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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.

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The X100/X100HT with Full Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in-vitro diagnostic use only. For professional use only.

The X100 / X100HT with Full Field Peripheral Blood Smear (PBS) Application ("Full Field PBS") is a digital cell morphology solution, presenting high resolution digital images of fixed and stained microscopy Peripheral Blood Smears. The Full Field PBS was previously cleared by the Agency on October 2, 2020, throughout the review of K201301 and on May 3, 2022, throughout the review of K220013. The system automatically locates and presents images of peripheral blood cells and streamlines the PBS analysis process with a review workflow composed of four steps: (1) full field review, (2) white blood cells (WBC) review (DSS for WBC Pre-Classification is available), (3) red blood cells (RBC) review and (4) platelet review (DSS for platelet estimation is available).

Under the proposed modification, subject of this 510(k) submission, additional DSS component is added to the RBC and Platelet review steps. Concerning RBC analysis, system-suggested RBC morphological pre-gradings are added as proposed DSS to the user by means of a dotted line around a suggested grading selection box. Notably, the user is still required to review the slide and actively mark the final grading, exactly as performed in the cleared workflow review.

The same approach is used with regard to the update to the platelet review step; A system-suggested platelet clump indication is presented to the user by means of a dotted line around a selection box. Notably, the user is still required to manually mark whether platelet clumps were detected, exactly as currently performed in the cleared workflow review.

The changes under discussion do not affect the cleared indications for use or intended use; the user's workflow of scanning and analyzing peripheral blood smears using the Full Field PBS Application remains otherwise unchanged as well.

The Scopio Labs X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application has received FDA 510(k) clearance (K243144) based on a modification that adds system-suggested pre-gradings for RBC morphology and platelet clump indications. The study involved a method comparison study, repeatability study, reproducibility study, and software verification and validation.

1. Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly state the numerical acceptance criteria for the method comparison study. However, it indicates that "The results met the pre-defined acceptance criteria." The reported performance metrics are presented as overall agreement, Positive Percent Agreement (PPA), and Negative Percent Agreement (NPA).

The precision studies (repeatability and reproducibility) also "met the pre-defined acceptance criteria." However, the specific numerical criteria for these studies are not detailed in the provided document.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A total of 1200 anonymized PBS slides were used for the method comparison study.
• Data Provenance: The slides were collected from the laboratory routine workload of three medical centers. The country of origin is not specified, but the submitter information lists "Tel Aviv, Israel" as the sponsor address, which may suggest the data originated from Israel, though this is not explicitly stated for the clinical evaluation. The data is retrospective, as it was collected from "routine workload."

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

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., years of experience). It implies that the ground truth was established by referring to "pre-defined acceptance criteria" and a "method comparison study," which typically involves comparison against human expert interpretation. However, the details of this expert interpretation are not provided.

4. Adjudication Method for the Test Set

The adjudication method used to establish the ground truth for the test set is not specified in the provided document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The study described is a method comparison study between the modified device (with added DSS) and either the previous cleared device or human expert consensus, but not a comparative effectiveness study measuring improvement in human reader performance.

6. Standalone Performance Study (Algorithm Only)

The document describes the device as providing "system-suggested RBC morphological pre-gradings" and "system-suggested platelet clump indication" by means of a dotted line, and that "the user is still required to review the slide and actively mark the final grading." This indicates that the device functions as an assistive tool (human-in-the-loop) rather than a completely standalone algorithm making final diagnoses. The performance metrics presented (Overall Agreement, PPA, NPA) are likely comparisons of the system's suggestions against ground truth, which implicitly reflects a standalone component, but the final reported performance is within the context of assisting a qualified technologist, not solely the algorithm's output. Therefore, a purely standalone (algorithm-only without human-in-the-loop) performance is not explicitly presented or claimed for clinical use.

