The balanceback ™ Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

Device Description

Eye movements have long been known to provide important clues to the identification and location of balance disorders. Physicians and other clinicians employ the VNG system to conduct a set of established, well-known and well-documented eye movement tests. The results of the VNG eye movement tests are combined with other clinical information so that the attending clinicians may render findings on the health of the patient's primary balance sensors and related balance processing system.

Using the Mobile VNG, clinicians guide patients through a series of eye movement tests. A testing battery (i.e., an examination) typically consists of all eight tests supported by the VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and highfrequency head shake. The attending physician may select one, several, or all tests, and has full flexibility in determining the sequence of the tests to be performed.

The patient under examination wears the iVNG goggles contain one IR light source and one IR camera for each eye. The IR video cameras sense the infrared signal reflected from the eyes and create a continuous monochromatic (grayscale) video motion picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations.

The video stream from the IR cameras is digitized and transferred into the memory of the digital computer where signal processing software tracks, records, analyzes and displays eve movements for the attending clinician. The Mobile iVNG system makes appropriate calculations and presents reports of well-known and well-documented parameters associated with each eye movement test.

Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the iVNG hardware, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and Mobile iVNG software record the patient's eve movements while he/she follows the stimulus.

AI/ML Overview

The provided document {0} does not contain explicit acceptance criteria and corresponding performance data for the balanceback™ Mobile VNG system as typically found in a clinical study report. Instead, it describes "Testing" related to verifying system specifications and conformance to recognized electrical and safety standards. There is no mention of a clinical study assessing the device's accuracy in identifying balance disorders or the specifics of algorithmic performance.

Therefore, the following information is based on the provided text, acknowledging the absence of direct answers to several points usually found in performance studies.

Acceptance Criteria and Reported Device Performance

Given the nature of the provided document, the "acceptance criteria" are related to system specifications and compliance with recognized standards, rather than direct clinical performance metrics (like sensitivity, specificity, accuracy for identifying balance disorders). The document states:

Acceptance Criterion	Reported Device Performance (as implied by document)
Verification of system specifications	Verification procedures with pass/fail criteria developed to ensure product met all specified requirements.
Conformance to recognized standards	Certification to pass tests for ANSI Z-136.1 (2000), IEC 60601-1 (1988) +A1 (1991) +A2 (1995), IEC 60601-1-1 (2000), IEC 60601-1-2 (2001), UL 60601-1 (2003).

Note: The document states, "The device will not be marketed or sold until it has been certified to pass these tests." The FDA's 510(k) clearance letter (pages {2} and {3}) indicates that the device was cleared for marketing, suggesting these criteria were met.

Study Information (Based on available text):

Sample size used for the test set and the data provenance:
- The document does not specify any sample size for a clinical or performance test set regarding the device's ability to "record, view, and analyze eye movements in support of identifying balance disorders."
- There is no information on data provenance (e.g., country of origin, retrospective or prospective) as no such study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The document does not describe a study where ground truth was established by experts for a test set related to balance disorder identification.
Adjudication method for the test set:
- Not applicable/Not provided. No clinical test set or adjudication method is mentioned.
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 such study is described. The device's indications for use explicitly state, "This device provides no diagnoses nor does it provide diagnostic recommendations." This implies the device is a tool for clinicians, not an AI system that would assist in diagnosis or require an MRMC study for improved human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study is described. The device is intended to be used by trained physicians or clinicians.
The type of ground truth used:
- Not applicable/Not provided. The document focuses on technical verification and substantial equivalence to a predicate device, not on validating its diagnostic accuracy against a clinical ground truth. The device "provides no diagnoses nor does it provide diagnostic recommendations," reinforcing that its purpose is to provide data for the clinician's interpretation.
The sample size for the training set:
- Not applicable/Not provided. The document does not describe any machine learning or AI components that would require a "training set" in the context of diagnostic algorithms.
How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no mention of a training set for an AI/ML algorithm, the method for establishing its ground truth is not discussed.

Summary

{0}------------------------------------------------

balanceback™ Mobile VNG 510 (k) Submission BBQMS M00100 ISO13485 4.2, 5.0, 7.3

Doc ID: MAR 3 0 2007

510(k) Summary E

070729

Submitter's Name:	Fall Prevention Technologies, LLC
Submitter's Address:	4601 Gateway CircleKettering, OH 45440
Submitter's Telephone:	937-434-5455
Contact Name:	Frank Scarpino, PhD
Date Summary wasPrepared:	December 10, 2006
Trade or Proprietary Name:	balanceback™ Mobile Intuitive VNG System
Common or Usual Name:	Mobile VNG
Classification Name:	Nystagmograph (21 CFR 882.1460), product code GWN,Class II
Predicate Devices:	Device Name510(k) Numberbalanceback™ Intuitive VNG SystemK042529	Device Name	510(k) Number	balanceback™ Intuitive VNG System	K042529
Device Name	510(k) Number
balanceback™ Intuitive VNG System	K042529

Indications for Use:

The balanceback " Mobile iVNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.

Description of the Device and Summary of the Technological Characteristics:

Fall Prevention Technologies, LLC

Page E-1

p. 1 of 2

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

balanceback™ Mobile VNG 510 (k) Submission

Doc ID: BBQMS_M00100 ISO13485 4.2, 5.0,

picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations.

Substantial Equivalence:

The balanceback "10 Mobile iVNG device is substantially equivalent to the balanceback TM iVNG Workstation System (Desktop Configuration). This device supports the recording. viewing, and analyzing of horizontal and vertical eve movements to assist in the identification of balance disorders in human subjects. This device uses near identical technology, including the same goggles mounted with video cameras and software handling all the same tests (such as: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, and optokinetic examinations). These devices use the same sampling rate and similar illumination wavelengths. The primary differences are the configuration (from desktop to laptop) and the controls of the control box (additional video management hardware).

Testing:

Various tests of the hardware and software are being performed to verify system specifications. Verification procedures with pass/fail criteria were developed to ensure that the product met all the specified requirements. As part of this verification, a certified body shall conduct tests to determine the conformance of the device to the recognized standards shown below. The device will not be marketed or sold until it has been certified to pass these tests.

· ANSI Z-136.1 (2000)
IEC 60601-1 (1988) +A1 (1991) +A2 (1995)
· IEC 60601-1-1 (2000)
· IEC 60601-1-2 (2001)
· UL 60601-1 (2003)

7.3

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fall Prevention Technologies, LLC % Intertek Testing Services Mr. Neil E. Devine, Jr. 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAR 3 0 2007

Re: K070729

Trade/Device Name: balanceback™ Mobile Intuitive VNG System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: February 14, 2007 Received: March 15, 2007

Dear Mr. Devine:

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 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.

{3}------------------------------------------------

Page 2 -- Mr. Neil E. Devine, Jr.

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) 276-0115. 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.

Mark A. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D Indications for Use Statement

Indications for Use

Ko 70729

510(k) Number (if known):

Device Name:

balanceback TM Mobile Intuitive VNG System

Indications for Use:

Prescription Use Yes AND/OR Over-The-Counter-Use No (Part 21 CFR 801 Subpart (Part 21 CFR 801 Subpart D) C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence o Evaluation (ODE) sion Sign-(Division Sign-on)
Division of General, Restorative, and Neurological Dev Fall Prevention Technologies, LLC 510(k) Number Page D-1

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).