Search Results

For the monitoring and control of processes for measuring the lipoproteins, HDL-C and LDL-C.

lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol.

The provided 510(k) summary for the Boehringer Mannheim Precipath® HDL/LDL-C Control is for a multi-analyte control device, not a diagnostic or prognostic algorithm. Therefore, many of the requested criteria related to algorithm performance, such as sensitivity, specificity, MRMC studies, and ground truth establishment from patient data, are not applicable.

The document primarily focuses on establishing substantial equivalence to a predicate device (Sigma Diagnostics Cardiolipid™ Controls) for its intended use: monitoring and control of processes for measuring HDL-C and LDL-C.

Here's an attempt to address the relevant points based on the provided text, and indicating where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document doesn't detail a specific "study" in the sense of a clinical trial or performance evaluation with statistical metrics for the control device itself. Instead, the acceptance criterion for regulatory clearance is based on demonstrating substantial equivalence to a predicate device. The primary "proof" is the comparison to the predicate device (Sigma Diagnostics Cardiolipid™ Controls), where the applicant asserts that the intended use and device characteristics are similar.

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

This is not applicable for a control device. Control devices are used to monitor the performance of other diagnostic assays; they are not themselves tested against a clinical "test set" of patient samples in the same way an algorithm or diagnostic test would be. The "sample" here refers to the manufacturing batch of the control solution itself, and its consistency across batches.

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

Not applicable. There is no "test set" or diagnostic ground truth being established for this control device. The performance of the control is a measure of its stability and consistency in providing known analyte levels, not its ability to diagnose a condition.

4. Adjudication Method for the Test Set

Not applicable for a control device.

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 and not an AI-powered diagnostic tool, nor does it involve human readers interpreting results.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of diagnostic ground truth. The "ground truth" for a control material would be the certified or established concentration of HDL-C and LDL-C within the control material itself, determined through reference methods or highly accurate analytical techniques during its manufacturing and characterization. The document does not detail how these internal "ground truths" (i.e., the labeled values) for the control were established.

8. The Sample Size for the Training Set

Not applicable. This is a control material, not an algorithm trained on data.

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

Not applicable.

Ask a specific question about this device