleavage of a FXa-specific peptide nitroanilide substrate (FXa Substrate). P-nitroaniline is produced, giving a color that can be measured spectrophotometrically by absorbance at 405 nm.

Based on the provided FDA 510(k) Clearance Letter, the device in question is the CRYOcheck Chromogenic Factor VIII. This document details the clearance of a modified version of an existing device, emphasizing the differences from the previous version regarding interference claims and recovery of Factor VIII replacement therapies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance claim in a quantified manner (e.g., "Interference must be less than X%"). Instead, it reports the limits of non-interference found in their studies, implying these served as the de facto acceptance criteria. For the Factor VIII replacement therapy recovery, the acceptance criterion appears to be "accurate evaluation" across a range of concentrations, with specific over/under recovery noted.

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

• Interference Studies: Plasma samples were "spiked with possible interferents," and "10 replicates were tested alongside 10 replicates of the corresponding blank matrix control." The total number of individual patient samples from which this plasma was derived is not specified, nor is the country of origin. The study design implies a prospective spiking experiment in a laboratory setting.
• Recovery of Factor VIII Replacement Therapy: "Congenital FVIII deficient plasma was spiked with 14 FVIII replacement therapies at seven concentrations." The number of individual patient plasma units or lots of deficient plasma used is not specified. The study design implies a prospective spiking experiment in a laboratory setting.

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

N/A. This is an in vitro diagnostic device for quantitative determination of factor VIII activity, not an AI/imaging device requiring expert human readers for ground truth generation. The ground truth for these studies is established by the known concentrations of spiked interferents or FVIII replacement therapies, and the intrinsic properties of the FVIII deficient plasma.

4. Adjudication Method for the Test Set

N/A. As this is a quantitative in vitro diagnostic device, an adjudication method in the context of human expert review of imaging or clinical data is not applicable. The results are measured spectrophotometrically.

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

No, an MRMC study was not done. This type of study is relevant for AI imaging devices where human readers interpret medical images with and without AI assistance. This document describes an in vitro diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, this entire submission describes the standalone performance of the CRYOcheck Chromogenic Factor VIII assay. The device itself performs the quantitative determination of FVIII activity, entirely without a "human-in-the-loop" once the sample is loaded and the assay run according to protocol.

7. The Type of Ground Truth Used

• Interference Studies: The ground truth was the known concentration of the spiked interferent (e.g., Hemoglobin, Intralipid, Bilirubin, etc.) added to plasma samples, and the corresponding blank matrix control.
• Recovery of Factor VIII Replacement Therapy: The ground truth was the known concentration of the spiked FVIII replacement therapy added to congenital FVIII deficient plasma at various concentrations.

8. The Sample Size for the Training Set

N/A. This document describes an in vitro diagnostic assay based on chromogenic principles, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's components (reagents, diluent buffer) and their interaction define the assay, which is then validated through performance studies.

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

N/A. See point 8. The "ground truth" for developing and optimizing such a chromogenic assay would stem from extensive biochemical research, characterization of reagents, and titrations against known standards, which is inherent in the development of any diagnostic assay, but not referred to as a "training set" or "ground truth establishment" in the AI/ML context.

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The Daxor BVA-200 is an automated system that is used to measure/calculate the red cell mass (mL), plasma volume (mL) and total blood volume (mL), along with the related deviations from ideal values by amount (mL) and percentage (%) in adults. In addition, the Normalized Hematocrit (%) and Albumin Transudation Rate (%/min) are calculated. It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter and accessory convenience kit.

The Daxor BVA-200 is intended to calculate human blood volumes by the method of tracer diffusion (Indicator dilution technique) with I-131 as the tracer after injection of I-131 Human Serum Albumin. The Daxor BVA-200 provides a Quantitative Assessment of total blood and plasma volumes using an automated system.

Data inputs to the software come from the measured characteristics of patient venous whole blood samples collected in K3EDTA vacutainer tubes (hematocrit and tracer concentration) and tracer calibration standards. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes are reported, with statistics showing the quality of the results.

For in vitro diagnostic use in a Clinical Laboratory setting and operated by laboratory technicians.

Rx use only.

The Daxor BVA-200 is an automated system that is used to calculate the red cell mass, plasma volume and total blood volume. It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter. The accessory convenience kit includes single-use whole blood cartridges and protective sleeves.

The Daxor BVA-200 is designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged serum albumin (I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes, are reported, with statistics showing the quality of the results.

The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program.

The BVA-200 has a touchscreen for operator interaction, and provides clear instructions and prompts for the steps necessary for performing the test.

