The SweetSpot Diabetes Data Management Service is intended for use in clinical settings by both patients and healthcare professionals, to assist in the review, analysis, and evaluation of blood glucose test results by the clinician to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.

Device Description

The SweetSpot Service allows patients or healthcare professionals to download data from blood glucose meters (BGM) and generates a report from the downloaded data. which is delivered to the healthcare professional for use in patient management. The Service is comprised of three different types of data retrieval stations, a Fetch Utility, a data processing and storage platform, report generation software, and an information delivery service.

The first type of data retrieval station is a Front-Office Kiosk - a dedicated off-the-shelf computer that a patient uses to download the data from their devices (if they download from multiple devices the Service will consolidate that data into a single report). A device-specific cable is required to connect the BGM to the Kiosk for data download. Once the data is downloaded, it is processed into a report and delivered according to the specific clinic's needs and workflow.

The second type of data retrieval station is a Back-Office Kiosk - a dedicated off-theshelf computer that healthcare professionals use to download patient devices and/or monitor reports. This kiosk is also configured for the workflow needs of the clinic.

The third type of data retrieval station is a Back-Office Web Application – a standalone application used by healthcare professionals that does not require a dedicated computer. Each customer uses a specific instance of the web application through a unique URL. This launches a proprietary web application configured for that specific clinic's needs and workflows.

The SweetSpot Fetch Utility retrieves data from various BGM manufacturers' devices and includes device drivers for multiple manufacturers. The Fetch Utility is centrally updated and maintained. When any version of the SweetSpot Services retrieval stations - in any setting - is directed to perform data retrieval, the Service ensures the most upto-date version of the Fetch Utility is used.

The SweetSpot Service is primarily web-based and is delivered using a software-as-aservice (SaaS) model. All data storage and processing takes place on remotely hosted virtualized computing resources on the Internet, often referred to as "cloud computing".

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SweetSpot Diabetes Data Management Service, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a formal study report for each specific performance metric with pre-defined thresholds. The "acceptance criteria" are implied by the successful outcomes of the user evaluations and software verification/validation.

Acceptance Criteria (Implied)	Reported Device Performance
Ease of Use (Lay Users - Front-Office Kiosk)	98% of users thought the Service was easy to use (4.9 average rating on a 1-5 scale, 5 being "Strongly Agree").
Increased Likelihood of Meter Use (Lay Users)	90% of users thought they would be more likely to bring their meters to appointments if the Service was available (ratings of 4.6 and 4.5).
Meter Download Success Rate (Lay Users - Front-Office Kiosk)	97.6% and 95.3% success rates (96.5% overall success rate).
Improvement in Workflow/Efficiency (HCPs - Back-Office Kiosk)	HCPs preferred the consistency, simplicity/ease of use, and speed of the SweetSpot download process to their previous processes; preferred one report format. HCPs thought these features would improve workflow, decrease meter download time, simplify decision-making, reduce training time, and reduce the chance for mistakes in data management. This is a qualitative assessment rather than a quantitative metric.
Accuracy of Data Fetch (Lay Users vs. Manufacturer Software)	100% agreement between download files obtained by lay users (SweetSpot Fetch) and SweetSpot employee (manufacturer's software).
Software Functionality (Verification & Validation)	Software verification and validation testing showed that the SweetSpot Service performs as designed. (No specific metrics or thresholds provided).

Study Details

2. Sample sizes used for the test set and the data provenance:

Lay User Evaluation (Front-Office Kiosk):
- Sample Size: 88 respondents (users)
- Data Provenance: Prospective. Performed by typical outpatients at two different typical sites of use. The specific country is not mentioned, but given the context of a US FDA submission, it can be inferred to be within the United States.
HCP User Evaluation (Back-Office Kiosk):
- Sample Size: 11 respondents (healthcare professionals)
- Data Provenance: Prospective. Performed at one typical site of use as part of a larger research study. Country inferred to be the United States.
Accuracy of Fetch Process:
- Sample Size: Not explicitly stated, but implies a comparison for an unspecified number of downloads/BGMs involving lay users and a SweetSpot employee.
- Data Provenance: Prospective, at one typical site of use. Country inferred to be the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For "Accuracy of Fetch Process": The ground truth was established by comparing the data downloaded via the SweetSpot Fetch Utility (by lay users) with data downloaded from the same BGM using the BGM manufacturer's own download software (by a SweetSpot employee). This implies the manufacturer's software acts as the de facto "ground truth" reference, operated by an employee who likely had expertise in operating such devices. The specific qualifications of the SweetSpot employee are not detailed beyond "SweetSpot employee."
For User Evaluations: The "ground truth" was the users' own perceptions and experiences, as captured in surveys, rather than an external expert-established truth.

4. Adjudication method for the test set:

User Evaluations: No formal adjudication method involving multiple experts is described. User feedback was collected via surveys.
Accuracy of Fetch Process: The comparison was direct ("100% agreement"). This suggests a binary comparison for each data point and no need for "adjudication" in the sense of resolving discrepancies between multiple expert opinions.

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 MRMC comparative effectiveness study is described. The device is a data management service, not an AI for image interpretation or diagnosis that would typically involve "readers" in the context of MRMC studies. The evaluations focused on usability and data integrity, not diagnostic accuracy improvement.

