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The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density.

DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate.

The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR).

For use with ONext.

For clinical professional laboratory and prescription use only.

For in vitro diagnostic use.

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

QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to:

• Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results.
• Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results.
• Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process.

To perform the operations for which it has been designed, QNext automatically follows the steps listed below:

• Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes.
• Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes.
• Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes.
• Management of test requests. ●
• Execution of test procedures.
• Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS.
• Management of disposable components. ●

The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module.

DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw сар.

DG-PT reagent is used to perform PT tests for:

• the evaluation of the extrinsic and common coagulation pathways.
• The monitoring Oral Anticoagulant Therapy with warfarin.

The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.

The provided text describes the performance testing of the ONext instrument and DG-PT reagent for Prothrombin Time (PT) determination, but it does not contain information related to an AI/ML powered device. Therefore, many of the requested criteria regarding AI/ML device performance (e.g., multi-reader multi-case studies, human-in-the-loop performance, training set details, expert ground truth adjudication) are not applicable to this document.

However, I can extract and present the acceptance criteria and performance data for the described in-vitro diagnostic device:

Device: ONext (fully-automated hemostasis instrument) and DG-PT (thromboplastin reagent for PT determination).

Study Proving Device Meets Acceptance Criteria:
The submission details several performance studies conducted according to CLSI guidelines to demonstrate the substantial equivalence of the ONext and DG-PT to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria thresholds for each study (e.g., "Precision CV must be less than X%"). Instead, it presents the results of various performance studies (Precision, Reference Interval, Sensitivity, Specificity, Method Comparison) which are implicitly understood to meet the necessary performance characteristics for substantial equivalence. The "performance" column therefore reflects the observed results from these studies.

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

• Precision Studies:
  • Repeatability and Within-laboratory: 7 patient-derived samples. Data provenance not explicitly stated (e.g., country of origin), assumed to be clinical samples. Retrospective/prospective not specified, but typically for precision studies, these would be collected prospectively or obtained from a biobank.
  • Reproducibility: 7 patient-derived samples. Data provenance not explicitly stated (e.g., country of origin), assumed to be clinical samples. Retrospective/prospective not specified.
• Reference Interval Study: 243 reference samples. Data provenance not explicitly stated.
• Sensitivity Study: Not specified, but involved a set of samples spanning from 100% to

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• HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
• HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
• HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
  For in vitro diagnostic use.

• The HemosIL Routine Control Level 1 is a lyophilized product prepared using human citrated plasma from healthy donors. It contains buffer, stabilizers and preservatives.
• The HemosIL Routine Control Level 2 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
• The HemosIL Routine Control Level 3 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.

The provided document describes the "HemosIL Routine Control Levels 1, 2, and 3" which are medical devices intended for quality control of coagulation assays. This is not an AI/ML powered device, therefore, many of the requested criteria such as "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (algorithm only) performance" are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for the device, but it presents precision data as the primary performance characteristic to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the device's precision (measured by Within-Run %CV) is comparable to or better than established or acceptable values for coagulation controls.

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

• Sample Size for Test Set: For each combination of control level, analyte, reagent, and instrument, the "Mean (n=80)" indicates that 80 measurements were performed to assess within-run precision.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Instrumentation Laboratory Co. is based in Lexington, MA, USA, it's likely the studies were conducted within the US. The nature of precision studies for quality controls usually implies prospective testing.

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

• Not Applicable. This device is a quality control material for laboratory tests, not a diagnostic device that requires expert interpretation of images or patient data to establish ground truth. The "truth" or target values for these controls are established through scientific measurement and statistical analysis against reference methods and materials, not expert consensus.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, this is not a diagnostic device involving expert interpretation or consensus.

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

• Not Applicable. This is not an AI-powered diagnostic tool, and therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. This is a physical control material, not an algorithm, so standalone performance is not relevant.

7. Type of Ground Truth Used:

• The "ground truth" for the HemosIL Routine Controls is established by analytical measurement against reference methods and materials, and characterized by its mean value and precision (within-run %CV). This is a form of analytical performance data, not clinical outcomes or expert consensus. The controls are designed to mimic human plasma, and their performance is evaluated based on their stability and reproducibility on various coagulation systems.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set." The product's characteristics are determined through manufacturing processes and analytical testing.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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