STAT TRACKS by AWARENESS TECHNOLOGY, INC.

This accessory program may be used by customers with the general purpose analyzer (K882938) who want to link their instrument to a PC for the purpose of transferring the data from the general purpose instrument to the PC, instead of having the data typed manually by a data entry person

Device Description

Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stat Tracks device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Design will produce intended results.	"Stat Tracks has been tested to verify that the design will produce intended results."
Activation of appropriate error messages.	"Studies confirm activation of appropriate error messages as well."
No device-induced case of mis-identification of a patient result.	"No device-induced case of mis-identification of a patient result has been found under any circumstance of testing."
Device is comparable to other commercially available software and manual methods for data handling.	"Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing." (This is a statement of equivalence, not a direct performance metric, but relevant to the overall acceptance of the device's function).
Facilitate the lab worker's job, mainly by saving time and money.	While not a direct acceptance criterion reported with performance data, the "USE OF THE DEVICE" section states this as the device's purpose, implying it was an intended outcome of the design. The text doesn't quantify this saving.

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

Sample Size for Test Set: Not explicitly stated. The text mentions "Design Assurance Testing" and that "Stat Tracks has been tested," but does not provide details on the number of tests, cases, or scenarios included in this testing.
Data Provenance: Not specified. It's likely that the testing was internal to Awareness Technology, Inc., given the nature of a software interface. There's no indication of independent testing or specific geographical origin beyond the company's location in Palm City, FL, USA. The testing appears to be prospective in the sense that it was conducted as part of the device's development and verification.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The testing would have likely involved "laboratory professionals" as they are the intended users, but their specific qualifications for evaluating the software's performance are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a software interface for data transfer, it's unlikely that a formal adjudication process involving multiple readers was employed in the same way it would be for diagnostic image interpretation. The testing likely focused on functional verification and error checking.

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

No, an MRMC comparative effectiveness study was not done. The document describes a software tool for data transfer, not a diagnostic aid that would typically involve human readers interpreting complex cases. The comparison is made to "other commercially available software" and "manual methods," but this is a statement of equivalence rather than a formal MRMC study.
Effect Size of Human Reader Improvement with AI vs. Without AI Assistance: Not applicable, as this was not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone performance assessment was done. The "Design Assurance Testing" described is essentially a standalone assessment of the software's functionality, focusing on whether it produces intended results, activates error messages, and avoids patient mis-identification. The device's primary function is to automate data transfer, which it does without direct human intervention during the transfer process itself (though a human initiates it). The phrase "No device-induced case of mis-identification of a patient result has been found under any circumstance of testing" directly refers to the algorithm's standalone performance in preventing errors.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device appears to be defined by:
- Functional correctness: Whether data is transferred accurately and as intended.
- Error message activation: Whether specific error conditions correctly trigger appropriate messages.
- Absence of data mis-identification: Verifying that patient results are not mistakenly linked to the wrong patient or test.
- This is essentially a form of functional verification against predefined specifications and expected outputs.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a software interface and reporting tool, not a machine learning or artificial intelligence algorithm that requires a "training set" in the conventional sense. Its "training" would be its development and debugging process.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no traditional "training set" for this type of software. The "ground truth" for the software's development would be its functional specifications and adherence to programming logic.

Summary

{0}------------------------------------------------

JAN 2 8 1998

Image /page/0/Picture/1 description: The image shows the logo for Awareness Technology Inc. The logo consists of a square shape with lines radiating outward from the center, resembling a microchip. Below the symbol, the word "AWARENESS" is written in large, bold letters, followed by "TECHNOLOGY" and "INC." in smaller font sizes.

K974762

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This summary of 510(k) safety and effectiveness informtion is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. It is submitted by Mary Freeman of Awareness Technology which is located at the address given below. The telephone and fax numbers are also given below.

BASIS FOR EQUIVALENCE: Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing.

USE OF THE DEVICE: Stat Tracks is to used by the lab technician operating the analyzer so that computer entry and data storage can replace manual methods. This software is not used to measure, calculate, or qualify test results. The purpose of this program is to facilitate the lab workers job, mainly by saving time and money. Instead of buying a pre-printed lab report form and typing in the results, for example, the lab can print a form from the computer with the results in it.

CRITICALITY: The program is not used with any device that comes in contact with patients, nor any life supporting equipment. It is used by laboratory professionals in the processing of diagnostic in vitro testing. The worse case senario is that a correct laboratory result is printed for the wrong test or patient, somehow caused by the software, and that it is reported and considered plausible by the treating physician, and leads to delayed or inappropriate treatment having adverse effects. Use of this software in place of another program or a manual method, does not increase the likelihood of such an event. Since the chemistry analyzer is a manual one, the user remains responsible for entering the specimens one-by-one in the correct order.

DESIGN ASSURANCE TESTING: Stat Tracks has been tested to verify that the design will produce intended results. Studies confirm activation of appropriate error messages as well. No device-induced case of mis-identification of a patient result has been found under any circumstance of testing.

3T OFFICE DRAWER 1679/1995 SW MARTIN HIGHWAY/PALM CITY, FL 34991 (561) 283-8020

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 1998

Mary Freeman President Awareness Technology Inc. P.O. Box 1679 1995 SW Martin Highway Palm City, Florida 34991

K974752 Re: Stat Tracks Requlatory Class: I Product Code: JJQ December 18, 1997 Dated: December 19, 1997 --Received:

Dear Ms. Freeman:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good 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 Title 21, Parts 800 to 895. Federal Requlations, 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 requlation 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 requlations.

{2}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 markets 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 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 the regulation encreace, "Mobilanding by Subscribe eral 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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

Enclosure

{3}------------------------------------------------

Page_1_of 1

K974762 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

common name = PC program; proprietary name = Stat Tracks Device Name:_

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓
OR
Over-The-Counter Use
(Per 21 CFR 801.109)....
(Optional Format 1-2-96)
(Off)
Division of Clinical Laboratory Devices
510(k) Number. K974762

Regulation Number and Section

§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.

(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(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.