(142 days)
Pathromtin SL is a reagent for the determination of the activated partial thromboplastin time in human plasma.
Pathromtin SL is a reagent consisting of a phospholipid (vegetable) and a surface activator (silicon dioxide particles) used to activate the factors of the intrinsic coagulation system.
The provided text describes a 510(k) submission for a medical device called Pathromtin SL, a reagent used for determining activated partial thromboplastin time (aPTT). The document focuses on demonstrating equivalence to an existing legally marketed device, Dade® Actin® FS Activated PTT Reagent, rather than establishing acceptance criteria and conducting a comprehensive study for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, ground truth, expert involvement, and MRMC studies is not present or applicable in this context.
Here's an analysis based on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Pathromtin SL vs. Actin® FS aPTT Reagent) |
|---|---|
| Correlation | A strong positive correlation between Pathromtin SL and the predicate device is desired, indicating that they measure the same parameter similarly. |
| Y-intercept | A y-intercept close to 0 suggests minimal systematic bias between the two methods when the Pathromtin SL reading is zero. |
| Slope | A slope close to 1 suggests that the rate of change in results is similar between the two methods, meaning they respond proportionally to changes in aPTT. |
| Precision | Low intra-assay and inter-assay variability indicates consistent and reliable measurements by the device. |
2. Sample size used for the test set and the data provenance
- Sample Size: 212 plasma samples were used for the correlation study.
- Data Provenance: Not explicitly stated. It's not mentioned if the data is retrospective or prospective, nor the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. For an aPTT reagent, the "ground truth" is typically established by the measurement of the predicate device (Dade® Actin® FS aPTT Reagent) itself, or by accepted reference methods in a laboratory setting, rather than by human expert consensus on image interpretation or similar. The document doesn't mention interpretation by experts for the test set.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where human experts are making judgments (e.g., classifying medical images), and their agreement needs to be resolved. This is not relevant for a chemical reagent comparison study where objective quantitative measurements are being compared.
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 image analysis or decision support tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The performance characteristics (correlation, precision) are for the reagent itself, which is essentially a "standalone" chemical assay. It's a direct measurement capability, not an algorithm requiring human interaction for interpretation in the way AI systems do. The comparison is between two reagent systems.
7. The type of ground truth used
- The "ground truth" for the comparative study was the results obtained from the legally marketed predicate device (Dade® Actin® FS Activated PTT Reagent). The study aimed to show that Pathromtin SL gives results equivalent to this established device.
8. The sample size for the training set
- Not applicable/Not provided. For a chemical reagent, there isn't a "training set" in the machine learning sense. The formulation of the reagent itself is developed through chemical and biological research and optimization, not by training on a dataset. The performance studies mentioned are for validation, not training.
9. How the ground truth for the training set was established
- Not applicable (as explained in point 8).
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).