7. Type of Ground Truth Used

Based on the description of the "method comparison study" and the nature of the device (assisting a qualified technologist), the ground truth was likely established by expert consensus or through a reference method performed by qualified experts in hematology/morphology. The context of "laboratory routine workload" and comparison implies an existing gold standard interpretation.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the AI/DSS components. It only details the test set used for performance evaluation of the modified device.

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

The document does not provide information on how the ground truth for the training set was established. It states that "Cell images are analysed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." This implies a training process, but the details of ground truth establishment for that training are omitted.

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The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XR-Series module (XR-10) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Units (XR-10) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-01) which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.

This document describes the acceptance criteria and the studies conducted to prove that the Sysmex XR-Series (XR-10) Automated Hematology Analyzer meets these criteria, demonstrating substantial equivalence to its predicate device, the Sysmex XN-20.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) clearance letter does not explicitly present a neatly formatted table of acceptance criteria alongside the reported performance for all parameters. Instead, it describes various performance studies (Precision, Linearity, Analytical Specificity/Interferences, Sample Stability, Detection Limit, Carry-Over, Comparison Studies, Matrix Studies, Bridging Studies, Clinical Studies, and Expected Values/Reference Range) and states that the XR-10 met "manufacturer's specifications or predefined acceptance criteria requirements" for each.

However, based on the provided data, we can infer some general acceptance criteria, particularly from the method comparison study which uses correlation coefficient (r) and percent bias (%Bias) as metrics. The clinical sensitivity and specificity tables also present implied acceptance criteria based on the demonstrated performance.

Inferred Acceptance Criteria & Reported Performance (Selection of Key Metrics)

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

• Test Set Sample Size & Provenance:
  • Precision (Repeatability - Whole Blood): Residual K2EDTA whole blood samples for 10 replicates for target values, and three samples for other parameters. This was across three US clinical sites (Site 01, 05, 24).
  • Precision (Reproducibility - Whole Blood): XN CHECK whole blood control material, 90 results per control level (3 levels x 3 replicates x 2 runs x 5 days). Conducted at three US clinical sites.
  • Precision (Body Fluid): Residual peritoneal, pleural, and synovial fluid samples (K2EDTA) and CSF (no anticoagulant) for 10 replicates for target values. Conducted at three US clinical sites.
  • Linearity (Whole Blood & Body Fluid): Minimum of seven sample dilutions. Performed at one internal site.
  • Analytical Specificity/Interferences: Whole blood K2EDTA samples from donors. Number of samples not specified, but collected for this study purpose.
  • Sample Stability (Whole Blood): 8 unique leftover samples and 12 prospectively collected K2EDTA venous whole blood samples (20 samples total). Conducted at one internal site.
  • Sample Stability (Body Fluid): 12 unique de-identified leftover body fluid samples (3-CSF, 3-peritoneal, 3-pleural, 3-synovial). Conducted at 1 external site.
  • Detection Limit: Four blank samples and four low concentration samples for each parameter. Conducted across 2 XR-10 analyzers (implied internal or multi-site for the overall study context).
  • Carry-Over: High and low target concentration samples (number not specified). Conducted at three US clinical sites.
  • Comparison Studies (Whole Blood): 865 unique residual whole blood samples from pediatrics (

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The XR-Series module (XR-20) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XR-Series module (XR-20) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Unit (XR-20) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) One Auto Sampler Unit which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.

The XR-20 analyzer has an additional white progenitor cell (WPC) measuring channel and associated WPC reagents. The new WPC channel provides two separate flags for blasts and abnormal lymphocytes.

The provided FDA 510(k) Clearance Letter details the performance testing conducted for the Sysmex XR-Series (XR-20) Automated Hematology Analyzer to demonstrate its substantial equivalence to the predicate device, Sysmex XN-20. Due to the nature of the document being an FDA clearance letter summarizing performance studies rather than the full study reports, some requested details (e.g., exact sample provenance for all studies beyond "US clinical sites," specific qualifications for all experts, and the comprehensive list of acceptance criteria for all individual parameters in specific studies) are not exhaustively provided.

