The STUDIO on the Cloud Data Manager Software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities.

Device Description

The STUDIO on the Cloud Data Management ("STUDIO") Software is comprised of a data analysis and storage platform, report generation software, and an information delivery service.

Specifically, the proposed STUDIO Software performs the following functions:

Data Upload: the SweetSpot Fetch Utility application will be used to access data from ● a Receiver, using either Mac or PC operating systems;
Data Analysis: certain SweetSpot Platform functions will be used to validate. ● aggregate, and analyze (e.g., correlate) CGM data, and to create charts and reports that mimic the current STUDIO Pattern and Glucose Strips charts and reports;
. Reports: The current STUDIO Pattern charts will be displayed on the user's computer screen, and both the Pattern and Glucose Strip charts can be saved to the user's computer in PDF format. Both reports may be printed by the user as a PDF document.

The STUDIO Software uses only retrospective data stored on the G4 PLATINUM device to create statistical reports, and does not make treatment recommendations.

AI/ML Overview

Here's an analysis of the acceptance criteria and study for the STUDIO on the Cloud Data Management Software, based on the provided text:

Acceptance Criteria and Device Performance for STUDIO on the Cloud Data Management Software

The provided document describes a Continuous Glucose Monitor Data Management System which primarily involves software for data analysis and display, not a device with analytical performance characteristics in the traditional sense (like a diagnostic test). Therefore, the acceptance criteria are focused on the software's functionality, usability, and data accuracy in transferring and displaying retrospective CGM data.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this software device, the "performance" is largely about its functional correctness and usability.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Data Accuracy	All data fields uploaded from the Dexcom G4 PLATINUM receiver should be 100% accurate when compared to the data downloaded to a PC.	100% Accurate: ("All data fields were reported to be 100% accurate.")
Usability (Ease of Use)	Users (lay and professional) should be able to complete assigned tasks without assistance, demonstrating ease of use and label comprehension.	96% Task Completion: ("96% of assigned tasks were able to be completed by users without assistance.")
Software Functionality	The software should correctly perform data upload, analysis (validation, aggregation, correlation), and report generation, mimicking existing STUDIO Pattern and Glucose Strips charts. (Implicit criteria for software development processes)	Acceptable: Documentation related to software development (hazard analysis, requirements, design, traceability, V&V testing) was reviewed and found acceptable. The software performs listed functions as described in the device description. (Implicit from successful review)
Risk Mitigation	Identified risks (e.g., device malfunction leading to diabetes mismanagement) must be adequately mitigated by general controls, including design controls.	Adequately Mitigated: Risks determined to be adequately mitigated by general controls, design controls, and prescription device restrictions.

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

Data Accuracy (Bench Testing):
- Sample Size: Forty (40) Dexcom G4 PLATINUM receivers.
- Data Provenance: Not explicitly stated, but it implies data from these physical receivers, which would contain retrospective CGM data. The context suggests this was internal bench testing, likely with a mix of real or simulated data that would be representative of data produced by the G4 PLATINUM system. It is retrospective in nature as it uses data already stored on the receivers.
Usability Study:
- Sample Size: Forty-four (44) lay and professional users.
- Data Provenance: The study was likely prospective in the sense that these users performed tasks during the study. The demographic characteristics (age, sex, and education level) of the users were varied. The location/country of origin of these users is not specified, but typically for FDA submissions, these would be US-based participants if not otherwise stated.

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

Data Accuracy (Bench Testing): The "ground truth" for the data accuracy test was the same data downloaded directly to a PC. This implies a direct file comparison or database comparison. Therefore, no external experts were used to establish a subjective "ground truth." The ground truth was the original, unaltered data itself.
Usability Study: No explicit mention of experts establishing a "ground truth" for task completion. The "ground truth" for success was likely objective: did the user successfully complete the assigned task? The assessment would have been done by study administrators observing user interactions.

4. Adjudication Method for the Test Set

Data Accuracy (Bench Testing): Not applicable in the traditional sense of expert adjudication. The comparison was direct, likely automated or manual side-by-side comparison of data fields between the software-uploaded data and the PC-downloaded data. Any discrepancy would be a definitive error, not something requiring adjudication.
Usability Study: The document does not specify an adjudication method. Task completion would typically be assessed by study observers or through automated logging of user actions. Given it's reporting "96% of assigned tasks were able to be completed by users without assistance," it implies a clear "pass/fail" for each task for each user, summing up to the total percentage. If there were ambiguities, a predefined scoring rubric or internal review process would be used, but this is not detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret medical images or data, and the AI's assistance to these readers is being evaluated.
The STUDIO software is a data management tool for retrospective CGM data, not an AI-powered diagnostic aide. Its purpose is to present existing data, not to make interpretations or recommendations itself, nor to assist human readers in making new interpretations.

