(90 days)
The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.
The Behring Coagulation System (BCS) is a fully automated coagulation instrument. The BCS is used in conjunction with Behring Diagnostics test kits to perform various coagulometric and chromogenic coagulation tests.
This 510(k) summary for the Behring Coagulation System (BCS) focuses on establishing substantial equivalence to previously cleared devices rather than defining and proving specific acceptance criteria in the manner of a new device demonstrating clinical performance. Therefore, many of the requested elements for a study demonstrating acceptance criteria are not directly applicable or explicitly stated in this document.
However, I will extract the information that is present and explain why other requested information is not available in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, specific "acceptance criteria" for novel clinical performance metrics are not explicitly defined in the document. Instead, the performance is compared against previously cleared devices (Behring Coagulation Timer (BCT) and Behring Fibrintimer A (BFA)). The criteria used for substantial equivalence in this context are:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Behring Coagulation System (BCS)) |
|---|---|
| Correlation with Predicate Devices: Regression analysis correlation coefficient (r) for various coagulometric and chromogenic assays. | Range of 0.97 to 0.996 when compared to BCT or BFA instruments. |
| Precision (Within-Run): Following NCCLS EP5 guideline using normal and abnormal range samples. | Range of 0.5 to 6.3% |
| Precision (Total): Following NCCLS EP5 guideline using normal and abnormal range samples. | Range of 0.90 to 8.1% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Comparative Analysis (Regression): Not explicitly stated. The document mentions "Sample correlation data were collected... using various coagulometric and chromogenic assays," but does not provide the number of samples or patients used for these correlations.
- Sample Size for Precision Studies: Not explicitly stated. The document mentions "Precision studies were performed... using samples which were in the normal and abnormal ranges," but does not provide the number of samples or replicates.
- Data Provenance: Not explicitly stated. Typically, for such instrument validations, the studies would be conducted internally by the manufacturer or by a contracted lab. The country of origin is not mentioned, nor is whether the data was retrospective or prospective. Given the nature of laboratory instrument validation, it would likely involve prospectively run samples on the new and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For an in vitro diagnostic (IVD) instrument like the Behring Coagulation System, the "ground truth" for the test set is established by the reference methods or predicate devices themselves for comparative studies, or by the inherent properties of the quality control materials used for precision studies. Expert opinion is not typically used to establish ground truth for quantitative laboratory measurements in this context.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in imaging or diagnostic accuracy studies where expert readers might disagree on an interpretation. For a quantitative IVD instrument, the results are numerical, and the comparison is statistical (e.g., regression, precision statistics) rather than interpretive, so no adjudication method is required.
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 is an in vitro diagnostic instrument, not an AI-powered diagnostic system that assists human readers in interpretation. Therefore, an MRMC study or analysis of human reader improvement with AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The performance data presented (correlation and precision) reflects the "standalone" performance of the Behring Coagulation System instrument itself, without human interpretation influencing the measurement results. The instrument processes samples and generates numerical results directly.
7. The Type of Ground Truth Used
The "ground truth" in this context is established in two ways:
- For Comparative Analysis: The results obtained from the predicate devices (Behring Coagulation Timer and Behring Fibrintimer A) for the same samples serve as the comparative reference.
- For Precision Studies: The accepted values or expected ranges of the quality control materials used are considered the reference point for assessing precision.
8. The Sample Size for the Training Set
Not applicable. The Behring Coagulation System is an analytical instrument, not a machine learning or AI algorithm that requires a "training set." Its operation is based on established electrochemical or optical principles for coagulation assays, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.