The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

Device Description

The ASiManager-AT is an integrated digital particle analyzer designed to objectively interpret certain slide agglutination tests manufactured by Arlington Scientific Inc. (ASI). Qualitative and semiquantitative tests are performed by laboratory professionals who use the ASiManager-AT to provide standardized test interpretation using criteria that define reactive and nonreactive agglutination reactions. The ASiManager-AT also delivers an initial predictive titer analysis for the ASI RPR Card Test for Syphilis.
The ASiManager-AT employs a CCD (charge-coupled device) camera that uses light reflectance to create a highly sensitive and high-resolution image of the agglutination immunoassay. This image is then analyzed by the proprietary software algorithm to interpret the agglutination pattern.
The ASiManager-AT further provides tools that enable the creation, storage. retrieval and transmittal of the test results.

AI/ML Overview

The ASiManager-AT device is an integrated digital particle analyzer designed to objectively interpret the ASI RPR Card Test for Syphilis, provide standardized test interpretation, an initial predictive titer analysis, and manage test results.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Qualitative Interpretation	Substantial equivalence to visual interpretation by trained laboratory professionals. Implied high agreement rates for reactive and nonreactive samples.	Prospective: 100% positive agreement (reactive), 100% negative agreement (nonreactive) (375 samples).Retrospective: 98.4% positive agreement (reactive), 95.5% negative agreement (nonreactive) (3131 samples).
Predictive Titer Analysis (Initial)	Within ±1 dilution of visual interpretation.	93.6% concordance (1146 out of 1224 reactive samples).
Endpoint Titer Determination	Within ±1 dilution of visual interpretation.	98.9% concordance (700 out of 708 reactive samples).

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

Qualitative Interpretation:
- Prospective study: 375 samples.
- Retrospective study: 3131 samples.
Predictive Titer Analysis: 1224 reactive samples (a subset of the 1849 reactive samples from qualitative testing).
Endpoint Titer Determination: 708 reactive samples (a subset of the 1849 reactive samples from qualitative testing).

The document states that the data are "results from three testing sites." It doesn't specify the country of origin. The test sets were a mix of prospective (375 samples) and retrospective (3131 samples) data for qualitative interpretation.

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

The ground truth was established by "trained laboratory professionals" performing "visual interpretation." The document does not specify the number of experts or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). It describes a comparison between the ASiManager-AT's digital results and "visual interpretation" by trained laboratory professionals, implying that the visual interpretation served as the primary reference or ground truth for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 done in the context of human readers with AI assistance versus without AI assistance. The study compares the device's performance against human visual interpretation (the ground truth), not how the device assists human readers to improve their performance. The device is described as providing "standardized test interpretation," suggesting it's designed to replace or provide an objective alternative to subjective visual interpretation.

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

Yes, the studies described are essentially standalone performance studies for the ASiManager-AT device. The device's proprietary software algorithm interprets the agglutination pattern and determines results independently, which are then compared to the ground truth established by human visual interpretation.

7. The Type of Ground Truth Used

The ground truth used was expert visual interpretation by "trained laboratory professionals."

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set of the ASiManager-AT's proprietary software algorithm. It only details the performance studies for validation.

9. How the 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. It only mentions that the ASiManager-AT uses a "proprietary software algorithm" that interprets the agglutination pattern based on "criteria that define reactive and nonreactive agglutination reactions." This implies that historical data, expert knowledge, or other methods were used to train the algorithm and define these criteria.

Summary

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510/k) Premarket Notification Submission

ASiManager-A T

Arlington Scientific. Inc.

