The MediByte™ is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the assist software enables the trained human professional typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report.

Target Population: Children and adult patients who are screened during sleep disorder studies.

Environment of Use: The majority of the screenings occur either in the home at in a clinical setting.

The MediByte™ is intended to be used only by or on the order of a physician.

Device Description

The MediByte™ is a palm-sized recording device capable of acquiring and storing physiological signals from FDAcleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port.

The MediByte™ records up to 8 channels of physiological signals: either electromyogram (EMG), or electrocardiogram (EKG); as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SpO2); and pulse rate. The signals cannot be viewed in real time, but can be downloaded after collection for assisted analysis by a human professional trained in the analysis and reporting of sleep disorders medicine.

The MediByte™ is powered by one ½ AA battery and connects to a computer via the MediByte™ USB communication cable. The MediByte™ and sensors are both typically worn by the patient during the recording and all patient contact materials consist of latex-free biocompatible material.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the MediByte™ device, primarily through comparison to a predicate device, the MediPalm®.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Functional Performance	Capable of meeting stated performance specifications and producing readable output. (Passed all tests)
Software Compliance	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). (Passed all tests)
Software Verification/Validation	Compliance with "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (Jan 11, 2002). (Passed all tests)
Environmental & Electrical Safety	Compliance with "Electroencephalograph Devices Guidance for 510(k) Content" (Nov 03, 1997). (Passed all tests)
Signal Quality/Equivalence	Recorded readable and appropriate signals. Performance was "identical" to the predicate device (MediPalm®) in simulation tests.

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

Sample Size: The document mentions "Analysis of overnight studies" and "Simulation tests" without specifying the exact number of patients or samples used for these tests. Therefore, the sample size for the test set is not explicitly stated.
Data Provenance: The studies appear to be internal tests conducted by BRAEBON Medical Corporation to demonstrate equivalence. The document does not specify country of origin for the data (e.g., patient demographics from a specific country) or whether the data was retrospective or prospective clinical data. It primarily describes internal testing and simulations.

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

The document implies that "Assisted analysis by a human professional trained in the analysis and reporting of sleep disorders medicine" for verifying results the software generates. However, it does not specify the number of experts used for establishing the ground truth of the test set, nor their specific qualifications (e.g., years of experience) beyond "trained human professional typically a Registered Sleep Technologist or Medical Doctor."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not specify any formal adjudication method (like 2+1 or 3+1) for establishing ground truth within the context of performance testing or a clinical study. It implies that a "trained human professional" verifies the results but doesn't detail a consensus or arbitration process.

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 description indicates that "assisted software enables the trained human professional... to verify the results of the study and generate a report," suggesting a human-in-the-loop system. However, the performance testing section focuses on the device's functional integrity and signal equivalence to a predicate device, not on the comparative effectiveness of human readers with vs. without AI assistance. Therefore, no effect size for human reader improvement is reported.

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

The device's intended use explicitly states: "The data is downloaded after the recording is completed and the assist software enables the trained human professional... to verify the results of the study and generate a report." This clearly indicates a human-in-the-loop system, not a standalone (algorithm only) performance evaluation. The device is a "portable sleep data recorder," where the software assists a human professional, implying the algorithm is not intended for standalone diagnostic decisions.

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

For the core performance assessment related to signal quality and equivalence, the ground truth appears to be based on comparison to the established performance of the legally marketed predicate device, MediPalm®. The statement "The performance of the BRAEBON Medical Corporation MediByte™ (subject device) was identical to that of MediPalm® (predicate device)" suggests that the MediPalm's output served as the reference for signal accuracy. For the "overnight studies," the ground truth for interpreting the physiological signals would presumably come from standard sleep study analysis by qualified professionals, but this isn't explicitly detailed as an expert consensus process for setting a definitive "ground truth" for the test set itself.

8. The sample size for the training set:

The document does not mention a "training set" in the context of machine learning or AI development. The device appears to be a signal acquisition and recording device with "auto assist software," rather than a deep learning model that requires explicit training data. The testing described is primarily functional and comparative to a predicate device, not an evaluation of an AI algorithm's learned performance.

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

Since there's no mention of a training set or an AI algorithm that was "trained," there's no information on how a ground truth for such a set would have been established.

Summary

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31 Ford St. Extension

1-120 Walgreen Drive RR#3 Carp Ontario, Canada KOA 1LO Tel: 613.831.6690 Fax: 613.831.6699 www.braebon.com

K 061764

510(K) Summary

SEP - 6 2006

BRAEBON Medical Corporation MediByte ™

August 23, 2006

The following safety and effectiveness summary has been prepared according to the requirement for 510(k) summaries specified in 21 CFR 807.92c.

