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HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

· When used with HemosIL Heparin Calibrators:

Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.

· When used with HemosIL Apixaban Calibrators:

Quantitative determination of apixaban on the ACL TOP Family 50 Series through measurement of factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:

• Patients at risk for major bleeding

• Patients experiencing a bleeding episode

· When used with HemosIL Rivaroxaban Calibrators:

Quantitative determination of rivaroxaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of factor Xa activity, which is inversely proportional to the rivaroxaban level. With HemosL Rivaroxaban Calibrators, the assay is intended to measure rivaroxaban concentrations in patients on rivaroxaban therapy in the following situations where measurement of rivaroxaban levels could be useful to have as additional information:

• Patients at risk for major bleeding

• Patients experiencing a bleeding episode

The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. For use in adult population. For prescription use only.

HemosIL Liquid Anti-Xa is a one stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. The assay provides quantitative rivaroxaban results on 3.2% citrated human plasma as follows: Rivaroxaban levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Rivaroxaban Calibrators. Rivaroxaban directly inhibits Factor Xa activity independent of the antithrombin present. The Factor Xa activity measured by the assay is exogenous. Factor Xa is neutralized directly by rivaroxaban. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the rivaroxaban level in the sample.

HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

When used with HemosIL Heparin Calibrators:
• Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.

When used with HemosIL Apixaban Calibrators:
• Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:

• Patients at risk for major bleeding
• Patients experiencing a bleeding episode

When used with HemosIL Rivaroxaban Calibrators:
• Quantitative determination of rivaroxaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of factor Xa activity, which is inversely proportional to the rivaroxaban level. With HemosIL Rivaroxaban Calibrators, the assay is intended to measure rivaroxaban concentrations in patients on rivaroxaban therapy in the following situations where measurement of rivaroxaban levels could be useful to have as additional information:

• Patients at risk for major bleeding
• Patients experiencing a bleeding episode

The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.

For use in adult population. For prescription use only.

This appears to be a 510(k) summary for a medical device called "HemosIL Liquid Anti-Xa," which is an in vitro diagnostic assay. The document details the device's technical specifications and performance studies to demonstrate substantial equivalence to a predicate device.

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

Important Note: The document focuses on demonstrating substantial equivalence for the HemosIL Liquid Anti-Xa assay for rivaroxaban measurement, comparing it to an existing HemosIL Liquid Anti-Xa device for apixaban measurement. Therefore, the "acceptance criteria" table below will reflect the performance characteristics the manufacturer is demonstrating for the new rivaroxaban application, and how its performance stacks up against those established for the predicate or against generally accepted analytical performance standards for such assays. It's not about a specific "AI" device as might be implied by some questions in the prompt, but rather a diagnostic assay.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical targets. Instead, it presents various performance study results (Precision, Reproducibility, LoB/LoD/LoQ, Linearity, Interferences, Stability, Method Comparison) which collectively demonstrate the device's analytical performance. The acceptance is implied by the successful completion of these studies and the presented data.

Here's a table summarizing the reported device performance for the HemosIL Liquid Anti-Xa for rivaroxaban measurement. The implicit acceptance criteria are that these performance characteristics are adequate for the intended use and comparable to or better than the predicate device/industry standards.

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HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

• · When used with HemosIL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.
• · When used with HemosIL Apixaban Calibrators:

Quantitative determination of apixaban on the ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:

• Patients at risk for major bleeding
• Patients experiencing a bleeding episode

The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.

For use in adult population. For prescription use only.

HemosIL Liquid Anti-Xa is a one stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

. When used with HemosIL Heparin Calibrators:

Heparin levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Heparin Calibrators.

Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the heparinantithrombin complex is formed, two competing reactions take place.

• 1. Factor Xa is neutralized by heparin-antithrombin complex.
• 2. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.

In order to reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.

When used with HemosIL Apixaban Calibrators: .

Apixaban levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Apixaban Calibrators.

Apixaban directly inhibits Factor Xa activity independent of the antithrombin present. The Factor Xa activity measured by the assay is exogenous. Factor Xa is neutralized directly by apixaban.

Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the apixaban level in the sample.

Measurement of apixaban concentration is recommended by the International Society of Thrombosis and Hemostasis Subcommittee on Control of Anticoagulation in certain clinical scenarios including bleeding episodes, perioperative management, and suspicion of overdose.

The provided document is a 510(k) summary for a medical device (HemosIL Liquid Anti-Xa), primarily focused on a specific change: modifying the labeled on-board instrument stability claim from 7 days to 4 days and removing claims for a particular instrument family (ACL Elite/Elite Pro). This type of submission (Special 510(k)) indicates that the core device and its fundamental performance characteristics are already established and the submission is for a minor modification.