NOV - 9 2011

510(k) Summarv 5.0

5.1 Preparation Date: 05-13-2011

Submitted By

David Binks MT (ASCP), MBA Director of QA/Requlatory Affairs Arlington Scientific, Inc. 1840 North Technology Dr. Springville, UT 84663 Phone 801-489-8911 / Fax 801-489-5552

5.2 Trade Name - ASiManager-AT

Common Name - Densitometer/scanner

Classification Name (21 CFR 862.2400) Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

5.3 Predicate Device(s) - ASI RPR Card Test for Syphilis - K851504

Device Description The ASiManager-AT is an integrated digital particle analyzer 5.4 designed to objectively interpret certain slide agglutination tests manufactured by Arlington Scientific Inc. (ASI). Qualitative and semiquantitative tests are performed by laboratory professionals who use the ASiManager-AT to provide standardized test interpretation using criteria that define reactive and nonreactive agglutination reactions. The ASiManager-AT also delivers an initial predictive titer analysis for the ASI RPR Card Test for Syphilis.
The ASiManager-AT employs a CCD (charge-coupled device) camera that uses light reflectance to create a highly sensitive and high-resolution image of the agglutination immunoassay. This image is then analyzed by the proprietary software algorithm to interpret the agglutination pattern.

The ASiManager-AT further provides tools that enable the creation, storage. retrieval and transmittal of the test results.

Intended Use – The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

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ASiManager-A T

5.5 Summary of Comparison Data - A comparison of the digital interpretation of the results of testing samples with the ASI RPR Card Test for Syphilis using the ASiManager-AT and visual interpretation by trained laboratory professionals was conducted to show substantial equivalence.
The following data are the results from three testing sites:

		ASiManager-AT Digital Results
		Reactive	Nonreactive
VisualResults	Reactive	3	0
	Nonreactive	0	372

Combined Prospective Sample Testing - 375 Samples

These results give a percent agreement positive of 100% with reactive samples and 100% with nonreactive samples.

Combined Retrospective Sample Testing - 3131 Sample
ASiManager-AT Digital Results
	Reactive	Nonreactive
VisualResults	Reactive	1799	58
	Nonreactive	29	1245

These results give a percent agreement positive of 98.4% with reactive samples and 95.5% with nonreactive samples.

Of the 1849 reactive samples from the qualitative testing 1224 were used to determine the predictive titer. The ASiManager-AT is programmed to project or predict the endpoint titer of each qualitative test by reading the undiluted serum (1:1) and determining its corresponding endpoint for reactive serums. This is done using a proprietary algorithm that interprets the reaction in the undiluted sample and projects what the endpoint titer of the sample will be. A one dilution difference is an acceptable range for equivalency because the minimal reactive endpoint titer is subject to interpretation between different observers due to many factors such as lighting, visual acuity, and fatigue, etc. Of the 1224 reactive samples tested 1146 were within the ±1 titer acceptance criteria, for a concordance of 93.6%

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510(k) Premarket Notification Submission

ASiManager-A T

Arlington Scientific, Inc.

Of the 1849 reactive samples from the qualitative testing 708 were used to determine the endpoint titer. The ASiManager-AT is programmed to determine the true endpoint titer of a serial diluted specimen using the RPR endpoint titer function on the instrument. The RPR endpoint titer (semiquantitative) function analyzes the entire card and indentifies in which well the serial diluted sample becomes nonreactive. The software then calculates the endpoint titer. A one dilution difference is an acceptable range for equivalency because the minimal reactive endpoint titer is subject to interpretation between different observers due to many factors such as lighting, visual acuity, and fatigue, etc. Of the 708 reactive samples tested 700 were within the ±1 titer acceptance criteria, for a concordance of 98.9%

5.6 Conclusion - The ASiManager-AT is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, with three wavy lines forming a shape reminiscent of a bird or a stylized human form.

10903 New Hampshire Avenue Silver Spring, MD 20993

Arlington Scientific, Inc. c/o Mr. David Binks Director of QA/Regulatory Affairs 1840 North Technology Drive Springville, UT 84663

NOV - 9 2011

K111356 Trade/Device Name: ASiManager-AT Regulation Number: 21CFR §862.2400 Regulation Name: Densitometer/scanner ( intergrating.reflectance, TLC, or radiochromatogram) for clinical use Regulatory Class: Class I Product Code: JQT Dated: November 7, 2011 Received: November 8, 2011

Dear Mr. Binks:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a

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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 regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vally attor

Sally A. Hojvat, M.Sc Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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ASiManager-A T

.. ..

Arlington Scientific, Inc.

Indications for Use Statement

510(k) Number (if known):

Device Name: ASiManager-AT

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Eredalee the Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K/// 357

Regulation Number and Section

§ 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

(a)
Identification. A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.