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

Yes, a form of standalone performance was assessed regarding data accuracy. The "Bench Testing" compared the data processed by the software against the original data downloaded to a PC. This is an algorithm-only evaluation of data integrity during transfer and processing. The software's ability to accurately present the retrospective data is its primary "standalone" function.
The "usability study" is human-in-the-loop, but it evaluates the human's interaction with the software, not the software's inherent analytical capabilities on its own.

7. The Type of Ground Truth Used

Data Accuracy: The ground truth was the original, raw CGM data as directly downloaded from the Dexcom G4 PLATINUM receiver to a PC. This is a very objective, "reference data" type of ground truth.
Usability: The ground truth for usability was successful completion of pre-defined tasks by users without assistance, measured objectively by study observers or system logs.

8. The Sample Size for the Training Set

The document does not specify a separate training set size. This is typical for data management software that primarily performs aggregation, storage, and visualization of existing data, rather than machine learning models that require explicit "training." The software's design and functionality are based on defined rules and processes for handling CGM data, not on learning from a dataset.

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

As no explicit training set is mentioned for a machine learning model, this question is not applicable. The "ground truth" for the software's development (which could be considered analogous to a training phase in a different context) would be the specifications and expected behavior, informed by the Dexcom G4 PLATINUM data format and intended display logic. This would be established through engineering requirements and design (based on established CGM data structures and diabetes management reporting needs).

Summary

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EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software

DECISION SUMMARY

A. DEN Number:

DEN140016

B. Purpose for Submission:

De novo request for adjunct data management software

C. Measurand:

Not applicable. The submission is for a continuous glucose monitor data management software device.

D. Type of Test:

Diabetes data management system

E. Applicant:

Dexcom, Inc.

F. Proprietary and Established Names:

STUDIO on the Cloud Data Management Software

G. Regulatory Information:

1. Regulation: 21 CFR 862.2120, Continuous glucose monitor data management system.
1. Classification: Class I, exempt
PHV 3. Product code:
1. Panel: Chemistry (75)

H. Intended Use:

1. Intended use(s):

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1. Indication(s) for use:
  Same as intended use
1. Special conditions for use statement(s):
  For prescription home use.

This device is intended for display of retrospective glucose data and not for real-time display of glucose results.

This device is not intended for making treatment decisions.

This device is not intended for calculating insulin or other drug doses.

This device is not intended for controlling insulin pumps or other drug delivery systems.

1. Special instrument requirements:
  Dexcom G4 PLATINUM Continuous Glucose Monitoring System

I. Device Description:

The STUDIO on the Cloud Data Management ("STUDIO") Software is comprised of a data analysis and storage platform, report generation software, and an information delivery service.

Specifically, the proposed STUDIO Software performs the following functions:

Data Upload: the SweetSpot Fetch Utility application will be used to access data from ● a Receiver, using either Mac or PC operating systems;
Data Analysis: certain SweetSpot Platform functions will be used to validate. ● aggregate, and analyze (e.g., correlate) CGM data, and to create charts and reports that mimic the current STUDIO Pattern and Glucose Strips charts and reports;
. Reports: The current STUDIO Pattern charts will be displayed on the user's computer screen, and both the Pattern and Glucose Strip charts can be saved to the user's computer in PDF format. Both reports may be printed by the user as a PDF document.

The STUDIO Software uses only retrospective data stored on the G4 PLATINUM device to create statistical reports, and does not make treatment recommendations.

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J. Standard/Guidance Documents Referenced:

1. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999
1. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
1. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry & FDA Staff, June 13, 2013
1. Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 14, 2005
1. General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 11, 2002
1. Guidance for Industry and Food and Drug Administration Staff, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, March 28, 2012
1. ISO 14971:2012 Medical devices Application of risk management to medical devices
1. IEC/TR 80002-1:2009 Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software
1. ANSI/AAMI/IEC 62304:2006 Medical device software Software life cycle processes
1. ISO 13485: Quality Systems Medical Devices System Requirements for Regulatory Purposes
1. U.S. Food and Drug Administration, 21 CFR Part 820: Quality System Regulation
1. NIST SP 800-53 rev3: Recommended Security Controls for Federal Information Systems and Organizations
1. HIPAA: Health Insurance Portability and Accountability Act

K. Test Principle:

Not applicable.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Reproducibility/Precision

Not applicable.

b. Linearity/assay reportable range:

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Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Not applicable.
d. Detection limit

Not applicable.

e. Analytical specificity:
Not applicable.
1. Comparison studies:
- a. Method comparison with predicate device:

Not applicable.

b. Matrix comparison:
Not applicable.
1. Clinical studies:
  A usability study was performed with Forty Four (44) lay and professional users with varying demographic characteristics (age, sex, and education level). The intent of the study was to verify software ease of use and label comprehension. The study determined that 96% of assigned tasks were able to be completed by users without assistance.
1. Expected Values
  Not applicable.

M. Instrument Names:

STUDIO on the Cloud Data Management Software

N. System Description:

1. Modes of Operation:
  Does the applicant's device contain the ability to transmit data to a computer, webserver, or mobile device? Yes X_ or No _

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Does the applicant's device transmit data to a computer, webserver, or mobile device using wireless transmission: Yes or No X > > .

