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.

Device Description

AI/ML Overview

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 < 6%	CV < 6% for all studies

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

Beta Sites Performance Studies:
- Sample Size: More than 45 samples (each potentially comprising a PT and APTT measurement) were analyzed at each of the three physician office laboratories (POLs). So, a total of 3 POLs * >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.

Summary

{0}------------------------------------------------

510(k) NOTIFICATION

Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103

KC 1 A Micro Coagulation Analyzer December 15, 1995

MAR 12 4955334

ATTACHMENT 1

Summary of Safety and Effectiveness

{1}------------------------------------------------

510(k) NOTIFICATION

Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103

KC 1 A Micro Coagulation Analyzer December 15, 1995

ATTACHMENT 1

510(k) Summary of Safety and Effectiveness

In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 1 A. Split samples from the same specimens were also analyzed using the KC 1 A at Sigma Diagnostics, the study's reference laboratory. PT and APTT assays were performed at all sites. The correlation coefficient and the regression equation for these comparisons were as follows:

Site #1:	PT:	r = 0.981	y = 1.018x + 0.129
	APTT:	r = 0.935	y = 1.050x + 2.057
Site #2:	PT:	r = 0.992	y = 0.950x + 0.617
	APTT:	r = 0.922	y = 1.026x + 1.924
Site #3:	PT:	r = 0.981	y = 1.012x + 0.181
	APTT:	r = 0.929	y = 0.961x + 3.964

Precision studies were also performed at all sites. Results were within acceptable limits.

In in-house performance studies. PT and APTT were performed on more than one hundred samples using both the KC 1 A and the Fibrometer. The CA-5000 was used as the predicate device for the fibrinogen. The correlation coefficient and the regression equation were as follows:

PT:	r = 0.987	$y = 1.046x - 0.280$
APTT:	r = 0.867	$y = 1.263x - 1.647$
Fibrinogen:	r = 0.932	$y = 1.065x + 29.375$

Precision studies were performed in-house. The coefficient of variation (CV) for all studies was less than 6%.

These data clearly demonstrate that the performance of the KC 1 A Micro Coagulation Analyzer is substantially equivalent to the performance of the predicate device.

Regulation Number and Section

§ 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.