OneTouch® Reveal™ is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.

Device Description

OneTouch® Reveal™ is a Web-based Diabetes management system. The application is designed to assist health care professionals and people with diabetes to track blood glucose levels and insulin doses. The application identifies patterns to help patients manage glycemic control. OneTouch® Reveal™ includes pattern recognition messages, reports, and the ability to view patient data remotely.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the LifeScan OneTouch® Reveal™ device, based on the provided text:

Device: OneTouch® Reveal™ (Web-based Diabetes management system)

The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria for a new clinical study. For software devices like OneTouch® Reveal™, "performance" often refers to software verification and validation, and usability, rather than a clinical accuracy study directly analogous to a blood glucose meter.

Based on the available information, here's what can be extracted and what is not explicitly stated:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Software Functionality	Meets required specifications	Demonstrated to meet required specifications and perform as intended.
Usability/Human Factors	Satisfactory usability for intended users	Demonstrated satisfactory performance in Human Factors Usability Studies.
Intended Use	Successfully transmits data and supports diabetes management as intended.	The device performs as intended, supporting diabetes management by tracking blood glucose and insulin doses, identifying patterns, and viewing patient data remotely.
Safety and Effectiveness	No new questions of safety and effectiveness raised compared to predicate.	Substantially equivalent to predicate device (Aidera Diasend System) in intended use, performance, safety, effectiveness, and underlying scientific and operating principles.

Important Note: The document does not provide specific numerical acceptance criteria (e.g., minimum accuracy percentages, specific error rates) that are typical for diagnostic devices, as this is a software system for data management. The "performance data" section broadly states that the device "meets its required specifications and performs as intended."

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "software verification and validation testing" and "Human Factors Usability Studies," but does not provide specific sample sizes (e.g., number of test cases for software, number of participants for usability).
- Data Provenance: Not explicitly stated. For software testing, this would typically involve synthetic data, simulated data, and potentially real patient data for validation. For Human Factors, this would involve participants simulating real-world use. The location of these activities is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. For software verification, "ground truth" would be the expected output based on specifications, which is established by software engineers and subject matter experts. For usability, "truth" is often observed user behavior against defined tasks. No specific number or qualifications of such experts are provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints where expert consensus is needed on a subjective interpretation (e.g., image reading). For software functionality and usability testing, this type of adjudication is generally not directly applicable.
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, an MRMC comparative effectiveness study was not done. This device is a data management system, not an AI-assisted diagnostic tool that would be evaluated with human readers. Its primary function is to track, identify patterns, and display data for users, not to provide interpretations that human readers would then review or be assisted by.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the "software verification and validation testing" evaluates the algorithm's performance in a standalone manner against its specifications (i.e., does the software correctly process data, identify patterns, and generate reports as designed). The document implies this was done when it states the device "meets its required specifications and performs as intended."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For software verification: The "ground truth" would be the expected outcomes and behaviors defined by the software requirements and design specifications. This is derived from scientific principles of glucose monitoring and diabetes management.
- For human factors: The "ground truth" would be the successful completion of tasks by users, adherence to usability principles, and user satisfaction metrics.
The sample size for the training set:
- Not applicable as this is not a machine learning/AI device in the sense of requiring a "training set" for model development. It's a rules-based software system for data management and pattern recognition. The "patterns" it identifies are likely based on predefined clinical rules or thresholds, not derived from a machine learning training dataset.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7. The "ground truth" for the system's logic (e.g., what constitutes a "pattern" or "high glucose event") would be established by clinical experts and engineers based on established medical guidelines for diabetes management, not through a machine learning training process with labeled data.

Summary

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·KV32618

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DEC 1 6 2013

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4. 510(k) Summary

Name of Firm:	LifeScan Inc.A Johnson & Johnson Company965 Chesterbrook Bld.Wayne, PA 19087
Primary 510(k) Contact:	Gabrielle LoganRegulatory Affairs AnalystLifeScan Inc.A Johnson & Johnson Diabetes Care FranchisePhone: 484-328-6159Fax: 610-651-7271Email: GLogan2@its.jnj.com
Secondary 510(k) Contact:	Amy SmithDirector, Regulatory AffairsAdvanced Sterilization ProductsA Johnson & Johnson CompanyPhone: 949-789-3803Email: ASmith21@its.jnj.com
Date Prepared:	August 19, 2013
Device Trade Name:	OneTouch® Reveal™
Device Generic Name:	Accessories, Pump, Infusion SystemTest, Blood Glucose, Over The Counter
Device Class:	II
Review Panel:	General Hospital
Product Code:	Classification Product Code: MRZSubsequent Product Code: NBW
Regulation Number:	Infusion Pump 21 CFR § 880.5725
Predicate Device:	K101806 -- Aidera Diasend System (Aidera AB)
Device Description:	OneTouch® Reveal™ is a Web-based Diabetes managementsystem. The application is designed to assist health careprofessionals and people with diabetes to track blood glucoselevels and insulin doses. The application identifies patterns tohelp patients manage glycemic control. OneTouch® Reveal™includes pattern recognition messages, reports, and the ability toview patient data remotely.
Traditional 510(k)	Confidential
Intended Use /Indications for Use:	OneTouch® Reveal™ is indicated for use by individuals orhealth care professionals in the home or health care facilities fortransmitting data from home monitoring devices such asglucose meters and insulin pumps to a server database tosupport diabetes management. The device is indicated forprofessional use and over-the-counter sales.
Comparison of thetechnologicalcharacteristics of thedevice to the predicatedevice:	The LifeScan Inc.'s OneTouch® Reveal™ is substantiallyequivalent to the legally marketed predicate, Aidera DiasendSystem and incorporates the following similar technology andfunctionality including:OTC and Rx Web-based software application Manage patient accounts, filter/sort/search patients, print reports Unlike the predicate, the LifeScan Inc.'s OneTouch® Reveal™does not use a transmitter to transfer data.
Performance Data(Nonclinical and/orClinical):	Performance testing consisted of software verification andvalidation testing and Human Factors Usability Studies thatdemonstrated OneTouch® Reveal™ meets its requiredspecifications and performs as intended.
Substantial Equivalence toPredicate Device:	Based on the information presented in this submission,OneTouch® Reveal™ does not raise new questions of safetyand effectiveness and is substantially equivalent in its intendeduse, performance, safety, effectiveness and underlying scientificand operating principles compared to the predicate.

: : : :

LifeScan OneTouch® Reveal™

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Traditional 510(k) LifeScan OneTouch® Reveal™ Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

December 16, 2013

LifeScan Incorporated A Johnson & Johnson Company Ms. Gabrielle Logan Regulatory Affairs Analyst 965 Chesterbrook Bld Wayne, PA 19087

Re: K132618

Trade/Device Name: OneTouch® Reveal™ Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, NBW Dated: November 13, 2013 Received: November 14, 2013

Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Logan

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132618

Device Name

OneTouch® Reveal™

Indications for Use (Describe)

OneTouch® Reveal™ is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server databes management. The device is indicated for professional use and over-the-counter sales.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

.. FOR FDA USE ONLY . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman Date: 2013.12.16 12:15:19 -05'00' PSC Publishing Services (301) 443-6740 FORM FDA 3881 (9/13) EI

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).