(245 days)
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
| Parameter/Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | %CV less than 4% | Total precision for all assays had a %CV of less than 4%. |
| Method Comparison | Line of regression at a 95% confidence interval shows statistical identity between MTX II and MTX III. | Line of regression at a 95% confidence interval demonstrated statistical identity. |
| Interference Testing | High positive correlation coefficient (e.g., 0.88-0.99) for samples with interfering substances, demonstrating equivalence to predicate device. | High positive correlation coefficient range 0.88-0.99 was observed. Equivalent to Coag-A-Mate MTX II. |
| On-board Stability | Equivalent performance to the Coag-A-Mate MTX II. | Demonstrated equivalence to the Coag-A-Mate MTX II. |
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.
§ 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.