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The Lipid Panel Test Strips are intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism , or various endocrine disorders.

The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.

The BioScanner Plus is a reflectance photometer for in vitro diagnostic use with Polymer Technology System's (PTS) test strips to measure color developed in a chemical reaction that occurs when whole blood is placed on a test strip. The color is measured and converted into concentration for each analyte.

The Lipid Panel Test Strips are dry phase test strips that are constructed from a plastic strip holder that holds chemically treated membranes. When whole blood is placed on the test strip, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membranc and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus reflectance photometer.

The only modification that was made to the BioScanner to produce the BioScanner Plus was: A fourth optical read window was added to the three optical read windows in the BioScanner.

The only modification that was made to the Cholesterol, HDL Cholesterol and Triglycerides test strips to produce the Lipid Panel Test Strips is that the reaction membranes from the three individual test strips were assembled together on one test strip holder that holds all three at once.

Here's a breakdown of the acceptance criteria and study information for the BioScanner Plus Lipid Panel Test Strips, based on the provided 510(k) summary:

This document is a 510(k) summary for a medical device modification, not a standalone study report. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria or a comprehensive study analysis of a novel device. Therefore, some information requested, particularly regarding detailed acceptance criteria, specific performance metrics, sample sizes for test sets, expert-derived ground truth, and MRMC studies, is not explicitly present in this type of submission. The focus is on comparing the modified device's performance to the predicate device's established performance.

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds). Instead, the criterion for acceptance is "substantial equivalence" to the predicate device. This implies that the modified device (BioScanner Plus and Lipid Panel Test Strips) must perform comparably to the predicate device (BioScanner and its individual Cholesterol, HDL Cholesterol, and Triglycerides Test Strips).

The "performance" described is the functionality and analytical method, with the implicit understanding that the analytical performance (accuracy, precision) would be equivalent to the predicate. The changes made were structural (four optical windows instead of three) and organizational (combining three test strips into one Lipid Panel Test Strip), not fundamental changes to the chemical reaction or measurement principle.

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. 510(k) summaries for device modifications often do not include the detailed sample sizes of validation studies if the modifications are considered minor and don't significantly alter the fundamental performance. The focus is on demonstrating that the changes do not negatively impact performance compared to the predicate, often through bridging studies rather than full-scale clinical trials.

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

This information is not provided in the 510(k) summary. Given that this is an in vitro diagnostic device measuring standard analytes, ground truth would typically be established using validated laboratory reference methods, not necessarily by human expert consensus as might be the case for image-based diagnostic aids.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This type of study is typically performed for diagnostic aids where human interpretation is involved (e.g., radiology AI). The BioScanner Plus is an automated in vitro diagnostic device for quantitative measurements; direct human reader involvement in the measurement process for improvement with AI assistance is not applicable here.

6. Standalone Performance Study (Algorithm Only)

The 510(k) summary describes a standalone device (BioScanner Plus with Lipid Panel Test Strips). However, it does not detail a specific "algorithm only" study in the sense of comparing an AI algorithm's performance in isolation. The device itself is the "algorithm only" in the context of its chemical and optical measurement system. The performance is assessed by comparing its output (analyte concentrations) to accepted reference methods or the predicate device, not by comparing an AI algorithm's output to human expert readings.

7. Type of Ground Truth Used for the Test Set

The type of ground truth used would almost certainly be reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry, or other established analytical methods) for Cholesterol, HDL Cholesterol, and Triglycerides. This is standard practice for validating in vitro diagnostic devices. However, the specific methods are not detailed in this summary.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The BioScanner Plus is a reflectance photometer, which uses a chemical reaction and optical detection, not an AI or machine learning algorithm that typically requires a distinct "training set" in the common sense. The "training" in this context refers to the calibration curves established for each lot of test strips.

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

The "ground truth" for the "training set" (calibration) in this device is established via a multipoint curve that is set for each lot of test strips. This involves measuring known concentrations of the analytes (standards) to generate a calibration curve. This curve information is then programmed into a lot-specific electronically erasable programmable read-only memory (EEPROM) chip. The exact methods for determining the "known concentrations" (standards) are not detailed in this summary but would involve highly accurate reference methods.

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