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510(k) Data Aggregation
(69 days)
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.
Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.
INR is used to monitor the patients receiving anticoagulation therapy.
Semi-automated system for in vitro coagulation studies, clot based and photo-optical.
Here's a breakdown of the acceptance criteria and study information for the POTENS+ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format. Instead, it describes performance characteristics that demonstrated substantial equivalence to predicate devices. The key performance metrics are correlation coefficients (r-values) and precision (Coefficient of Variation - CVs).
| Performance Metric | Acceptance Criteria (from predicate equivalence) | Reported Device Performance (POTENS+) |
|---|---|---|
| Correlation Coefficients (r-values) | ||
| Fibrinogen | Not explicitly stated as acceptance criteria, but predicate equivalence was shown for values ≥ 0.973 (based on reported range) | 0.973 to 0.980 |
| PT | Not explicitly stated, but predicate equivalence was shown for values ≥ 0.95 (based on reported range) | 0.95 to 0.974 |
| INR | Not explicitly stated, but predicate equivalence was shown for values ≥ 0.919 (based on reported range) | 0.919 to 0.963 |
| Precision (Coefficient of Variation - CV) | ||
| Fibrinogen | NCCLS recommendations (CVs < 6%) | < 6% |
| PT | NCCLS recommendations (CVs < 5%) | < 5% |
| INR | NCCLS recommendations (CVs < 8%) | < 8% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states that a "comparison study was conducted using patient specimens over the normal, diagnostic, and therapeutic range." It does not specify the exact number of patient specimens used.
- Data Provenance: The data comes from "patient specimens," implying clinical samples. The country of origin is not specified, but the submission is to the FDA (USA), suggesting it could be US-based, although not explicitly stated. The study was prospective in the sense that it was conducted specifically for this submission, comparing the new device to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by the predicate devices (Organon Tecknika Coag-A-Mate MTX for Fibrinogen and Organon Tecknika MDA-180 for PT & INR) and "commercially available methods/products."
4. Adjudication Method for the Test Set:
No adjudication method is mentioned. The comparison was directly between the POTENS+ device results and those from the predicate devices using patient specimens.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) system for laboratory analysis, not an imaging device or system that requires human interpretation in the same way. Therefore, the concept of "human readers" and "AI assistance" in the context of an MRMC study is not applicable here.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
Yes, a standalone performance study was done. The entire submission focuses on the performance of the POTENS+ device itself (the "algorithm only") in comparison to predicate devices, without human-in-the-loop performance considerations for its core function.
7. Type of Ground Truth Used:
The ground truth used was primarily:
- Predicate device results: The results obtained from the legally marketed predicate devices (Organon Tecknika Coag-A-Mate MTX for Fibrinogen and MDA-180 for PT & INR) were used as the reference standard for comparison.
- Commercially available methods/products: The text also states that equivalence was demonstrated using "commercially available methods/product along with patient specimens."
8. Sample Size for the Training Set:
The document does not mention a "training set" or "training data" as it typically would for machine learning algorithms. The POTENS+ device is described as a semi-automated system for in-vitro coagulation studies using clot-based and photo-optical methodologies, not an AI/ML-driven device in the modern sense that requires a separate training phase with a distinct dataset. The "training" in this context would likely refer to internal calibration and factory settings, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established:
As no specific "training set" is described for an AI/ML model, the concept of establishing ground truth for it is not applicable directly from this document. The device's operation is based on established scientific principles of coagulation assays, and its accuracy is validated against existing, proven methods and devices.
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