(55 days)
The TRAQS is a database management system that is designed specifically to collect, organize, and store Thrombolytic Assessment System (TAS) analyzer records
TRAQS is a software package designed for computers running the Windows 95 operating system. TRAQS provides features which allow the user to collect, view, and sort patient and control results from Thrombolytic Assessment System (TAS) analyzers. TRAQS also provides a method for the user to enter normal ranges and then compare the stored data set against the ranges. Stored results which fall outside the appropriate range are flagged on the screen and in printouts as out of range. Sets of stored TAS results displayed on the screen can be saved to archive files for later viewing or printing. TRAQS also keeps track of the number of results collected from TAS analyzers and can display this data by TAS serial numbers. No capability is provided to alter the data associated with TAS results. A comprehensive users manual is supplied with the software.
The provided text describes the "TAS Result Acquisition System (TRAQS)" software, its intended use, development, and testing. However, it does not contain specific quantitative acceptance criteria or a study demonstrating device performance against such criteria in the way typically expected for clinical devices (e.g., sensitivity, specificity, accuracy).
Instead, the document details a software validation process focused on meeting functional specifications and requirements.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated as Pass/Fail Criteria) | Reported Device Performance (Summary of Test Results) |
|---|---|
| "all test scripts are completed successfully by the version of software under test." (This implies that all stated functional requirements are met). | The "Test Data Summary" section describes the systematic testing performed: - Testing of TRAQS features: Viewing, sorting, and archiving records were methodically tested using modified TRAQS database files with known record sets. - Handling of TAS analyzer records: TRAQS was tested to ensure proper handling of all combinations of data (test type, sample type, error condition, patient ID, length, etc.) that could be received from a TAS analyzer. This included viewing, sorting, printing, and archiving. - Year 2000 (Y2K) compliance: A subset of records specifically tested the software's ability to handle Y2K issues. The overall implication is that these tests were successful, as the device received 510(k) clearance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The text does not provide a specific number for the sample size of the test set. It refers to "known record sets" and "a special set of test records" representing "every possible combination of test type, sample type, error condition, patient id, length, etc." This indicates a comprehensive, but unquantified, test set.
- Data Provenance: The data was synthetically generated or modified for the purpose of software testing.
- "modified TRAQS database files" (for known record sets)
- "TAS records received from a TAS analyzer running with modified software. The modification to the TAS analyzer created a function which filled the TAS analyzer's memory with a special set of test records."
It does not appear to be real patient data, nor is there information on the country of origin. This was a simulated/generated dataset for software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for this software validation was the expected output or behavior defined by the functional specifications. The "known record sets" and the "special set of test records" were specifically designed with expected outcomes against which the software's performance was compared. This is a characteristic of functional software testing, not clinical validation requiring expert review of primary data like medical images or pathology slides.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As described above, the testing involved comparing the software's output against predefined expected behaviors from the "Functional Specification" and the design of the "known record sets" and "special set of test records." There was no human adjudication process involved in establishing ground truth for individual cases.
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. This device is a software system for collecting, viewing, and organizing results from TAS analyzers, and indicating if results are within user-defined ranges. It is not an AI-assisted diagnostic tool or an imaging modality that would involve human readers making interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The validation described is of the standalone software functionality. The tests verified that the TRAQS software independently collected, sorted, viewed, archived data, and correctly flagged out-of-range results as per its defined specifications. There is no "human-in-the-loop" aspect to its core functional validation; it's about the software performing its programmed tasks correctly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth was established by the Functional Specification documents and the design of the test data sets. The "known record sets" and the "special set of test records" were created with predefined expected results, allowing for direct comparison against the software's output. This is typical for rigorous software validation.
8. The sample size for the training set
- Not applicable. This is a rule-based software for data management, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software's functionality is derived from its programming according to specifications, not from learning from data.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set for a machine learning model.
