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510(k) Data Aggregation
(444 days)
NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplast time. For in vitro diagnostic use.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the NoFact IX Deficient Plasma device:
Important Note: The provided document is a 510(k) summary for an in vitro diagnostic device, specifically a deficient plasma product used in laboratory tests. It is not an AI or imaging device, and therefore many sections of your request (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance") are not applicable to this type of medical device submission. I will address only the relevant information from the document.
Acceptance Criteria and Device Performance for NoFact IX Deficient Plasma
The device, NoFact IX Deficient Plasma, is an in vitro diagnostic intended for the quantitative determination of Factor IX activity. Its performance is demonstrated through a comparison study with a legally marketed predicate device (STA Deficient IX) and precision testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for an in vitro diagnostic, the "acceptance criteria" are not explicitly stated with numerical thresholds in the provided summary in the same way they might be for an AI model. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device through a strong correlation in quantitative measurements and acceptable precision. The reported performance metrics are derived from this equivalence study and precision assessment.
| Performance Metric | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (NoFact IX vs. Predicate) |
|---|---|---|
| Comparative Study (Linear Regression) | All Labs (N=233) | |
| - Coefficient of Determination (r²) | Strong correlation with predicate device (typically r² > 0.90 is desired for quantitative comparison) | 0.915 |
| - Correlation Coefficient (r) | Strong linear relationship | 0.956 |
| - Slope | Close to 1 (indicating proportional agreement) | 0.858 |
| - Intercept | Close to 0 (indicating minimal constant bias) | 5.729 |
| Precision (CV%) - Normal Control | Acceptable within-run and lot-to-lot variability for an IVD measuring coagulation factors (target typically <10% for CV) | Within-run: 5.1%, Lot-to-Lot: 1.1%, Within-Device: 7.2% |
| Precision (CV%) - Abnormal Control | Acceptable within-run and lot-to-lot variability | Within-run: 4.6%, Lot-to-Lot: 2.9%, Within-Device: 7.7% |
| Precision (CV%) - Low FIX Patient | Acceptable within-run and lot-to-lot variability | Within-run: 5.7%, Lot-to-Lot: 2.2%, Within-Device: 7.8% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Comparative Study (Test Set): 233 plasma samples.
- Data Provenance: The plasma samples were analyzed across three different laboratories ("sites"). The document does not specify the country of origin, nor whether the samples were collected retrospectively or prospectively. It just indicates they were "plasma samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is an in vitro diagnostic device where the "ground truth" is established by the highly controlled, quantitative measurement from an established predicate device and internal controls, not expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
This is not applicable for an in vitro diagnostic device that quantifies a substance in plasma. There is no human interpretation or adjudication involved in generating the raw measurement data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable. An MRMC study is relevant for imaging or diagnostic tools where human readers interpret results, and the AI is meant to assist that interpretation. This device is a reagent used in an automated laboratory test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of AI algorithms. This device is a reagent; its "standalone" performance is assessed by its ability to accurately measure Factor IX activity in a laboratory setting, which is directly addressed by the comparative study and precision data.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- The Stago PTT-A FIX assay using the predicate STA IX deficient plasma. The comparison seeks to show that the NoFact IX Deficient Plasma yields equivalent quantitative results to this established method.
- Known control plasma samples (Normal Control Plasma, Abnormal Control Plasma) and pooled patient plasma with a known Low FIX concentration for precision testing.
8. The Sample Size for the Training Set
This is not applicable. This is not an AI or machine learning device that utilizes a "training set." The device is a manufactured biological reagent.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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