(222 days)
The Dade Behring BFTII is a semi-automated device intended for use to determine PT, aPTT, and Fibrinogen.
Dade Behring BFTII is a semi-automated opto-mechanical coagulation analyzer. The BFTII is used in conjunction with coagulation reagents for measurement of various coagulometric tests.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring BFTII, based on the provided 510(k) notification:
This document focuses on a medical device, not an AI algorithm. Therefore, many of the requested fields pertinent to AI studies (like MRMC effectiveness, training set details, or ground truth establishment for a training set) are not applicable or directly derivable from this type of submission. The study described is a performance comparison of a new medical device against legally marketed predicate devices, not an AI efficacy study.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list "acceptance criteria" in the traditional sense of a specified threshold for performance metrics. Instead, it claims substantial equivalence to existing legally marketed devices (Dade Behring BCT and CA-6000) based on similar intended use and results obtained through quantitative measurement of coagulometric tests via optical clot detection.
The comparison information provided is summarized conceptually as:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (BFTII) |
|---|---|---|
| Intended Use | Substantially equivalent to BCT & CA-6000 | Intended for use to determine PT, aPTT, and Fibrinogen (Same as predicates) |
| Measurement Method | Substantially equivalent to BCT & CA-6000 | Performs quantitative measurement of coagulometric tests by optical clot detection (Same as predicates) |
| Results Obtained | Substantially equivalent to BCT & CA-6000 | (Implied to be comparable, specific data not provided in summary) |
Note: The 510(k) summary is a high-level overview. Detailed performance data (e.g., precision, accuracy, correlation with predicate devices) would be found in the full 510(k) submission, which is not fully provided here. The summary focuses on stating the basis for substantial equivalence rather than presenting raw performance numbers against pre-defined thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be in the detailed performance data submitted to the FDA, but it's not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this device and submission. The BFTII is an automated laboratory analyzer. Its "ground truth" for PT, aPTT, and Fibrinogen measurements would be established through comparison with reference methods or existing validated devices, often involving statistical analysis of quantitative results, not expert consensus on image interpretation or clinical diagnoses.
4. Adjudication Method for the Test Set
This is not applicable as the device performs quantitative measurements, not subjective interpretation requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
This is not applicable. The BFTII is a semi-automated coagulation analyzer and does not involve human readers for interpretation in the way an imaging AI algorithm would. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a "standalone" instrument in that it performs the measurements automatically. The performance study would have focused on the accuracy, precision, and comparability of its quantitative output to predicate devices or reference methods. It's a device, not an AI algorithm, so the term "standalone algorithm performance" doesn't directly apply in the AI sense. Its performance is intrinsically "standalone" in its operation.
7. The Type of Ground Truth Used
For a coagulation analyzer, the "ground truth" would typically be established through:
- Comparison to a gold standard or reference method: Highly accurate laboratory assays known for their reliability.
- Comparison to legally marketed predicate devices: As implied by the substantial equivalence claim. This involves running the same patient samples on both the new device and the predicate(s) and comparing the quantitative results statistically (e.g., correlation, bias, agreement).
The summary implies the ground truth for comparison was established via results obtained from legally marketed predicate devices (Dade Behring BCT and CA-6000) for coagulometric tests.
8. The Sample Size for the Training Set
This is not applicable. The BFTII is a hardware and software system for performing specific laboratory tests, not a machine learning model that undergoes a "training phase" with a labeled dataset in the AI sense. Its design and calibration would follow engineering, chemistry, and metrology principles, not AI training paradigms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. The device is not an AI algorithm that learns from data.
§ 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.