Confidant 2.5 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 2.5 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 wireless 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's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.5 does not provide diagnosis of any disease or medical condition.

Confidant 2.5 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 2.5 is not intended for emergency calls or for transmission of any real-time alarms or timecritical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Confidant 2.5 is intended for over-the-counter use.

Device Description

Confidant 2.5 currently supports several models of glucose meters, noninvasive blood pressure cuffs and weight scales.

AI/ML Overview

The provided text describes the Confidant 2.5 system, its intended use, and its equivalence to predicate devices, but it does not contain information about specific acceptance criteria or an explicit study proving performance against those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

Same supported monitoring devices
Same operating features
Same fundamental technology

The "Discussion of functional and safety testing" section (page 2) states:
"Testing of Confidant 2.5 included electrical safety and EMC testing of the Confidant Connector component; software testing of the Confidant Collector and Confidant Server components; and low-level, device compatibility testing with each of the supported monitoring devices. The test results demonstrate that Confidant 2.5 is in compliance with the applied standards and that it performed within its specifications and functional requirements."

This general statement asserts that the device met its specifications and functional requirements, but it does not define what those specifications or functional requirements were (i.e., the acceptance criteria), nor does it provide details about the study methodology, sample sizes, or outcome metrics.

Therefore, I cannot populate the requested table or answer most of the questions as the specific details are not present in the provided text.

Here's what can be inferred or explicitly stated based on the text, with the understanding that key details for many points are missing:

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

Acceptance Criteria	Reported Device Performance
Specific criteria not defined in the document	"Confidant 2.5 is in compliance with the applied standards and that it performed within its specifications and functional requirements."
Electrical Safety & EMC	Compliance with applied standards.
Software functionality	Performed within specifications and functional requirements.
Device compatibility with supported monitoring devices	Compatibility testing demonstrated performance within specifications and functional requirements.

2. Sample sized used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

Number of experts: Not applicable, as this device primarily involves data collection and messaging, not interpretation requiring expert ground truth in the traditional sense (e.g., for image analysis or diagnosis). The testing described is functional and safety-oriented.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not applicable, as the testing described is functional and safety-oriented, not involving subjective interpretation requiring adjudication.

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, an MRMC comparative effectiveness study was not done. The device is a data collection and messaging system, not an AI-assisted diagnostic tool for human readers.

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

The software testing of the Confidant Collector and Confidant Server components could be considered a form of standalone performance evaluation for the algorithmic aspects (e.g., data processing, message generation). However, specific metrics, methodology, and results for "standalone performance" in a quantitative sense (like accuracy, sensitivity, specificity) are not provided. The conclusion statement vaguely refers to "performance testing."

7. The type of ground truth used

For electrical safety, EMC, and device compatibility, the "ground truth" would be established by relevant engineering standards and physical verification methods. For software, it would be its design specifications and functional requirements. There is no mention of expert consensus, pathology, or outcomes data in the context of this device's testing.

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (data collector/messenger) and its testing for 510(k) clearance, not an AI/ML-based diagnostic device that typically involves training data sets. While it selects messages based on "currently submitted and recent historic data," this refers to patient data for operational use, not a separate "training set" for model development in the context of a performance study.

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

Not applicable, as no training set (in the AI/ML context) is described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for DC Confidant. The logo consists of two curved shapes resembling the letters 'D' and 'C'. To the right of the curved shapes, the word "CONFIDANT" is written in capital letters. The font appears to be a serif font.

510(K) SUMMARY

K072698

In accordance with 21 CFR 807.92, the following information constitutes Confidant's summary for the Confidant 2.5 System.

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

Confidant International, LLC 2530 Meridian Parkway, Suite 300 Daniel R. Plonski Director of Product Management (919) 806-4323 (919) 806-4802 September 20, 2007

Identification of device 1

Proprietary Name: Confidant 2.5 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 2.5 is substantially equivalent to the following legally marketed devices:

Confidant 2.0 Honeywell HomMed Genesis K062215 OTC Monitor System K061087 Confidant Inc. Honeywell HomMed, LLC

Description of the device 3

Confidant 2.5 currently supports several models of glucose meters, noninvasive blood pressure cuffs and weight scales.

Page 1 OF 3

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4 Intended use

Confidant 2.5 does not provide diagnosis of any disease or medical condition.

Confidant 2.5 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 2.5 is intended for over-the-counter use.

page 2 of 3

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

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Technological characteristics, comparison to predicate 5 device.

Confidant 2.5 utilizes the same technology as one or both of the predicate devices (Confidant 2.0, K062215 and/or Honeywell HomMed Genesis OTC Monitor System, K061087) including:

The same supported monitoring devices �
The same operating features .
The same fundamental technology .

Discussion of functional and safety testing. 6

Testing of Confidant 2.5 included electrical safety and EMC testing of the Confidant Connector component; software testing of the Confidant Collector and Confidant Server components; and low-level, device compatibility testing with each of the supported monitoring devices. The test results demonstrate that Confidant 2.5 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 electrical safety. EMC, device compatibility and performance testing, it is our conclusion that Confidant 2.5 is as safe, as effective and performs as well as the legally marketed predicate devices.

Page 3 of 3

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the symbol of the HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

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

Re: K072698

Device Name: Confidant 2.5 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: September 20, 2007 Received: September 24, 2007

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.

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Page 2 - Mr. Daniel R. Plonski

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 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 Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B.Jemimson for

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): K072698

Device Name: Confidant 2.5

Indications For Use: Confidant 2.5 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 2.5 does not provide diagnosis of any disease or medical condition.

Confidant 2.5 is intended for over-the-counter use.

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima

Page 1 of 1

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).