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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.

Device Description

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.

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.

AI/ML Overview

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.

Performance Characteristic	Acceptance Criteria (Implicit/Industry Standard)	Reported Device Performance (HemosIL Liquid Anti-Xa for Rivaroxaban)
Precision	Low CV% (e.g., <5-10% for clinical assays)	ACL TOP Family:- Rivaroxaban Low Control: CV% (Total) 4.1%- Rivaroxaban High Control: CV% (Total) 2.4%- Samples 1-6: CV% (Total) 1.0% - 5.5%
		ACL TOP Family 50 Series:- Rivaroxaban Low Control: CV% (Total) 4.9%- Rivaroxaban High Control: CV% (Total) 2.4%- Samples 1-6: CV% (Total) 1.2% - 4.5%
Reproducibility	Low CV% across sites, days, runs, lots	Pooled 3 Site Data:- Rivaroxaban Low Control: CV% (Total) 4.1%- Rivaroxaban High Control: CV% (Total) 2.3%- Samples: CV% (Total) 3.9% - 9.8%
Limit of Blank (LoB)	As low as clinically relevant	2.4 ng/mL
Limit of Detection (LoD)	As low as clinically relevant	8 ng/mL
Limit of Quantitation (LoQ)	Clinical relevance for lower reportable limit	20 ng/mL (lower limit of linear range)
Linearity (Reportable Range)	Wide enough for clinical utility	20 to 1000 ng/mL
Interferences	Minimal impact from common interferents	No significant effect from Hemoglobin (600 mg/dL), Bilirubin (40 mg/dL), Triglycerides (921 mg/dL), Acetylsalicylic acid (3.00 mg/dL), Atorvastatin (0.075 mg/dL), Isosorbide dinitrate (0.600 mg/dL), Ticagrelor (0.188 mg/dL), Warfarin (7.50 mg/dL), Lupus anticoagulant (dRVVT Screen/Confirm Ratio 2.47). Note: Falsely elevated results post-andexanet alfa administration.
Stability (Open Vial)	Clinically practical	1 Month (2-8°C)
Stability (On-Board Instrument)	Clinically practical	4 Days (15-25°C)
Shelf-life	Adequate for manufacturing/distribution	30 Months (2-8°C)
Method Comparison (vs. LC-MS/MS)	Good correlation (r value close to 1) and low bias	Pooled Data (N=337):- r = 0.995- Slope = 0.971- Intercept = -0.697- Mean Bias = -2.8% (individual sites ranged from -8.7% to 2.0%)
Method Comparison (ACL TOP Family 50 Series vs. ACL TOP Family)	Good correlation	Rivaroxaban:- Slope = 0.972- Intercept = 0.810- r = 0.999

2. Sample Sizes and Data Provenance

Precision Study:
- Sample Size: n=80 per instrument/lot for each sample level, tested over 20 days (2 runs/day, 2 replicates/run). 6 citrated plasma samples + Rivaroxaban Controls.
- Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). Implied to be internal laboratory studies.
Reproducibility Study:
- Sample Size: 270 replicates per level (Rivaroxaban Controls and 5 citrated plasma samples). Each material tested in triplicate, twice a day for 5 days.
- Data Provenance: Conducted at 3 sites. No specific country of origin or retrospective/prospective status is given, but "multicenter" implies multiple distinct lab settings.
LoB, LoD, LoQ Studies:
- Sample Size: Not explicitly stated but implied to be sufficient to meet CLSI EP17-A2 guidelines.
- Data Provenance: Not explicitly stated, implied to be internal laboratory studies.
Linearity Studies:
- Sample Size: Each rivaroxaban level tested in quadruplicate for Analytical Measuring Interval (13 concentrations) and Extended Measuring Interval (9 concentrations).
- Data Provenance: Not explicitly stated, implied to be internal laboratory studies.
Interference Studies:
- Sample Size: Not explicitly stated but implied to be sufficient to meet CLSI EP07 guidelines.
- Data Provenance: Not explicitly stated, implied to be internal laboratory studies.
In-Use Stability and Shelf-life Studies:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, implied to be internal laboratory studies.
Method Comparison (HemosIL Liquid Anti-Xa vs. LC-MS/MS):
- Sample Size: 337 samples.
- Data Provenance: Multicenter study (3 laboratory sites). Samples were from patients treated with rivaroxaban, including 12 from bleeding patients and 261 from patients at risk of major bleeding. This indicates retrospective clinical samples where the rivaroxaban levels were already established or patients were undergoing treatment. No country of origin is specified.

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

N/A for this type of diagnostic assay. The "ground truth" for the method comparison study was established using a gold standard analytical method (LC-MS/MS), not by human experts interpreting images or clinical cases.

4. Adjudication Method for the Test Set

N/A. This is a quantitative diagnostic assay. The comparison is against a reference analytical method (LC-MS/MS), not subjective human interpretations requiring adjudication.

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

No, this is not applicable. An MRMC study is relevant for imaging or diagnostic tools where human interpretation is a primary component of the diagnostic process (e.g., radiologists reading scans). This device is an automated, chromogenic assay delivering quantitative results.

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

Yes, in essence, the entire performance evaluation (Precision, Reproducibility, LoB/LoD/LoQ, Linearity, Interferences, Stability) is a "standalone" evaluation of the assay's analytical performance. The method comparison study also evaluates the assay (algorithm + reagents + instrument) against a reference method. Human involvement is limited to performing the tests and interpreting the instrument's numerical output, not making a subjective diagnosis based on qualitative assay results.

7. The Type of Ground Truth Used

For Analytical Performance Studies (Precision, Reproducibility, LoB/LoD/LoQ, Linearity, Interferences, Stability): The "ground truth" is established through carefully prepared samples with known concentrations (e.g., calibrators, controls, spiked samples) or by evaluating the assay's intrinsic performance characteristics against statistical and analytical chemistry standards (e.g., CLSI guidelines).
For Method Comparison Study: The ground truth was established using LC-MS/MS (Liquid Chromatography–Mass Spectrometry/Mass Spectrometry), which is considered a highly accurate and precise reference method for drug concentration measurement in biological samples.

8. The Sample Size for the Training Set

N/A. This is an assay based on established chromogenic chemistry, not a machine learning or AI model that requires a "training set" in the computational sense. The device's calibration curves are established using calibrators with known concentrations, which are analogous to a very small "training set" in terms of how the system learns to relate absorbance to concentration, but it's not a large-scale data training as seen with AI.

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

N/A. As above, there is no "training set" in the AI/ML context. The assay's performance relies on its chemical and enzymatic principles, and its calibration is set using commercially supplied or manufactured calibrators with assigned values based on internal reference methods.

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