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

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

Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor X. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor X in the patient plasma, interpolated from a calibration curve.

Acceptance Criteria and Study for HemosIL Factor X Deficient Plasma

This document describes the acceptance criteria and the study that demonstrates the HemosIL Factor X Deficient Plasma device meets these criteria, as derived from the provided 510(k) summary (K031122).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance metrics presented for substantial equivalence to predicate devices. These criteria are based on method comparison (slope and correlation coefficient) and precision (within-run and between-run coefficient of variation).

vs. Predicate IL Test Factor X Deficient Plasma on ACL Family:
ACL 3000 (n=62): Slope = 1.0328, r = 0.9849
ACL Futura (n=62): Slope = 1.0680, r = 0.9840 |
| Slope | A slope close to 1.0 (indicating proportional agreement) | A slope close to 1.0 (indicating proportional agreement) | Demonstrated to be close to 1.0 across different systems and predicates (e.g., 0.9461 to 1.0680). |
| Correlation Coefficient (r) | A high correlation coefficient (typically ≥ 0.975 as a common standard for method comparison in IVDs) | A high correlation coefficient (typically ≥ 0.975) | Demonstrated to be high across different systems and predicates (e.g., 0.9840 to 0.9948). |
| Within Run Precision| (Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs) | (Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs) | CV% for Normal Control: Low (e.g.,

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