Therefore, the document does not contain the information typically found in a clinical study report that would establish the initial acceptance criteria and prove the device meets them from scratch. It refers to a guideline (CLSI EP25-A) for the testing conducted for the stability claim change, but doesn't detail the acceptance criteria for the entire device's performance (e.g., accuracy, precision, linearity, etc., across its full analytical range).

The information requested in the prompt (sample size for test set, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training and test sets) is characteristic of studies for diagnostic devices, particularly AI/software-as-a-medical-device (SaMD) products, where performance is often evaluated against human expert consensus or clinical outcomes. The HemosIL Liquid Anti-Xa is an in vitro diagnostic (IVD) assay, not an AI/SaMD product that requires human expert review of images or signals for ground truth. Its performance validation relies on analytical studies (e.g., accuracy against reference methods, precision, linearity, interference studies).

Based on the provided document, I cannot fulfill most of the requested information because it is not contained within this 510(k) summary.

Specifically, the document:

• Does not provide a full table of acceptance criteria for the device's overall performance (only discusses a change in stability claim).
• Does not discuss aspects like sample size for test sets in the context of clinical performance evaluation against a human-established ground truth, data provenance for such sets, expert numbers/qualifications, or adjudication methods, as these are typically not relevant for an IVD reagent's analytical performance assessment in the same way they are for image-based AI diagnostics.
• Does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, as it's not an AI-assisted diagnostic tool.
• Does not discuss standalone algorithm performance, as it's a reagent for an automated instrument.
• Does not specify the type of ground truth used in the context of human expert review. For an IVD, "ground truth" would typically refer to reference method results or clinical diagnosis established through established laboratory and clinical procedures.
• Does not provide information on training set sample size or how ground truth was established for a training set, as it is not an AI/machine learning device that undergoes a training phase in the typical sense.

The only relevant information that can be extracted regarding a "study" is for the change being submitted:

1. Acceptance Criteria and Device Performance (for On-Board Stability Change):

The document states the study was conducted "based on testing to the current CLSI EP25-A guideline" to support the change in on-board stability from 7 days to 4 days. While it doesn't explicitly list the numerical acceptance criteria for this specific study, the implication is that the data collected over 4 days met the performance specifications (e.g., accuracy, precision) as defined by the CLSI EP25-A guideline for reagent stability. The reported performance is that the device meets the 4-day stability claim, leading to the regulatory approval.

2. Sample Size and Data Provenance for Stability Test: While the specific sample size for the stability study is not detailed, it would involve multiple replicates of control and/or patient samples measured over the 4-day period on the specified instruments (ACL TOP Family and ACL TOP Family 50 Series) stored at 15-25°C. Data provenance would be from internal laboratory studies of Instrumentation Laboratory Co. (the manufacturer). This would be a prospective analytical study designed to assess reagent stability under defined conditions.

3. Number of Experts and Qualifications / Adjudication Method / MRMC Study / Standalone Performance: Not applicable for this type of IVD reagent validation. There are no human experts involved in establishing ground truth for analytical performance, nor is there a multi-reader study or standalone algorithm.

4. Type of Ground Truth Used: For analytical performance like stability, the "ground truth" would be the initial performance of the freshly prepared reagent or its performance compared to a reference method, against which subsequent measurements over time are compared to assess degradation. This is an analytical ground truth, not a clinical ground truth established by human experts.

5. Training Set Sample Size and Ground Truth Establishment: Not applicable. This is an IVD reagent and not an AI/ML device that requires a "training set" in the sense of machine learning. The design and parameters of the assay are established through chemical and biological research and development, not data-driven machine learning.

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HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

. When used with HemosIL Heparin Calibrators:

Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family, ACL TOP Family 50 Series, and ACL Elite/Elite Pro.

· When used with HemosIL Apixaban Calibrators:

Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:

• Patients at risk for major bleeding
• Patients experiencing a bleeding episode

The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.

For use in adult population. For prescription use only.

HemosIL Liquid Heparin and HemosIL Liquid Anti-Xa are one stage chromogenic assays based on a synthetic chromogenic substrate and on Factor Xa inactivation. The assay provides quantitative apixaban results on 3.2% citrated human plasma when used with HemosIL Heparin Calibrators and/or HemosIL Apixaban Calibrators.

The assay contains:

• Factor Xa reagent purified bovine Factor Xa, Tris-Buffer, EDTA, dextran sulfate, . sodium chloride, and bovine serum albumin
• Chromogenic substrate liquid chromogenic substrate S-2732 and bulking agent .

