FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range. The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are a combination of the two predicate devices. The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains heparin.

AI/ML Overview

The provided text is a 510(k) summary for the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and does not contain information about acceptance criteria or a study demonstrating device performance against such criteria in the way a typical efficacy or performance study would.

This document describes a quality control material, which is used to verify the calibration of an already approved diagnostic device (the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter). The purpose of this 510(k) submission is to demonstrate substantial equivalence to previously approved predicate devices, not to establish the diagnostic performance of a new primary diagnostic tool.

Therefore, many of the requested sections about acceptance criteria, clinical study design, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth for a diagnostic device are not applicable or cannot be extracted from this document, as this is not the type of study presented for quality control materials for calibration verification.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated for this quality control material in terms of diagnostic performance. For quality control materials, acceptance criteria would typically relate to their stability, homogeneity, and their ability to produce expected results within a predefined range when run on the associated diagnostic system. These specific criteria are not detailed in the provided summary.
Reported Device Performance: The primary "performance" reported is its substantial equivalence to predicate devices, noting the only difference is the matrix (EDTA vs. heparin). No specific numerical performance metrics are provided for the control material itself in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. A "test set" in the context of clinical performance is not relevant here as this is a calibration verification control.

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

Not applicable; "ground truth" in a diagnostic sense is not relevant for a calibration control material.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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 a quality control material, not a diagnostic device involving human readers or AI.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm or a diagnostic test with a "training set" in that sense.

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

Not applicable.

Summary of what is available from the document:

The study presented is a substantial equivalence comparison between the new device and predicate devices.

Key finding: The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are substantially equivalent to previously approved predicate devices (Triage® Cardiac Calibration Verification Controls (K974827) and Triage® BNP Calibration Verification Controls (K000231)).
Difference from Predicates: The only difference noted is that the new controls are prepared in a matrix containing EDTA, while the predicate Triage® Cardiac Calibration Verification Controls were prepared in a matrix containing heparin. This indicates that the study likely focused on demonstrating that this change in matrix did not negatively affect the control's ability to perform its intended function (verify calibration) compared to the heparin-based controls.
Intended Use: To verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range when used with the Triage® Meter.

In conclusion, this document describes a regulatory submission for a quality control product, not a clinical study to establish diagnostic performance against specific acceptance criteria in the manner requested.

Summary

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.