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510(k) Data Aggregation
(85 days)
The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 1 A.
The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sigma Diagnostics KC 1 A Micro Coagulation Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format with pass/fail thresholds. Instead, it presents correlation coefficients and regression equations as measures of performance compared to a reference method or predicate device. For the purpose of this table, I will interpret the presented correlation coefficients as the demonstrated performance, with the implicit acceptance being that these values demonstrate "substantial equivalence."
| Metric / Test | Acceptance Criteria (Implicit) | Reported Device Performance (KC 1 A vs. Reference/Predicate) |
|---|---|---|
| Beta Sites Performance Studies (KC 1 A vs. Sigma Diagnostics Lab Reference) | ||
| Site #1 PT | High correlation (e.g., r > 0.9) | r = 0.981 |
| Site #1 APTT | High correlation (e.g., r > 0.9) | r = 0.935 |
| Site #2 PT | High correlation (e.g., r > 0.9) | r = 0.992 |
| Site #2 APTT | High correlation (e.g., r > 0.9) | r = 0.922 |
| Site #3 PT | High correlation (e.g., r > 0.9) | r = 0.981 |
| Site #3 APTT | High correlation (e.g., r > 0.9) | r = 0.961 |
| Precision (all sites) | Within acceptable limits | "Results were within acceptable limits" |
| In-House Performance Studies (KC 1 A vs. Fibrometer for PT/APTT, CA-5000 for Fibrinogen) | ||
| PT | High correlation (e.g., r > 0.9) | r = 0.987 |
| APTT | High correlation (e.g., r > 0.85) | r = 0.867 |
| Fibrinogen | High correlation (e.g., r > 0.9) | r = 0.932 |
| Precision (in-house) | CV 45 samples = >135 samples for the comparison with the reference lab. |
* **Data Provenance:** Retrospective (split samples from the same specimens). The country of origin is not specified, but the manufacturer is US-based (St. Louis, MO), suggesting the studies were likely conducted in the US.
- In-House Performance Studies:
- Sample Size: More than one hundred samples for PT and APTT. Fibrinogen sample size is not explicitly stated but is implied to be similar or part of the same "more than one hundred samples."
- Data Provenance: Retrospective (implied by "in-house performance studies" using existing samples). Country of origin is not specified but is likely US, given the manufacturer's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable as the device is an in-vitro diagnostic (IVD) intended for quantitative measurements, not for interpretation by human experts. The "ground truth" or reference standard for these studies comes from established laboratory reference methods (e.g., the Sigma Diagnostics reference laboratory, Fibrometer, CA-5000) and not from human expert consensus.
4. Adjudication Method for the Test Set:
- This information is not applicable for the same reason as point 3. There was no expert adjudication involved; performance was compared against quantitative reference measurements.
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:
- No, an MRMC comparative effectiveness study was not conducted. This device is an automated coagulation analyzer, not an AI-powered diagnostic imaging or interpretation tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, the entire study focuses on the standalone performance of the KC 1 A Micro Coagulation Analyzer. It is a completely automated system for clot detection, and its performance is evaluated independent of human interpretation or intervention during the measurement process. The comparison is between the KC 1 A's measurements and those of reference methods.
7. The Type of Ground Truth Used:
- The "ground truth" was established by measurements obtained from established, predicate, or reference laboratory methods:
- For the beta site studies, the reference was the KC 1 A results from Sigma Diagnostics, the study's reference laboratory. This implies the Sigma Diagnostics lab was performing the tests on a gold-standard or highly accurate method.
- For the in-house studies, the reference for PT and APTT was the Fibrometer, and for Fibrinogen, it was the CA-5000 (identified as the predicate device).
8. The Sample Size for the Training Set:
- The provided text does not mention a training set. This device is a mechanical clot detection system, not a machine learning or AI-based device that would typically require a training set for model development. Its performance is based on its mechanical and optical principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as no training set was mentioned or implied for this type of device.
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