(13 days)
The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to assist the laboratory in monitoring test performance.
The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to assist the laboratory in monitoring test performance.
This 510(k) summary describes a device that is a quality control material, not a diagnostic or prognostic device that relies on studies with human subjects. Therefore, many of the typical acceptance criteria and study design elements requested in the prompt (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
The document focuses on demonstrating substantial equivalence to predicate devices, which is the standard for 510(k) clearances for such products.
Here's a breakdown of the available information in relation to your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance criterion for this 510(k) submission is "substantial equivalence" to predicate devices. The reported "performance" is that the device is substantially equivalent.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The Triage® Cardio ProfilER / Triage® Cardiac Controls are substantially equivalent to previously approved predicate devices (Triage® Cardiac Controls K974461 and Triage® BNP Controls K000230). |
| Safe and Effective for Intended Use | The Triage® Cardio ProfilER / Triage® Cardiac Controls are safe and effective for their intended use (monitoring test performance of the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter). |
Study Information (as applicable for a Quality Control Device)
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Sample size used for the test set and the data provenance: Not applicable. This is a quality control material, not a diagnostic test evaluated on patient samples. The "test set" would typically refer to stability studies, linearity, or value assignment studies for the control material itself, but these details are not provided in this 510(k) summary. The comparison focuses on the matrix difference.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for a quality control material's 510(k) submission.
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Adjudication method for the test set: Not applicable.
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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 not an AI device or a diagnostic device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical control material, not an algorithm.
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The type of ground truth used: Not applicable in the sense of clinical "ground truth." The ground truth for a control material would be its assigned target values based on a robust value assignment process, but this is not detailed in the summary.
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The sample size for the training set: Not applicable. There is no "training set" in the context of an algorithm or AI.
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How the ground truth for the training set was established: Not applicable.
Explanation Based on Device Type
This 510(k) submission is for Quality Control Material. For such devices, "studies" usually involve:
- Manufacturing and Lot Release Testing: Ensuring consistency between lots, correct analyte concentrations, and stability over the shelf life.
- Method Comparison: If there are changes to components or manufacturing, studies may show that the new control material behaves similarly in the assay to the previous version or predicate.
- Value Assignment: Determining the target values and ranges for the control material using accepted statistical methods and reference instruments/methods.
The core of this 510(k) summary revolves around the statement: "The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Controls are prepared in a matrix that contains heparin." This implies that the manufacturer would have performed internal testing to demonstrate that this matrix difference does not adversely affect the control's performance with the intended assay, thus maintaining substantial equivalence. These details, however, are not explicitly provided in the summary but would have been part of the full 510(k) submission.
§ 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.