Search Results

The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.

The MICRO21 with Retic is an automated microscopic system that locates reticulated red blood cells (retics), stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the Reticulocyte Count procedure. The process involves preparing a blood wedge smear stained with a supravital stain, affixing a bar code to each slide, placing the slides into a frame holder and inserting the frame into the MICRO21. The instrument locates 1000 RBCs. The reticulated RBCs are stored as high magnification color images (1000x magnification). The images of retics stored by the instrument are displayed on a color monitor for review by a technologist. The technologist confirms that each reticulated RBC image displayed contains retic markings. If the image does not contain retic markings, the image is eliminated by the technologist and consequently not included in the retic count. A report of the percent of retics per 1000 RBCs is printed.

Here's a breakdown of the acceptance criteria and study details for the MICRO21™ with Retic, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 40 patient samples, from which 80 slides were created (two slides per sample).
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective as it involves prepared slides from patient samples.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Two certified technologists.
• Qualifications of Experts: Certified technologists. The document does not specify their years of experience or precise certifications beyond "certified technologists."

4. Adjudication Method

• For Test Method One (correlation with manual method): Two technologists independently performed manual retic counts. The text does not explicitly state an adjudication method (like 2+1 or 3+1) if there were discrepancies between the two technologists' manual counts. It seems their individual manual counts were used for comparison.
• For Test Method Two (sensitivity): Two certified technologists independently observed the MICRO21's ability to locate RBCs and reticulated RBCs. The "agreement with the technologist" for sensitivity suggests their observations were the reference, but no specific adjudication process for disagreement is described.

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

• No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The study focused on correlating the device's output with manual methods performed by technologists and assessing the device's ability to locate cells, rather than measuring the improvement in human reader performance with augmentation versus without augmentation.

6. Standalone (Algorithm Only) Performance

• A standalone performance evaluation was implicitly conducted for some aspects. Test Method Two focused on the MICRO21's "ability to locate RBCs and reticulated RBCs" independently, with its sensitivity measured against technologists' observations. The device's fundamental function of identifying and storing images of retics before technologist review demonstrates an algorithmic component. However, the overall "process" described always includes technologist review (step 5 and 6), meaning the final "count" isn't purely standalone.

7. Type of Ground Truth Used

• Expert Consensus / Technologist Observation:
  • For Test Method One (correlation): The ground truth for the reticulocyte count was established by manual retic counts performed independently by two technologists.
  • For Test Method Two (sensitivity): The ground truth for RBC and reticulated RBC location was the agreement with the technologist's observation.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. Only the test set details are given.

9. How Ground Truth for the Training Set was Established

• The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training process or data.

Ask a specific question about this device