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HemosIL Factor VIII deficient plasma is human plasma, depleted of Factor VIII, which is intended for the in vitro diagnostic quantitative determination of Factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on the ACL TOP® Family analyzers. HemosIL Factor VIII deficient plasma is indicated for use on patients who are suspected of congenital or acquired deficiency based on the activated partial thromboplastin time (APTT) assay results.

The assay determines the functional activity of Factor VIII by measuring the degree of prolongation of activated partial thromboplastin time in the presence of a contact activator, thromboplastin, phospholipids and calcium ions. Factor VIII activity is correlated with the prolongation of the clotting time of the Factor VIII deficient plasma to which diluted patient sample has been added.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details performance characteristics rather than explicit "acceptance criteria" for regulatory approval in every instance. However, it implicitly defines satisfactory performance through comparisons to the predicate device and established linearity/precision targets. Due to the nature of the submission (Reagent formulation change), the primary acceptance criterion is demonstrating comparable performance to the predicate device.

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

• Precision Study:

  • Sample Size: 80 replicates per instrument/lot per control level (e.g., 4 control levels x 3 lots x 3 instruments x 80 = 2880 individual measurements if all were run, but data is shown for one representative instrument/reagent/lot).
  • Data Provenance: Not explicitly stated, but clinical laboratory samples (normal and abnormal types) were used. Implied to be prospective within the context of the study design (20 days, 2 runs/day, 2 replicates/run). Country of origin is not specified, but the applicant is US-based.

• Linearity Study:

  • Sample Size: 4 replicates for each Factor VIII sample level.
  • Data Provenance: Not explicitly stated, but generated in-house using prepared Factor VIII samples ranging from 150%. Implied prospective within the study.

• Interference Study:

  • Sample Size: Not specified, but involved testing samples spiked with various interferents.
  • Data Provenance: Not specified, likely in-house laboratory testing, prospective.

• In-House Method Comparison Study:

  • Sample Size: Not explicitly stated for the regression analysis. The table shows 'N' for the ACL TOP 500 CTS as 90 (likely 90 samples tested).
  • Data Provenance: "In-House Study," likely prospective laboratory testing.

• Field Site Study:

  • Sample Size:
    • OUS site: n = 109
    • US #1 site: n = 125
    • US #2 site: n = 102
  • Data Provenance: Conducted at "2 US sites and one OUS site." The document states "Both normal and abnormal samples were tested." Implied prospective testing at these sites.

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

This device is an in vitro diagnostic reagent kit for quantitative determination of Factor VIII activity. The "ground truth" for Factor VIII activity in the test samples is typically established by assigned values from reference materials or by established laboratory methods using calibrated instruments, not by expert human interpretation like in imaging or pathology. The document mentions "assigned values" for the HemosIL Calibration plasma (for calibration curves) and "assigned values" for samples in the linearity study, but does not detail how these assignments were made in terms of human experts. It's a quantitative chemical assay, where "ground truth" is analytical, not based on expert consensus for a "reading."

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative diagnostic assay, not a diagnostic imaging or pathology device where human interpretation and adjudication would be typically required for a "test set" in the sense of establishing truth for diagnostic accuracy. The performance is assessed against known or assigned values for Factor VIII activity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic reagent, not an AI-powered diagnostic aid for human readers. It functions as a standalone laboratory test.

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

Yes. This device (HemosIL Factor VIII deficient plasma) is a reagent used in an automated assay on ACL TOP Family analyzers. Its performance characteristics (precision, linearity, interference, method comparison) are evaluated as a standalone component of the in vitro diagnostic system, independent of direct human interpretive "reading" of the results in the same way an imaging device would be read. The "performance" described is the analytical performance of the reagent used with the specified instruments.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the analytical studies (precision, linearity, method comparison), the "ground truth" is based on:

• Reference materials/assigned values: HemosIL Calibration plasma values are assigned for Factor VIII Activity and used to calibrate the standard curve. In the linearity study, samples had "assigned values."
• Established methods: The predicate device itself serves as the "truth" for comparative purposes in the method comparison studies.
• Known concentrations: For interference studies, samples are spiked with known concentrations of interferents.

This is primarily an analytical ground truth derived from laboratory standards, calibrated materials, and established predicate device performance.

8. The Sample Size for the Training Set

Not applicable. This is an IVD reagent, not a machine learning or AI-based device that requires a "training set" in the context of algorithm development. The reagent itself does not learn or get "trained."

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

Not applicable, as there is no "training set" for this type of device.

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

HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.

The provided text describes the 510(k) summary for the HemosIL Factor VIII Deficient Plasma device, which is an in vitro diagnostic intended for quantitative determination of factor VIII activity. The study presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical acceptance criteria in the way an AI/ML device would.

However, I can extract the performance data provided and frame it in a table, even if explicit "acceptance criteria" are not stated as pass/fail thresholds in the document. The study's aim was to show comparable performance to predicate devices.

1. A table of acceptance criteria and the reported device performance

For a diagnostic device like this, "acceptance criteria" are typically met by demonstrating performance (like correlation and precision) that is comparable to or better than a legally marketed predicate device. The document states that the device is "substantially equivalent... in performance, intended use and safety and effectiveness."

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • Method Comparison: Approximately 60 citrated plasma samples (30 normal and 30 abnormal) were used for each predicate comparison.
  • Within-Run and Between-Run Precision: Not explicitly stated as a number of samples, but assessed over "multiple runs (n=80) on different instruments using a specific lot of APTT reagent and both normal and abnormal samples." This refers to the number of runs, not individual patient samples. Typically, controls are run multiple times.
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of in vitro diagnostic device study does not typically involve human expert adjudication for ground truth in the same way an AI image analysis device would. The "ground truth" for method comparison is the result obtained from the predicate device (another established diagnostic test). For precision, the "ground truth" is the expected value of the control sample. Therefore, this section is not applicable.

4. Adjudication method for the test set

Not applicable. As noted above, this study compares the device's measurements to predicate device measurements or established control values, not to adjudicated expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

Yes, this is a standalone device. The performance data presented (method comparison, precision) reflects the device's intrinsic analytical performance when run on the specified coagulation systems. It's a reagent that works with an instrument to produce a result, without direct human-in-the-loop interpretation of that result in the way an AI would assist.

7. The type of ground truth used

• For Method Comparison: The "ground truth" was the results obtained from the predicate devices (Hemoliance Factor VIII Deficient Plasma and IL Test Factor VIII Deficient Plasma) on their respective analytical systems.
• For Precision: The "ground truth" was the assigned values of normal and low abnormal control plasmas.

8. The sample size for the training set

Not applicable. This is a conventional in vitro diagnostic device, not an AI/ML device that requires a "training set" in that sense. The device's formulation and manufacturing processes are developed to achieve the intended performance characteristics.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of device.

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