The assay requires the following components which are not included in the assay kit:

• HemosIL Apixaban Calibrators two levels ( and ( ( ng/mL) of lyophilized calibrators . prepared from human citrated plasma containing apixaban, buffers, and stabilizers.
• HemosIL Apixaban Controls two levels (1) and (1) of lyophilized controls . prepared from human citrated plasma containing apixaban, buffers, and stabilizers,
• HemosIL Heparin Calibrator three levels (0, 0.8 and 2.0 IU/mL) of lyophilized . calibrators prepared from human citrated plasma containing heparin, buffer and stablizers.
• HemosIL LMW Heparin Controls two levels (low and high) of lyophilized controls . prepared from human citrated plasma containing low molecular weight (LMW) heparin, buffers and stabilizers. Each lot of LMW Heparin Controls is traceable to the 3rd International WHO Standadrd 11/176 for LMW heparin.
• Hemos IL UF Heparin Controls two levels (low and high) of lyophilized controls . prepared from human citrated plasma containing unfractionated (UF) heparin, buffers and stabilizers. Each lot of UF Heparin Controls is traceable to the 6th International WHO standard 07/328 for UF heparin.
• Cleaning solution .
• Cleaning agent .
• Factor diluent .

The HemosIL Liquid Anti-Xa assay is an automated chromogenic assay designed for in vitro diagnostic use to quantitatively determine unfractionated heparin (UFH), low molecular weight heparin (LMWH) activity, and apixaban levels in citrated human plasma.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on analytical performance for apixaban, as heparin performance was previously reported. The key performance criteria evaluated for apixaban are precision, linearity/reportable range, traceability, stability, detection limits, and analytical specificity.

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

• Precision Studies (Test Set):
  • Study 1: 240 determinations (80 per reagent lot).
  • Study 2: Total number of determinations not fully specified, but involved multiple instrument models and reagent lots.
  • Study 3: No specific number of determinations given, states "prodeterminations".
  • Study 4: 270 determinations (multisite).
  • Study 5: 270 determinations (multisite).
• Linearity Studies (Test Set): Normal pooled plasma (NPP) spiked with known concentrations of apixaban, tested in four replicates.
• Detection Limit Studies (Test Set):
  • LoB: n=60 determinations per reagent lot per instrument model (using four citrated plasma pools).
  • LoD: n=60 determinations per reagent lot per instrument model (using four citrated plasma pools).
  • LoQ: n=40 determinations per reagent lot per instrument model (using four citrated plasma pools).
• Analytical Specificity/Interference Studies (Test Set): Test samples (spiked with apixaban) and control samples, tested in a minimum of four replicates.
• Clinical Accuracy (Method Comparison Study Test Set): 367 clinical samples collected from patients receiving apixaban.
• Data Provenance: The method comparison study involved clinical samples collected from three different U.S. clinical sites. This indicates the data is prospective or retrospective clinical data, collected in a real-world setting.
  • For the analytical studies (precision, linearity, detection limits, interference), these were laboratory-controlled studies using spiked or pooled plasma samples.

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

For the clinical accuracy study, the ground truth was established by a validated apixaban LC-MS/MS method. The document does not specify the number or qualifications of experts involved in running or validating this LC-MS/MS method, as LC-MS/MS is a highly sensitive and precise analytical technique typically performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the clinical accuracy study was established by a quantitative instrumental method (LC-MS/MS), not through expert consensus requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not an imaging or diagnostic interpretation device that would typically involve human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies reported are standalone performance evaluations of the HemosIL Liquid Anti-Xa assay (an automated algorithm/instrument system). The performance characteristics presented are for the device itself, generating quantitative results. While the device results are intended to be used by laboratory professionals and clinicians, the performance of the device is measured directly, not in conjunction with human interpretation for accuracy.

7. The Type of Ground Truth Used

• Analytical Performance Studies (Precision, Linearity, Detection Limits): Ground truth was established by known concentrations of apixaban used to spike samples, or intrinsic properties of control materials and pooled plasma.
• Clinical Accuracy (Method Comparison Study): Ground truth was established by a validated apixaban Liquid Chromatography - tandem Mass Spectrometry (LC-MS/MS) method. LC-MS/MS is considered a gold standard for drug quantification.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The HemosIL Liquid Anti-Xa is a chromogenic assay based on biochemical reactions and factor Xa inactivation, not a machine learning algorithm that requires specific training data in the traditional sense. The development of such assays involves extensive R&D, reagent optimization, and calibration curve generation, which could be seen as analogous to "training" but is not reported with a distinct sample size for "training set" in this context.

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

As noted above, a traditional "training set" as understood in machine learning is not applicable here. The assay relies on established biochemical principles and calibration against known standards.

• Calibration: For apixaban, calibrator value assignments are traceable to apixaban supplied by the manufacturer and quantitated in plasma assayed by LC-MS/MS. This process ensures the assay accurately measures apixaban concentrations.

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