However, based on the information available, here's a breakdown of the acceptance criteria and the studies proving the device meets them:

Overall Acceptance Criteria & Study Design Philosophy:

The overarching acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device, Sysmex XN-20 (K112605). This is primarily proven through:

• Analytical Performance Studies: Demonstrating that the XR-20 analyzer's performance (precision, linearity, analytical specificity, stability, limits of detection, carry-over) is "acceptable" or "met manufacturer's specifications/predefined acceptance criteria requirements."
• Method Comparison Studies: Showing a strong correlation and acceptable bias between the XR-20 and the predicate XN-20 for all claimed parameters across various patient populations and challenging samples.
• Clinical Sensitivity and Specificity Studies: For flagging capabilities, demonstrating acceptable agreement (sensitivity/specificity, PPA/NPA/OPA) with a reference method (manual microscopy) and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a single, consolidated table of all acceptance criteria for every parameter across all tests. Instead, it states that results "met manufacturer's specifications or predefined acceptance criteria requirements" for analytical performance tests, and provides specific correlation coefficients, slopes, intercepts, and mean differences/percent differences for method comparison studies.

Here's a partial table based on the quantifiable data presented for Method Comparison Studies (Whole Blood - Combined Sites), which is a key performance indicator for substantial equivalence. The "Acceptance Criteria" are implied by what is generally considered acceptable in hematology analyzer comparisons for FDA submissions (high correlation, small bias), and explicitly stated for certain parameters like HGB.

Implicit Acceptance Criteria (General expectation for Method Comparison based on FDA context):

• Correlation Coefficient (r): Typically > 0.95 (ideally > 0.98 or 0.99 for robust parameters)
• Slope: Close to 1.0 (ideally between 0.95 and 1.05)
• Intercept: Close to 0
• Mean Difference / % Mean Difference / Estimated Bias: Within clinically acceptable limits (often derived from biological variation or regulatory guidelines). The document explicitly mentions a bias limit for HGB: ±2% or 0.2 g/dL.

Table 1: Partial Acceptance Criteria and Reported Device Performance (Method Comparison - Whole Blood)

For other analytical performance studies (Precision, Linearity, Detection Limit, Carry-Over, Specificity, Stability), the document consistently states that the XR-20 "met manufacturer's specifications or predefined acceptance criteria requirements," supporting that specific numerical acceptance criteria were defined and achieved.

2. Sample Size and Data Provenance

• Test Set:

  • Whole Blood Method Comparison: A total of 865 unique residual whole blood samples.
  • Body Fluid Method Comparison: A total of 397 residual body fluid samples.
  • Provenance: All studies were conducted at three US clinical sites (for major studies like method comparison and reproducibility) or one internal site (for some linearity, stability, and matrix studies).
  • Retrospective/Prospective: Samples are described as "residual" (implying retrospective, de-identified leftover samples) or "prospectively collected" where specified (e.g., for some stability studies).

• Training Set: The document does not specify a training set for the algorithm, as this is a traditional in-vitro diagnostic (IVD) device (Automated Hematology Analyzer) which likely relies on fixed algorithms and established measurement principles (RF/DC Detection, Sheath Flow DC Detection, Flow Cytometry) rather than a machine learning model that requires explicit training data for its core functionality. The performance characterization is about its analytical capabilities, not about learning from a dataset to perform a task.

3. Number of Experts and Qualifications (for Ground Truth)

• Clinical Sensitivity and Specificity (Flagging Capabilities): The ground truth for flagging capabilities was established by "manual differential counts and peripheral blood smear review by experienced examiners using light microscopy (reference method) at each of the three external clinical sites." The exact number and specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, but the term "experienced examiners" implies qualified personnel (e.g., clinical laboratory scientists, pathologists). Given this is a hematology analyzer, these would typically be clinical laboratory specialists or hematopathologists.

