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

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

The provided 510(k) summary for the HemosIL Factor II Deficient Plasma does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device had to meet. Instead, the study demonstrates that the new device is "substantially equivalent" to predicate devices by showing comparable performance.

However, we can infer performance metrics that were deemed acceptable for substantial equivalence based on the presented data. The study primarily relies on method comparison and precision data.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" are not given. The study aims to demonstrate substantial equivalence to predicate devices. We can infer that correlation coefficients (r) close to 1.0, slopes close to 1.0, and small intercepts compared to predicate devices, along with acceptable precision (%CV), were considered evidence of substantial equivalence.

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

• Sample Size (Method Comparison): Approximately 60 citrated plasma samples for the in-house method comparison study. A separate clinical study used n=61 samples.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from Massachusetts, USA. The studies are described as "in-house" and "clinical," suggesting they were conducted by the manufacturer or collaborators, likely within the US, but this is not definitively stated.
  • Retrospective or Prospective: Not explicitly stated. The description "evaluating approximately 60 citrated plasma samples" and "clinical study" doesn't specify the collection method. However, for method comparison, samples are often either prospectively collected or selected from an existing bank that represents the intended use population.

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

• Ground Truth Establishment: For in-vitro diagnostic (IVD) devices like this, "ground truth" for method comparison and precision is established by the reference method (the predicate device) and by validated control materials, rather than by human expert consensus or pathology review.
• Number and Qualifications of Experts: Not applicable in the traditional sense for this type of IVD performance study. The "truth" is based on the performance of a legally marketed predicate device and well-characterized control materials.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is a quantitative IVD method comparison study where results are numerical and compared against a reference method, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging where human readers interpret results. The HemosIL Factor II Deficient Plasma is an in-vitro diagnostic reagent designed for automated analyzers.

6. If a Standalone Study Was Done

• Standalone Study: Yes, the performance data presented is for the algorithm/device (HemosIL Factor II Deficient Plasma) operating on various IL Coagulation and ELECTRA systems. The "method comparison" directly compares the new device's performance against legally marketed predicate devices, demonstrating its standalone functionality in achieving comparable results. The precision studies also show its standalone performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for assessment of the new device is based on the performance of the legally marketed predicate devices (Hemoliance Factor II Deficient Plasma and HemosIL Factor II Deficient Plasma predicate versions) and using known normal and abnormal control materials.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not describe a "training set" in the context of machine learning or AI models. This device is a diagnostic reagent, and its development typically involves formulation optimization and analytical verification rather than algorithmic training on a dataset. Therefore, this concept is not directly applicable.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this IVD device. The development of such a reagent involves analytical chemistry, reagent formulation, and stability studies, rather than training on a data set with an established ground truth.

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