Search Results
Found 1 results
510(k) Data Aggregation
(58 days)
CHOLESITE TEST SYSTEM
The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood. It is intended for the sole use with the GDS® Stat-Site® Meter.
This whole blood cholesterol test system consists of a CholeSite® Test Card, Test Card specific Test Module, and the hand-held Stat-Site® electronic reflectance photometer (Meter), The test methodology employs a dry reagent technology based on the cholesterel esterase method. When a drop of whole blood is applied to the top opening on the Test Card. The cholesters present in the patient's blood sample are hydrolyzed by cholesterol esterase. The free cholesterol is then oxidized by cholesterol oxidase, producing hydrogen peroxide, which substantially reacts with TOOS in a reaction catalyzed by peroxidase to produce a colored compound on the bottom of the Test Card. The Stat-Site® Meter, using reflectance at 660 nm, measures the color characteristics produced and converts the reflectance reading to a correlated cholesterol concentration value,
CholeSite® Test System: Acceptance Criteria and Performance Study Summary
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria for the CholeSite® Test System. However, the study aims to demonstrate acceptable comparison with established reference methods. We can infer the performance metrics reported are intended to show this acceptability.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Correlation to Abell-Kendall | High correlation desired | Slope = 1.192, Intercept = 27.94, Correlation Coefficient (R) = 0.96 |
| Correlation to COBAS Bio Reference | High correlation desired | Slope = 1.000, Intercept = 0.91, Correlation Coefficient (R) = 0.9437 |
| Precision (Total CV) | Low CV desired | Below 5.4% (at 135 and 300 mg/dL cholesterol concentrations) |
| Individual Meter Precision (CV) | Low CV desired | No single Meter having CVs above 4.2% (at 135 and 300 mg/dL cholesterol concentrations) |
2. Sample Sizes and Data Provenance for Test Set
- Clinical Samples:
- Venous whole blood: 148 samples
- Capillary whole blood: 148 samples
- Provenance: Obtained at 3 different physician's office sites (Prospective, US-based as per FDA context).
- In-House Samples:
- Venous whole blood: 40 samples
- Capillary whole blood: 40 samples
- Provenance: In-house testing.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The study does not mention the use of "experts" in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth for the test set was established by established laboratory methods and reference instruments. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to image interpretation or clinical diagnosis does not directly apply here. The expertise lies in the validated methodologies and operation of the reference instruments.
4. Adjudication Method for Test Set
Not applicable. The ground truth was established by direct measurement using reference standard methodologies and instruments, not through expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a study evaluating a diagnostic device for total cholesterol measurement against laboratory reference methods, not an AI-assisted interpretation system for human readers. Therefore, an MRMC study and the concept of "human readers improve with AI vs without AI assistance" are not relevant here.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance study was conducted. The CholeSite® Test System, which includes the Test Card, Test Module, and Stat-Site® electronic reflectance photometer (Meter), performed the measurements and generated the cholesterol concentration values independently of human interpretation influence. Its performance was then compared directly to the reference methods.
7. Type of Ground Truth Used
Two types of ground truth were used:
- Abell-Kendall Reference Standard Methodology: This is described as the "industry 'gold standard' cholesterol test reference method." This represents a highly accurate and established laboratory method.
- COBAS Bio Reference (GDS® reference method): This was used for in-house testing and serves as another established laboratory reference instrument for cholesterol determination.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or a machine learning model being trained. The CholeSite® Test System appears to be a dry reagent technology with a photometric measurement system, implying that its underlying principles are based on known biochemical reactions and calibration, rather than a data-driven machine learning model requiring a large training dataset in the conventional sense. If any form of calibration or internal adjustment was performed, the data used for that is not specified as a "training set."
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a "training set" in the context of machine learning is not explicitly mentioned or implied. The system's operation is based on biochemical reactions and a calibrated photometer. Any initial calibration or validation would likely have used commercially available reference standards or samples analyzed by established laboratory methods. However, the details of such a process are not provided or referred to as a "training set."
Ask a specific question about this device
Page 1 of 1