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HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX in the patient plasma, interpolated from a calibration curve.

Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor IX Deficient Plasma device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of specific slope and correlation coefficient ranges. Instead, it implies that the device is acceptable if it demonstrates "substantial equivalence" to predicate devices through method comparison and satisfactory precision.

Vs. IL Test Factor IX Deficient Plasma (on ACL Family - ACL 3000):
n=76, Slope = 1.1076, r = 0.9793 |
| Precision (Within-Run) | Acceptable reproducibility of results. (No specific quantitative criteria provided). | ACL 6000: Normal 5.8% CV, Low Abnormal 8.5% CV
ACL 9000: Normal 3.0% CV, Low Abnormal 2.3% CV
ACL Futura: Normal 4.4% CV, Low Abnormal 6.0% CV
ELECTRA 1400C: Normal 8.4% CV, Low Abnormal 8.0% CV
ELECTRA 1800C: Normal 8.8% CV, Low Abnormal 8.8% CV |
| Precision (Between-Run)| Acceptable reproducibility of results across different runs. (No specific quantitative criteria provided). | ACL 6000: Normal 2.6% CV, Low Abnormal 4.1% CV
ACL 9000: Normal 3.8% CV, Low Abnormal 5.9% CV
ACL Futura: Normal 2.9% CV, Low Abnormal 2.7% CV
ELECTRA 1400C: Normal 8.3% CV, Low Abnormal 7.6% CV
ELECTRA 1800C: Normal 5.7% CV, Low Abnormal 6.4% CV |

Study Description:

The study to prove the device meets acceptance criteria involved two main parts: Method Comparison and Precision.

Method Comparison Study:

• Sample size used for the test set:
  • 65 citrated plasma samples for comparison against Hemoliance Factor IX Deficient Plasma on the E1600C.
  • 76 citrated plasma samples for comparison against IL Test Factor IX Deficient Plasma on the ACL 3000.
• Data provenance: Not explicitly stated, but "field site studies" suggest prospective collection. Country of origin not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study compares the new device's measurements against established predicate devices, which serve as the reference.
• Adjudication method for the test set: Not applicable. Direct comparison of numerical results.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an in-vitro diagnostic device measuring an analyte, not an imaging or diagnostic device requiring human interpretation of cases.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the device's performance is measured in a standalone fashion, comparing its output to that of predicate devices. There is no "human-in-the-loop" component in the measurement itself.
• The type of ground truth used: The results obtained from the predicate devices (Hemoliance Factor IX Deficient Plasma and IL Test Factor IX Deficient Plasma) served as the comparative 'ground truth' or reference for demonstrating substantial equivalence.
• The sample size for the training set: Not applicable. This is not a machine learning model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Precision Study (Within-Run and Between-Run):

• Sample size used for the test set: "multiple runs (n=80)" for each instrument/control combination (40 measurements for Normal Control, 40 measurements for Low Abnormal Control on each of the 5 instruments listed, for a total of 80 measurements per instrument/control pair over the multiple runs).
• Data provenance: Not explicitly stated, but implies laboratory testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Precision is about the device's own consistency.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone performance metric of the device's reproducibility.
• The type of ground truth used: Not applicable. This study assesses the consistency of the device's measurements on control samples, rather than comparing to an independent ground truth. The "control" samples themselves have established target ranges, but the study measures the device's variability around the mean.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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