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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).

Note: The acceptance criteria for the predicate devices are not explicitly stated in this summary. However, for a 510(k) submission, the new device is typically considered to meet acceptance criteria if its performance is "substantially equivalent" to that of the predicate device. This usually implies that the reported performance metrics for the new device fall within acceptable ranges relative to the predicate, often demonstrated by meeting similar or better statistical measures (slopes close to 1, high correlation coefficients, and low coefficients of variation).

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

• Sample Sizes:
  • Method Comparison (vs. Hemoliance Factor X Deficient Plasma on ELECTRA): n = 63 citrated plasma samples (normal and abnormal)
  • Method Comparison (vs. IL Test Factor X Deficient Plasma on ACL Family): n = 62 citrated plasma samples (normal and abnormal) for both ACL 3000 and ACL Futura.
  • Precision Studies: n = 80 measurements (over multiple runs) for each control level (Normal Control and Low Abnormal Control) on each instrument (ACL 300, ACL 6000, ACL 9000, ACL Futura, ELECTRA 1400C).
• Data Provenance: The studies were conducted as "field site studies." The country of origin of the data is not specified, but given the applicant's location (Lexington, MA, USA), it is likely to be primarily U.S. data. The data is retrospective in the sense that existing plasma samples were used, or it could be prospective if samples were collected for the purpose of the study. The summary does not specify this detail.

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

This information is not applicable and not provided in the given 510(k) summary. For in vitro diagnostic devices like HemosIL Factor X Deficient Plasma, "ground truth" is typically established by the reference method or comparative method (the predicate device) itself, or by accepted laboratory standards/controls, rather than expert consensus on diagnostic images or clinical outcomes. The performance is assessed by comparing the device's quantitative output to known values (controls) or to the results from the predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image reading, where multiple experts interpret data independently and then resolve discrepancies. For a quantitative diagnostic like Factor X activity, the measurement itself is the primary output, and discrepancies would typically be handled by re-testing or applying established quality control rules, not expert adjudication in the same sense.

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

This information is not applicable and not provided. MRMC studies are relevant for devices where human readers interpret data, often with or without AI assistance, and the impact of the AI on reader performance is evaluated. The HemosIL Factor X Deficient Plasma is a laboratory reagent used in an automated system, not a device that involves human reader interpretation in the context of an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The studies presented are effectively standalone performance studies for the device. The "algorithm" here is the chemical reaction and measurement process of the HemosIL Factor X Deficient Plasma test on the specified automated coagulation analyzers (IL Coagulation and ELECTRA Systems). The performance data (method comparison, precision) reflects the device's analytical performance independent of human interpretive input in the diagnostic process.

7. Type of Ground Truth Used

The "ground truth" for the test set was established through:

• Comparative Analysis with Predicate Devices: For the method comparison studies, the results obtained using the HemosIL Factor X Deficient Plasma were compared against the results obtained using the legally marketed predicate devices (Hemoliance Factor X Deficient Plasma and IL Test Factor X Deficient Plasma). The predicate devices' results served as the reference or comparative "ground truth."
• Control Materials: For the precision studies, Normal Control and Low Abnormal Control materials with known or expected Factor X activity levels were used. These control materials serve as an established reference for evaluating the accuracy and reproducibility of the device.

8. Sample Size for the Training Set

This information is not applicable and not provided in the given 510(k) summary. This device is a diagnostic reagent, not a machine learning or AI-based system that requires a "training set" in the typical sense of algorithm development. Its performance is based on chemical and electrochemical principles.

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

This information is not applicable and not provided as there is no "training set" for this type of device.

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