Search Results

SEDRite™ Plus is a bi-level control for use in monitoring erythrocyte sedimentation rate (ESR) values obtained from manual and automated ESR methods.

SEDRite™ Plus is an in vitro diagnostic reagent composed of mammalian erythrocytes suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of monitoring the performance of manual and automated ESR methods. Overall performance of the system is monitored including the analyzer, disposable equipment, and technique. SEDRite™ Plus is available in two levels and is run in the same manner as patient specimens.

Here's a breakdown of the acceptance criteria and study information for the SEDRite™ Plus Hematology Erythrocyte Sedimentation Rate Control, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the stability characteristics of the control device. Specific quantitative acceptance criteria (e.g., specific ranges for ESR values) are not explicitly stated in this summary. Instead, the general criterion is "recovery of values within the Expected Range."

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

• Sample Size: The document does not specify the exact sample size (number of control vials or specific tests performed) used for the stability studies. It broadly refers to "Results of studies."
• Data Provenance: The document does not explicitly state the country of origin for the data. Given R&D Systems, Inc. is located in Minneapolis, MN, USA, it's highly probable the studies were conducted in the United States. The studies are prospective in nature, as they involve testing the device over time to establish stability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. For a hematology control, "ground truth" would typically refer to the established expected range of ESR values, which are usually determined through rigorous testing against reference methods or extensive historical data, often involving highly skilled laboratory professionals but not "experts" in the same sense as radiologists interpreting medical images.

4. Adjudication Method for the Test Set

This is not applicable and therefore not mentioned. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are interpreting results, often for diagnostic accuracy assessments. This device is a control material, so its performance is assessed against established laboratory parameters and expected ranges, not through expert consensus in the same way.

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

This is not applicable and therefore not mentioned. MRMC studies are used to assess the impact of a new diagnostic aid (like AI) on human performance. This device is a hematology control for monitoring existing ESR methods, not an AI diagnostic tool.

6. Standalone Performance Study

Yes, a standalone study was performed to demonstrate the device's stability. The "Discussion of performance data" section states: "Results of studies met acceptance criteria for stability was tested by recovery of values within the Expected Range through the life of the product." This refers to the independent performance of the control material itself over time.

7. Type of Ground Truth Used

The "ground truth" for the performance of this control device is the "Expected Range" of Erythrocyte Sedimentation Rate (ESR) values. This range would be established for specific ESR methods and instrumentation, likely through extensive internal validation and external reference methods, ensuring that the control material behaves consistently within these known and acceptable biological and analytical limits.

8. Sample Size for the Training Set

This is not applicable and therefore not mentioned. This device is a control material, not an AI algorithm that requires a "training set."

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

This is not applicable as there is no "training set" for this device.

Ask a specific question about this device