The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results.

Device Description

An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice.

AI/ML Overview

The provided document is a 510(k) summary for the ACCU-CHEK® Advisor Insulin Guidance Software, which received clearance in 2005. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. Therefore, much of the requested information cannot be extracted directly from this document.

Here's an analysis based on the available information:

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

The document does not provide a table of acceptance criteria with specific performance metrics such as accuracy, sensitivity, or specificity. The 510(k) summary primarily asserts substantial equivalence based on features and intended use.

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

The document does not mention a specific 'test set' or 'sample size' for performance evaluation. It describes a comparison to a predicate device based on features and functionality. There is no information on data provenance.

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. The clearance is based on comparison to a predicate device, not on an independent clinical performance study involving expert-established ground truth.

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

This information is not provided.

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

The document does not mention an MRMC study or any study evaluating the comparative effectiveness with and without AI assistance for human readers. The device is software for managing blood glucose data and providing guidance within a pre-planned treatment program, not a diagnostic AI system for image interpretation.

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

While the software provides "guidance" and "direction," the indication for use states it is "to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results." This implies a human-in-the-loop scenario. The document does not describe a standalone performance study of the algorithm without human involvement. The "Insulin Guidance Software" itself is the "algorithm only" in the sense that it processes data and provides recommendations, but its ultimate use is in conjunction with patient and healthcare professional review. No specific standalone performance metrics are provided.

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

The document does not specify the type of ground truth used for performance validation. Given the nature of the device (insulin guidance software), ground truth would likely relate to the accuracy of calculations, the appropriateness of guidance based on input data according to established medical guidelines, or correlation with patient outcomes, but no details are provided.

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of detail is usually associated with machine learning or AI model development, which is not explicitly discussed in this 2005 510(k) summary focused on substantial equivalence to a predicate.

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

Not applicable, as a training set and its ground truth are not mentioned.

Summary of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

Based on the provided 510(k) summary, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics from a specific clinical study with defined acceptance criteria.

The core of the documentation provided is a comparison table that highlights similarities in features and claims between the ACCU-CHEK® Advisor Insulin Guidance Software and the predicate device, Diacare Monitoring System Software.

Acceptance Criteria (Implicitly based on Substantial Equivalence):

The implied acceptance criteria revolve around the device possessing similar technological characteristics and having the same intended use as a legally marketed predicate device. The features outlined in the "Comparison to Predicate Device" section serve as the basis for this:

Feature/Claim	Implicit Acceptance Criteria (Demonstrated Similarity)	Reported Device Performance (as stated in document)
Meter data upload	Ability to upload meter data	Yes.
Support	Provision of support mechanisms	Yes; through call center support, labeling and health care professionals.
Data storage	Ability to store data	On computer media.
Reports and graphs	Generation of similar reports and graphs	Similar graphs and reports can be generated for viewing on a display screen, and hard copy printout.
Manual Data Entry	Methods for manual data entry	Similar methods of manually entering data into the software.
Delete Data	Methods for deleting data	Similar methods of deleting data.
Track non-blood glucose data	Ability to track various patient data	Tracks similar data sets. (i.e. Carbohydrates, insulin, timeblocks, event codes).
Overall Intended Use	Aid in review, analysis, and evaluation of blood glucose results and provide insulin adjustment direction within a pre-planned program.	The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice.

The Study that Proves the Device Meets the Acceptance Criteria:

The document describes a 510(k) premarket notification process where the device was reviewed for substantial equivalence. The "study" in this context is the detailed comparison to the legally cleared Diacare Monitoring System Software presented in the 510(k) summary. This comparison asserts that the ACCU-CHEK® Advisor Insulin Guidance Software has sufficient similarities in features, claims, and intended use as the predicate device to be substantially equivalent and therefore safe and effective. No independent clinical performance study with statistical endpoints is detailed in this regulatory submission.

Summary

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Roche Diagnostics Corporation Scott Thiel Regulatory Affairs Program Principal Patient Care Division 9115 Hague Road Indianapolis. Indiana 46250

May 17, 2024

Re: K043529

Trade/Device Name: ACCU-CHEK® Advisor Insulin Guidance Software Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: NDC

Dear Scott Thiel:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 8, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code NDC.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Juliane Lessard, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6126, Juliane.Lessard(@fda.hhs.gov.

Sincerelv.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery, General Hospital and Human Factors Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

APR 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Thiel Regulatory Affairs Program Principal Roche Diagnostics Corporation Patient Care Division 9115 Hague Road Indianapolis. Indiana 46250

Re: K043529

Trade/Device Name: ACCU-CHEK® Advisor Insulin Guidance Software Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LNX Dated: March 30, 2005 Received: March 31, 2005

Dear Mr. Thiel:

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.

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Page 2 - Mr. Thiel

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 Part 801); 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 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number (if known): KO43529

Device Name: ACCU-CHEK® Advisor Insulin Guidance Software

Indications For Use:

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim Vur

il Aneshesiology, General Hospital, tion Control, Dental Devices

Page I of

:) Number

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APR 8 2005

510(k) Summary

్రాల్య

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contact	Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-2000 ext. 3362 Contact Person: Scott Thiel Date Prepared: December 17, 2004
2) Device name	Proprietary name: ACCU-CHEK® Advisor Insulin Guidance Software Common name: diabetes management software Classification name: computers and software, medical Product Code: LNX
3) Predicate device	We claim substantial equivalence to the current legally cleared Diacare Monitoring System Software.
4) Device Description	An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice.
5) Intended use	The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results.

Continued on next page

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510(k) Summary, Continued

Comparison to Predicate Device

The Roche Diagnostics ACCU-CHEK Advisor Insulin Similarities Guidance is substantially equivalent to the current legally cleared version Diacare Monitoring System Software. The following is a list of some of the claims and features found to be similar to the predicate device.

Feature/Claim	Detail
Meter dataupload	Yes.
Support	Yes; through call center support, labeling and health careprofessionals.
Data storage	On computer media.
Reports andgraphs	Similar graphs and reports can be generated for viewingon a display screen, and hard copy printout.
Manual DataEntry	Similar methods of manually entering data into thesoftware.
Delete Data	Similar methods of deleting data.
Track non-blood glucosedata	Tracks similar data sets. (i.e. Carbohydrates, insulin,timeblocks, event codes).

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).