1.0 Manufacturer Name

BRAEBON Medical Corporation Suite 1, 120 Walgreen Drive RR#3 Carp, Ontario Canada, K0A 1L0

2.0 Proprietary Name of Device

MediByte™M

3.0 Common Name of Device

Polysomnograph / Portable Sleep Data Recorder

4.0 Device Classification

Devices of this type have been class II by the Anesthesiology Devices Panel. Devices of this classification have a classification code of MNR, Ventilatory Effort Recorder (21 CFR 868.2375).

5.0 Intended Use

Target Population: Children and adult patients who are screened during sleep disorder studies.

Environment of Use: The majority of the screenings occur either in the home at in a clinical setting.

The MediByte™ is intended to be used only by or on the order of a physician.

6.0 Device Description

{1}------------------------------------------------

BRAEBON
MEDICAL
CORPORATION

2981 Ford St. Extension shura NY

1-120 Walgreen Drive RR#3 Carp Ontario, Canada KOA 1LO Tel: 613.831.6690 Fax: 613.831.6699 www.braebon.com

7.0 Predicate Device Equivalence

We are claiming substantial equivalence to the following devices all manufactured and sold by BRAEBON Medical Corporation:

MediPalm®: K031202, Braebon Medical Corporation 1.
Ultima Airflow Pressure Sensor; K984431, BRAEBON Medical Corporation 2.
Ultima Respiratory Effort Sensor; K982216, Braebon Medical Corporation 3.
Ultima Snore Microphone; K020312, Braebon Medical Corporation 4.

Intended Use	No difference
Indications Statement	No difference
Method of Connection to Patient	No difference
Power Source	No difference. The MediByte™, like the predicate devices, is batterypowered.
Safety Characteristics	No difference.
Reuse and Hygiene Characteristics	No difference.
Design	No difference. The MediByte™ is smaller than the MediPalm® predicatedevice.
Performance Data Conclusions	No difference.

8.0 Similarities and Differences Between Subject and Predicate Devices

9.0 Performance Testing

Functional testing was performed to confirm that the MediByte™ is capable of meeting its stated performance specifications and that the device output is readable. MediByte™ passed all tests.

All software testing was performed in accordance with the May 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The MediByte™ passed all tests.

All software verification and validation testing was performed in accordance with the January 11, 2002 "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." The MediByte™ passed all tests.

All environmental and electrical safety testing was performed in accordance with the November 03, 1997 "Electroencephalograph Devices Guidance for 510(k) Content." The MediByte™ passed all tests.

Analysis of overnight studies supports a substantial equivalence determination. The MediByte™ was run to verify that readable, appropriate signals were being recorded. Simulation tests comparing the MediByte™ to the

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Image /page/2/Picture/0 description: The image shows the logo for BRAEBON MEDICAL CORPORATION. The word "BRAEBON" is in large, bold, sans-serif font on the top line. Below that, "MEDICAL CORPORATION" is written in a smaller, sans-serif font.

02-2981 Ford St. Extension gdensburg, NY 69-3474

MediPalm® were also performed to gather comparative performance data. The performance of the BRAEBON Medical Corporation MediByte™ (subject device) was identical to that of MediPalm® (predicate device).

10.0 Conclusions

We conclude that MediByte™ is equivalent in safety and performance to the legally marketed predicate devices. The MediByte™ meets its stated performance specifications and the criteria outlined in the Reviewers Guidance publication specified above, and the MediByte™ will operate safely in the intended environment and fulfill its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard A. Bonato, Ph.D. Braebon Medical Corporation 120 Walgreen Drive, Suite 1, RR#3 Carp, Ontario CANADA KOA 1L0

SEP -6 2006

Re: K061764

Trade/Device Name: MediByteTM Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR, DQA Dated: August 23, 2006 Received: August 25, 2006

Dear Dr. Bonato:

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 - Dr. Bonato

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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:	K061764
Device Name:	MediByte™
Indications for Use:	The MediByte™ is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the auto assist software enables the trained human professional - typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report.
Target Population:	Children and adult patients who are screened during sleep disorder studies.
Environment of Use	The majority of the screenings occur either in the home at in a clinical setting.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH. Office of Device Evaluation (ODE)

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Lasion of Anesthesiology, General Hospital,
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Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).