Confidant 2.6 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.

Confidant 2.6 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard communication technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.6 does not provide diagnosis of any disease or medical condition.

Confidant 2.6 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Confidant 2.6 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Confidant 2.6 is intended for over-the-counter use.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the Confidant 2.6 System, focusing on acceptance criteria and supporting studies:

The provided 510(k) summary for the Confidant 2.6 System primarily focuses on demonstrating substantial equivalence to a predicate device (Confidant 2.5, K072698) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/algorithm.

Therefore, much of the requested information (like specific performance metrics for an AI, sample sizes for training/test sets, expert qualifications, MRMC studies, stand-alone performance, and detailed ground truth establishment) is not present in this document because the device is a data collection and messaging system, not an AI for diagnosis or interpretation of medical images/signals.

However, I will extract what is available and indicate when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Equivalence)	Reported Device Performance
Functional Performance	- Compliance with applied standards. - Performance within specifications and functional requirements.	"The test results demonstrate that Confidant 2.6 is in compliance with the applied standards and that it performed within its specifications and functional requirements."
Device Compatibility	- Compatibility with supported home monitoring devices (glucose meters, blood pressure cuffs, weight scales), including new devices like the OMNIS glucose meter.	"low-level, device compatibility verification for the OMNIS glucose meter." "Confidant 2.6 currently supports several models of glucose meters, a non-invasive blood pressure cuffs and a weight scale."
Technological Equivalence	- Same types of supported monitoring devices as predicate.- Same operational features as predicate.- Same fundamental technology as predicate.	"Confidant 2.6 utilizes the same technology as the predicate device (Confidant 2.5, K072698) including: The same types of supported monitoring devices, The same operational features, The same fundamental technology."
Safety and Effectiveness	- As safe and effective as the legally marketed predicate device.	"it is our conclusion that Confidant 2.6 is as safe, as effective and performs as well as the legally marketed predicate device."

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

The document does not specify a distinct "test set" sample size in the context of typical AI/algorithm evaluation (e.g., number of patients, images, or data points). The testing described is "functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter." This suggests hardware/software integration and basic functionality checks rather than a clinical performance study with a patient data test set.

Sample size for test set: Not specified beyond general "testing" of the PC Interface and OMNIS glucose meter.
Data provenance: Not specified. Given the nature of the device (collects data from home monitoring devices and sends messages), the "data" being tested would likely be simulated or actual readings from these monitoring devices to verify correct transmission and message generation. It's not a study on patient outcomes or disease detection.

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

Not applicable/Not provided. The Confidant 2.6 System is not an AI diagnostic device that requires expert-established ground truth for medical conditions. Its function is to collect data, transmit it, and generate pre-defined motivational messages based on that data. The "ground truth" for its testing would involve verifying that the data is transmitted correctly and that the appropriate messages are triggered under specific data conditions, which does not require medical experts for truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Since there's no expert clinical ground truth being established for diagnostic accuracy, there's no need for an adjudication method. Testing would involve engineering validations (e.g., does data transfer correctly, are messages generated as expected).

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

No. An MRMC study is used to assess the diagnostic performance of a system (often an imaging CADx system) by comparing multiple human readers with and without AI assistance on multiple cases. The Confidant 2.6 is a data collection and messaging system, not a diagnostic AI that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device's core functionality is standalone in terms of data collection and message generation. However, it's not an "algorithm only" device in the sense of making diagnostic or treatment decisions. It automates information flow and feedback messages, but explicitly states: "Confidant 2.6 does not provide diagnosis of any disease or medical condition." and "Confidant 2.6 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment."

The performance evaluation described ("functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter") is essentially a standalone test of its stated functions.

7. The Type of Ground Truth Used

For the described testing, the "ground truth" would be:

Expected data transmission: Verification that data from home monitors is accurately received by the server.
Expected message generation: Verification that the system generates the correct pre-defined feedback messages based on the received data, according to its internal logic.
Compatibility verification: That the device successfully interfaces with and collects data from specified home monitoring devices (e.g., OMNIS glucose meter).

