(29 days)
HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
This document describes the performance data for the HemosIL SynthASil device after optimization of its APTT parameter settings on the ACL Futura and ACL Advance systems. The stated purpose of this submission is to demonstrate substantial equivalence to the predicate device (K953981 HemosIL SynthASil) and to the HemosIL SynthASil reagent run on the ACL TOP system (K033414).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly uses the performance of the predicate device (K953981 HemosIL SynthASil) and the HemosIL SynthASil on the ACL TOP (K033414) as the acceptance criteria for achieving "improved correlation" and "substantial equivalence." While explicit numerical acceptance criteria are not presented in a table format, the performance data provided aims to demonstrate this correlation.
| Performance Metric | Acceptance Criteria (Implicit - from predicate/ACL TOP) | Reported Device Performance (ACL Futura/Advance with optimized settings) |
|---|---|---|
| Within Run Precision | Similar or equivalent precision to predicate device and/or HemosIL SynthASil on ACL TOP. | Normal: Mean 28.5 seconds, CV% (Within run) 0.6, CV% (Total) 0.6 |
| Low Abnormal: Mean 49.0 seconds, CV% (Within run) 0.8, CV% (Total) 0.9 | ||
| High Abnormal: Mean 62.5 seconds, CV% (Within run) 0.7, CV% (Total) 0.8 | ||
| Method Comparison | Strong correlation with the predicate device/ACL TOP system, indicated by slope close to 1, intercept close to 0, and high correlation coefficient (r close to 1). | Slope: 1.011, 0.984, 0.994, 0.973 (across 4 lots) |
| Intercept: -0.664, 0.293, 0.159, 1.260 (across 4 lots) | ||
| r: 0.9979, 0.9987, 0.9976, 0.9973 (across 4 lots) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set: The sample size for the precision study is not explicitly stated as a number of individual samples. It mentions "three levels of control plasma" and "assessed over multiple runs." This implies multiple measurements were taken for each of these three control levels.
- Method Comparison Test Set: For each of the four SynthASil lots, n=93 or n=92 citrated plasma samples were used.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, performed to optimize and validate the device settings for regulatory submission. The samples are referred to as "human citrated plasma."
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 (reagent for APTT determination) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" for the method comparison is the measurement obtained from the predicate device or the ACL TOP system, which are themselves validated instruments. Therefore, there were no human experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an objective measurement study comparing an optimized device's performance to established methods, not subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This study concerns the performance of an in-vitro diagnostic reagent and instrument settings, not a device that involves human interpretation of results requiring a comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, this is effectively a standalone performance study. The document describes the performance of the HemosIL SynthASil reagent and its optimized settings on the ACL Futura and ACL Advance instruments. The results reported (precision, slope, intercept, r) are direct measurements from the device system without requiring human-in-the-loop analysis. The "algorithm" here refers to the optimized parameter settings and the reagent's performance characteristics.
7. Type of Ground Truth Used
- The ground truth used for the method comparison study was the measurements obtained from a legally marketed predicate device (K953981 HemosIL SynthASil) or an equivalent, legally marketed device (HemosIL SynthASil on the ACL TOP system - K033414). This is a form of "reference standard" or "comparative standard" established by existing, validated medical devices.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. Instead, it refers to the "optimization" of APTT parameter settings. While this optimization process would have involved testing and refining these settings on various samples, the specific sample size, type, and method used for this optimization are not detailed in this summary. It's implied that the "optimization" process served a similar purpose to training, but no specific dataset is identified as a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicitly defined "training set" in the context of an AI/ML model, the concept of establishing ground truth for it is not directly applicable here. The "optimization" likely involved iterative adjustments of the parameter settings and testing them against known reference values or comparative measurements (similar to the method comparison's ground truth, but likely a larger or different set of samples used during development) to achieve the desired performance, particularly for correlation with the ACL TOP and predicate devices.
§ 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).