(35 days)
HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
- Fibrinogen on IL Coagulation Systems only .
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
- . Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.
Here's an analysis of the provided text regarding the HemosIL RecombiPlasTin device, focusing on acceptance criteria, study details, and ground truth establishment:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device appear to be primarily focused on its analytical performance metrics, specifically method comparison (correlation coefficient and slope) and precision (CV%). The document compares the new parameter settings on the ACL Futura/Advance to a legally marketed predicate device on the ACL TOP.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (HemosIL RecombiPlasTin with optimized parameters on ACL Advance) |
|---|---|---|
| Prothrombin Time (PT) | ||
| CV% (Within run) | Not explicitly stated (but shown for predicate) | Normal Control: 0.9%, Low Abnormal: 1.4%, High Abnormal: 1.4% |
| CV% (Total) | Not explicitly stated (but shown for predicate) | Normal Control: 1.3%, Low Abnormal: 2.3%, High Abnormal: 3.9% |
| Correlation Coefficient (r) | Close to 1.0 (High correlation with predicate) | 0.9985 |
| Slope | Close to 1.0 (Agreement with predicate) | 1.039 |
| Fibrinogen | ||
| CV% (Within run) | Not explicitly stated (but shown for predicate) | Not provided for Fibrinogen in this table |
| CV% (Total) | Not explicitly stated (but shown for predicate) | Not provided for Fibrinogen in this table |
| Correlation Coefficient (r) | Close to 1.0 (High correlation with predicate) | 0.9811 |
| Slope | Close to 1.0 (Agreement with predicate) | 0.938 |
Note: The exact numerical acceptance criteria are not explicitly stated as "must be greater than X" or "less than Y." Instead, the performance values of the legally marketed predicate device (HemosIL RecombiPlasTin on ACL TOP and HemosIL Fibrinogen-C on ACL TOP) serve as the benchmark for substantial equivalence. The reported values demonstrate very strong correlation and close agreement with the predicate for both PT and Fibrinogen, indicating the device meets the implied acceptance criteria for equivalence.
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 98 citrated plasma samples used for the method comparison study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "citrated plasma samples," which are human biological specimens. It's not specified if they were prospective or retrospective samples. As this is an in vitro diagnostic test for coagulation, the samples would likely be from a clinical setting, but further details are not provided.
3. Number of Experts and Qualifications for Ground Truth of the Test Set
This type of device (Prothrombin Time and Fibrinogen determination) relies on quantitative measurements, not subjective interpretation. Therefore, there are no "experts" in the traditional sense establishing a ground truth based on visual or interpretive assessment. The "ground truth" or reference method is the measurement obtained from the legally marketed predicate device (HemosIL RecombiPlasTin on ACL TOP for PT and HemosIL Fibrinogen-C on ACL TOP for fibrinogen).
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is established by a reference measurement from a predicate device, not through expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable.
- This is an in vitro diagnostic (IVD) device, specifically a reagent for automated coagulation analyzers.
- It does not involve human readers interpreting images or data in a way that would necessitate an MRMC study.
- The comparison is between two automated systems (the new device on ACL Futura/Advance vs. the predicate on ACL TOP), not between human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, this is essentially a standalone performance study. The HemosIL RecombiPlasTin reagent, when run on the ACL Futura/Advance, performs the measurements automatically. The reported performance metrics (precision, slope, correlation) represent the analytical performance of the optimized reagent-instrument combination without human intervention in the measurement process itself. The "comparison" is the standalone performance of the new configuration against the standalone performance of the predicate configuration.
7. Type of Ground Truth Used
The ground truth used is a reference measurement from a legally marketed predicate device. Specifically:
- For Prothrombin Time (PT), the reference was the HemosIL RecombiPlasTin on the ACL TOP.
- For Fibrinogen, the reference was the HemosIL Fibrinogen-C on the ACL TOP.
This is a common approach for demonstrating substantial equivalence for IVD devices, comparing the new device's measurements to those of an established, cleared device.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" in the context of machine learning or AI models. This device is a reagent with optimized parameters for existing instruments. The text states:
"The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert."
This "optimization" process would involve internal development and testing to fine-tune the parameters. However, the specific size of the dataset used during this optimization phase is not provided in this 510(k) summary. The 98 plasma samples are explicitly described as being part of the method comparison study (which acts as the test set for regulatory submission).
9. How the Ground Truth for the Training Set Was Established
As there isn't a "training set" in the common AI/machine learning sense, the ground truth for any internal optimization would likely have been established in a similar manner to the test set: by running control plasmas and potentially patient samples on the predicate device (ACL TOP) to define the target reference values that the optimized parameters on the new instruments (ACL Futura/Advance) aimed to match. The goal was to achieve "improved correlation with the ACL TOP."
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).