Intelligent Medical Imaging, Inc.'s MICRO21® with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result.

Device Description

The MICRO21 with Urine Sediment Analysis, is an automated microscopic system that locates formed elements of wine sediment, digital stores images of the constituents and displays the images in an organized manner to aid technologists in performing an Urine Sediment Analysis procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the MICRO21® with Urine Sediment Analysis device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes categories of testing rather than explicit numerical acceptance criteria. The "Conclusion" section summarizes that the device met the implicit acceptance criteria for each test.

Acceptance Criteria Category	Reported Device Performance (Summary)
Precision	No significant variation demonstrated.
Reproducibility	No significant variation demonstrated.
Linearity	No significant variation demonstrated.
Correlation	Demonstrated for RBC, WBC, Squamous Epithelial cells, Hyaline Casts, Amorphous, Calcium Oxalate, and Triple Phosphate Crystals, Mucous, Sperm and Yeast. For quantitative results, the average value from each range was used for computing regression analysis values (R values). For qualitative results, correlation/equivalence was determined to be within one reporting range.

Study Details

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

Sample Size (Test Set): 182 stained samples. An additional 31 stained samples were created using serial dilution and enrichment to generate a wider range of urinary constituents.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in that existing samples were processed and then compared to manual methods. The generation of additional samples via serial dilution and enrichment suggests a controlled laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Three.
Qualifications of Experts: Certified Medical Technologists.

4. Adjudication Method for the Test Set

The text states, "Using blinded experimental methods, the stained samples were reviewed manually, and processed by the MCRO21 and resultant images reviewed by the technologists." It doesn't explicitly describe an adjudication method (like 2+1 or 3+1) for resolving disagreements among the three technologists when establishing the manual ground truth. It implies their manual review was the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The study describes a comparison between the MICRO21 system and the "manual urine microscopic reference method using standard correlation statistics." This is a comparative study, and it involved multiple readers (three certified medical technologists) reviewing both the manual slides and the MICRO21 images.

Effect Size of Human Readers with AI vs. Without AI Assistance: The document does not provide a specific "effect size" or quantitative measure of how much human readers improve with AI assistance. Instead, it aims to demonstrate that the MICRO21 system's results correlate well with the manual method, suggesting the device is "safe and effective for its intended use of locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result." The phrasing "the MICRO21 process is substantially equivalent to the manual microscopic process" and the conclusion of correlation across various elements implies that performance with the device is comparable to human-only assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The MICRO21 is described as an "automated microscopic system that locates formed elements...digital stores images...and displays the images...to aid technologists in performing an Urine Sediment Analysis procedure." Crucially, item 8 of the process workflow states, "The technologist reviews the images and quantifies the results." This clearly indicates that the device is designed for human-in-the-loop operation, not standalone algorithmic interpretation. Therefore, a standalone performance study of the algorithm without human review was not performed or intended according to this document.

7. The Type of Ground Truth Used

Expert Consensus (Manual Method): The ground truth was established by three certified medical technologists performing the "manual urine microscopic reference method." This serves as the benchmark against which the MICRO21 results were compared.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description of testing focuses on "performance testing" to assess precision, accuracy, linearity, and correlation, which typically refers to evaluation on a test set.

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

Since a separate training set is not described, the method for establishing its ground truth is not provided.

Summary

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AUG - 7 1998

Image /page/0/Picture/1 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo includes the letters "IMI" in a stylized font, with a network of lines and dots above the letters. Below the logo is the text "Intelligent Medical Imaging, Inc.". The number "K982301" is written below the company name.

510(k) Summary

Assigned 510(k) number :

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.2.

Designated Point of Contact:	R. Otto Stellner
Title:	Vice President, Regulatory Compliance
Project Management	Susan M. Steele BSMT
Title:	Product Development Laboratory Coordinator
Sean D. Murphy, Ph.D.
Title:	Product Development Technical Coordinator
Date:	Tuesday, June 30, 1998
Trade Name:	MICRO21® with Urine Sediment Analysis
Classification Name:	Automated Cell Locating Device
Classification Number:	81JOY
Class:	II
Regulation Number:	864.5260

Intended Use For In Vitro Diagnostic Use

Intelligent Medical Imaging, Inc.'s MICRO21 @ with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result.

