Search Results

The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.

The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KC 40 Micro Coagulation Analyzer:

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. The "acceptance criteria" are implied by the comparison studies, where strong correlation and acceptable coefficients of variation indicate performance similar to existing, approved devices.

Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are not explicitly stated as distinct thresholds but are inferred from the comparison study results, demonstrating equivalence to predicate devices. The reported device performance is presented as regression statistics (r-values, slope, intercept) and coefficients of variation (CV%).

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not specify the sample size (number of patient samples) used for the comparison studies.
   • Data Provenance: The document does not specify the country of origin of the data. It implies the studies are retrospective comparisons to established predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not fully applicable as the "ground truth" for this type of device (a coagulation analyzer) is typically established by the results obtained from a predicate device (an already approved and validated analyzer) or by established laboratory reference methods, rather than human expert consensus. The predicate devices (TOA Medical Electronics CA-5000 and BBL Fibrometer) serve as the reference for comparison.

3. Adjudication method for the test set:

   • Not applicable. This type of device validation does not involve human adjudication of results in the traditional sense. The comparison is quantitative between two analytical instruments.

4. 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 a device for automated coagulation analysis, not an AI-assisted diagnostic imaging system involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, implicitly. The comparison studies demonstrate the performance of the KC 40 Micro Coagulation Analyzer as a standalone automated device by comparing its output directly to that of other standalone automated analyzers. There is no mention of human-in-the-loop interaction affecting the analytical results themselves.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" is established by the results obtained from the predicate devices (TOA Medical Electronics CA-5000 and BBL Fibrometer). These are considered the accepted standard for coagulation measurements against which the new device is being compared for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This device is not described as using machine learning or AI that requires a "training set" in the conventional sense. Its operational parameters and algorithms are likely based on established coagulation science and engineering principles, not on iterative machine learning from a data set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a training set for a machine learning algorithm.

Summary of the K960875 Submission:

This 510(k) notification for the Sigma Diagnostics KC 40 Micro Coagulation Analyzer demonstrates substantial equivalence by comparing its performance against two predicate devices: the TOA Medical Electronics CA-5000 and the BBL Fibrometer. The key performance metrics are correlation coefficients (r-values) and linear regression equations for PT, APTT, Fibrinogen, Factor IX, and Factor X, showing strong agreement with the predicate devices. Additionally, precision studies reported low coefficients of variation (CV%) for these assays, indicating good reproducibility. The submission relies on the established performance of the predicate devices as the benchmark for safety and effectiveness.

Ask a specific question about this device