The ClinDataLinkTM Version 1.0 for Spirometry is an application software that will collect spirometry data for clinical research studies in male/females, pediatrics to adults, and measure FVC, MVV, and SVC, in a hospital, clinic, or home use environment. Prescription device by a physician.

Device Description

ClinDataLink Version 1.0 is a software application that will be used to collect spirometry data for clinical research studies using QRS Diagnostics, LLC Type II PCMCIA cards and software development kit. ClinDataLink will capture demographic data, spirometry data (FVC, SVC, and MVV) and time/date of visits based upon Protocol Wizard.

AI/ML Overview

The provided text describes a software application, ClinDataLink Version 1.0 for Spirometry, but it is lacking the specific details required to answer many of your questions, particularly regarding acceptance criteria and a detailed study proving device performance in the way you've outlined.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance efficacy data for a novel device. As such, it highlights system verification and validation but doesn't delve into clinical performance metrics or studies in the manner typical for an AI/ML device.

Here's an attempt to answer your questions based on the available information, with direct statements about missing information where applicable:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly stated or presented in the provided document. The document discusses "extensive validations of the four operating systems via standard verification/validation activities" to ensure compatibility and functionality, but it does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for diagnostic tasks) nor report clinical performance data against such criteria.

The device's function is to collect spirometry data, not to interpret or diagnose. Therefore, typical diagnostic performance metrics wouldn't apply in the same way they would for an AI-driven diagnostic tool. The "performance" here refers more to reliable data capture and management.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary does not detail specific test sets or clinical data used to validate the data collection capabilities of ClinDataLink. It refers to the use of "QRS Diagnostics, LLC Type II PCMCIA cards and software development kit" and the FDA-cleared "ORS SpiroCard" for data collection, implying that the core spirometry measurements are handled by the QRS hardware/software, and ClinDataLink's role is in collecting and managing that data.

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)

This information is not provided in the document. Since the device's primary function is data collection and management, the concept of "ground truth" for diagnostic performance in the context of expert review isn't directly applicable to its stated purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically used in studies where expert consensus is needed to establish ground truth for diagnostic or evaluative tasks, which is not the primary function of this data collection software.

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

This information is not applicable/provided. The ClinDataLink device is a data collection and management software for spirometry data, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its stated function or described validation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. ClinDataLink is an application software for data collection, not a standalone diagnostic algorithm. Its performance is implicitly tied to its ability to accurately capture and manage data from the QRS SpiroCard system, which itself is a diagnostic spirometer requiring human operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the document. Given the device's function as data collection software, the "ground truth" would likely relate to the accuracy and integrity of the data it collects compared to the raw output from the connected QRS SpiroCard. However, details of such comparisons or any specific ground truth definition are not included.

8. The sample size for the training set

This information is not provided in the document. As ClinDataLink is a software application for data collection and management, not an AI/ML model, the concept of a "training set" in the context of machine learning is not applicable here. Its development would involve software engineering and testing principles rather than machine learning training.

9. How the ground truth for the training set was established

This information is not applicable/provided. As noted above, the concept of a "training set" for an AI/ML model doesn't apply to this software.

Summary

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JUL 2 4 2002 COMPLEWARE® CORPORATION

K 820004

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1.	Submitter's Name:	CompleWare Corporation
2.	Address:	221 East Burlington StreetIowa CityIowa 52240
3.	Telephone:	319-338-8888
4.	Contact Person:	Kay Weiler
5.	Date Prepared:	December 18, 2001
6.	Registration Number:	FDA Form 2891 Submitted
Device
1.	Name:	ClinDataLink Version 1.0 for Spirometry
2.	Trade Name:	ClinDataLink

Application Software and Diagnostic Spirometry 3. Common Name:
Classification Name: 4. Spirometer, Diagnostic
1. Product Code: BZG
1. Class: II
1. Regulation Number: 868.1840

C. Identification of Legally Marketed Devices

1. Name: SpiroCard
1. K Number: K973138

Comple Ware Corporation - PO Box 3090 - Iowa City, Iowa 52244-3090 Phone: 319-338-8888 - Fax: 319-338-1604 - Web: www.compleware.com

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1. Date Cleared: October 28, 1998

D. Description of the Device

ClinDataLink will capture demographic data, spirometry data (FVC, SVC, and MVV) and time/date of visits based upon Protocol Wizard.

The components of the ClinDataLink System are the following:

. ClinDataLink Version 1.0 on CD-ROM.
ClinDataLink User's Guide ●
ClinDataLink Help File .
. Pentium II with a 200 MHZ processor with 32 MB of RAM and 2 GB hard drive
Windows 98, 98SE, ME, or 2000 Operating System ●
QRS PCMCIA Card Type II ●
QRS Software
QRS SpiroCard, PC Card to sample the respiratory function of a ● patient via an attached pressure/transducer/mouthpiece and convert the measured pressure difference to an electrical signal.
. QRS Pressure Tubes
QRS Disposable Pneumotach (Mouthpiece)
QRS User's Manual .

E. Intended Use Statement

The ClinDataLink Version 1.0 is an application software that will be used to collect spirometry data for clinical research studies using the FDA Cleared ORS

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The ClinDataLink Version 1.0 is an application software that will be used to collect spirometry data for clinical research studies using the FDA Cleared ORS Diagnostics, LLC Type II PCMCIA cards and software development kit. The ORS SpiroCard was cleared by the agency on October 28, 1998 via K973138.

ClinDataLink will permit the entry and management of these data and the transmission to a central or local database for integration with other clinical research data.

ClinDataLink is compliant with 21 CFR Part 11 requirements for electronic records.

F. Technical Characteristics Summary

The ClinDataLink Version 1.0 for Spirometry is substantially equivalent to the ORS SpiroCard cleared on October 28, 1998.

The ClinDataLink utilizes the QRS SpiroCard to collect spirometry data for clinical research studies.

The ClinDataLink was verified by QRS to support the usage of four operating systems with their components.

CompleWare Corporation undertook extensive validations of the four operating systems via standard verification/validation activities.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2002

Ms. Kay Weiler Vice President CompleWare Corporation 221 East Burlington Street Iowa City, Iowa 52240

Re: K020004

Trade/Device Name: ClinDataLink Version 1.0 for Spirometry Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: April 24, 2002 Received: April 25, 2002

Dear Ms. Weiler:

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, 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 (PMA), 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.

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Page 2 - Ms. Weiler

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy W. Ulatowski

Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: To be determined

Device Name: ClinDataLinkTM Version 1.0 for Spirometry

Indications for Use:

The ClinDataLinkTM Version 1.0 for Spirometry is an application software . that will collect spirometry data for clinical research studies in male/females, pediatrics to adults, and measure FVC, MVV, and SVC, in a hospital, clinic, or home use environment.
Prescription device by a physician. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.

OVER-THE-COUNTER USE_ (optional Form 1-2-96)

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).