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NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

Here's a breakdown of the acceptance criteria and the study details for the NoFact VIII Deficient Plasma device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for NoFact VIII Deficient Plasma focuses on demonstrating substantial equivalence to a predicate device (Stago VIII Deficient Plasma) through performance comparison and precision evaluation. While explicit "acceptance criteria" for each metric are not stated numerically, the narrative implies that the performance must be comparable to the predicate device and demonstrate acceptable precision.

Note: The document states "NoFact VIII Deficient Plasma provided acceptable precision" without numerical thresholds, implying adherence to general CLSI guidelines for precision for such assays.

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

• Sample Size: 233 frozen plasma samples.
• Data Provenance: The samples were analyzed across three different laboratories. The document does not specify the country of origin but implies a multi-site study within a regulatory context that often points to domestic (US) or internationally recognized sites. The data is retrospective as it refers to "frozen plasma samples."

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

This type of in vitro diagnostic device (IVD) for factor deficiency measurement typically does not use human experts to establish "ground truth" for individual samples in the way a diagnostic imaging AI might. Instead, the "ground truth" for the test set is established by the measurement of Factor VIII activity using the predicate device's reagent (Stago FVIII deficient plasma) coupled with the Stago PTT-A FVIII assay. The comparison is between the new device's performance and the established performance of the legally marketed predicate. Therefore, no experts were specifically used to establish ground truth in the context of interpretation or diagnosis for each sample.

4. Adjudication Method for the Test Set

As explained above, this study design compares the new device’s performance to an existing, validated method (the predicate device). There is no "adjudication" in the sense of resolving discrepancies between multiple human readers or between an AI and a human. The "ground truth" is the result obtained with the predicate device, and the new device's results are compared directly to those values.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic system that assists human readers in interpreting complex data like medical images. Therefore, the concept of "human readers improving with AI assistance" does not apply here.

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

Yes, in spirit, a standalone performance was done. The "NoFact VIII Deficient Plasma" is a reagent. Its performance is evaluated directly in an assay (Stago PTT-A FVIII assay) on an automated analyzer (STA Compact). The results (Factor VIII activity) are generated solely by the interaction of the sample, the reagent, and the analyzer, and then compared to the results obtained with the predicate reagent on the same analyzer using the same assay. There is no human "loop" involved in generating the primary measurement data, only in setting up the assay and validating the results.

7. The Type of Ground Truth Used

The ground truth used for performance comparison was the quantitative Factor VIII activity values obtained from the predicate device (Stago VIII Deficient Plasma) using the Stago PTT-A FVIII assay. This represents a "reference standard" established by an already legally marketed and validated assay.

8. The Sample Size for the Training Set

The document does not provide information on a "training set." This is typical for an in vitro diagnostic reagent. Reagents are generally developed and then their performance is validated against predicate devices or established methods. There isn't an "AI model" that requires a distinct training phase with labeled data in the same way an imaging algorithm would. The development (analogous to training) would involve optimizing the reagent's formulation and manufacturing processes, but this isn't detailed as a "training set" in the context of performance studies.

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

Since no specific "training set" is mentioned for an AI model, the concept of establishing ground truth for it is not applicable here. The focus is on validating the performance of the final reagent product against a recognized standard (the predicate device).

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