(78 days)
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:
- Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA slide.
- Each slide has three control wells and nine patient wells.
- Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing.
- The MICRO21 locates the central area of each well on the slide and captures four images from each well.
- The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist.
- The technologist reviews the images and confirms a positive determination by selecting the appropriate result.
- 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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence of nDNA image presentation on MICRO21 to manual method (bright light microscope) | "The results which are reported in the Summary of Results confirm that the nDNA image presentation on the MICRO21 is equivalent to the manual method." |
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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Image /page/0/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo consists of the letters "IMI" in a bold, stylized font, with a series of interconnected dots and lines above the letters. Below the letters, the full name of the company, "Intelligent Medical Imaging, Inc.", is written in a smaller, simpler font.
K964165
JAN. 3, 1997
510(K) SUMMARY
Prepared by: Title Date:
Christine B. Harper, MBA,MT(ASCP) Senior Product Development Manager September 18, 1996
Trade Name: Classification Name: Classification Number: Class: Regulation Number:
MICRO21™ with nDNA Automated Cell Locating Device 81JOY I 864 - 260
The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process
Description:
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:
-
- Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA slide.
- Each slide has three control wells and nine patient wells. 2.
-
- Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing.
-
- The MICRO21 locates the central area of each well on the slide and captures four images from each well.
- પં The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist.
-
- The technologist reviews the images and confirms a positive determination by selecting the appropriate result.
-
- A report of the nDNA screening result for each patient well is printed.
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Image /page/1/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo features the letters "IMI" in a stylized font, with a network of lines and dots above the letters. The full name of the company, "Intelligent Medical Imaging, Inc.," is printed in a smaller font below the logo.
Test Method:
The Test Method compared 205 pa Summer MICRO21 to the same 205 patient nDNA images viewed under a bright light m s done to confirm that the nDNA image presentation on the MICRO21 is equivalent to the nDNA umage presentation for the manual method under the bright light microscope.
The Test Method consisted of 205 patient nDNA images with 91 Positives and 114 Negatives as identified by a technologist at Immuno Concepts who manually read the 205 nDNA patient tests using a bright light microscope. The nDNA slides containing the 205 patient nDNA tests were then loaded onto the MICRO21 and an image from each sample was captured, stored, and displayed on the review monitor. A technologist reviewed each stored nDNA patient image and graded the result as Positive or Negative. The results which are reported in the Summary of Results confirm that the nDNA image presentation on the MICRO21 is equivalent to the manual method.
Conclusion:
The image comparison performed in the Test Method confirms the safety and effectiveness of the MICRO21 with nDNA for the intended use of location, storage and display of nDNA images to aid the technologist in performing the nDNA Test Screen.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).