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The MICRO21 with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA which is an aid in the detection of systemic rheumatic disease.

The MICRO21 with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA which is an aid in the detection of systemic rheumatic disease. The nDNA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® nDNA Test System. A summary of the MICRO21 with nDNA process is as follow:

1. Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA slide.
2. Each slide has three control wells and nine patient wells.
3. Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing.
4. The MICRO21 locates the central area of each well on the slide and captures four images from each well.
5. The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist.
6. The technologist reviews the images and confirms a positive determination by selecting the appropriate result.
7. A report of the nDNA screening result for each patient well is printed.

This document describes the validation study for the MICRO21™ with nDNA automated cell locating device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 205 patient nDNA images.
• Data Provenance: Retrospective, as the images were pre-identified as Positive or Negative by a technologist at Immuno Concepts manually reading the tests. The country of origin is not explicitly stated.

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

• Number of Experts: One technologist.
• Qualifications of Experts: A technologist at Immuno Concepts who manually read the 205 nDNA patient tests using a bright light microscope. No further details on experience or specific certifications are provided.

4. Adjudication method for the test set:

• The document implies a single-reader manual interpretation for establishing ground truth, followed by a comparison of the MICRO21 displayed images to this ground truth. There is no mention of multiple expert agreement or an adjudication process (e.g., 2+1, 3+1).

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done in this context. The study focuses on the equivalence of image presentation and not on human reader performance improvement with AI assistance. The MICRO21 is presented as a tool to aid the technologist by locating, storing, and displaying images, effectively streamlining the manual review process rather than replacing it or directly enhancing diagnostic accuracy through AI interpretation.

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

• No, a standalone (algorithm-only) performance was not done. The device's function is to "aid the technologist," and the final determination of Positive or Negative results is made by a human technologist reviewing the displayed images. The device itself does not provide a diagnostic output.

7. The type of ground truth used:

• Expert Consensus: The ground truth for the 205 patient nDNA images was established by a single technologist at Immuno Concepts who manually reviewed the slides using a bright light microscope. While it's expert opinion, it's explicitly a single expert's determination, not a consensus among multiple experts.

8. The sample size for the training set:

• The document does not provide information about a training set. The study described is a performance comparison, implying the MICRO21 device was already developed.

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

• Since there's no mention of a training set, there's no information on how its ground truth was established.

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