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The IRMA TRUpoint™ Creatinine Control Kit is for use on the IRMA TRUpoint™ Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System. For in vitro Diagnostic Use Only

The Creatinine Control Kit includes creatinine control materials at two levels for monitoring the IRMA analyzer performance at different points in the range of intended clinical utility. The control materials are packaged in capped luer lock syringes, each containing 1.5 ml of solution. The syringes are in turn packaged in pouches. Three (3) pouches/syringes for low level and three (3) pouches/syringes for high level are packaged in a box. The Cr control is an aqueous based solution of creatinine and sucrose. This control contains no human or biological materials.

The provided document is a 510(k) summary for the IRMA TRUpoint™ Creatinine Control Kit. This submission is for a quality control material intended to monitor the performance of an analyzer, not for a diagnostic device that measures patient analytes directly. Therefore, the concepts of sensitivity, specificity, or diagnostic accuracy as typically applied to medical devices for patient diagnosis or screening do not apply in the same way.

The "acceptance criteria" for a quality control material generally relate to its stability, consistency, and ability to generate expected values when tested on the intended analyzer. The study presented here is a demonstration of substantial equivalence to existing legally marketed predicate devices, rather than a performance study with traditional clinical acceptance criteria.

Here's an interpretation based on the provided text, aligning with the spirit of the request by describing the implicit "acceptance criteria" for a QC device and how the submission addresses them:

Acceptance Criteria and Device Performance for a Quality Control Material (Derived from Substantial Equivalence)

For a Quality Control material like the IRMA TRUpoint™ Creatinine Control Kit, the "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to predicate devices. This means it performs its intended function (monitoring analyzer performance) in a comparable manner, considering its form, matrix, intended use, and storage conditions.

Study Details (Based on the 510(k) Summary)

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicates rather than presenting de novo clinical study data with detailed performance metrics. Therefore, many of the requested details about specific study design (e.g., sample sizes, ground truth establishment, expert adjudication) are not applicable or not explicitly provided for this type of submission.

Here's an attempt to address the points based solely on the provided text, indicating when information is not available:

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

   • Addressed in the table above. The "acceptance criteria" are implied by the requirements for substantial equivalence. The "reported device performance" is the claim of substantial equivalence based on the comparisons made.

2. Sample size used for the test set and the data provenance:

   • Not explicitly provided. This submission describes the device and compares its technical characteristics to predicates to establish substantial equivalence. It does not detail specific performance testing data (e.g., precision, accuracy, stability studies) that would typically involve a "test set" in the context of diagnostic accuracy. While such studies would have been performed by the manufacturer, the 510(k) summary focuses on the comparative argument.

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

   • Not applicable / Not provided. For a quality control material, "ground truth" isn't established by experts in the same way it would be for a diagnostic image or pathology slide. The "truth" for a QC material is its known concentration of the analyte, which is verified through analytical methods. The submission doesn't detail the analytical validation process for the control itself, only its comparison to predicates.

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

   • Not applicable / Not provided. Adjudication is relevant for subjective assessments (e.g., human reader interpretations). This is a technical comparison for a quality control material, not a diagnostic interpretation study.

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 submission is for a quality control material, not an AI or imaging diagnostic device that would involve human readers.

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

   • Not applicable. This is a quality control material, not an algorithm.

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

   • Not explicitly stated/Not applicable in the human-centric sense. For a quality control material, the "ground truth" would be the assigned value or target value for creatinine, determined through highly accurate reference methods or inter-laboratory consensus, which the control material is manufactured to. The document does not detail how these target values were established for the IRMA TRUpoint™ Creatinine Control Kit, but focuses on its equivalence in form and function to other marketed QC materials.

8. The sample size for the training set:

   • Not applicable. This is a physical quality control material, not a machine learning model, so there is no "training set."

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

   • Not applicable. See point 8.

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