1. Software:
  FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes X_ or No _________________________________________________________________________________________________________________________________________________________

1. Specimen Identification:
  Not Applicable
1. Specimen Sampling and Handling:
  Not Applicable
1. Calibration:
  Not Applicable
1. Quality Control:
  Not Applicable

O. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above:

1. The following documentation related to the STUDIO on the Cloud Data Management Software was reviewed and found to be acceptable: level of concern, software description, device hazard analysis, software requirements specifications, architecture design chart, software design specification, traceability analysis, software development environment description, verification and validation testing, and revision level history.
1. Bench Testing was perfomed using data from forty (40) G4 PLATINUM receivers. CGM data were uploaded from the receivers using the STUDIO on the Cloud Data Management Software and were compared to the same data downloaded to a PC. All data fields were reported to be 100% accurate.

P. Proposed Labeling:

The labeling is sufficient and satisfies the requirements of 21 CFR Part 801, 21 CFR Part 809, and 801.109.

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Q. Identified Potential Risks and Required Mitigations

Identified Risk	Required Mitigation
Device malfunction (e.g., incorrect dataanalysis, etc.)	General controls, including design controls

Identified Risks and Required Mitigations Table

Device malfunction (e.g., incorrect data analysis, etc.) may lead to diabetes mismanagement and poor glycemic control. This risk can be adequately mitigated by general controls, including design controls and restriction as a prescription device that must comply with 21 CFR 801.109.

R. Benefit/Risk Analysis

Summary
Summary ofthe Benefit(s)	The STUDIO on the Cloud Data Management Software is convenient to use since itanalyzes and correlates several sources of diabetes management-relevant information(e.g. user glucose levels, meals, insulin delivery, and exercise data) into one softwareprogram. The data sorting and presentation functions of the STUDIO on the CloudData Management Software provide patients and their doctors access to a morecomplete clinical picture of a patient's current disease, as well as of the impact of pastdiabetes management decisions on a patient's glucose levels. The convenience ofusing the device should translate into better record-keeping compliance by the patient,and the greater access provided to data should assist the patient and their physicianwith the identification of the patient's unique glucose excursion triggers; together,these benefits should allow patients and their doctors to make rational modifications tothe patient's diabetes management plan, with the goal of achieving better glycemiccontrol.
Summary ofthe Risk(s)	Device malfunction may lead to diabetes mismanagement and poor glycemic control.Decisions made based on incorrect data or faulty analyses may put the patient at risk of more frequent acute episodes of hypoglycemic and/or hyperglycemic excursions.These episodes increase the likelihood of hospitalization and/or death. Chronic poor glycemic control could lead to irreversible diabetes-related sequelae (e.g. retinopathy, neuropathy, nephropathy and arteriosclerosis). These risks can be adequately mitigated by the sponsor's verification and validation and design control activities which ensure that the risk of malfunction is very low.Continuous glucose meters are only approved for tracking and trending; therefore another risk is that users could modify their current insulin dosage based directly on current CGM glucose values provided by the STUDIO on the Cloud Data Management Software. This risk is mitigated by product labeling which states that users should not make changes in their treatment program without talking to their healthcare providers. In addition, only retrospective CGM glucose values are provided by the software, so real-time CGM glucose values are not readily available to users. Risks are mitigated by general controls, including requiring design controls and restriction as a prescription device that must comply with 21 CFR 801.109.
Summary ofOther Factors	Patients are willing to tolerate the low risk associated with use of the STUDIO on the Cloud Data Management Software because they benefit from a substantial improvement in the analysis and correlation of retrospective continuous glucose monitoring information (e.g. glucose values over time, paired with meal, exercise, and insulin bolus information), which can be used by the patients and their doctors to assist in making adjustments to their diabetes management program, with the goal of reducing glucose excursions and maintaining proper glycemic control.
ConclusionsDo theprobablebenefitsoutweigh theprobable risks?	Yes. The device is likely to provide benefits in improved diabetes management with a low associated risk.

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S. Conclusion:

The information provided in this de novo submission is sufficient to classify this device into class I, exempt from premarket notification requirements subject to the limitations in 21 CFR 862.9, under regulation 21 CFR 862.2120. As a software containing device, this device type is also subject to design controls. FDA believes that applicable general controls, including design controls, provide reasonable assurance of the safety and effectiveness of the device type. The device is classified under the following:

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Product Code:	PHV
Device Type:	Continuous glucose monitor data management system
Class:	I (general controls)
Regulation:	21 CFR 862.2120

(a) Identification. A continuous glucose monitor data management system is an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.

(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 the limitations in § 862.9.

Regulation Number and Section

§ 862.2120 Continuous glucose monitor data management system.

(a)
Identification. A continuous glucose monitor data management system is an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.(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 the limitations in § 862.9.