Here's a breakdown of the acceptance criteria and study information for the Daxor Blood Volume Analyzer (200), based on the provided FDA 510(k) clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format. However, it provides performance metrics from a clinical comparison study and precision, linearity, carryover, and stability studies. The implicit acceptance criteria are that the device performance should be substantially equivalent to the predicate device and demonstrate acceptable precision and linearity.

Implicit Acceptance Criteria and Reported Device Performance for BVA-200 (vs. BVA-100)

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

• Sample Size for Test Set: 319 unique, independent, comparable measurements.
• Data Provenance:
  • Blood derived from patients undergoing blood volume measurement with the BVA-100 (predicate device) as part of their clinical treatment or as part of a research study.
  • The document implies the data is retrospective for the clinical comparison, as it used blood derived from patients undergoing measurement with the predicate device.
  • For precision, linearity, sample stability, handling, and interference studies, contrived samples and venous whole blood samples from male and female volunteers were used. No specific country of origin is mentioned.

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

The document does not mention the use of experts to establish ground truth for the test set in the context of a reader study or image interpretation. The ground truth for the clinical comparison study was established by the predicate device (Daxor BVA-100) measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the clinical comparison was based on measurements from the predicate device, not expert adjudication of subjective assessments.

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

No, an MRMC comparative effectiveness study was not done. This device is a quantitative measurement system, not an AI software intended for interpretation by human readers. The clinical study focused on comparing the performance of the new device (BVA-200) to its predicate (BVA-100) on quantitative measurements.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies performed focused on the standalone performance of the BVA-200. The device is an automated system that measures and calculates blood volumes. The performance data presented (clinical comparison, precision, linearity, stability, etc.) represents the device's output independently, without human interpretation as part of a "human-in-the-loop" workflow being evaluated.

7. The Type of Ground Truth Used

The ground truth for the primary clinical comparison study was the measurements obtained from the predicate device, the Daxor BVA-100. For other studies (precision, linearity, stability, etc.), the ground truth was based on known properties of contrived samples or established physical/biological principles (e.g., known decay rate of I-131).

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This suggests that the BVA-200, similar to its predicate BVA-100, is likely based on established physiological and radiological principles (indicator dilution technique, I-131 decay) rather than a machine learning model that requires a distinct "training set." The software performs calculations based on these principles and measured inputs, not through a learned model from a training set.

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

Not applicable, as a "training set" in the context of machine learning is not implied or described in the document for this device.

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For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood coagulation. Fibrinogen is also a useful marker in the evaluation of several disease states including disseminated intravascular coagulation, liver disease, inflammatory diseases and malignancy. High levels of fibrinogen are associated with an increased risk for cardiovascular disease. Increased levels are also found during pregnancy and oral contraceptive use, while reduced levels are found during thrombolytic therapy.

The HemosIL Fibrinogen-C kit and HemosIL Fibrinogen-C XL kit use an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of fibrinogen concentration.

This document, an FDA 510(k) clearance letter for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL, does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary clearly states:

• Reason for Submission: "This Special 510(k) is being submitted to remove the reconstituted reagent frozen stability claim of 1 month at -20°C in the original vial for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL."
• Data Requirement: "No new performance data are needed to remove the reconstituted reagent frozen stability claim."
• No new performance claims: "Changes to labeled performance claims, except to remove the reconstituted reagent frozen stability claim from the Instructions for Use and add 'Do not freeze reconstituted reagent.'"

Therefore, the document explicitly states that no new performance data or studies were required or submitted for this particular 510(k) clearance. The clearance is based on a minor labeling change related to reagent stability, not on new performance validation.

To provide the information you requested (acceptance criteria, study details, sample sizes, expert involvement, ground truth, etc.), you would need a different type of submission document, such as an original 510(k) application or a PMA, where initial and comprehensive performance validation studies are typically included.

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The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microINR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microINR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For self-testing use: The system is intended for properly trained users under specific prescription of a physician.

Caution: The microINR System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. The microINR System is not intended to be used for screening purposes.

The microINR System is comprised of a portable measuring device (microINR, microINR Link and microINR Expert meter) and test strips (microINR Chips) in which the capillary blood sample flows through capillary action.

The microINR Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR meters measure International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR Chip based on microfluidic technology with machine vision detection.

The microINR System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.

The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR) for monitoring oral anticoagulant therapy with warfarin.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for slope, intercept, Pearson correlation, SD, or CV%. Instead, it presents the performance characteristics demonstrated by the studies. The comparison to predicate devices, and the conclusion of substantial equivalence, imply that these reported performance values were considered acceptable.

