Search Results

Not Found

Not Found

Here's a breakdown of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Technicon H+3 RTC/RTX reticulocyte method are implied by the reported performance characteristics and the stated goals of the evaluation. While explicit threshold values are not given, the device is considered to meet acceptance criteria if its performance is comparable to established methods (NCCLS for reticulocytes) and demonstrates high correlation and low bias for RBC indices.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Study Information

Accuracy, precision, linearity, carryover, and sample stability of the Technicon H+3 RTC/RTX reticulocyte method were evaluated.

1. Sample Sized used for the test set and the data provenance:

• Reticulocyte Accuracy: 50 samples from apparently healthy donors and 48 samples from hospital patients (a total of 98 unique samples). Each sample was assayed in duplicate on the Technicon H+3 and independently counted by two technologists using the NCCLS method. This resulted in a total of n=196 (98 samples x 2 duplicates) for the Technicon H+3 analysis and 98 samples for manual counting.

• RBC Indices Accuracy: The same n=196 (98 samples x 2 duplicates) from the reticulocyte accuracy study were used.

• Precision: 5 samples. Each sample underwent 25 replicate assays, resulting in 125 assays (5 samples x 25 replicates).

• Linearity: Not explicitly stated, but involved a "human pool prepared to obtain a high reticulocyte count."

• Carryover: "High level human pools" were used. Specific sample size not detailed.

• Prepared Sample Stability: 15 prepared samples from apparently healthy donors.

• Data Provenance: The origin of the samples (e.g., country) is not specified. The study appears to be prospective in nature, as samples were obtained, prepared, and then analyzed according to the study protocol.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Reticulocyte Accuracy: Two technologists independently performed the manual reticulocyte count using the NCCLS method. Their specific qualifications (e.g., years of experience) are not provided, but it's implied they are qualified to perform the NCCLS proposed standard.
• RBC Indices Accuracy: The "ground truth" for RBC indices was established by comparison to the Technicon H+3 RBC/platelet and hemoglobin methods (CBC/Diff mode), which are presumably established and validated methods for these parameters. No human experts were explicitly involved in establishing this ground truth for the indices in the same way as for reticulocytes.
• Other studies (Precision, Linearity, Carryover, Stability): The ground truth was established by repeated measurements or by reference to established laboratory protocols and expected biological responses rather than by human expert interpretation.

3. Adjudication method for the test set:

• Reticulocyte Accuracy: The text states, "Each sample was counted independently by two technologists using the NCCLS method." It does not explicitly mention an adjudication method (like 2+1 or 3+1) if their counts differed significantly. However, it does note that "laboratories performing similar accuracy evaluations may obtain incorrect least squares regression coefficients when the range of samples is small. In this event, the coefficients can be corrected by averaging manual results from 4 or more technologists, or by calculating the regression coefficients using a method derived by Deming." This suggests an awareness of potential variability in manual counts and a recommended approach (averaging more technologists or a statistical method) to handle it, but not a specific adjudication protocol for the two technologists used in this particular study. Assuming industry standard best practices, close agreement would be expected, or discrepancies would be resolved, but the exact method isn't detailed.

4. 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, an MRMC comparative effectiveness study was not done. This study evaluates the performance of an automated device (Technicon H+3 RTC/RTX) compared to a manual method (for reticulocytes) or another automated method (for RBC indices). It does not involve human readers using or not using AI assistance. The device is the "AI" or automated component here, replacing a manual process for reticulocytes rather than assisting a human reader.

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

• Yes, a standalone performance evaluation was done. The entire study is a standalone evaluation of the Technicon H+3 RTC/RTX device. The reported performance characteristics (accuracy, precision, linearity, carryover, stability) are for the device operating independently. For reticulocyte counts, the device's performance is compared against a manual method, but the device itself operates in a standalone fashion.

6. The type of ground truth used:

• Reticulocyte Count: Expert consensus (implied agreement between two technologists) using a gold standard method (NCCLS proposed standard for reticulocyte counting using new methylene blue).
• Absolute Reticulocyte Count: Derived from the two technologists' % reticulocyte results and an RBC count from a Technicon H+2 system.
• RBC Indices: Comparison to established measurement from an existing device (Technicon H+3 CBC/Diff mode).
• Other studies (Precision, Linearity, Carryover, Stability): Ground truth was established by meticulous experimental design, serial dilutions, high-level pools, or timed assays, relying on the inherent characteristics of the samples and the ability of reference methods/measurements to define the expected outcomes.

7. The sample size for the training set:

• Not applicable. This study describes the performance evaluation of a medical device (Technicon H+3 RTC/RTX), which is a laboratory analyzer, not a machine learning algorithm that requires a separate "training set" for model development. The device would have been developed and internally validated by the manufacturer, but the provided text only details the performance characteristics for regulatory submission.

8. How the ground truth for the training set was established:

• Not applicable. As this is a medical device performance study, not a machine learning algorithm study with a defined "training set," this question does not apply.

Ask a specific question about this device