4. Adjudication Method (for the Test Set)

• Clinical Sensitivity and Specificity (Flagging): The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for resolving discrepancies between multiple manual reviews. It states "peripheral blood smear review by experienced examiners," primarily using manual microscopy as the reference method. This implies there might be a single expert review or an internal consensus process, but no detail on conflict resolution is provided.

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

• No MRMC study was described. This type of study (MRMC) is typically performed for AI-assisted diagnostic tools where human reader performance is a direct outcome of interest and needs to be compared with and without AI assistance. The Sysmex XR-20 is an automated analyzer, a standalone device that performs measurements and classifications. While it outputs flags that may assist human review, its primary function isn't human-in-the-loop assistance in interpretation (like an AI for radiology image reading). Therefore, an MRMC study is not applicable for this device.

6. Standalone (Algorithm Only) Performance

• Yes, the primary performance studies are standalone algorithm/device performance. All analytical performance studies (Precision, Linearity, Detection Limit, Carry-Over, Analytical Specificity, Sample Stability) and the method comparison studies (comparing XR-20 results directly against the predicate XN-20) represent the standalone performance of the XR-20 analyzer. The device functions automatically without human input during the analysis process; therefore, human-in-the-loop performance is not directly evaluated as a primary outcome for its measurement capabilities.

7. Type of Ground Truth Used

• Analytical Ground Truth: For most analytical performance studies (Precision, Linearity, Detection Limits, Carry-Over), the "ground truth" is established by the performance of the predicate device (Sysmex XN-20) or by a well-controlled experimental setup (e.g., known dilutions for linearity, blank samples for LoB).
• Clinical Ground Truth (for flagging): For clinical sensitivity and specificity of flagging capabilities, the ground truth was expert consensus / manual review against peripheral blood smear using light microscopy. The document refers to this as the "reference method."

8. Sample Size for the Training Set

• As mentioned in point 2, no explicit training set for a machine learning algorithm is described. This device's core functionality relies on established physical and chemical principles and traditional signal processing for cell counting and classification, not a learnable AI model from a training data set in the typical sense.

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

• Since there's no described "training set" for an AI/ML algorithm, this point is not applicable in the context of this traditional IVD device. The "ground truth" for verifying its performance (as detailed above) was established through comparisons to a legally marketed predicate device (XN-20) and a gold standard manual method (microscopy).

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The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods.

The performance of this device has not been established in neonate and pediatric patient populations.

The CN-Series (CN-6000) coagulation analyzer is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the IPU (Information Processing Unit) screen. They can be printed on external printers or transmitted to a host computer.

Sold separately from the instrument are the associated reagents, controls, calibrators, and consumable materials. The subject of this 510(k) notification is the analyzer together with the reagent applications which perform the coagulation tests:

• Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
• Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
• Fibrinogen (Fbg) with Dade® Thrombin Reagent
• Antithrombin (AT) with INNOVANCE® Antithrombin
• D-dimer with INNOVANCE® D-Dimer.

The analysis principles used on the instrument are reflected by the reagent application testing provided in this submission and are described in the table below. These reagents were selected to show the analytical technology of the instrument while also selecting commonly used applications in coagulation laboratories in the United States.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Sysmex CN-6000 Automated Blood Coagulation Analyzer.

The provided text is a 510(k) clearance letter for an in vitro diagnostic device, specifically an automated blood coagulation analyzer. The information focuses on demonstrating substantial equivalence to a predicate device (Sysmex CS-5100 K150678) rather than providing detailed acceptance criteria and proof of exceeding them in the format typically seen for novel AI/ML devices. Therefore, the information has been extracted and interpreted as closely as possible to the requested structure, with explanations where the requested information is not explicitly present due to the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like the CN-6000, acceptance criteria are generally defined as meeting performance specifications comparable to the predicate device and within clinically acceptable ranges. The "acceptance criteria" for each study are generally defined as the results meeting these pre-established standards. The reported device performance is presented as the outcomes of these studies.

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