Description:

A summary of the MICRO21 with Urine Sediment Analysis process is as follows:

Patient urine samples are prepared by a technologist pouring off 12mL of fresh urine into a centrifyge tube and capping 1. the tube.
1. Each capped tube is then centrifuged at a relative centrifugal force of 400 for 5 minutes; approximately 1500 revolutions per minute with a 6 inch rotor radius (NCCLS Protocol GP 16-A).
1. The tubes are then removed from the centrifyge without disturbing the sediment, uncapped and decanted to 1mL.
After resuspending the sediment, 20 ul of commercial urine sediment stain (Sternheimer-Malbin) are added to the 4. sediment and mixed. Herein referred to as Stained Sample.
One drop of the stained sample is placed into the designated well of the urine slide can hold up to 8 ર. individual stained samples.
1. The technologist then enters the test order into the MCRO21 Review station Order Entry Screen, prints a barcode and places it on the urine slide. The barcode corresponds to the urine slide and wells allocated for the individual samples.
1. The MCRO21 captures a minimum of 40 microscopic images, 16 at 100x magnification, 16 images at 200x magnification, and 8 images at 400x magnification, digitizes the images and stores them for display on a color monitor for review by a technologist.

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Image /page/1/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo consists of a stylized graphic element above the company name. The graphic element appears to be a network of interconnected lines and dots, possibly representing a neural network or a complex system. The text "Intelligent Medical Imaging, Inc." is written in a clear, bold font.

The technologist reviews the images and quantifies the results. 8.
A report of the results for each patient is printed. 9.

Effectiveness Testing

To demonstrate the validity of the procedure, performance testing was conducted to assess the instrument's precision, accuracy, linearity, and correlation with the manual method. A summary of each is presented.

Test Method 1: Precision

To confirm instrument precision, a stained specimen sample from one processed and reviewed 5 times on the 10 commin there specimens, one each from a low, normal and high range were tested. The results were reviewed and recorded for each samples.

Test Method 2: Reproducibility

To confirm linearity, specimens containing reportable ranges for RBC's and squamous epithelial cells were processed and reviewed on the MICRO21. RBC and WBC were recorded at 200x magnification. Squamous epithelial cells were recorded at 100x magnification. Selected highly concentrated specimens were used and dilutions of the specimen were made to obtain ranges. The results were reviewed and recorded for each sample.

Test Method 3: Linearity

To confirm linearity, specimens containing reportable ranges for RBC's and squamous epithelial cells were processed and reviewed on the MICRO21. The results were reviewed and recorded for each sample.

Test Method 4: Correlation

The MICRO21 with Urine Sediment Analysis results were compared to the manual urine microscopic reference method using standard correlation statistics. Results are reported as number of formed elements per reportable range, as recommended by NCCLS in GP16-A, Urinalysis and Collection, Transportation of Urine Specimens, Approved Guideline. For quantitative results, the average value from each range was used for computing the regression analysis values. For quantitative items. R values were used to demonstrate correlation. For qualitative results, correlation or equivalence was determined to be within one reporting range of each other, as recommended in NCCLS GP16-A, section 2.3.2 Microsopic Urinalysis.

There were 182 stained samples were analyzed both manually and on theMICRO21 by three certified medical technologists. To generate a wider range of urinary constituents, 31 stained samples were created using serial dilution and enrichment. Using blinded experimental methods, the stained samples were reviewed manually, and processed by the MCRO21 and resultant images reviewed by the technologists.

Conclusion

There was no significant variation in the precision, reproducibility, and linear testing demonstrating the method. Correlation was demonstrated for RBC, WBC, Squamous Epithelial cells, Hyaline Casts, Amorphous, Calcium Oxalate, and Triple Phosphate Crystals, Mucous, Sperm and Yeast. The data presented support the claim that the MCCRO21 with Urine Sediment Analysis is safe and effective for it's intended use of locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result.

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AUG - 7 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. R. Otto Stellner Vice President, Regulatory Compliance Intelligent Medical Imaging, Inc.™ 4360 Northlake Boulevard, Suite 214 Palm Beach Gardens, Florida 33410

Re: K982301 Trade Name: MICRO21® with Urine Sediment Analysis Requlatory Class: II Product Code: JOY Dated: June 30, 1998 Received: July 1, 1998

Dear Mr. Stellner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982301

510(k) Number (if known):

Device Name:

べ

MICRO21 with Urine Sediment Analysis

Indications for Use:

For In Vitro Diagnostic Use

INTELLIGENT MEDICAL IMAGING, INC. DOES NOT PROMOTE THE USE, PROVIDE SUPPORT FOR, MAKE CLAIMS OF EFFECTIVENESS OF, OR ASSUME LIABILITY OF THIS DEVICE IN ANY OTHER COMMERCIAL, EXPERIMENTAL OR INVESTIGATIONAL APPLICATION.

Use of this device in any manner that is inconsistent with its intended use may be in violation of federal law.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) OR

1,1

Over-The-Counter Use (Optional Format 1-2-96)

Audie Meson
8/5/98

(Dinsici Sign-Off) Division of Chincal Labo S . ciki Number -

Regulation Number and Section

§ 864.5260 Automated cell-locating device.

(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).