This is a form of functional/technical validation rather than medical ground truth (e.g., pathology, outcomes).

8. The Sample Size for the Training Set

Not applicable/Not provided. The Confidant 2.6 is not an AI device developed using machine learning that requires a "training set" in the conventional sense. It's a rules-based system that processes data and generates messages based on pre-programmed logic rather than learning from data.

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

Not applicable/Not provided. As there is no training set mentioned, this information is not relevant to the described device.

Summary

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KO83331

CONFIDANT

JAN - 9 2009

510(K) SUMMARY

In accordance with 21 CFR 807.92, the following information constitutes Confidant's summary for the Confidant 2.6 System.

SUBMITTER'S NAME: ADDRESS: CONTACT PERSON: CONTACT PERSON TITLE: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION: '

Confidant International, LLC 2530 Meridian Parkwav, Suite 300 Daniel R. Plonski Director of Product Management (919) 806-4323 (919) 806-4802 November 7, 2008

Identification of device 1

Proprietary Name: Confidant 2.6 Common Name: Physiological Transmitter and Receiver Classification Status: Class II per regulations 870.2910 Product Codes: DRG

2 Equivalent devices

Confidant Inc. believes that Confidant 2.6 is substantially equivalent to the following legally marketed device:

Confidant 2.5 K072698 Confidant International, LLC

3 Description of the device

2530 Meridian Parkway, Ste 300 Durham, NC 27713 (W) 919.806.4620 (F) 919.806.4802 confidation com

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Intended use 4

Confidant 2.6 does not provide diagnosis of any disease or medical condition.

Confidant 2.6 is intended for over-the-counter use.

2530 Meridian Parkway, Ste 300 Durham, NC 27713 (W) 919.806.4620 (F) 919.806.4802 confidantine.com

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5 Technological characteristics, comparison to predicate device.

Confidant 2.6 utilizes the same technology as the predicate device (Confidant 2.5, K072698) including:

The same types of supported monitoring devices .
The same operational features .
The same fundamental technology .

Discussion of functional and safety testing. 6

Testing of Confidant 2.6 included functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter. The test results demonstrate that Confidant 2.6 is in compliance with the applied standards and that it performed within its specifications and functional requirements.

Conclusion 7

Based on the comparison of intended use, supported monitoring devices, operational features and technology and the results of functional performance, and device compatibility testing, it is our conclusion that Confidant 2.6 is as safe, as effective and performs as well as the legally marketed predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines representing the body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2009

Confidant International, LLC c/o Mr. Daniel R. Plonski Director of Product Management 2530 Meridian Parkway, Suite 300 Durham, North Carolina 27713

Re: K083331

Trade/Device Name: Confidant 2.6 System Regulation Number: 21 CFR 870.2910 Regulation Name: Physiological Transmitter and Receiver Regulatory Class: Class II Product Codes: DRG, NBW Dated: December 29, 2008 Received: December 30, 2008

Dear Mr. Plonski:

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. You must

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Page 2 - Mr. Daniel R. Plonski

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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours,

7 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 长O&333 )

Device Name: Confidant 2.6

Indications For Use: Confidant 2.6 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.

Confidant 2.6 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard communication technologies. Upon receipt of newly submitted patient data, the Confidant Server software will gencrate and send one or more feedback messages directly to the patient, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.6 does not provide diagnosis of any disease or medical condition.

Confidant 2.6 is intended for over-the-counter use.

Prescription Use(21 CFR Part 801 Subpart D)	And/Or
-------------------------------------------------	--------

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office Device Evaluation (ODE)

(Division Sign-Off)
	B Zuckermad
	1/8/09

(Division Sign-Off) (8/8)
Division of Cardiovascular Devices

KO83331 510(k) Number___

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).