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This is a multipurpose system for in vitro diagnostic coagulation studies and capable of performing clotting, chromogenic, and immunoassays.

The COAG-A-MATE MTX III is a multipurpose system for in vitro diagnostic coagulation studies capable of performing clotting, chromogenic, and immunoassays. It uses a photo-optical detection principle with an LED based optical system. The measuring module consists of a measuring rotor and a photometer with two channels, each containing 2 LEDs (405 nm and 570 nm), 3 lenses, filters, and a photo-detector. A light beam passes through the cuvette and is received by the photo-detector. Changes in light transmittance are detected and converted into an electrical signal. The software controls the mechanical, fluidic, thermal, and optical functions to manipulate patient fluids, combine reagents with samples in a cuvette ring, track samples, integrate the relevant cuvette, and return results to be analyzed by the applicable assay algorithm. The software also provides an operator interface for managing patient information and test results.

The provided document outlines the acceptance criteria and study findings for the Coag-A-Mate MTX® III, a multipurpose system for in vitro coagulation studies.

1. Table of Acceptance Criteria and Reported Device Performance

Overall Conclusion: The studies consistently demonstrated that the overall performance of the Coag-A-Mate MTX III system is equivalent to that of the predicate Coag-A-Mate MTX II system.

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

• Precision Study: Not explicitly stated, but performed according to NCCLS Document EP5-A.
• Method Comparison Experiment: Plasma from normal donors and clinically abnormal specimens were tested over twenty-two testing days. Each plasma sample was tested in duplicate. The total number of individual samples is not specified.
• Interference Testing: Clinical samples with noticeable levels of lipemia, bilirubin, or both were used. The exact number of samples is not specified.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission to the FDA, it's likely conducted in the US or under US regulatory guidelines. The studies appear to be prospective for the purpose of validating the new device against its predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is an in-vitro diagnostic system that measures clotting times and other coagulation parameters directly. The "ground truth" for its performance is established through quantitative measurements and comparisons with a predicate device, as opposed to qualitative expert interpretation of images or other data. Therefore, expert consensus on test set ground truth is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for the performance evaluation of this in-vitro diagnostic device.

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 device, not an AI-assisted diagnostic tool that requires human reader interpretation. No MRMC study was conducted or is relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described (precision, method comparison, interference testing, and on-board stability) assess the standalone performance of the Coag-A-Mate MTX III system. The device itself, described as having "identical analysis algorithm methodologies" to its predecessor, operates without human-in-the-loop performance for result generation.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Coag-A-Mate MTX III was primarily based on:

• Quantitative measurements: Direct coagulation times (in seconds for clotting assays) and extinction values (mE/sec for chromogenic assays).
• Comparison to a predicate device: The Coag-A-Mate MTX II system served as the established "truth" or reference standard, with the goal of demonstrating statistical equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an in-vitro diagnostic instrument, not the training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. The device's underlying algorithms are based on established photo-optical detection principles and analysis methodologies rather than iterative learning from a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm in this context.

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The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.

Automated system for in vitro coagulation studies, clot based and chromogenic.

The provided text describes the Coag-A-Mate MTX, a multipurpose system for in vitro coagulation studies. Here's a breakdown of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a quantitative format before presenting the results. Instead, it presents performance metrics and compares them to typical system performance and NCCLS recommendations, implying these form the basis of acceptance.

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

• Sample Size for Test Set: The document mentions "patient specimens over the normal, diagnostic and therapeutic range." It does not provide a specific number of patient samples used for the comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It refers to "patient specimens," implying real-world data. It is a prospective study in the sense that the study was conducted for this device clearance, but the patient samples themselves could have been collected prospectively or retrospectively. The document doesn't clarify this detail.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The documentation describes performance using "patient specimens" and control plasma. For coagulation assays, the ground truth is typically assessed through established reference methods and/or comparison against a predicate device. There is no mention of "experts" establishing ground truth in the context of interpreting results or consensus. The ground truth for such devices is usually the result of a validated reference method or the performance of a legally marketed predicate device.

4. Adjudication Method for the Test Set

• Not applicable. This type of device (in vitro diagnostic for coagulation studies) does not typically involve human adjudication of results in the way image analysis or clinical endpoint studies might. The results are quantitative measurements compared against established ranges or predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective clinical assessments where multiple human readers interpret cases. The Coag-A-Mate MTX is an automated system providing quantitative measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

• Yes, the performance data presented is for the device in a standalone capacity. The device is an automated system, and its performance (correlation, precision, etc.) is measured directly on patient samples and controls, not as a human-assisted tool.

7. The Type of Ground Truth Used

• The ground truth used was based on:
  • Comparison to a Legally Marketed Predicate Device: The study's primary goal was to demonstrate substantial equivalence to the Organon Teknika MDA-180 and Organon Teknika Coag-A-Mate X2.
  • Established Clinical Ranges and Controls: Performance was evaluated across normal, diagnostic, and therapeutic ranges, likely utilizing results from established reference methods or assays for these ranges.
  • Commercially Available Normal and Abnormal Control Plasma: Used for precision studies.

8. The Sample Size for the Training Set

• Not applicable as this is an in-vitro diagnostic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's operational parameters and algorithms are designed and validated, not trained from data in the same way an AI model would be.

9. How the Ground Truth for the Training Set was Established

• Not applicable for the reasons stated in point 8.

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