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The Medi-Test Combi 11 Reagent Strip for Urinalysis is a dip-and-read test strip. The product is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes, metabolic, abnormalities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract.

The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen by visual comparison with a color chart for each concentration range.

The Medi-Test Combi 11 Reagent Strip for urinalysis is a dip-and-read test strip. The Medi-Test Combi 11 provides reagent areas on the strip for testing urine physiological parameters.

The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, ascorbic acid, protein, blood, nitrite, pH, ketones, bilirubin and urobilinogen by visual comparison with a color chart for each concentration range.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K991927, for the Medi-Test Combi 11, focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria or rigorously quantifying device performance against such. The primary assessment states:

• Acceptance Criteria Implied: Substantially equivalent performance to the predicate devices (Bayer Multistix 10SG and Dia Strip System) for common parameters, and clinical effectiveness for the added parameters (leucocytes and specific gravity).
• Reported Device Performance: The "Penn Elm study indicates the Combi 11 had very similar results to the Bayer Multistix 10 for the reagent parameters." And "A clinical study demonstrated the clinical effectiveness of the added reagent strip areas for screening for leucocytes and specific gravity in urine."

Given this, a formal table of explicit acceptance criteria and corresponding numerical performance metrics is not directly available in the provided text. The evaluation is largely qualitative and comparative.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 100 randomly-selected urine samples.
• Data Provenance: Prospective clinical use study from the Penn Elm Medical Group, USA, conducted during the normal course of providing patient care. Includes asymptomatic patients and those with specific diagnostic complaints.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications used to establish ground truth. It states that the study was conducted by the "Penn Elm Medical Group" during "normal course of providing patient care" and included "urinalyses." This suggests the ground truth was likely established by standard laboratory procedures and clinical assessment by the medical group's personnel, but specific expert details are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "Penn Elm study" compares the Combi 11 to the Bayer Multistix 10, implying a direct comparison of results rather than an independent expert adjudication process on the Combi 11's readings.

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

No MRMC study was performed or mentioned. This device is a dip-and-read test strip for visual comparison with a color chart, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. This is a visual dip-and-read test strip, not an algorithm-based device.

7. The Type of Ground Truth Used

The ground truth for the comparison was based on results from the predicate device, Bayer Multistix 10, and implied clinical assessment as part of "normal course of providing patient care" for the "clinical effectiveness" demonstration of the added parameters.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a traditional diagnostic test strip, not a machine learning or AI-driven device that typically requires a separate training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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