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MAY 2 6 1998
510(k) Summary of Safety and Effectiveness Information
| Submitted by: | Greg GodlevskiDirector of Software Development |
|---|---|
| Address: | Cardiovascular Diagnostics Inc.5301 Departure Dr.Raleigh, NC 27616 |
| Phone: | 1-800-247-42341-919-874-6088 |
| Fax: | 1-919-954-9932 |
| Contact: | Greg GodlevskiDirector of Software DevelopmentorPeter ScottVP of Quality Assurance and Regulatory Affairs |
| Date of Summary: | March, 1998 |
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510(k) Summary of Safety and Effectiveness Information
Trade Name: TAS Result Acquisition System (TRAQS)
Common Name: TRAQS
Classification Name: Accessory to systems for in vitro coagulation studies, automated or semiautomated instruments and associated reagents and controls used to perform a series of coagulation studies and coagulation factor assays (Class II. 21 CFR864.5425)
Description of Accessory TRAQS is a software package designed for computers running the Windows 95 operating system. TRAQS provides features which allow the user to collect, view, and sort patient and control results from Thrombolytic Assessment System (TAS) analyzers. TRAQS also provides a method for the user to enter normal ranges and then compare the stored data set against the ranges. Stored results which fall outside the appropriate range are flagged on the screen and in printouts as out of range. Sets of stored TAS results displayed on the screen can be saved to archive files for later viewing or printing. TRAQS also keeps track of the number of results collected from TAS analyzers and can display this data by TAS serial numbers. No capability is provided to alter the data associated with TAS results. A comprehensive users manual is supplied with the software.
Intended Use: TRAQS software was designed specifically to gather and archive results from TAS analyzers. TRAQS is also intended to indicate whether collected results are within user defined ranges.
Development Environment: The TRAQS application was developed under the control of the CVDI Software Development Life Cycle (SDLC). The CVDI SDLC is based on IEEE software engineering standards. The CVDI SDLC requires that, before any software is written for a product, a Concept document, a Systems Requirement, and a Functional Specification document are written. These documents have been developed for the TRAQS application. The Functional Specification is of particular importance, since it is used to create the test scripts needed during the Validation phase of a project. Prior to the TRAQS Construction phase, the TRAQS Test Plan was written which described the testing methods and pass/fail criteria which would be employed during the Validation phase.
The SDLC dictates that traceability is to be maintained from the System Requirements through Validation. This is accomplished for the TRAQS application with Traceability Matrices that relate the System Requirements to the Functional Specifications and the Functional Specifications to the individual Functional Test Scripts therefore ensuring full coverage of all application features .
Configuration management topics are covered in a specific TRAQS Configuration Management document which describes the creation of software libraries, software module naming conventions, change control, interface control, and status accounting
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510(k) Summary of Safety and Effectiveness Information
Test Plan Summary and Release Criteria: The TRAQS Test Plan states the Validation phase of the TRAOS software development effort shall consist of Functional testing of the TRAQS software. Functional testing consists of the generation of test scripts which specifically test each of the requirements identified in the TRAQS Functional Specification. The Test Plan states that a Functional Test Protocol is to be written to guide the creation of the test scripts.
The Pass/Fail criteria for the Validation phase is stated in the TRAQS Test Plan. The Pass/Fail criteria requires that all test scripts are completed successfully by the version of software under test.
Test Data Summary: Two types of test data sets were used during the Functional testing of the TRAOS software.
The first type of data set consisted of modified TRAQS database files. Since the TRAQS software uses a Microsoft Access database engine, the Microsoft Access application could be used to created TRAQS databases with known record sets. These known record sets were used to methodically test TRAQS features such as viewing, sorting, and archiving records.
The second type of data set consisted of TAS records received from a TAS analyzer running with modified software. The modification to the TAS analyzer created a function which filled the TAS analyzer's memory with a special set of test records. The set of test records represented every possible combination of test type, sample type, error condition, patient id, length, etc. This record set was then transferred to the TRAQS software using the normal operating procedure for capturing TAS results. TRAQS features such as viewing, sorting, printing, and archiving were then tested to ensure that TRAQS would properly handle all combinations of data that could be received from a TAS analyzer. Additionally, a subset of this record set was designed to specifically test the software's ability to properly handle year 2000 issues.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and formed by thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 6 1998
Peter J. Scott Vice President of Quality Assurance and Regulatory Affairs Cardiovascular Diagnostics Inc. 5301 Departure Drive Raleigh, NC 27616
Re: K981206
Trade Name: Tas Results Data Acquisition System (TRAOS) Regulatory Class: II Product Code: GKP Dated: March 27, 1998 Received: April 1. 1998
Dear Mr. Scott:
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, 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, 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Register. 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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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 device and thus, permits vour 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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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Page_ L_of_ /
510(k) Number (if Known):
Device Name: Tas Results Data Acquisition System (TRAQS)
Indications For Use:
The TRAQS is a database management system that is designed specifically to collect, organize, and store Thrombolytic Assessment System (TAS) analyzer records
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Peter E. Maher
Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number_
Prescription Use_ (Per CFR 801.109)
OR
Over-The-Counter use ( Optional Format 1-2-96)
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.