(56 days)
HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems. Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor XII in the patient plasma, interpolated from a calibration curve.
Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor XII Deficient Plasma, based on the provided text:
Acceptance Criteria and Reported Device Performance
For this specific device, the acceptance criteria are not explicitly stated as numerical cutoffs. Instead, the study aims to demonstrate substantial equivalence to predicate devices. This means that the new device's performance, as measured by method comparison and precision, should be comparable to the legally marketed predicates.
The summary highlights:
- Method Comparison: Consistency in results (slope and correlation coefficients) when compared to predicate devices across different IL systems. A slope close to 1 and a correlation coefficient (r) close to 1 indicate strong agreement.
- Precision: Acceptably low variability (Within run %CV and Between Run %CV) for both normal and abnormal controls.
| Performance Metric | Specific Criterion (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Method Comparison (New vs. Predicate HemosIL Factor XII Deficient Plasma on ACL Family) | ||
| ACL 3000 (n=71) | Slope ≈ 1, r ≈ 1 | Slope: 0.9284, r: 0.9882 |
| ACL 10000 (n=71) | Slope ≈ 1, r ≈ 1 | Slope: 0.9116, r: 0.9704 |
| ACL Advance (n=70) | Slope ≈ 1, r ≈ 1 | Slope: 1.0065, r: 0.9687 |
| ACL TOP (n=72) | Slope ≈ 1, r ≈ 1 | Slope: 1.0739, r: 0.9551 |
| Method Comparison (New vs. Predicate Hemoliance Factor XII Deficient Plasma on ELECTRA) | ||
| E1600C (n=73) | Slope ≈ 1, r ≈ 1 | Slope: 0.9918, r: 0.9863 |
| Within Run Precision (%CV) | Low %CV for both normal and abnormal controls | |
| ACL 9000 Normal Control | 1.9 %CV | |
| ACL 9000 Special Test Control Level 2 | 2.6 %CV | |
| ACL Futura Normal Control | 3.0 %CV | |
| ACL Futura Special Test Control Level 2 | 2.3 %CV | |
| ACL TOP Normal Control | 4.7 %CV | |
| ACL TOP Special Test Control Level 2 | 6.1 %CV | |
| ELECTRA 1600C Normal Control | 3.4 %CV | |
| ELECTRA 1600C Special Test Control Level 2 | 3.5 %CV | |
| Between Run Precision (%CV) | Low %CV for both normal and abnormal controls | |
| ACL 9000 Normal Control | 3.4 %CV | |
| ACL 9000 Special Test Control Level 2 | 3.3 %CV | |
| ACL Futura Normal Control | 2.9 %CV | |
| ACL Futura Special Test Control Level 2 | 3.8 %CV | |
| ACL TOP Normal Control | 3.1 %CV | |
| ACL TOP Special Test Control Level 2 | 3.2 %CV | |
| ELECTRA 1600C Normal Control | 7.8 %CV | |
| ELECTRA 1600C Special Test Control Level 2 | 4.3 %CV |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size (Method Comparison): Approximately 70-73 citrated plasma samples per comparison (e.g., 71 for ACL 3000, 70 for ACL Advance, 73 for ELECTRA 1600C).
- Sample Size (Precision): Not explicitly stated how many unique samples were used to create the controls, but precision was assessed over multiple runs (n=80) for each instrument and control type.
- Data Provenance: "In-house method comparison study." This suggests the data was generated by the manufacturer, likely in a controlled laboratory setting. The country of origin is not specified, but the manufacturer is based in Lexington, MA, USA. The study appears to be prospective for the new device as it's being compared to established predicates.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an in vitro diagnostic (IVD) for quantitative determination of factor XII activity, not an image-based diagnostic or clinical decision support system that relies on expert human interpretation for ground truth. The "ground truth" (or reference standard) in this context is the measurement obtained from the predicate devices.
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Adjudication method for the test set:
- Not applicable. As above, this is an IVD device measuring a quantitative value, not subject to expert adjudication in the way an imaging study or qualitative diagnostic might be. The comparison is objective, based on measured values.
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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 is an IVD device, not an AI-assisted diagnostic tool that involves human readers interpreting results.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. Its performance is evaluated directly on patient samples (or controls) by comparing its measurements to those of predicate devices. The "algorithm" here is the biochemical assay and the instrument's processing of the reaction, without human interpretation as a performance variable.
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The type of ground truth used:
- For the method comparison, the "ground truth" or reference standard for comparison was the measurements obtained from the predicate devices (HemosIL Factor XII Deficient Plasma on ACL Family and Hemoliance Factor XII Deficient Plasma on ELECTRA). These are established, legally marketed devices.
- For precision, the ground truth is against the statistical mean of the measurements themselves, for "Normal Control" and "Special Test Control Level 2" materials.
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The sample size for the training set:
- Not applicable in the typical sense of machine learning. This device functions as a biochemical assay, not an AI/ML model that requires a "training set" to learn from data. Its performance is based on the inherent chemical and biological principles of the assay and its manufacturing quality, not a learned algorithm.
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How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).