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AlbuTrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems.

AlbuTrol is an assayed urine albumin control material. AlbuTrol control material is filled of in dropper bottles. Each dropper bottle contains 1.0 mL human urine with a specific amount of human albumin. AlbuTrol provides two physiologically relevant levels covering the clincally interesting ranges of urine albumin: ~25 mg/L albumin and ~75 mg/L aboumin. The assigned values of each batch are printed on both the carton box and the dropper bottles.

AlbuTrol is packed in carton boxes. Each carton box contains 2 dropper bottles of the same level on a carton tray. An insert with Intended Use is packed in each box of album of the

The provided text describes the 510(k) summary for AlbuTrol, a quality control material. It focuses on the product's description, intended use, technological characteristics, and a brief statement about performance assessment.

However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• Explicit acceptance criteria: The document states that AlbuTrol is for "verification of the precision and accuracy" of HemoCue systems, but it does not specify quantitative targets or thresholds for this precision and accuracy (e.g., a specific coefficient of variation, bias limits, etc.).
• Detailed study methodology: It mentions "Studies were conducted in-house to demonstrate the performance," but provides no details about these studies, such as sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
• Reported device performance: While it assures performance, it doesn't present actual results against any criteria.
• Information on training sets, MRMC studies, or standalone performance.

Therefore, I cannot populate most of your requested tables and sections based solely on the provided text.

Here's an attempt to answer based on the limited information available, with significant gaps noted:

Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria or detailed reported performance values. It only generically states the material's purpose is for "verification of the precision and accuracy."

Study Details

Due to the lack of detailed study information in the provided 510(k) summary, much of this section will be marked as "Not provided" or "Not applicable."

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

   • Sample size: Not provided. The document only states "Studies were conducted in-house."
   • Data provenance: "In-house," implying data generated by Eurotrol B.V. or HemoCue. Retrospective/Prospective status is not specified.

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

   • Not provided. For quality control materials like AlbuTrol, ground truth (assigned values) is typically established by the manufacturer using calibrated reference methods on in-house instruments. The document states: "Values of AlbuTrol are assigned on factory calibrated HemoCue Albumin 201 systems." This implies internal expert consensus on how to perform and interpret these reference measurements, but specific numbers or qualifications are not detailed.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation) where human experts might disagree. For quantitative control materials, the ground truth is established by precise measurements on reference instruments, not by adjudicating expert opinions.

4. 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 device is a quality control material for in-vitro diagnostic systems, not an AI-powered diagnostic device or a system designed to assist human readers. Therefore, an MRMC study comparing human performance with/without AI assistance is irrelevant to this product.

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

   • Not applicable. This device is a quality control material. It does not involve an algorithm, nor is it a standalone diagnostic tool in the typical sense. Its "performance" is its ability to have stable and accurate assigned values, and to behave like human urine when measured by the HemoCue systems.

6. The type of ground truth used:

   • The ground truth for AlbuTrol is its assigned value, which is established via measurements on factory-calibrated reference instruments (HemoCue Albumin 201 systems) using validated methods. This is akin to a reference method or gold standard for control materials.

7. The sample size for the training set:

   • Not applicable. This product is a quality control material, not a machine learning model. There is no "training set" in the context of developing this control material itself. The development involves formulation, stability testing, and value assignment, not algorithm training.

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

   • Not applicable, as there is no "training set" for this product. See point 7.

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