Note: The "Acceptance Criteria (Implied)" are derived from the typical expectations for such medical devices and the fact that these results led to FDA clearance, indicating they met regulatory standards.

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

• Accuracy Study (microINR System vs. Laboratory Reference Device):

  • N: 1016 microINR System results.
  • Data Provenance: Capillary blood samples from control subjects and patients recruited at ten clinical sites. This suggests a prospective collection from multiple geographical locations, though specific countries are not mentioned.

• Accuracy Study (Self-testing patients vs. Laboratory Reference Device):

  • N: 248 INR test results obtained by self-testing patients (compared to laboratory systems).
  • Data Provenance: Collected at seven clinical sites. This also implies prospective data collection.

• Accuracy Study (Self-testing patients vs. Healthcare Professionals using microINR System):

  • N: 461 INR test results.
  • Data Provenance: Collected at seven clinical sites, comparing self-testers to healthcare professionals. This is likely prospective.

• Precision Study (microINR System):

  • N: Duplicate measurements from 502 control subjects and patients.
  • Data Provenance: Performed at ten clinical sites, suggesting prospective collection.

• Precision Study (Trained PSTs):

  • N: Duplicate measurements from 111 patients ("Paired results").
  • Data Provenance: Performed at four clinical sites. Implies prospective collection.

• Precision Study (Untrained PSTs with high INR values):

  • N: Duplicate measurements from 13 patients ("Paired results").
  • Data Provenance: Performed at three clinical sites. Implies prospective collection.

The general provenance is from multiple clinical sites, suggesting a diverse patient population, but specific countries are not detailed. All studies appear to be prospectively collected for the purpose of validating the device performance.

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

• The document mentions comparisons to "laboratory systems ACL TOP 500 or ACL TOP 750" as reference methods. These are established laboratory analyzers.
• For the "Accuracy of the microINR System by self-testing patients" study, the comparison also includes "Healthcare professionals (HCP) using the microINR System." While HCPs are involved, specific qualifications beyond their professional role are not detailed for the purpose of establishing a "ground truth" other than operating the device.
• The ground truth for the clinical method comparison studies seems to be based on the results from the ACL TOP 500 or ACL TOP 750 laboratory systems, which are considered the gold standard for PT/INR measurement, rather than human experts adjudicating individual cases.
• The document does not explicitly describe "experts" in the sense of radiologists reviewing images; rather, it refers to standardized laboratory methods and healthcare professionals. Therefore, the specific "number of experts" or their "qualifications" for establishing ground truth, beyond the inherent accuracy of the reference laboratory devices, is not provided.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. Given that the ground truth appears to be established by comparison to highly accurate and standardized laboratory reference instruments (ACL TOP 500/750), a human adjudication process for individual test results is typically not required or described in such device submissions. The comparison is quantitative against these reference devices.

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

No MRMC comparative effectiveness study, detailing how much human readers improve with AI vs. without AI assistance, was performed or presented. This device is a standalone diagnostic system (a meter and test strips) and not an AI-assisted diagnostic tool that aids human interpretation of complex medical images or data. The "readers" in this context are the device users (patients or healthcare professionals), and the study compares their results directly to a laboratory reference, or compares self-testers to healthcare professionals using the same device, rather than measuring an improvement in human diagnostic accuracy with an AI assist.

6. Standalone Performance

Yes, standalone performance was done. The entire set of performance characteristics, particularly the "Accuracy of the microINR System" (comparing the microINR System against a laboratory reference device) and "Precision of the microINR System," represents the standalone performance of the device without explicit human-in-the-loop interpretation beyond operating the device as intended. The system itself measures and displays the INR.

7. Type of Ground Truth Used

The primary ground truth used is comparison to established laboratory reference methods, specifically ACL TOP 500 or ACL TOP 750 laboratory systems, which measure PT/INR from citrate venous plasma samples. This is a highly standardized and accepted method for determining INR.

8. Sample Size for the Training Set

The document does not provide details on a specific "training set" for the device, as it is not an AI/machine learning model in the typical sense that requires a training and a separate test set. The changes implemented are "only SW changes... for increasing the INR measuring range... and the removal of the limitation for LVAD patients," implying a modification to an existing algorithm rather than a completely new, data-trained AI model. The studies presented are for validation of these changes.

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

As noted above, no specific "training set" is mentioned in the context of a machine learning model. The device's underlying principle relies on microfluidic technology and machine vision detection of a prothrombin time assay. The calibration of the chips is done against "International Reference Thromboplastin of the World Health Organization," which serves as a fundamental standard rather than a "ground truth" for a training set in data science terms.

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