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

The "Accuracy of Fetch Process" study can be considered a form of standalone performance evaluation for the data retrieval component. It assessed the algorithm's ability to accurately retrieve data without human intervention altering the data content itself, comparing it to a trusted reference (manufacturer's software).
The software verification and validation also represent standalone testing of the algorithm's functionality and performance as designed.

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

For "Accuracy of Fetch Process": The ground truth was established by the output of the BGM manufacturer's own download software, considered the authoritative source for the BGM data.
For User Evaluations: The ground truth was the self-reported user experience and perceptions (e.g., ease of use, likelihood of meter use).

8. The sample size for the training set:

The document does not mention a "training set" in the context of machine learning or AI. The SweetSpot Service is described as a data management service, implying it facilitates data transfer and presentation, but not necessarily using a machine learning model that would require a dedicated training set. The software was likely developed and refined through standard software development and testing cycles rather than ML model training.

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

As no "training set" is described for an ML model, this question is not applicable based on the provided text.

Summary

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NOV - 9 2011

SweetSpot Diabetes Care, Inc. SweetSpot Diabetes Data Management Service Response to Request for Additional Information dated July 17, 2011

510(k) Summarv

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ _ K111509

A. Submitter	SweetSpot Diabetes Care, Inc.
Contact:	Christopher Logan, CEO
Telephone:	503-893-2448
Email:	chris@sweetspotdiabetes.com

Date Prepared: September 28, 2011

B. Device Names

Classification names

System, Test, Blood Glucose, Over the Counter, Class II at 862.1345, NBW 2) Calculator/data processingmodule for clinical use, Class I at 862.2100, JQP

Common/usual names

Blood glucose meter
Data management software

Proprietary names

Various, from various manufacturers
SweetSpot Diabetes Data Management Service

C. Predicate Device

MyCareTeam-Diabetes, K073699, NBW/JQP

D. Device Description

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ய் Intended Use

The SweetSpot Diabetes Data Management Service is intended for use in in clinical settings by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.

ட் Comparison with the Predicate Device

The SweetSpot Service is substantially equivalent to the MyCareTeam (MCT-Diabetes product), K073699. Both devices are intended to provide access to BGM data to assist in the monitoring of an individual's blood glucose levels. Both devices are designed for use by patients and by healthcare professionals. Both devices support the most commonly used blood glucose meters. The SweetSpot Service has the same technological characteristics as the predicate device with minor exceptions (e.g., the predicate device operates only on PC operating systems while the SweetSpot Service operates on both PC and Mac OS; report contents and data presentation are slightly different), but the exceptions do not affect safety or effectiveness. Any differences in technology have been addressed by software validation and verification testing, and usability testing (conducted in accordance with ISO15197: 2003).

G. Nonclinical Data

Software verification and validation testing showed that the SweetSpot Service performs as designed.

Clinical Data - User Evaluations H.

・・

A lay user evaluation was performed by typical outpatients at two different typical sites of use. A total of 88 respondents completed a user survey after using the SweetSpot Front-Office Kiosk. On a scale of 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree", 98% of the users thought that the SweetSpot Service was easy to use (4.9 average rating at both evaluation sites), and 90% thought that they would be more likely to bring their meters to appointments in the future if the SweetSpot Service was available (ratings of 4.6 and 4.5, respectively, at the user evaluation sites). Meter download success rates were 97.6% and 95.3%, respectively (96.5% overall success rate).

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A separate user evaluation of the Back-Office Kiosk was performed by healthcare professionals (HCP) at one typical site of use. A total of 11 respondents completed a user survey after using the SweetSpot Back-Office Kiosk as part of a larger research study. The HCP preferred the consistency, simplicity/ease of use, and speed of the SweetSpot download process to their previous various meter-specific processes, and also preferred the consistency of having one report format for all patients vs. their previous different meter-specific report formats. The HCP thought that these features would improve workflow, decrease meter download time, simplify decision-making, reduce training time, and reduce the chance for mistakes in data management.

The accuracy of the Fetch process in lay users' hands was evaluated at a typical site of use, where lay users used the Front-Office Kiosk to download data from their BGM, and a SweetSpot employee used the BGM manufacturer's download software to download data from the same BGM. The two download files were compared, and there was 100% agreement between the download files, demonstrating that the lay user does not introduce error into the download process when using the Front-Office Kiosk and the SweetSpot Fetch process.

Conclusions Drawn from Testing .

Software verification and validation testing and user evaluations showed that the SweetSpot Service performs as designed and meets the users' needs.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 three wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SweetSpot Diabetes Care, Inc. c/o Chris Logan CEO 2538 Ne 48th Ave. Portland, OR 97213-1924

NOV - 9 2011

Re: K111509

Trade/Device Name: SweetSpot Diabetes Data Management Service Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: September 30, 2011 Received: October 3, 2011

Dear Mr. Logan:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ( 30) ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Response to Request for Additional Information dated July 17, 2011

Indications for Use Form

510(k) Number (if known): K111509 Device Name: SweetSpot Diabetes Data Management Service

Indications for Use:

Prescription Use	X
(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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K 11150 9

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Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.